JANUARY 2012
WEEK ENDING JANUARY 28
PRODUCT
Trilogy 100, 200 and 202
Ventilators The device is intended to be used in home, institution/hospital,
and portable applications such as wheelchairs and gurneys, and may be used for
both invasive and non-invasive ventilation.
CODE
Serial Numbers: GV111030238,
GV111040533, GV111040627, GV111040632, GV111040640, GV111040651, GV111040652,
GV111040653, TV011031510, TV011040511, TV011040516, TV011040518, TV011040524,
TV011040529, TV011040530, TV011040601, TV011040602, TV011040609, TV011040615,
TV109081805, TV109081806, TV109081807, TV111021835, TV111022551, TV0111022832,
TV111030422, TV111030441, TV111030445, TV111030453, TV111030774, TV111030790,
TV111030853, TV111030932, TV111030947, TV111030976, TV111030978, TV111031001,
TV111031011, TV111031037, TV111031045, TV111031057, TV111031064, TV111031067,
TV111031113, TV111031403, TV111031413, TV111031420, TV111031462, TV111031554,
TV111032252, TV111032254, TV111032306, TV111032316, TV111032562, TV111032809,
TV111032811, TV111032812, TV111032822, TV111032827, TV111032829, TV111032830,
TV111032832, TV111032833, TV111032901, TV111032905, TV111032906, TV111032909,
TV111032912, TV111032913, TV111032914, TV111032920, TV111032923, TV111032924,
TV111032925, TV111032926, TV111032929, TV111032934, TV111032935, TV111032938,
TV111032939, TV111032940, TV111033001, TV111033004, TV111033005, TV111033006,
TV111033009, TV111033010, TV111033016, TV111033018, TV111033019, TV111040110,
TV111040113, TV111040117, TV111040404, TV111040405, TV111040411, TV111040415,
TV111040416, TV111040418, TV111040419, TV111040420, TV111040423, TV111040424,
TV111040428, TV111040432, TV111040438, TV111040703, TV111040729, TV111040735,
TV111040803, TV111040808, TV111040830, TV111041118, TV111041304, TV111041306,
TV111041435, TV111041436, TV211032405, TV211032409, TV211032412, TV211032413,
TV211032414, TV211032415, TV211032419, TV211032420, TV211032430, TV211032431
RECALLING FIRM/MANUFACTURER
Respironics, Inc., Murrysville,
PA,
REASON
Units being recalled due to low
impeller press-force used during the manufacturing process. If the press force
were low enough, theoretically the impeller could move up the shaft and come
into contact with the inside of the blower housing/impeller enclosure. This
may impact therapy.
VOLUME OF PRODUCT IN COMMERCE
127 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
1) LifeStar ACT I Sensor
Ambulatory Cardiac Telemetry; an automatically activated system with a single
channel EKG, office hookup and auto send/auto detect that requires no patient
intervention to either capture or transmit an arrhythmia when it occurs; Model
FG-00065 LifeStar ACT provides critical ECG information by capturing the onset
and termination/escape of an arrhythmia to assist in correctly identifying and
treating the patient. Patients are monitored for up to 30 days and all of the
data is available at the request of the physician during the service period
and for 7 days following the end of service.
2) LifeStar ACT III Platinum
Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a
high performance triple channel EKG, office hookup and auto send/auto detect
that requires no patient intervention to either capture or transmit an
arrhythmia when it occurs; Model FG-00084 LifeStar ACT provides critical ECG
information by capturing the onset and termination/escape of an arrhythmia to
assist in correctly identifying and treating the patient. Patients are
monitored for up to 30 days and all of the data is available at the request of
the physician during the service period and for 7 days following the end of
service. The ACT III will provide more sensitive data for initial or early
detection of arrhythmia in patients that have minimal or atypical symptoms.
3) ACT Cellular Phone Monitor; a
component of the ACT Ambulatory Cardiac Telemetry; an automatically activated
system with a high performance EKG, office hookup and auto send/auto detect
that requires no patient intervention to either capture or transmit an
arrhythmia when it occurs; there are two models used with either the ACT 1
sensor or the ACT III sensor: a) Model Ozone-HTC b) Model BlackJack2 SGH-i617
LifeStar ACT provides critical ECG information by capturing the onset and
termination/escape of an arrhythmia to assist in correctly identifying and
treating the patient. Patients are monitored for up to 30 days and all of the
data is available at the request of the physician during the service period
and for 7 days following the end of service.
CODE
1) All serial numbers with
firmware REV 01.G;
2) All serial numbers with
firmware REV 10.4;
3) All serial numbers with
software version 5.5.9
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lifewatch Services
Inc., Rosemont, IL,
Manufacturer: Card Guard
Scientific Survival LTD, Rehovot, Israel.
REASON
LifeWatch received complaints of
minor shocks and burns during use of the LifeStar ACT systems with shorts in
the leads.
VOLUME OF PRODUCT IN COMMERCE
562 sensors, 532 phones
PRODUCT
SoftPath GUI versions: 3.17.5 to
3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. SoftPath is a laboratory
information system to be used in a clinical laboratory by knowledgeable,
trained, and experienced personnel. SoftPath enables the user to document
steps in the receiving and processing of surgical, gynecological, medical
cytological, and autopsy case specimens within the Pathology labs, for the
purpose of generating Pathology reports for requesting physicians and label
creation for identification of specimen/case material.
CODE
SoftPath GUI versions: 3.17.5 to
3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL,
REASON
SoftPath architecture does not
correctly handle AP macros and data fields inside report sections that are
stored in the database. Improper information can be displayed in all places
where the diagnosis from the database is read and displayed.
VOLUME OF PRODUCT IN COMMERCE
142 units
DISTRIBUTION
Nationwide, PR, and Canada
PRODUCT
SoftLab GUI versions
4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4. SoftLab is a
laboratory information system to be used in a medical research or clinical
laboratory by knowledgeable, trained, and experienced personnel. SoftLab
enables the user to handle data-processing and laboratory activities, for the
purpose of storing, managing, querying, and report laboratory data.
CODE
SoftLab GUI versions
4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL,
REASON
A client reported the PT and INR
results did not get flagged. The PROT should have been flagged as HIGH and the
INR should have been flagged as PANIC. Neither test was flagged.
VOLUME OF PRODUCT IN COMMERCE
69 units
DISTRIBUTION
Nationwide and Canada
PRODUCT
Elekta Synergy XVI X-ray Volume
Imaging System to be used as part of radiation therapy treatment process.
CODE
Units: G30369, G29103, G34727,
G32313, G30367, G29101, G31330, G34401, G32304, G30962, G30610, G30668,
G29986, G28427, G28581, G28673, G28430, G28755, G28576, G28574, G28676,
G28678, G28811, G28763, G28806, G28863, G28809, G28864, G28936, G29035,
G29042, G30720, G28929, G29043, G29102, G28421, G29296, G29299, G29843,
G31188, G29832, G29838, G29844, G29840, G29983, G30300, G30027, G29980,
G30210, G30213, G30034, G30208, G30309, G30310, G30530, G30533, G30558,
G30565, G32986, G30606, G30611, G30961, G30718, G30662, G30717, G31397,
G31326, G31186, G31190, G31323, G29842, G34393, G31404, G31512, G31522,
G31518, G31515, G31517, G30073, G32359, G32363, G32305, G32364, G32366,
G32385, G32425, G32389, G32501, G32680, G32682, G32809, G32814, G34285,
G32905, G32820, G32821, G32824, G32904, G32908, G33335, G33339, G33338,
G33428, G33433, G34150, G34288, G34151, G34159, G34290, G34348, G34347,
G34350, G34397, G34501, G34684, G34502, G34505, G34689, G30974, G34691,
G34980, G34983, G34726
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc.,
Norcross, GA,
Manufacturer: Elekta Oncology
Systems (Fmrl Philipps). Crawley, West Sussex, UK.
REASON
A small number of sites have
experienced situations with kV generator transformers overheating due to a
diode failure on the interface board.
VOLUME OF PRODUCT IN COMMERCE
123 units
DISTRIBUTION
Nationwide, DC, PR
PRODUCT
1) Maquet Servo-i ventilator
system Device Part number 64 87 800, 510 k 041223 Device Listing No. B052264.
Intended for treatment of and monitoring of patients in range of neonates,
infants and adults with respiratory failure of respiratory insufficiency; used
only by healthcare providers in hospitals or healthcare facilities and for in
hospital transport.
2) Maquet Servo-S ventilator
system Device Part number 66 40 440, 510 k 041223; Device Listing No. B052264.
Intended for treatment of and monitoring of patients in range of neonates,
infants and adults with respiratory failure of respiratory insufficiency; used
only by healthcare providers in hospitals or healthcare facilities and for in
hospital transport.
3) Maquet PC Board PC1772 Spare
Part Device Part number 64 67 620, 510 k 041223 Device Listing No. B052264.
Intended for treatment of and monitoring of patients in range of neonates,
infants and adults with respiratory failure of respiratory insufficiency; used
only by healthcare providers in hospitals or healthcare facilities and for in
hospital transport.
CODE
1) Lot number S/N 48396-49564;
2) Lot number S/N 16783-17318;
3) No lot S/N
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet Inc.,
Wayne, NJ,
Manufacturer: Maquet Critical Care
AB, Solna, Sweden.
REASON
Servo-I and Servo--S ventilator
systems are equipped with a specific revision of a printed circuit board
(PC1772 revision 22) that includes a component that has generated a number of
nuisance alarms due to technical error message 24 (TE 24).
VOLUME OF PRODUCT IN COMMERCE
202 units
PRODUCT
RayStation Version 2.0.0.15
Consult instruction for use. RayStation is a software system designed for
treatment planning and analysis of radiation therapy. The treatment plans
provide treatment unit set-up parameters and estimates of dose distributions
expected during the proposed treatment, and may be used to administer
treatments after review and approval by the intended user. The system
functionality can be configured based on user needs. The intended users of
RayStation shall be clinically qualified radiation therapy staff trained in
using the system.
CODE
Software version and build number
is 2.0.0.15
RECALLING FIRM/MANUFACTURER
RaySearch Laboratories AB,
Stockholm, Sweden,
REASON
The firm has found an issue with
DICOM RT Image representation of DRR images from RayStation 2.0 which needs to
be clarified in the user manual. The symptoms involve the Pixel Spacing and
Image Position attributes in the RT images being incorrect, thus enabling the
user to make measurements that are erroneous and possibly misalign the
patient.
VOLUME OF PRODUCT IN COMMERCE
19 Units (14 units Nationwide; 5
units Internationally)
DISTRIBUTION
Nationwide and Netherlands
PRODUCT
1) ActiveCare +SFT Medical
Compression Systems. Intended for use in: Preventing deep Vein Thrombosis;
Enhancing blood circulation; Diminishing post-operative pain and swelling;
Reducing wound healing time; treatment and assistance in healing of stasis
dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic
venous insufficiency and; Reducing edema. Device Catalog Number A502B-0001-01
and A502B-0002-01.
2) ActiveCare DVT Medical
Compression Systems. Intended for use in: Preventing deep Vein Thrombosis;
Enhancing blood circulation; Diminishing post-operative pain and swelling;
Reducing wound healing time; treatment and assistance in healing of stasis
dermatitis, venous stasis ulcers and diabetic leg ulcers; Treatment of chronic
venous insufficiency and; Reducing edema. Device Catalog Number A502B-0001-02
and H502B-0001-07.
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Genesis
Manufacturing Inc., Fortville, IN,
Manufacturer: Medical Compression
Systems, OR Aqiva, Israel.
REASON
MCS has received a limited number
of reports involving the use of a non-MCS AC/DC adaptor with the ActiveCare
DVT and ActiveCare+S.F.T. devices. The firm found that an ActiveCare DVT
device may work improperly if connected to a non-MCS AC/DC adaptor with a
higher nominal voltage. As specified in each product's User Manual, the
ActiveCare DVT devices must only be used with the MCS AC/DC Adaptor. The
ActiveCare DVT device could result in the device overheating and render the
device unusable.
VOLUME OF PRODUCT IN COMMERCE
2768 (ActiveCare DVT 2217 units
and ActiveCare+SFT 551 units)
PRODUCT
Maxcem Elite(TM)
self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part #
33872, CLEAR --- Refill Kit Contents: 2 Syringes (5 g ea), 10 Automix tips
(regular) 4:1, 10 Automix tips (wide) 4:1, 10 Intra-oral tips Dental resin
cement. Self-etch, self-adhesive resin cement. High bond strength without
adhesive needed. Easy to clean up and can be used with all anterior and
posterior ceramics, PFMs, and CAD/CAM materials. Color stable and aesthetic.
Works with all substrates from opaque to translucent. HSI number 123-7426.
CODE
Lot numbers 3285932 (exp.
01/2011), 3461229 (exp. 11/2011), 3566373 (exp. 05/2012)
RECALLING FIRM/MANUFACTURER
Henry Schein, Inc., Melville, NY,
REASON
The specific lots of Maxcem Elite
Refill Kit appear not to be authentic.
VOLUME OF PRODUCT IN COMMERCE
18,855 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Dental cement under the brand name
a) Cement-It, Part No. N33, N33A; and b) Natural Elegance (private label of
Cement-It) Part No. SHN9004110. The intended use of this device is to affix
dental devices such as crowns or bridges onto the tooth. Cement-It and Natural
Elegance (private label of Cement-It), are indicated as a luting cement
bonding system for porcelain crowns, inlays, and onlays and other dental
restorations, including ceramics, metal alloys and composite restoratives.
CODE
a) Syringe Lot No. 183058; Package
Lot No. 186272, 186665, 186676; b) Syringe Lot No. 183058; Package Lot 182990,
186133, 188996
RECALLING FIRM/MANUFACTURER
Kerr/pentron Dba Kerr Corporation
and Pentron Clinical, Orange, CA,
REASON
Product sets faster than specified
in the "Directions for Use" and in release specifications.
VOLUME OF PRODUCT IN COMMERCE
157 units
DISTRIBUTION
Nationwide, Canada, Egypt, Israel,
Netherlands, Sweden and UK
PRODUCT
1) Baxter Interlink System
Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Luer Lock
Adapter, Standard Bore 3-Way Stopcock Manifold, Extension Set, 44" (112
cm), Vol. 6.6 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile,
nonpyrogenic fluid pathway for the administration of sterile I.V. fluids to
the patient; product code 1C8369. Intended use: for the administration of drug
and solutions to patient's vascular system through a vascular access device.
2) Baxter Interlink System
Continu-Flo Solution Set, 69" (1.8 m), 2 Injection Sites, Male Luer Lock
Adapter, Standard Bore 4-Way Stopcock with Rotating Male Luer Lock,, Extension
Set, 61" (155 cm), Vol. 8.5 mL, 2 Injection Sites, Male Luer Lock Adapter
with Retractable Collar; an Rx sterile, nonpyrogenic fluid pathway for the
administration of sterile I.V. fluids to the patient; product code 1C8371
Intended use: for the administration of drug and solutions to patient's
vascular system through a vascular access device.
3) Baxter Interlink System
Extension Set, 20" (51 cm), Vol. 2.9 mL, Injection Site, Male Luer Lock
Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of
sterile I.V. fluids to the patient; product code 1C8376 Intended use: for the
administration of sterile I.V. fluids to the patient.
4) Baxter Interlink System Vented
Continu-Flo Solution Set, 100" (2.5 m), Vol. 2.9 mL, 3 Injection Sites,
Male Luer Lock Adapter with Retractable Collar; an Rx sterile, nonpyrogenic
fluid pathway for the administration of sterile I.V. fluids to the patient;
product code 1C8533 Intended use: for the administration of sterile I.V.
fluids to the patient.
5) Baxter Interlink System Y-Type
Solution Set, 78" (2.0 m), 2 Injection Sites, Male Luer Lock Adapter; an
Rx sterile, nonpyrogenic fluid pathway for the administration of sterile I.V.
fluids to the patient; product code 1C8581 Intended use: for the
administration of drug and solutions to patient's vascular system through a
vascular access device.
6) Baxter Interlink System
Continu-Flo Solution Set with Control-A-Flo Regulator, 89" (2.3 m), 2
Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid
pathway for the administration of sterile I.V. fluids to the patient; product
code 1C8621 Intended use: for the administration of drug and solutions to
patient's vascular system through a vascular access device.
7) Baxter Interlink System
Extension Set, 13" (32 cm), Check Valve, Injection Site, Male Luer Lock
Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of
sterile I.V. fluids to the patient; product code 2C6605 Intended use: for the
administration of drug and solutions to patient's vascular system through a
vascular access device.
8) Baxter Interlink System 3-Port
Manifold with Check Valves, Vol. 1.0 mL, Large Bore 4-Way Stopcock Extension
Set, Vol. 6.2 mL, 41" (104 cm), 2 Injection Sites, Male Luer Lock
Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of
sterile I.V. fluids to the patient; product code 2C6921 Intended use: for the
administration of sterile I.V. fluids to the patient.
9) Baxter Interlink System
Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, Male
Luer Lock Adapter, 3-Port Manifold with Check Valves, Vol. 1.0 mL, Large Bore
4-Way Stopcock Extension Set, Vol. 6.2 mL, Length 41" (104 cm), 2
Injection Sites, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid
pathway for the administration of sterile I.V. fluids to the patient; product
code 2C6931 Intended use: for the administration of sterile I.V. fluids to the
patient.
10) Baxter Interlink System
Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, Male
Luer Lock Adapter, 3-Port Manifold with Check Valves, Vol. 1.0 mL, Extension
Set, Vol. 5.6 mL, Length 39" (99 cm), 2 Injection Sites, Male Luer Lock
Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of
sterile I.V. fluids to the patient; product code 2C6951 Intended use: for the
administration of sterile I.V. fluids to the patient.
11) Baxter Interlink System
Solution Set, 67" (1.7 m), Injection Site, Male Luer Lock Adapter,
Standard Bore 4-Way Stopcock Manifold, Extension Set, 43" (109 cm), Vol.
6.5 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic
fluid pathway for the administration of sterile I.V. fluids to the patient;
product code 3C0039 Intended use: for the administration of drug and solutions
to patient's vascular system through a vascular access device.
12) Baxter Interlink System
Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Luer Lock
Adapter, Standard Bore 4-Way Stopcock Manifold, Standard Bore 4-Way Stopcock
with Rotating Male Luer Lock, Extension Set, 39" (99 cm), Vol. 5.8 mL,
Injection Site, Male Luer Lock Adapter, Extension Set, 8" (20 cm), Vol.
1.1 mL, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for
the administration of sterile I.V. fluids to the patient; product code 3C0142
Intended use: for the administration of sterile I.V. fluids to the patient.
13) Baxter Interlink System
Straight Type Blood Set with 40 and 150 Micron Dual Screen Filter, Length
86" (2.2 m), Injection Site, Male Luer Lock Adapter; an Rx sterile,
nonpyrogenic fluid pathway for the removal of micro aggregates from whole
blood or red blood cells and transfusion of platelets; product code 4C6832
Intended use: for the removal of micro aggregates from whole blood or red
blood cells and transfusion of platelets.
14) Baxter Interlink System Y-Type
Blood/Solution Set with 40 and 150 Micron Dual Screen Filter, Length 95"
(2.4 m), Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic
fluid pathway for the removal of micro aggregates from whole blood or red
blood cells and transfusion of platelets; product code 4C6838 Intended use:
for the removal of micro aggregates from whole blood or red blood cells and
transfusion of platelets.
CODE
1) Lot number GR296251;
2) Lot number GR295493;
3) Lot number GR294363;
4) Lot number GR295337;
5) Lot number GR296137;
6) Lot numbers GR295352, GR296095
and GR296335;
7) Lot number GR295725;
8) Lot number GR295634;
9) Lot numbers GR295956, GR296095,
GR296848 and GR297416;
10) Lot number GR296053;
11) Lot number GR295642;
12) Lot numbers: GR295287 and
GR29641;
13) Lot number: GR296319;
14) Lot number: GR295386
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare
Corp. Round Lake, IL,
Manufacturer: Baxter Healthcare
Corp., Cleveland, MS.
REASON
During production of the IV sets,
solvent was inadvertently applied to the locking collar of the male luer
connector, which may have damaged the component, preventing proper engagement
of the locking collar to secure a connection.
VOLUME OF PRODUCT IN COMMERCE
48,489 units
DISTRIBUTION
Nationwide and New Zealand
PRODUCT
Portal Vision, R-Arm with 4D
Integrated Treatment Console; Model H80, H81. The Portal Vision device is used
for verification of the treatment field and shielding block in relation to
anatomical landmarks in radiotherapy treatment. Portal Vision will also allow
for verification of the exit dose in radiotherapy treatment.
CODE
Serial numbers: H800017 H800447
H800692 H801949 H803815 H803912 H803999 H804090 H804178 H804271 H804348
H804439 H804523 H800031 H800453 H800693 H801951 H803816 H803913 H804000
H804091 H804179 H804272 H804349 H804442 H804524 H800037 H800457 H800696
H801952 H803818 H803914 H804002 H804092 H804188 H804273 H804350 H804443
H804525 H800054 H800467 H800703 H801955 H803822 H803919 H804003 H804094
H804191 H804274 H804351 H804444 H804526 H800060 H800469 H800708 H801969
H803825 H803922 H804004 H804095 H804192 H804275 H804352 H804446 H804527
H800064 H800470 H800710 H801971 H803826 H803923 H804006 H804097 H804193
H804276 H804354 H804447 H804528 H800065 H800474 H800713 H801976 H803827
H803925 H804007 H804099 H804194 H804278 H804355 H804448 H804529 H800073
H800489 H800714 H801986 H803828 H803928 H804008 H804100 H804198 H804279
H804356 H804449 H804530 H800077 H800490 H800800 H801991 H803829 H803930
H804009 H804101 H804199 H804280 H804358 H804450 H804531 H800079 H800498
H800801 H801993 H803830 H803932 H804010 H804105 H804200 H804281 H804362
H804451 H804534 H800085 H800500 H800802 H801994 H803834 H803933 H804012
H804106 H804202 H804282 H804364 H804452 H804535 H800091 H800501 H800812
H801996 H803835 H803934 H804013 H804108 H804203 H804284 H804365 H804454
H804536 H800095 H800503 H800819 H801997 H803836 H803935 H804014 H804111
H804205 H804287 H804367 H804455 H804537 H800096 H800505 H800827 H802000
H803838 H803937 H804015 H804112 H804207 H804288 H804368 H804456 H804540
H800100 H800521 H800844 H802011 H803840 H803938 H804017 H804113 H804208
H804289 H804370 H804458 H804541 H800103 H800522 H800859 H802017 H803841
H803940 H804018 H804114 H804209 H804291 H804371 H804459 H804542 H800109
H800527 H800860 H802019 H803845 H803941 H804021 H804115 H804212 H804294
H804372 H804461 H804543 H800133 H800528 H800868 H802022 H803847 H803942
H804023 H804116 H804213 H804295 H804373 H804464 H804544 H800138 H800532
H800885 H802026 H803848 H803945 H804025 H804118 H804215 H804296 H804374
H804465 H804545 H800141 H800537 H800887 H802030 H803849 H803948 H804027
H804119 H804216 H804298 H804375 H804466 H804547 H800143 H800538 H800888
H802032 H803852 H803949 H804028 H804120 H804217 H804299 H804376 H804468
H804548 H800147 H800541 H800913 H802033 H803853 H803951 H804029 H804121
H804218 H804300 H804377 H804471 H804549 H800181 H800542 H800919 H802034
H803855 H803954 H804030 H804122 H804220 H804302 H804380 H804473 H804551
H800194 H800545 H800920 H802035 H803857 H803955 H804033 H804123 H804221
H804305 H804382 H804474 H804552 H800195 H800555 H800923 H802036 H803859
H803958 H804034 H804124 H804222 H804308 H804383 H804476 H804554 H800198
H800566 H800925 H802038 H803860 H803959 H804036 H804125 H804227 H804309
H804384 H804477 H804555 H800202 H800567 H800929 H802057 H803863 H803960
H804037 H804128 H804228 H804310 H804386 H804479 H804556 H800219 H800574
H800947 H802058 H803865 H803963 H804038 H804129 H804229 H804311 H804387
H804482 H804557 H800220 H800575 H801325 H802061 H803866 H803964 H804039
H804132 H804230 H804312 H804388 H804483 H804558 H800227 H800580 H801336
H802062 H803869 H803965 H804044 H804135 H804232 H804314 H804390 H804484
H804560 H800231 H800585 H801460 H802069 H803870 H803966 H804045 H804136
H804233 H804315 H804392 H804485 H804561 H800238 H800586 H801805 H802070
H803871 H803967 H804047 H804137 H804234 H804316 H804393 H804487 H804563
H800241 H800598 H801806 H802072 H803872 H803968 H804049 H804138 H804235
H804317 H804394 H804488 H804565 H800242 H800600 H801807 H802073 H803873
H803969 H804050 H804140 H804238 H804319 H804395 H804489 H804566 H800252
H800602 H801813 H802079 H803875 H803970 H804051 H804141 H804239 H804320
H804396 H804491 H804567 H800257 H800614 H801819 H802086 H803876 H803971
H804052 H804142 H804240 H804321 H804402 H804492 H804568 H800260 H800616
H801824 H802087 H803879 H803973 H804053 H804143 H804241 H804322 H804403
H804493 H804569 H800265 H800617 H801845 H802092 H803880 H803974 H804054
H804144 H804242 H804323 H804407 H804494 H804570 H800271 H800618 H801849
H802094 H803883 H803975 H804055 H804146 H804243 H804324 H804408 H804495
H804572 H800274 H800625 H801851 H802096 H803884 H803977 H804056 H804147
H804244 H804325 H804414 H804497 H804573 H800278 H800626 H801856 H802097
H803885 H803978 H804059 H804148 H804245 H804326 H804415 H804500 H804574
H800296 H800632 H801863 H802100 H803886 H803979 H804060 H804149 H804246
H804327 H804416 H804501 H804575 H800298 H800634 H801869 H802101 H803887
H803981 H804063 H804150 H804247 H804329 H804417 H804502 H804576 H800315
H800637 H801874 H802105 H803889 H803982 H804064 H804151 H804251 H804330
H804418 H804503 H804577 H800327 H800638 H801889 H802107 H803890 H803983
H804066 H804156 H804253 H804331 H804419 H804505 H804580 H800333 H800641
H801912 H802110 H803893 H803984 H804068 H804159 H804254 H804332 H804420
H804508 H804581 H800335 H800643 H801915 H802111 H803894 H803985 H804070
H804160 H804255 H804333 H804422 H804510 H804584 H800339 H800646 H801916
H802112 H803896 H803986 H804071 H804161 H804256 H804334 H804424 H804511
H804586 H800343 H800648 H801917 H802116 H803897 H803987 H804072 H804162
H804257 H804335 H804425 H804512 H804588 H800419 H800654 H801926 H802118
H803898 H803988 H804073 H804163 H804259 H804338 H804426 H804513 H804589
H800421 H800655 H801934 H802133 H803900 H803989 H804074 H804165 H804261
H804339 H804427 H804515 H804591 H800423 H800660 H801935 H802283 H803901
H803990 H804080 H804166 H804262 H804340 H804428 H804516 H804592 H800425
H800662 H801938 H802402 H803904 H803991 H804081 H804167 H804264 H804341
H804429 H804517 H804599 H800429 H800665 H801940 H802925 H803905 H803993
H804083 H804168 H804265 H804342 H804430 H804518 H804600 H800434 H800670
H801942 H803043 H803907 H803994 H804084 H804172 H804266 H804343 H804431
H804519 H804601 H800435 H800679 H801943 H803382 H803908 H803995 H804085
H804175 H804267 H804344 H804432 H804520 H804602 H800438 H800689 H801944
H803608 H803910 H803997 H804087 H804176 H804268 H804346 H804434 H804521
H804606 H800444 H800690 H801945 H803806 H803911 H803998 H804089 H804177
H804270 H804347 H804438 H804522 H804607
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc.
Oncology Systems, Palo Alto, CA,
REASON
An anomaly was discovered when
using the 4DITC in combination with an R-Arm to acquire double exposure MV
images.
VOLUME OF PRODUCT IN COMMERCE
1486 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Rusch Flexi-slip Endotracheal Tube
Stylet with Soft Distal Tip, 6FR, Catalog number: 502501. Used temporarily to
make rigid a flexible tracheal tube to aid its insertion into a patient.
CODE
Lot numbers: 10JG05, 10JG28,
10JG35, 10JG42, 10KG07, 10KG30, 10KE48, 10LG22, 10LG25, 11AG02, 11AG25,
11GE07, 11BG11, 11BE08, 11BE09, 11CG16, 11CG19, 11DE15, 11EE30, 11EE21,
11FE24, 11GE29, 11GE30 and 11GG41
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical,
Research Triangle Park, NC,
Manufacturer: Teleflex Medical,
Perak, Malaysia.
REASON
Complaints of difficulty removing
stylet from the endotracheal tube and possible PVC sheath separation were
received.
VOLUME OF PRODUCT IN COMMERCE
73,381 units
DISTRIBUTION
Nationwide and Canada and Europe
PRODUCT
1) GE Healthcare Definium 8000,
Digital Radiographic Systems. Revolution XR/d Digital Radiographic Imaging
System with Image Pasting and Auto positioning is indicated for use in
generating radiographic images of human anatomy. This device is not intended
for mammographic applications.
2) GE Healthcare Discovery XR650,
Digital Radiographic Systems. System ID SLQDSC1. Revolution XR/d Digital
Radiographic Imaging System with Image Pasting and Auto positioning is
indicated for use in generating radiographic images of human anatomy. This
device is not intended for mammographic applications.
CODE
1) 205801KDEF1 734671DEF1
205801KDEF2 336716BCR4 907580RM5 305325SM1 252847DEF6 313745ORTHO1 540536DRAD2
OCPINED8K 614566DR1 808951XRDB 315376D8K 843789VR2 419621DR 313745ORTHO2
734998ORTHO1 361572MOBD8K 478MORTHOD8K 720494D8K 559SKDHD8K 734647DEF1 SLQDEF1
212533DEF 484565DEF2 808951XRDA SCOIVALD8000 210617H122 208422D8000
512268D8000 954265ME4 216844XRD1 706721MDR2 717763MPXRD1 SLPDEF1 NYPHC370913
603225DRAD 225358DEF1 708364D8K 708202D8K2 NYPHC370910 847688DX2 928757DR3
252ECHI8K 970DOA8K 856355DEF NYPHC370911 850416DXR NYPHC370914 NYPHC370912
503387D8K 419424DR 704323M8K 315338D8K 215823DEF1 828696RM1 617739RM1D1 MCCD8K
915564DRAD 573632CROR1 304256DEF 501868ACHBR 801285DR1 937296D8K 865429DR1
908522DIF 610526DEF1 330477XRD 813844USFR1 205949DEF1 360417SQRAD1 412688RM2
330543DR1 815525DEF8K 908668DIF 216844MSIXRD2 732294DIF 650474SNCTHU5
360417SQRAD1 216844MSIXRD 617754XRD2A 210208ER 573875CRM4 712264DF8000
314577CGRM3 313745PDDEF OAASPINE 706494HC1 503216XRD1 303340DXR 814234RAD5
717761XRD1 313745ERDEF 920885DXRD 617414ACC2 239593OTS 440974XRD3 210593RAD1
573875CRM4 210396XRD1 949219RAD OAAIMAGE 706494HC2 210804RAD1 641422RM5
617667ORTHO1 412749DEF8000 814234RAD7 617667DR6 617414ACC4 217383CDEF1
617724XR2A2 504868DF 706494HC4 210489RAD1 904WSRAD1 610954DEF 904WSER1
614293D8K 601984XRD1 330455XRD 608392DEF1 715839D8000 847437GEXRD1 973971RAD2
717544HCXRD1 717544HCXRD2 432522WCDR1 228809SRER 570621DEF 319272XRD8 903GSER
NYPAL240 617726XR1CP4 269789DEFINIUM 608785DEF 920965DEF 305662ER 952746XRD2
716250CH1 610378RM1 630978DEF 757466RM6 ACB21739DEF 903UTD8 850431ER1D
541677MOIDR2 724775DEF 570621DEF2 503216XRD1 412858DEF1 408363VATHU1
719553SCCD8 816234CDR4 765832WC2 901765DR 406782BODR1 305662RM3 864512EDRM2
636947DEFRM2 920965EDEF 410337ER1 801587DX2 NYP404030 801587DX3 304757DEF8000
281274THUNDER 318681SRM1 239432D8000 601968XRD1 801587DX1 228377ER 904996RAD
773STJXRD321 979282THUNDER 513247D8K 816501RAD2 863284XRD 806212DRAD 412647DEF
432685DDR1 202741XRD 718630XRD 206598UDEF245 206598UDEF204 817329D8000
816501RAD3 720225CRXRDX 240566DR1 719333DEFC 305662RM3 610886DX1 913588KUW8K
734671DWS ACB71029DEF NYPMIL3-113 360689DX 210704PDIG1 504896D8K 956323RM3
281477MWXD2 717299XRD1 860659D8000 913696CDR1 419383ORTHO3 225754DEF1
734998BWDEF 419383ORTHO1 610954DEF2 706721MDR1 330486XRD 757722C212 734936DEF1
503513XRD NYPVC113 830331DIG1 478633DF8 207283DEFRAD1 607274DRAD1 334826HCA
661SCOID8000 978774DX1 313343DEF1 973538RAD 863680RM6 2682721 517353DEF1
206598RAD1 419783DR 650696XRD2 614257D8K 614293DR 216778XRD1 920721DEF
617724XR1A2 325670DEF1 206598UDEF247 508941RM11 727767XRAY1 978466DEF1
915747ERRAD 586532D8000 314849SLO1 704783DEF2 781344XRD2 714966RM5 925939ER1
415600CALDEF 704323DEF1 COR381050 850883ER1 541743DR5 M54219 314523OD8K
412647EDR1 949759D8 505265XRM6 813879XRD 602277A2228 505265XRM4 801662DX
906225D8K 207553DEF 229DEF8000 804SMHER2 207779DEF 704783DEF5 904202ORAD
404251DEF1 650474SNCTHU2 417781SJER 281482DR1 732923DIF1 404712DEF1 719SGPDR1
760873RAD 330363R1 212241RAD1 541768RM1 334528EAORTHO 419455DR 406457HODR1
920406DEF 330558D8 734936DEF2 650497SHTHU1 216791XRD1 617889XR1CH 734930MSDEF
541267DR1 623327D8000 412784VADEF 650474SNCTHU4 573814VARAD1 407VADEF1
303399XRD8K HIP816DEF1 415UCDEFORTHO 619532DEF15 650474SNCTHU1 251415RAD
724836DEF1 321841DEF1 503732XRD 913588KD8K 281274MSD8000 904399CHEST
859313DEFB 732776D8K 812343DEF1 614293SRDR 706733VAUD2 609219D8K 704323DEF2
409839D8000 920725DEF 301295DEF8 925939ER2 SPINEDEF1 706322SFSC 517353DEF2
210638RAD3 412692ORTHO2 706787ORTHO 650474SNCTHU6 650474SNCTHU3 717544HPXRD1
JAC2W11 303651DEF2 757388RP3 706733VR6 217326CCH2 509837SDEF 337234LBJ1
503VAHD8K 412692R1 206764DEF 713441ORTHORAD 808433D8KRM4 425455PROORTHO
734998ORTHO2 404321DEF1 720225LMCD8K 239768RM1 386FHOR1 508422DEF4 210617H104
724772DEF1 218722DEF 425392PRO1 360414XRD1 985882RAD1 978XR1NS 813827DEF8K
303321XRD8K 816234COPC 360417RAD1 00100RAD05 00123RAD05 00440RAD16 00454RAD02
00356RAD07 00226RAD08 01059RAD02 00065RAD08 10563RAD03 00065RAD07 00824RAD02
00065RAD06 00521RAD05 10086RAD03 00116RAD04 00324RAD09 AE1010RX04 61007RAD02
61012RAD01 06014RAD02 856070190 426020XR03 K001RX02 M001RX32 M001RX34 O010RX07
K002RX03 CEE15654 DE641219 DEG27409 DE644605 DPN88401 MPX27410 DEN51301
FPG86423 DEN00500 DEN00300 DEN00400 FPG93006 YE626921 DEN00200 DEN00100
DPM32148 DEN00301 DEL89966 DEN00704 DE541A09 DEN00000 DEN01005 DEN00805
DEN00602 DEN01105 EP591318 FEG85904 DEN00611 DEN90700 DPM32147 DPN26321
CEL75708 CEZ08802 CE165327 CEZ04110 CE262911 DEN01708 DE203238 DPL32925
ME504381 UE535A106 NE203136 DPB15839 GEX00400 ZA1000RX05 SA2177RX01 RU1785RX02
RU1646RX03 850070809 850070813 850070760 850070763 850070767 850070773
850070766 850070778 850070751 PER64201 PER18111 PER18410 NO1015RX08 NO1108RX03
NO1052RX08 NO1016RX07 NO1077RX03 920079103 920079105 920079110 RTD0986
MQ1000RX09 JO1000RX02 WX0102 WX0210 WX0211 XK0102 WX0203 WX0202 WX0201 WX0204
WX0205 WX0206 A5102680 A5356251 A5300722 B5300707 A5115127 A5624113 B5120721
A5804416 A5814918 A5238814 A5317201 A5317202 A5164518 A5128409 C5237807
B5127421 IL1062XR11 IE1044RX01 IE1044RX02 IE1111RX01 828070118 828070120
828070121 828070125 828070124 828070109 828070113 828070117 H2009RAD35
UHAN01XR13 HC0881XR04 HROS01XR03 487692XR02 PC0362XR07 HC7048XR05 519926XR03
561559XR02 HC0399XR08 PC6132XR07 PF1000RX11 M4168064 X59007318 A4192906
P4211488 M4187723 M4202413 M1966307 B4191737 M4472226 M4195131 M4211061
M4215549 A1717401 M9164773 M2717507 M177858601 A4167326 X1135601 M4484739
M4135317 M4173815 B4195724 M4168125 M4171226 M4185525 M4467029 A190136602
M5484954 A2035104 FI1052RX02 FI1144RX01 FI1017RX01 FI1133RX01 DK1043RX03
CS1004RX05 CS1090RX02 CS1013RX07 CS1013RX06 CS1138RX01 CS1013RX08 82407210082
82407250068 82407130221 82407040419 82407070112 82407160269 82407070114
82407040429 082407120178T 82407160279 82407040366 82407040371 82407040372
82407040373 82407040374 82407040384 82407160242 82407040398 82407040393
82407160244 82407070117 82407120178 27305DEF 27305DEF2 416813DEF8000A
905883DEF3 905883DEF1 905883DEF2 902473DEF1 514338DEF2 514338DEF3 519646DEF1
709778ADEF1 709778DEF1 519534XRD2D 416756D8000 416284DEF 519376XRD1 506452RM2A
519986RAD 519376XRD2 905522DEF 519797DEF 416284DEF2 519538RAD2 204787DEF
204787DEF2 416469DEF2 514473DEF 709637DEFINIUM 506375DEF1 416469DEF2
604557RAD4 403639RAD1 604557RAD1 604557RAD3 905848DEF1 403349ARAD2 416323DEF
905848DEF2 905895DEF 506857DEF1 418276DEF8000 514431DEF 709737RAD5 709737RAD4
030240RX04 030419RX08 190059RX20 220078RX30 080041RX14 AH3403XR03 AH6834XR02
AP4502XR08 AP3408XR10 910072181 910074017 910072141 910092229 910073084
910073085 910072169 910074018 910074022 910074021 1821DEF80 3882754403XRMET;
2) 414649DIS650 603668C6
704323M650 843789VR1 202865XRD650 727581DC650 508693MVDR 423624DIS6 412367MPI
832505DR1 713873BONE1 734462LIVXR1 423624DEF8 614722D650 OCMATT650 704323U650
650497CHDIS1 908685D650 540498RM2 203694ER650A 605226XR650 651439XR650
573884XR2 573884XR1 573884XR3 281477MW650XR1 281477MW650XR2 713441MM650
605719XR650 716631DRAD1 309655FXR3 3026291 320202XR650 303PSL650 573884XR4
412367D650 415CPSUTDEF2 650MPXR6502 734998BW650 VALLCXR650 615349RM2 417625OPD
832505DR3 814375RM1 832505DR2 315787RAD1 443481SJK1 616267XR650A 913696CDR2
623251DR1063 650MPPAMOB 860749XR650 386FHDVR1 281MWXR6501 812482DR1 818364ER
617SHLL515 617SH4333 205933DXR 307773D650 413748RAD6 614722D650R2 504842RM2
802773D650 520DMXR650 915742DRAD1 301295XR650 210358DIG1 313576XR650
415221VA650 SLH650 810494D650A LLPMXR650R2 NYPAL172 814788D650 706733VR4
516608D650 ORMCXR380 816234CDR5 SLHWG650 ORMCXR386 443481ED2 409761PCP2
970395XR650 571231DX2 810494D650B 508334DRAD 573875XR3 650MPPAMF2
210358UCCHRM1 310319DISCXR5 310319DISCXR4 412623ER1 816234COPC1 310319DISCXR3
310319DISCXR2 585596DRAD 409761PCP1 301765RAD 719285XR650 406495SPDR1
816960CDR1 309655GPR1 415UCMBD6501 415UCMBD6502 0002852904BX 573815BR2D
920830RAD2 708202D650 713441MO650 908522D650 281STLV6501C143 504842RM1
601936ERXRD ORMCER2 ORMCER1 504349R9 571231DX1 609247RAD1 SLRBONE 00216RAD14
00001RAD11 00440RAD23 00424RAD06 AE1016RX10 AE1016RX09 856070221 S001RX08
M001RX40 M001RX39 ME051547 SA1011RX10 SA1056RX02 SA1012RX19 SA2191RX03
SA1008RX01 SA2235RX01 SA2249RX01 SA2191RX05 SA2244RX01 SA1056RX03 SA2253RX01
SA1056RX04 SA1011RX11 SA2240RX01 850070828 850070841 850070840 NO1051RX02
WV0301 WV0151 WV0201 WV0160 WV0251 WV0206 WV0210 WV0154 WV0303 WV0302 WV0304
WV0153 WV0208 WV0254 WV0209 WV0253 WV0152 A5604844 A51272107 A51026100
A51026102 828070123 PHAM02XR04 PP0034XR02 HC9059XR03 HC2636XR02 558739XR03
A4194835 M4173034 M4206219 M4008407 M2348213 M4461517 M23084302 M23084301
M1656626 B6010815 M4200018 M4196643 FI1128RX02 EE1016RX01 82407110065
82407040425 82407040432 82407100420 82407220044 82407040436 82407040447
82407100410 82407040431 82407110068 82416300005 82407300033 82407090149
506357RAD1 604869XR 905527DEF4 905527DEF2 613548RAD1 905527DEF1 604582XR2
604582XR1 250339XR1 250370XR1 514765XR650 250746XR1 905521XR650A 514934BRAD3
418689XRD 418547XR1 BA4080RX02 BA4017XR04 030220RX14 910073103 910072201
910074030 910075020 910072215
RECALLING FIRM/MANUFACTURER
GE Healthcare, LLC, Waukesha, WI,
REASON
The patient barrier rotating arms
that are used to position and stabilize the patient during image pasting
procedures may fail to retain residual friction at the arm pivot. This could
permit the arm to swing freely when the rotating arm locking lever is
released. Should this happen during use, injury to the patient and/or user
could occur.
VOLUME OF PRODUCT IN COMMERCE
911 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
1) DURAMAX 15.5 F x 22 cm Chronic
Hemodialysis Catheter Set (With Cuff 17 cm from Tip), DuraMax Stacked Tip 22
cm Str. Basic Kit, Catalog No./REF 10302802, STERILE. The AngioDynamics
DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining
long-term vascular access for Hemodialysis and apheresis.
2) DURAMAX 15.5 F x 24 cm Chronic
Hemodialysis Catheter Set (With Cuff 19 cm from Tip), DuraMax Stacked Tip 24
cm Str. Basic Kit, Catalog No./REF 10302803, STERILE --- The AngioDynamics
DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining
long-term vascular access for Hemodialysis and apheresis.
3) DURAMAX 15.5 F x 28 cm Chronic
Hemodialysis Catheter Set (With Cuff 23 cm from Tip), DuraMax Stacked Tip 28
cm Str. Basic Kit, Catalog No./REF 10302804, STERILE --- The AngioDynamics
DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining
long-term vascular access for Hemodialysis and apheresis.
4) DURAMAX 15.5 F x 32 cm Chronic
Hemodialysis Catheter Set (With Cuff 27 cm from Tip), DuraMax Stacked Tip 32
cm Str. Basic Kit, Catalog No./REF 10302805, STERILE --- The AngioDynamics
DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining
long-term vascular access for Hemodialysis and apheresis.
5) DURAMAX 15.5 F x 36 cm Chronic
Hemodialysis Catheter Set (With Cuff 31 cm from Tip), DuraMax Stacked Tip 36
cm Str. Basic Kit, Catalog No./REF 10302806, STERILE --- The AngioDynamics
DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining
long-term vascular access for Hemodialysis and apheresis.
CODE
1) Lot C28712;
2) Lots 500137, 500138, 527756,
C28713;
3) Lots 500139, 527573, 527755,
C28714;
4) Lots 527842, C28715;
5) Lots 523908, 527961, C28716
RECALLING FIRM/MANUFACTURERAngioDynamic
s, Inc., Queensbury,
NY,
REASON
AngioDynamics received customer
complaints for breakage of the tunneler sleeve during product use.
VOLUME OF PRODUCT IN COMMERCE
1124 units
PRODUCT
1) Orbit and Orbit Micro
Subcutaneous infusion set Triad alcohol wipes are co-packaged with the Orbit
devices. Our device is within its own separate sterile package and the wipes
are packaged with our devices within an outer container. Removal of the wipes
will not compromise the sterile barrier of our device and can easily be
identified and replaced. ;
2) IV Start Kits Convenience kit
for starting IVs. Triad wipes are packaged within the sterile barrier and
would require compromising the barrier to replace the wipe.
CODE
1) Catalog # Lot # B7905: 2010928,
2010955, 2010956, 2026848, 2026849, 2026852; B7932: 2010961, 2012567, 2012965,
2022800; M1861: 1724481 M2461: 1701070; M2491: 1706450; M3060: 1711976; M3091:
1701069; M4261: 1711981; P1005: 1992939; P1850: 1887213; P1851: 1646310,
1646311, 1750036, 1863485, 1887212, 1972548, 2013176; P1861: 1385494, 1711980,
1752814; P1881: 2027824; P1891: 1471913; P2450: 1800862; P2451: 1598200,
1598201, 1598206, 1750038, 1800860, 1815008, 1851423, 1887209, 1887216,
1972553; P2460: 1470415, 1722014; P2461: 1087509, 1385394, 1598097, 1774378,
1803640, 1848045, 1971554, 2022098; P2481: 1999027, 1999484, 2022794, 2027826;
P2491: 1363050, 1557296, 1692396, 1782845; P3051: 1366012, 1646308, 1646312,
1660580, 1660581, 1800858, 1841693, 1853574, 1887208, 1887215, 1887217,
1972556, 2027827; P3061: 1062302, 1087495, 1686643; P3081: 1919294, 1972551,
1978024, 2027828; P3091: 1244139, 1244140, 1244141, 1363051, 1598101, 1598102,
1686641, 1686644; P4251: 1646309, 1646313, 1871643, 2022795; P4260: 1439395;
P4261: 1363053, 1722015; P4281: 2027825, 2045107; P4290: 1439397; P4291:
1363049, 1722019, 1761743, 1774372, 1774374, 1774375, 1774376, 1774377,
1774379, 1774380, 1782841, 1782842, 1782843, 1782844, 1799794, 1799795,
1799796, 1799797, 1799798, 1814994, 1848046, 1855183, 1972546, 2007344,
2027816. P4291M: 1863467, 186468, 1863469, 18687998, 1887999, 1888000,
1888001, 1888002, 1888003, 1888004, 1888005, 1888006, 1972538, 1972539,
1972542, 1975233, 1990393, 1990395, 1991948, 2006952, 2006953, 2006954,
2006955, 2007432, 2022118, 2026307, 2026308, 2026309, 2027903, 2027904,
2028415;
2) Catalog # : Lot # B7825:
253026-SC, 253046-SC, 253069-SC, 253073-SC, 253081-SC, 253103, 253112, 253120,
253125, 253130, 253144, 253183, 253199, 253216, 253226, 253234, 253245,
253258, 253269, 253281, 253294, 253300, 253301, 253313, 253326, 253341,
253348, 253363; B7837: 233068-SC, 253037-SC, 253041-SC, 253049-SC, 253053-SC,
253057-SC, 253060-SC, 253064-SC, 253074-SC, 253080-SC, 253084-SC, 253087,
253088, 253097, 253100, 253104, 253109, 253113, 253121, 253126, 253133,
253136, 253140, 253146, 253149, 253152, 253159, 253168, 253171, 253177,
253181, 253187, 253188, 253190, 253194, 253196 253198, 253200, 253205, 253207,
253208, 253210, 253214, 253219, 253223, 253227, 253231, 253235, 253238,
253243, 253246, 253251, 253254, 253255, 253257, 253262, 253264, 253272,
253273, 253275, 253278, 253280, 253283, 253288, 253292, 253295, 253299,
253307, 253311, 253315, 253318, 253319, 253324-SC, 253328, 253331, 253336,
253338, 253342, 253350, 253351, 253356, 253358, 253366, 253370, 253372,
253374, 253381, 253384-SC, 253388, 253390, 253392, 253396, 253399, 253401,
253406, 253409, 253411, 253413, 253417, 253421, 253422, 253426, 253432,
253435, 253437, 253439, 253444, 253451, 253452, 253457, 253466, 253470,
253473, 253475, 253476, 253479, 253485, 253491, 253495, 253496, 253500,
253502, 253505, 253512, 253519, 857-SC4; B7841: 233163, 253028-SC, 253033-SC,
253052-SC, 253056-SC, 253065-SC, 253070-SC, 253078-SC, 253091, 253099, 253101,
253106, 253115, 253119, 253124, 253128, 253141, 253147, 253153, 253156,
253169, 253172, 253180, 253191, 253204, 253211, 253222, 253228, 253236,
253242, 253247, 253253, 253261, 253271, 253274, 253279, 253282, 253289,
253297, 253302, 253304, 253308, 253316, 253322, 253327, 253329, 253333,
253339, 253343, 253346, 253352, 253357, 253367, 253369, 253375 800 253379 ,
253383-SC, 253391, 253397, 253402, 253410, 253414, 253418, 253420, 253425,
253430, 253438, 253440, 253453, 253455, 253458, 253468, 253469, 253477,
253480, 253486, 253492, 253504, 253506, 253511, 253515, 253521, 253530; B7842:
20600, 253036-SC, 253040-SC, 253062-SC, 253079-SC, 253107, 253116, 253142,
253157, 253166, 253175, 253192, 253195, 253212, 253224, 253240, 253249,
253276, 253286, 253305, 253320, 253332, 253344, 253364, 253376, 253380,
253385, 253407, 253415, 253423, 253436, 253441, 253459, 253462, 253481,
253487, 253493, 253503, 253535; B7844: 253047-SC; B7846: 253513; B7905:
2010928, 2010955, 2010956, 2026848, 2026849, 2026852, 2066860, 2010928,
2010955, 2010956, 2026848, 2026849, 2026852, 2066860, 2098782, 2145226,
253009-SC, 253035-SC, 253066-SC, 253089, 253123, 253139, 253160, 253178,
253197, 253213, 253241, 253265, 253285, 253303, 253310, 253325, 253337,
253360, 253386, 253403, 253405, 253427, 253449, 253463, 857-SC1; B7928:
213167, 233061-SC, 253045-SC, 253055-SC, 253059-SC, 253077-SC, 253082-SC,
253086, 253093, 253095, 253102, 253111, 253118, 253129, 253137, 253145,
253151, 253158, 253173, 253176, 253186, 253193, 253201, 253206, 253209,
253218, 253220, 253230, 253232, 253239, 253248, 253252, 253256, 253260,
253268, 253277, 253287, 253291, 253296, 253306, 253312, 253317, 253323,
253330, 253334, 253340, 253345, 253349, 253353, 253359, 253368, 253371,
253382, 253389, 253393, 253398, 253404, 253408, 253416, 253424, 253429,
253433, 253442, 253448, 253454, 253460, 253464, 253471, 253478, 253483,
253488, 253494, 253497, 253501, 253507; B7932: 2010961, 2012567, 2012965,
2022800; B7937: 253355, 253362, 253377, 253394; B7938: 253354, 253361, 253378,
253395; Z0125: 78-458-YJ; Z8015: 59-941-SN, 61-164-LA, 61-898-LA, 62-799-R5,
63-307-YJ, 64-027-2A, 64-245-K4, 65-616-K4, 66-136-R5, 67-582-YJ, 67-803-2A,
69-758-R5, 70-155-K4, 71-538-LA, 73-027-YJ, 73-736-YJ, 74-402-K4, 74-962-R5,
76-203-2A, 77-360-R5, 80-869-R5, 80-957-K4, 85-657-LA, 88-569-2A, 89-613-SN,
92-782-R5, 94-196.2A, 94-196-2A; Z8017: 61-577-K4, 63-347-SN, 64-194-2A,
64-407-K4, 68-446-K4, 70-351-2A, 72-636-YJ, 73-735-YJ, 74-585-K4, 78-846-2A,
81-540-2A, 84-591-YJ, 86-016-SN, 89-540-LA, 91-210-LA, 92-295-YJ, 92-781-R5,
93-166-LA; Z8028: 57-112-R5, 58-440-LA, 62-236-R5, 62-239-R5, 63-308-YJ,
64-028-2A, 65-333-LA, 65-617-K4, 66-352-R5
RECALLING FIRM/MANUFACTURER
ICU Medical, Inc., San Clemente, CA,
REASON
The Triad alcohol prep pads have
the potential contamination of the bacteria, Bacillus cereus. The Triad Group
alcohol prep pads have been copackaged and distributed with ICU Medical Orbit
subcutaneous infustion sets, Orbit Micro subcutaneous infusion sets, and IV
Start kits. This recall involves those products marked as sterile as well as
non-sterile.
VOLUME OF PRODUCT IN COMMERCE
957,990 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
1) Exodus(TM) 8F (2.7 mm)/ 35 cm
Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/ Catalog
No. 10005, UPN/Product No. H965100051, STERILE --- Package/Box Units: Box of 5
eaches --- Made in USA. The Exodus Drainage Catheter consists of a radiopaque
polyurethane catheter. The distal end of the catheter is configured as a J-Tip
or a locking pigtail and is coated with a hydrophilic coating. Catheter
markings are provided in centimeters on the shaft to indicate the distance
from the distal tip. The Exodus Biliary Drainage Catheter includes a
radiopaque (RO) marker band located approximate 5 mm from the most proximal
drainage hole to assist with catheter placement. Biliary Drainage Catheters
are intended for percutaneous drainage of the biliary tree.
2) Exodus(TM) 10 F (3.4 mm)/ 35 cm
Standard Loop Biliary Drainage Catheter with Hydrophilic Coating, REF/Catalog
No. 10013, UPN/Product No. H965100131, STERILE --- Package/Box Units: Box of 5
each --- Made in USA. The Exodus Drainage Catheter consists of a radiopaque
polyurethane catheter. The distal end of the catheter is configured as a J-Tip
or a locking pigtail and is coated with a hydrophilic coating. Catheter
markings are provided in centimeters on the shaft to indicate the distance
from the distal tip. The Exodus Biliary Drainage Catheter includes a
radiopaque (RO) marker band located approximate 5 mm from the most proximal
drainage hole to assist with catheter placement. Biliary Drainage Catheters
are intended for percutaneous drainage of the biliary tree.
CODE
1) Lots: 1ML0052506, 1ML0062201,
1ML0080901;
2) Lots: 1ML0060705, 1ML0070901,
1PD0040501
RECALLING FIRM/MANUFACTURER
Recalling Firm: Navilyst Medical,
Inc., Glens Falls, NY,
Manufacturer: Navilyst Medical,
Inc., Glens Falls, NY;
Medventure Technology Corp.,
Jeffersonville, IN. .
REASON
The Exodus Standard Loop Biliary
Drainage Catheters exhibited a rate of reported failures (catheter tip
fragmentation) higher than anticipated.
VOLUME OF PRODUCT IN COMMERCE
118 boxes
DISTRIBUTION
Nationwide and South Africa
PRODUCT
1) Weck, DuraHook (6mm) and
(12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units,
10 Sales Units per Shipper, Rx Only. For use as skin retraction devices during
general surgery. DuraHooks are also cleared for use in procedures requiring
retraction of dura mater. Catalog numbers: 382800.
2) Weck, DermaHook (12mm),
Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales
Units per Shipper, Rx Only. For use as skin retraction devices during general
surgery. DuraHooks are also cleared for use in procedures requiring retraction
of dura mater. Catalog number: 382805.
CODE
1) Lot numbers: 01A1100009,
01A1100165, 01A1100251, 01A1100355, 01B1100028, 01B1100274, 01E1000297,
01F1000587, 01F1000588, 01F1000589, 01G1000138, 01G1000327, 01G1000433,
01G1000512, 01H1000112, 01H1000297, 01J1000548, 01K1000182, 01M1000218,
01M1000326 and 01M1000339;
2) Lot numbers: 01A1100470,
01A1100374, 01A1100517, 01A1100519, 01B1100006, 01B1100131, 01B1100159,
01B1100275, 01E1000026, 01F1000586, 01G1000137, 01G1000139, 01G1000251,
01G1000326, 01H1000271, 01H1000296, 01J1000267, 01J1000298, 01K1000005,
01K1000051, 01K1000181, 01K1000334, 01L1000282, 01L1000283, 01L1000292,
01M1000008, 01M1000144, 01M1000198, 01M1000199 and 01M1000200
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical,
Research Triangle Park, NC,
Manufacturer: Teleflex Medical,
Tecate, Mexico.
REASON
Teleflex Medical received
complaints that the elastic bands are breaking, cracking and /or deteriorating
prior to their expiration date. If the elastic bands break during use there is
a chance for operative exposure, loss of the band in the operative field as
well as inadvertent needle stick.
VOLUME OF PRODUCT IN COMMERCE
296,580 units
PRODUCT
NicVue Software version 2.9.2 and
3.0.1. Medical Device Data System (MDDS) Intended use: The NicVue software is
intended to be the patient database for various Nicolet applications. The
NicVue software is intended to aid the hospital in tracking patient data from
collection to review to archive. The NicVue Software includes the following
features and intended uses: Launch Applications, Enter patient information,
Import/Export patient information from the Hospital Information System, Move
data files, Archive data files on DVD or CDROM. Part Numbers: 828-050000,
828-062400, 828-062500, 828-062600, 828-050100, 828-062900, 828-063100,
828-063200, 828-063300, 828-063500.
CODE
NicVue Software version 2.9.2 and
3.0.1.
RECALLING FIRM/MANUFACTURER
Recalling Firm: CareFusion 209
Inc., Middleton, WI,
Manufacturers: CareFusion 209
Inc., Middleton, WI;
VIASYS Healthcare-Intermed
Precision Subsidiary, Galway, Ireland.
REASON
CareFusion recently discovered
that NicVue versions 2.9.2 and 3.0.1 contains a software issue that may affect
some workflows. To prevent this possibility, your NicVue version 2.9.2 must be
updated to 2.9.3 and 3.0.1 must be updated to NicVue version 3.0.2. Under
certain work flow processes, when selecting a new patient name in NicVue, the
associated exams list may not properly refresh, and may continue to display
the previous patient's exams. When the exam record is opened in the device
application software, the correct patient name associated with that record is
displayed at the top of the screen, but it may not be the intended patient's
record.
VOLUME OF PRODUCT IN COMMERCE
1676 (614 Nationwide; 1062
Internationally)
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Illumena 150mL Linden Luer Syringe
with Handi-Fil Straw (p/n 900103) & Illumena 150mL Regular Luer Syringe
with Handi-Fil (p/n 900101). The Liebel Flarsheim Illumena 150mL Syringes with
Handi-Fil Straw are designed for use with the Illumena Injector System. The
Angiomat Illumena is designed to inject a radiopaque contrast medium into the
vascular system for Angiographic or CT procedures; Catalog # 900103.
CODE
Lot # 0253304, Exp Date. 09/2013;
Lot # 0298222, Exp Date 10/2013; Lot # 0298223, Exp Date 10/2013; Lot #
0308031, Exp Date 11/2013; Lot # 0312202, Exp Date 11/2013; Lot # 0330293, Exp
Date 11/2013; Lot # 0344197, Exp Date 12/2013; Lot # 0351244, Exp Date
12/2013; Lot # 0351245, Exp Date 12/2013; Lot # 1007208, Exp Date 01/2013; Lot
# 1014335, Exp Date 01/2013; Lot # 1126136, Exp Date 05/2013; Lot # 1175144,
Exp Date 06/2013; Lot # 1189159, Exp Date 07/2013 & Lot # 1203154, Exp
Date 07/2013. Catalog # 900101 - Lot #, 0314042, Exp Date, 11/2013; Lot #,
0323224, Exp Date, 11/2013; Lot #, 0356041, Exp Date, 12/2013; Lot #, 1007265,
Exp Date, 01/2013; Lot #, 1119054, Exp Date, 04/2013 & Lot #, 1133140, Exp
Date, 05/2013
RECALLING FIRM/MANUFACTURER
Mallinckrodt Inc., Cincinnati OH,
REASON
Syringes packaged and labeled as
the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103,
contained the Illumena 150mL Syringe with Handi-Fil Straw, product 900101.
VOLUME OF PRODUCT IN COMMERCE
187,400 units (900103 syringe:
129,200; 900101 syringe: 58,200)
DISTRIBUTION
Nationwide and Internationally
PRODUCT
1) 37% Etching Gel-1ml syringe,
part # T06 The intended use of these devices is to etch tooth dentin/enamel in
order to prepare the tooth surface prior to the application of a bonding
agent. ;
2) 37% Etching Gel-1ml syringe 20
pk, part # T06A The intended use of these devices is to etch tooth
dentin/enamel in order to prepare the tooth surface prior to the application
of a bonding agent.
3) 37% Etching Gel-1ml syringe 50
pk, part # T06B The intended use of these devices is to etch tooth
dentin/enamel in order to prepare the tooth surface prior to the application
of a bonding agent.
4) 37% Etching Gel-3ml syringe,
part #N01H The intended use of these devices is to etch tooth dentin/enamel in
order to prepare the tooth surface prior to the application of a bonding
agent.
5) 37% Etching Gel-5ml syringe,
part #N01IB The intended use of these devices is to etch tooth dentin/enamel
in order to prepare the tooth surface prior to the application of a bonding
agent.
CODE
All lots produced since April 2007
RECALLING FIRM/MANUFACTURER
Kerr/pentron Dba Kerr Corporation
and Pentron Clinical, Orange, CA,
REASON
The product continues to extrude
out of the syringe even after pressure is no longer applied, and it contains a
higher percentage of phosphoric acid than that indicated on the label.
VOLUME OF PRODUCT IN COMMERCE
41,744 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT
Olympus OFP Flushing Pump
irrigation tubing The Olympus OFP Flushing Pump is a peristaltic flushing pump
intended for use with Olympus gastrointestinal videoscopes having an auxiliary
water inlet as part of an Olympus endoscopic imaging system to facilitate
washing of gastric and colonic mucosa to remove blood, feces and other organic
matter, enabling improved visualization, diagnosis and therapy during
endoscopic procedures. Catalog number 7501669.
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Olympus America
Inc., Center Valley, PA,
Manufacturer: KeyMed (Medical and
Industrial Equipment) Ltd. Southend-On-Sea, UK. .
REASON
Water may leak from the irrigation
tubing used on the Olympus Flushing Pump.
VOLUME OF PRODUCT IN COMMERCE
64,667 packages of 10 irrigation
tubes
PRODUCT
NXStage PureFlow SL SAK-303 - 2
dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx. The
NxStage PureFLow SL is an optional accessory to the NxStage System One that
prepares dialysate for use during hemodialysis, as prescribed by the
physician.
CODE
Lot 1117911, Exp. 2013-09
RECALLING FIRM/MANUFACTURER
Recalling Firm: NxStage Medical,
Inc., Lawrence, MA,
Manufacturer: Medimexico, S. de
R.L. de C.V., Tijuana, Mexico.
REASON
Report of high conductivity
failure alarms with the PureFlow SL due to excess concentrate by weight in the
product (SAK) dialysate Preparation System.
VOLUME OF PRODUCT IN COMMERCE
1,192 devices (596 cases
containing 2 SAKs)
DISTRIBUTION
Nationwide
WEEK ENDING JANUARY 21
Carefusion Provides
Update on Recall of Neurological Monitoring Software and Devices
CareFusion issued the following update
regarding its recall of the Nicolet® Cortical Stimulator Control Unit, Nicolet®
C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with
Cortical Stimulator License.
The company initiated the recall, which
affects 125 devices and 58 software licenses, in October 2011. The devices and
software subject to the recall were distributed to 38 customers between May 7,
2009 and July 11, 2011.
The company sent an urgent Medical
Device Recall Notification to customers stating the identified potential risks
associated with the Cortical Stimulator Control Unit, SSU Amplifier and related
software applications. Affected units have the potential to develop a short
circuit, and affected software licenses may display or capture the incorrect
electrode annotation label on the Cortical Stimulator Control Unit screen and in
the associated report.
In the notification letter, customers
were provided serial and version numbers of affected hardware and software. This
information is available at http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-nicoletone-software.aspx .
Instructions to customers Customer
inquiries related to this action should be addressed to the CareFusion NeuroCare
Call Center at 800-356-0007 (press option 2 for Technical Support).
3750 Torrey View Ct
San Diego, CA 92130
www.CareFusion.com
PRODUCT Varian
Clinac, Trilogy, Trilogy Tx and Novalis linear accelerators. Varian High
Energy Linear Accelerator is indicated for stereotactic radiosurgery and
precision radiotherapy for lesions, tumors and conditions anywhere in the body
where radiation treatment is indicated. Model numbers: H14, H18, H27 and
H29.
CODE
Code numbers: H140001 H140061 H140121
H140225 H140743 H140801 H140859 H140919 H180082 H180209 H180310 H180463
H180536 H140002 H140062 H140122 H140226 H140744 H140802 H140860 H140920
H180083 H180210 H180311 H180466 H180538 H140003 H140063 H140123 H140227
H140745 H140803 H140861 H140921 H180087 H180214 H180312 H180467 H180539
H140004 H140064 H140124 H140228 H140746 H140804 H140862 H140923 H180088
H180215 H180314 H180468 H180540 H140005 H140065 H140125 H140229 H140747
H140805 H140863 H140924 H180093 H180217 H180318 H180469 H180541 H140006
H140066 H140126 H140230 H140748 H140806 H140864 H140925 H180098 H180218
H180319 H180470 H180542 H140007 H140067 H140127 H140231 H140749 H140807
H140865 H140926 H180099 H180220 H180321 H180471 H180543 H140008 H140068
H140128 H140232 H140750 H140808 H140866 H140927 H180102 H180221 H180322
H180472 H180544 H140009 H140069 H140129 H140233 H140751 H140809 H140867
H140929 H180103 H180222 H180323 H180473 H180545 H140010 H140070 H140130
H140234 H140752 H140810 H140868 H140930 H180104 H180225 H180324 H180474
H180548 H140011 H140071 H140131 H140235 H140753 H140811 H140869 H140931
H180107 H180226 H180325 H180475 H180549 H140012 H140072 H140132 H140236
H140754 H140812 H140870 H140932 H180108 H180228 H180326 H180476 H180550
H140014 H140073 H140133 H140237 H140755 H140813 H140871 H140933 H180115
H180229 H180327 H180477 H180551 H140015 H140074 H140134 H140238 H140756
H140814 H140872 H140934 H180116 H180233 H180328 H180478 H180552 H140016
H140075 H140135 H140239 H140757 H140815 H140873 H140935 H180117 H180235
H180329 H180479 H180553 H140017 H140076 H140136 H140240 H140758 H140816
H140874 H140936 H180119 H180236 H180402 H180480 H180554 H140018 H140077
H140137 H140700 H140759 H140817 H140875 H140937 H180122 H180237 H180404
H180482 H180555 H140019 H140078 H140138 H140701 H140760 H140818 H140876
H140938 H180124 H180238 H180405 H180484 H180556 H140021 H140079 H140139
H140702 H140761 H140819 H140877 H140939 H180128 H180240 H180406 H180485
H180557 H140022 H140080 H140140 H140703 H140762 H140820 H140878 H140940
H180129 H180242 H180407 H180486 H180559 H140023 H140082 H140141 H140704
H140763 H140821 H140879 H140941 H180131 H180243 H180409 H180487 H180560
H140024 H140083 H140142 H140705 H140764 H140822 H140881 H140943 H180132
H180245 H180411 H180489 H180561 H140025 H140084 H140143 H140706 H140765
H140823 H140882 H140944 H180133 H180249 H180412 H180490 H180562 H140026
H140085 H140144 H140707 H140766 H140824 H140883 H140945 H180135 H180250
H180414 H180491 H180563 H140027 H140086 H140145 H140708 H140767 H140825
H140884 H140947 H180143 H180251 H180417 H180492 H180564 H140028 H140087
H140146 H140709 H140768 H140826 H140885 H140948 H180144 H180254 H180419
H180493 H180565 H140029 H140088 H140147 H140710 H140769 H140827 H140886
H140950 H180147 H180255 H180420 H180494 H180566 H140030 H140089 H140148
H140711 H140770 H140828 H140887 H140951 H180148 H180256 H180422 H180495
H180567 H140031 H140090 H140149 H140712 H140771 H140829 H140888 H140952
H180151 H180257 H180424 H180496 H180568 H140032 H140091 H140150 H140713
H140772 H140830 H140889 H140953 H180154 H180258 H180425 H180498 H180569
H140033 H140092 H140151 H140714 H140773 H140831 H140890 H180003 H180157
H180260 H180426 H180499 H180570 H140034 H140093 H140152 H140715 H140774
H140832 H140891 H180004 H180159 H180262 H180427 H180501 H180571 H140035
H140094 H140153 H140716 H140775 H140833 H140892 H180007 H180161 H180264
H180432 H180505 H180572 H140036 H140095 H140154 H140717 H140776 H140834
H140893 H180008 H180164 H180267 H180433 H180507 H180573 H140037 H140096
H140201 H140718 H140777 H140835 H140895 H180016 H180166 H180268 H180434
H180508 H180574 H140038 H140097 H140202 H140719 H140778 H140836 H140896
H180017 H180167 H180271 H180436 H180509 H180575 H140039 H140098 H140203
H140720 H140779 H140837 H140897 H180019 H180168 H180272 H180437 H180510
H180576 H140040 H140099 H140204 H140721 H140780 H140838 H140898 H180025
H180170 H180273 H180440 H180511 H180577 H140041 H140100 H140205 H140722
H140781 H140839 H140899 H180026 H180171 H180275 H180441 H180513 H180578
H140042 H140101 H140206 H140723 H140782 H140840 H140900 H180028 H180173
H180283 H180442 H180514 H180579 H140043 H140102 H140207 H140724 H140783
H140841 H140901 H180040 H180175 H180284 H180443 H180515 H180580 H140044
H140103 H140208 H140725 H140784 H140842 H140902 H180043 H180178 H180285
H180444 H180517 H180581 H140045 H140105 H140209 H140726 H140785 H140843
H140903 H180044 H180179 H180287 H180445 H180518 H180582 H140046 H140106
H140210 H140727 H140786 H140844 H140904 H180045 H180181 H180289 H180446
H180519 H180583 H140047 H140107 H140211 H140728 H140787 H140845 H140905
H180048 H180182 H180290 H180447 H180520 H180584 H140048 H140108 H140212
H140729 H140788 H140846 H140906 H180049 H180185 H180291 H180449 H180521
H180585 H140049 H140109 H140213 H140730 H140789 H140847 H140907 H180050
H180186 H180292 H180450 H180522 H180586 H140050 H140110 H140214 H140731
H140790 H140848 H140908 H180052 H180188 H180293 H180451 H180524 H180587
H140051 H140111 H140215 H140732 H140791 H140849 H140909 H180053 H180192
H180294 H180452 H180525 H180588 H140052 H140112 H140216 H140733 H140792
H140850 H140910 H180056 H180193 H180295 H180453 H180527 H180589 H140053
H140113 H140217 H140734 H140793 H140851 H140911 H180058 H180195 H180296
H180454 H180528 H180590 H140054 H140114 H140218 H140735 H140794 H140852
H140912 H180059 H180197 H180298 H180455 H180529 H180591 H140055 H140115
H140219 H140736 H140795 H140853 H140913 H180065 H180199 H180299 H180456
H180530 H180592 H140056 H140116 H140220 H140737 H140796 H140854 H140914
H180066 H180201 H180303 H180457 H180531 H180593 H140057 H140117 H140221
H140738 H140797 H140855 H140915 H180073 H180203 H180304 H180459 H180532
H180594 H140058 H140118 H140222 H140739 H140798 H140856 H140916 H180075
H180204 H180305 H180460 H180533 H180595 H140059 H140119 H140223 H140740
H140799 H140857 H140917 H180079 H180206 H180307 H180461 H180534 H180596
H140060 H140120 H140224 H140742 H140800 H140858 H140918 H180080 H180208
H180309 H180462 H180535 H180597 H180598 H180661 H180725 H180788 H180852
H181012 H181073 H181135 H181199 H270118 H270353 H270482 H270645 H180599
H180662 H180726 H180789 H180853 H181013 H181074 H181136 H181200 H270126
H270355 H270483 H270646 H180600 H180663 H180727 H180791 H180854 H181014
H181075 H181137 H181201 H270128 H270356 H270486 H270647 H180601 H180664
H180729 H180792 H180855 H181015 H181076 H181138 H181202 H270134 H270360
H270487 H270648 H180602 H180665 H180730 H180793 H180856 H181016 H181077
H181139 H181203 H270136 H270364 H270489 H270649 H180603 H180667 H180731
H180794 H180857 H181017 H181078 H181140 H181204 H270138 H270365 H270490
H270651 H180604 H180668 H180733 H180796 H180858 H181018 H181079 H181141
H181205 H270144 H270370 H270491 H270652 H180605 H180669 H180734 H180798
H180859 H181019 H181080 H181142 H181206 H270201 H270371 H270495 H270653
H180606 H180670 H180735 H180799 H180860 H181020 H181081 H181143 H181207
H270209 H270373 H270498 H270654 H180607 H180671 H180736 H180800 H180861
H181021 H181082 H181145 H181208 H270211 H270378 H270499 H270656 H180608
H180672 H180737 H180801 H180862 H181022 H181083 H181146 H181209 H270215
H270383 H270500 H270660 H180610 H180673 H180738 H180802 H180863 H181023
H181084 H181147 H181210 H270216 H270384 H270501 H270661 H180611 H180674
H180739 H180803 H180864 H181024 H181085 H181148 H181211 H270219 H270385
H270502 H270662 H180612 H180675 H180740 H180804 H180865 H181025 H181086
H181149 H181212 H270227 H270386 H270503 H270664 H180614 H180676 H180741
H180805 H180866 H181026 H181087 H181150 H181214 H270228 H270391 H270504
H270665 H180615 H180678 H180742 H180806 H180867 H181027 H181088 H181151
H181215 H270229 H270392 H270505 H270667 H180616 H180679 H180743 H180807
H180868 H181028 H181089 H181152 H181220 H270230 H270395 H270506 H270669
H180617 H180680 H180744 H180808 H180869 H181029 H181090 H181153 H181223
H270232 H270398 H270508 H270670 H180618 H180681 H180745 H180809 H180870
H181030 H181091 H181154 H182000 H270235 H270399 H270511 H270671 H180619
H180682 H180746 H180810 H180871 H181031 H181092 H181155 H182001 H270240
H270400 H270512 H270675 H180620 H180683 H180747 H180811 H180872 H181032
H181093 H181156 H182002 H270244 H270401 H270513 H270680 H180621 H180684
H180748 H180812 H180873 H181033 H181094 H181157 H182003 H270245 H270404
H270516 H270681 H180622 H180685 H180749 H180813 H180874 H181034 H181095
H181158 H182005 H270251 H270409 H270518 H270682 H180623 H180686 H180750
H180814 H180875 H181035 H181096 H181159 H182006 H270252 H270410 H270520
H270684 H180624 H180687 H180751 H180815 H180876 H181036 H181097 H181160
H182007 H270254 H270412 H270522 H270685 H180625 H180688 H180752 H180816
H180877 H181037 H181098 H181161 H182008 H270255 H270416 H270525 H270686
H180626 H180689 H180753 H180817 H180878 H181038 H181099 H181162 H182009
H270256 H270418 H270526 H270690 H180627 H180690 H180754 H180818 H180879
H181039 H181100 H181163 H182010 H270260 H270419 H270529 H270692 H180628
H180691 H180755 H180819 H180880 H181040 H181101 H181164 H182012 H270261
H270421 H270532 H270693 H180629 H180692 H180756 H180820 H180881 H181041
H181102 H181165 H182013 H270264 H270425 H270534 H270697 H180630 H180694
H180757 H180821 H180882 H181042 H181103 H181166 H182016 H270267 H270426
H270535 H270698 H180631 H180695 H180758 H180822 H180883 H181043 H181104
H181167 H182017 H270271 H270427 H270539 H270699 H180632 H180696 H180759
H180823 H180884 H181044 H181105 H181168 H182018 H270273 H270428 H270540
H270700 H180633 H180697 H180760 H180824 H180885 H181045 H181106 H181170
H182019 H270277 H270430 H270542 H270705 H180634 H180698 H180761 H180825
H180886 H181046 H181107 H181171 H182020 H270280 H270431 H270544 H270708
H180635 H180699 H180762 H180826 H180887 H181047 H181108 H181172 H182021
H270281 H270435 H270547 H270709 H180636 H180700 H180763 H180827 H180888
H181048 H181109 H181173 H182022 H270282 H270436 H270550 H270710 H180637
H180701 H180764 H180828 H180890 H181049 H181110 H181174 H182023 H270285
H270437 H270601 H270711 H180638 H180702 H180765 H180829 H180891 H181050
H181111 H181175 H270004 H270290 H270438 H270602 H270712 H180639 H180703
H180766 H180830 H180892 H181051 H181112 H181176 H270006 H270293 H270439
H270605 H270714 H180640 H180704 H180767 H180831 H180894 H181052 H181113
H181177 H270009 H270297 H270443 H270606 H270716 H180641 H180705 H180768
H180832 H180895 H181053 H181114 H181178 H270010 H270302 H270445 H270607
H270718 H180642 H180706 H180769 H180833 H180896 H181055 H181115 H181179
H270021 H270303 H270446 H270613 H270719 H180643 H180707 H180770 H180834
H180897 H181056 H181116 H181180 H270026 H270307 H270447 H270615 H270725
H180644 H180708 H180771 H180835 H180898 H181057 H181117 H181181 H270027
H270310 H270448 H270622 H270726 H180645 H180709 H180772 H180836 H180899
H181058 H181118 H181182 H270029 H270314 H270451 H270623 H270727 H180646
H180710 H180773 H180837 H180901 H181059 H181119 H181183 H270030 H270321
H270452 H270624 H270728 H180647 H180711 H180774 H180838 H180907 H181060
H181120 H181184 H270038 H270323 H270454 H270625 H270732 H180649 H180713
H180775 H180839 H181000 H181061 H181121 H181185 H270045 H270324 H270455
H270626 H270733 H180650 H180714 H180776 H180840 H181001 H181062 H181123
H181187 H270047 H270329 H270458 H270627 H270735 H180651 H180715 H180777
H180841 H181002 H181063 H181124 H181188 H270073 H270332 H270461 H270631
H270736 H180652 H180716 H180778 H180842 H181003 H181064 H181125 H181189
H270079 H270335 H270462 H270632 H270737 H180653 H180717 H180779 H180843
H181004 H181065 H181126 H181191 H270088 H270337 H270464 H270633 H270739
H180654 H180718 H180780 H180844 H181005 H181066 H181127 H181192 H270094
H270338 H270466 H270634 H270740 H180655 H180719 H180781 H180845 H181006
H181067 H181128 H181193 H270096 H270341 H270470 H270635 H270746 H180656
H180720 H180782 H180847 H181007 H181068 H181129 H181194 H270101 H270343
H270473 H270637 H270749 H180657 H180721 H180783 H180848 H181008 H181069
H181130 H181195 H270106 H270344 H270474 H270639 H270751 H180658 H180722
H180784 H180849 H181009 H181070 H181132 H181196 H270107 H270345 H270476
H270641 H270752 H180659 H180723 H180785 H180850 H181010 H181071 H181133
H181197 H270110 H270351 H270477 H270643 H270755 H180660 H180724 H180786
H180851 H181011 H181072 H181134 H181198 H270111 H270352 H270479 H270644
H270757 H270760 H270865 H271051 H271141 H271219 H271293 H271362 H271426
H271499 H271562 H271627 H271692 H271756 H270761 H270866 H271052 H271142
H271222 H271294 H271363 H271428 H271500 H271563 H271628 H271693 H271757
H270762 H270867 H271055 H271143 H271223 H271295 H271364 H271429 H271501
H271564 H271629 H271695 H271758 H270763 H270868 H271056 H271144 H271224
H271296 H271365 H271430 H271502 H271565 H271630 H271696 H271759 H270766
H270869 H271057 H271145 H271225 H271297 H271366 H271431 H271503 H271566
H271631 H271697 H271760 H270767 H270870 H271059 H271149 H271226 H271298
H271367 H271432 H271504 H271567 H271632 H271698 H271761 H270769 H270871
H271061 H271151 H271227 H271300 H271368 H271433 H271505 H271568 H271633
H271699 H271762 H270777 H270872 H271062 H271152 H271228 H271301 H271369
H271434 H271506 H271570 H271634 H271700 H271763 H270778 H270873 H271063
H271153 H271229 H271302 H271370 H271435 H271507 H271571 H271635 H271701
H271764 H270781 H270875 H271065 H271154 H271230 H271303 H271371 H271436
H271508 H271572 H271636 H271702 H271765 H270782 H270877 H271066 H271155
H271231 H271304 H271372 H271437 H271509 H271573 H271637 H271703 H271766
H270783 H270878 H271067 H271157 H271233 H271305 H271373 H271438 H271510
H271574 H271638 H271704 H271767 H270785 H270879 H271068 H271158 H271234
H271306 H271374 H271439 H271511 H271575 H271639 H271705 H271768 H270786
H270880 H271071 H271159 H271235 H271307 H271375 H271440 H271512 H271576
H271640 H271706 H271769 H270787 H270881 H271072 H271160 H271236 H271308
H271376 H271441 H271513 H271577 H271641 H271707 H271770 H270788 H270882
H271073 H271161 H271238 H271309 H271377 H271442 H271514 H271578 H271642
H271708 H271771 H270789 H270883 H271075 H271162 H271239 H271311 H271378
H271443 H271515 H271580 H271643 H271709 H271772 H270791 H270884 H271076
H271165 H271241 H271312 H271379 H271444 H271516 H271581 H271645 H271710
H271773 H270793 H270885 H271079 H271166 H271242 H271314 H271380 H271445
H271517 H271582 H271646 H271711 H271774 H270794 H270886 H271080 H271167
H271243 H271315 H271381 H271447 H271518 H271583 H271647 H271712 H271775
H270796 H270888 H271082 H271168 H271245 H271316 H271382 H271448 H271519
H271586 H271648 H271713 H271776 H270799 H270889 H271083 H271172 H271247
H271317 H271383 H271449 H271520 H271587 H271649 H271714 H271777 H270800
H270890 H271085 H271174 H271248 H271318 H271384 H271450 H271521 H271588
H271650 H271715 H271778 H270801 H270891 H271086 H271176 H271249 H271319
H271385 H271451 H271522 H271589 H271651 H271716 H271779 H270803 H270892
H271088 H271177 H271250 H271320 H271386 H271453 H271523 H271590 H271652
H271717 H271780 H270804 H270894 H271091 H271178 H271251 H271321 H271387
H271454 H271525 H271591 H271653 H271718 H271781 H270805 H270895 H271092
H271179 H271253 H271322 H271388 H271456 H271526 H271592 H271654 H271719
H271782 H270806 H270896 H271093 H271182 H271256 H271323 H271389 H271457
H271527 H271593 H271655 H271720 H271783 H270812 H270897 H271094 H271183
H271257 H271324 H271390 H271458 H271528 H271594 H271656 H271722 H271784
H270813 H270898 H271095 H271184 H271258 H271325 H271392 H271459 H271529
H271595 H271657 H271723 H271785 H270817 H270899 H271096 H271185 H271259
H271327 H271393 H271460 H271530 H271596 H271658 H271724 H271786 H270820
H271000 H271097 H271186 H271260 H271328 H271394 H271461 H271531 H271597
H271659 H271725 H271787 H270821 H271002 H271098 H271188 H271263 H271329
H271395 H271462 H271532 H271598 H271660 H271726 H271788 H270822 H271004
H271099 H271189 H271264 H271330 H271397 H271464 H271533 H271599 H271662
H271727 H271789 H270823 H271005 H271100 H271190 H271265 H271331 H271398
H271465 H271534 H271600 H271663 H271728 H271790 H270825 H271009 H271101
H271191 H271266 H271332 H271399 H271466 H271535 H271601 H271664 H271729
H271791 H270826 H271013 H271102 H271192 H271267 H271333 H271401 H271467
H271536 H271602 H271666 H271731 H271792 H270827 H271015 H271103 H271193
H271268 H271334 H271402 H271468 H271537 H271603 H271667 H271732 H271793
H270828 H271016 H271104 H271194 H271269 H271335 H271403 H271470 H271538
H271604 H271669 H271733 H271794 H270829 H271017 H271105 H271195 H271270
H271336 H271404 H271472 H271539 H271605 H271670 H271734 H271795 H270833
H271019 H271107 H271196 H271272 H271337 H271406 H271473 H271540 H271606
H271671 H271735 H271796 H270835 H271020 H271108 H271197 H271273 H271338
H271407 H271474 H271541 H271607 H271672 H271736 H271797 H270836 H271021
H271109 H271198 H271274 H271339 H271408 H271475 H271542 H271608 H271673
H271737 H271798 H270837 H271023 H271110 H271199 H271275 H271340 H271409
H271476 H271543 H271609 H271674 H271738 H271799 H270838 H271024 H271111
H271200 H271276 H271342 H271410 H271477 H271544 H271610 H271675 H271739
H271800 H270840 H271025 H271112 H271201 H271277 H271343 H271411 H271478
H271545 H271611 H271676 H271740 H271801 H270841 H271026 H271113 H271202
H271278 H271344 H271412 H271479 H271546 H271612 H271677 H271741 H271802
H270842 H271027 H271114 H271204 H271280 H271345 H271413 H271481 H271547
H271613 H271678 H271742 H271803 H270844 H271029 H271115 H271205 H271281
H271347 H271414 H271483 H271548 H271614 H271679 H271743 H271804 H270845
H271031 H271116 H271206 H271282 H271349 H271415 H271484 H271549 H271615
H271680 H271744 H271805 H270846 H271032 H271117 H271207 H271283 H271350
H271416 H271485 H271550 H271616 H271681 H271746 H271806 H270852 H271034
H271120 H271208 H271284 H271351 H271417 H271487 H271551 H271617 H271682
H271747 H271807 H270854 H271035 H271121 H271209 H271285 H271353 H271418
H271488 H271552 H271618 H271683 H271748 H271808 H270855 H271037 H271125
H271210 H271286 H271355 H271419 H271490 H271553 H271619 H271684 H271749
H271809 H270857 H271038 H271127 H271211 H271287 H271356 H271420 H271492
H271554 H271620 H271685 H271750 H271810 H270858 H271039 H271131 H271212
H271288 H271357 H271421 H271493 H271555 H271621 H271686 H271751 H271811
H270859 H271041 H271132 H271214 H271289 H271358 H271422 H271494 H271557
H271622 H271687 H271752 H271812 H270861 H271042 H271135 H271216 H271290
H271359 H271423 H271495 H271558 H271624 H271688 H271753 H271813 H270863
H271043 H271136 H271217 H271291 H271360 H271424 H271497 H271559 H271625
H271689 H271754 H271814 H270864 H271044 H271137 H271218 H271292 H271361
H271425 H271498 H271561 H271626 H271691 H271755 H271815 H271816 H271876
H271937 H271998 H272062 H272124 H272184 H272246 H272308 H272368 H272428
H272492 H272855 H271817 H271877 H271938 H271999 H272063 H272125 H272185
H272247 H272309 H272369 H272429 H272493 H272856 H271818 H271878 H271939
H272000 H272064 H272126 H272186 H272248 H272310 H272370 H272430 H272494
H272857 H271819 H271879 H271940 H272001 H272065 H272127 H272187 H272249
H272311 H272371 H272431 H272495 H272858 H271820 H271880 H271941 H272002
H272066 H272128 H272188 H272250 H272312 H272372 H272432 H272496 H272859
H271821 H271881 H271942 H272003 H272067 H272129 H272189 H272251 H272313
H272373 H272433 H272497 H272860 H271822 H271882 H271943 H272004 H272068
H272130 H272190 H272253 H272314 H272374 H272434 H272500 H272861 H271823
H271883 H271944 H272005 H272069 H272131 H272191 H272254 H272315 H272375
H272435 H272800 H272862 H271824 H271884 H271945 H272006 H272070 H272132
H272192 H272255 H272316 H272376 H272436 H272801 H272863 H271825 H271885
H271946 H272007 H272071 H272133 H272193 H272256 H272317 H272377 H272437
H272802 H272864 H271826 H271886 H271947 H272009 H272072 H272134 H272194
H272257 H272318 H272378 H272438 H272803 H272865 H271827 H271887 H271948
H272010 H272073 H272135 H272195 H272258 H272319 H272379 H272439 H272804
H272866 H271828 H271888 H271949 H272011 H272074 H272136 H272196 H272259
H272320 H272380 H272440 H272805 H272867 H271829 H271889 H271950 H272012
H272075 H272137 H272197 H272260 H272321 H272381 H272441 H272806 H272868
H271830 H271890 H271951 H272013 H272076 H272138 H272198 H272261 H272322
H272382 H272442 H272807 H272869 H271831 H271891 H271952 H272014 H272077
H272139 H272199 H272262 H272323 H272383 H272443 H272808 H272870 H271832
H271892 H271953 H272015 H272078 H272140 H272200 H272263 H272324 H272384
H272444 H272809 H272871 H271833 H271893 H271954 H272016 H272079 H272141
H272201 H272264 H272325 H272385 H272445 H272810 H272872 H271834 H271894
H271955 H272017 H272080 H272142 H272202 H272265 H272326 H272386 H272446
H272811 H272873 H271835 H271895 H271956 H272018 H272081 H272143 H272203
H272266 H272327 H272387 H272447 H272812 H272875 H271836 H271896 H271957
H272019 H272082 H272144 H272204 H272267 H272328 H272388 H272448 H272813
H272876 H271837 H271897 H271958 H272020 H272083 H272145 H272205 H272268
H272329 H272389 H272449 H272814 H272877 H271838 H271898 H271959 H272021
H272084 H272146 H272206 H272269 H272330 H272390 H272450 H272815 H272878
H271839 H271899 H271960 H272022 H272085 H272147 H272207 H272270 H272331
H272391 H272451 H272816 H272879 H271840 H271901 H271961 H272023 H272086
H272148 H272208 H272271 H272332 H272392 H272452 H272817 H272880 H271841
H271902 H271962 H272024 H272087 H272149 H272209 H272272 H272333 H272393
H272453 H272818 H272881 H271842 H271903 H271963 H272025 H272088 H272150
H272210 H272273 H272334 H272394 H272454 H272819 H272882 H271843 H271904
H271964 H272026 H272089 H272151 H272211 H272274 H272335 H272395 H272455
H272820 H272883 H271844 H271905 H271965 H272027 H272090 H272152 H272212
H272276 H272336 H272396 H272456 H272821 H272884 H271845 H271906 H271966
H272028 H272091 H272153 H272213 H272277 H272337 H272397 H272457 H272822
H272885 H271846 H271907 H271967 H272029 H272092 H272154 H272215 H272278
H272338 H272398 H272458 H272823 H272886 H271847 H271908 H271968 H272030
H272093 H272155 H272216 H272279 H272339 H272399 H272459 H272824 H272887
H271848 H271909 H271969 H272031 H272094 H272156 H272217 H272280 H272340
H272400 H272460 H272825 H272888 H271849 H271910 H271970 H272032 H272095
H272157 H272218 H272281 H272341 H272401 H272461 H272826 H272889 H271850
H271911 H271971 H272033 H272096 H272158 H272219 H272282 H272342 H272402
H272462 H272827 H272890 H271851 H271912 H271972 H272034 H272097 H272159
H272220 H272283 H272343 H272403 H272463 H272828 H272891 H271852 H271913
H271973 H272035 H272098 H272160 H272221 H272284 H272344 H272404 H272464
H272829 H272892 H271853 H271914 H271974 H272036 H272099 H272161 H272222
H272285 H272345 H272405 H272465 H272830 H272893 H271854 H271915 H271975
H272038 H272100 H272162 H272223 H272286 H272346 H272406 H272466 H272831
H272894 H271855 H271916 H271976 H272039 H272101 H272163 H272224 H272287
H272347 H272407 H272467 H272833 H272895 H271856 H271917 H271977 H272040
H272102 H272164 H272226 H272288 H272348 H272408 H272468 H272834 H272896
H271857 H271918 H271978 H272041 H272103 H272165 H272227 H272289 H272349
H272409 H272469 H272836 H272897 H271858 H271919 H271979 H272043 H272104
H272166 H272228 H272290 H272350 H272410 H272470 H272837 H272898 H271859
H271920 H271980 H272045 H272106 H272167 H272229 H272291 H272351 H272411
H272471 H272838 H272899 H271860 H271921 H271981 H272046 H272107 H272168
H272230 H272292 H272352 H272412 H272472 H272839 H272900 H271861 H271922
H271982 H272047 H272108 H272169 H272231 H272293 H272353 H272413 H272473
H272840 H272901 H271862 H271923 H271983 H272048 H272109 H272170 H272232
H272294 H272354 H272414 H272475 H272841 H272902 H271863 H271924 H271984
H272049 H272110 H272171 H272233 H272295 H272355 H272415 H272476 H272842
H272903 H271864 H271925 H271985 H272050 H272111 H272172 H272234 H272296
H272356 H272416 H272477 H272843 H272904 H271865 H271926 H271986 H272051
H272112 H272173 H272235 H272297 H272357 H272417 H272478 H272844 H272905
H271866 H271927 H271987 H272052 H272113 H272174 H272236 H272298 H272358
H272418 H272479 H272845 H272906 H271867 H271928 H271988 H272053 H272114
H272175 H272237 H272299 H272359 H272419 H272480 H272846 H272907 H271868
H271929 H271989 H272054 H272115 H272176 H272238 H272300 H272360 H272420
H272482 H272847 H272908 H271869 H271930 H271990 H272055 H272116 H272177
H272239 H272301 H272361 H272421 H272483 H272848 H272909 H271870 H271931
H271991 H272056 H272117 H272178 H272240 H272302 H272362 H272422 H272484
H272849 H272910 H271871 H271932 H271992 H272057 H272118 H272179 H272241
H272303 H272363 H272423 H272485 H272850 H272911 H271872 H271933 H271993
H272058 H272119 H272180 H272242 H272304 H272364 H272424 H272488 H272851
H272912 H271873 H271934 H271994 H272059 H272121 H272181 H272243 H272305
H272365 H272425 H272489 H272852 H272913 H271874 H271935 H271996 H272060
H272122 H272182 H272244 H272306 H272366 H272426 H272490 H272853 H272914
H271875 H271936 H271997 H272061 H272123 H272183 H272245 H272307 H272367
H272427 H272491 H272854 H272915 H272916 H272977 H273040 H273104 H273171
H290125 H290215 H290282 H290346 H290409 H290545 H291045 H291106 H272917
H272978 H273041 H273105 H273172 H290128 H290216 H290283 H290347 H290410
H290546 H291046 H291107 H272918 H272979 H273042 H273106 H273173 H290130
H290217 H290284 H290348 H290411 H290547 H291047 H291108 H272919 H272980
H273043 H273107 H273174 H290132 H290219 H290285 H290349 H290412 H290548
H291048 H291109 H272920 H272981 H273044 H273108 H273175 H290135 H290220
H290286 H290350 H290413 H290549 H291049 H291111 H272921 H272982 H273045
H273109 H273176 H290137 H290221 H290287 H290351 H290414 H290550 H291050
H291112 H272922 H272983 H273046 H273110 H273177 H290138 H290222 H290288
H290352 H290415 H290551 H291051 H291113 H272923 H272984 H273047 H273111
H273178 H290139 H290223 H290289 H290353 H290416 H290552 H291052 H291114
H272924 H272985 H273048 H273112 H273179 H290141 H290224 H290290 H290354
H290417 H290553 H291053 H291115 H272925 H272986 H273049 H273113 H273180
H290143 H290225 H290291 H290355 H290422 H290554 H291054 H291116 H272926
H272988 H273050 H273114 H273181 H290144 H290226 H290292 H290356 H290423
H290555 H291055 H291117 H272927 H272989 H273051 H273115 H273182 H290145
H290227 H290293 H290357 H290424 H290556 H291056 H291118 H272928 H272990
H273052 H273116 H273183 H290146 H290229 H290295 H290358 H290425 H290557
H291057 H291119 H272929 H272991 H273053 H273117 H273184 H290151 H290230
H290296 H290359 H290426 H290558 H291058 H291120 H272930 H272992 H273054
H273118 H273185 H290152 H290231 H290297 H290360 H290427 H290559 H291059
H291121 H272931 H272993 H273055 H273119 H273186 H290154 H290232 H290299
H290362 H290500 H290560 H291060 H291122 H272932 H272994 H273056 H273120
H273187 H290155 H290233 H290301 H290363 H290501 H290561 H291061 H291123
H272933 H272995 H273057 H273121 H273189 H290156 H290234 H290302 H290364
H290502 H290600 H291062 H291124 H272934 H272996 H273058 H273122 H273190
H290157 H290235 H290304 H290365 H290503 H291001 H291063 H291125 H272935
H272997 H273059 H273123 H273191 H290158 H290236 H290305 H290366 H290504
H291003 H291064 H291126 H272936 H272998 H273060 H273124 H273193 H290159
H290237 H290306 H290367 H290505 H291004 H291065 H291127 H272937 H272999
H273061 H273125 H273194 H290160 H290239 H290307 H290368 H290506 H291005
H291066 H291128 H272938 H273000 H273062 H273126 H273195 H290161 H290240
H290308 H290369 H290507 H291006 H291067 H291129 H272939 H273001 H273063
H273127 H273196 H290162 H290241 H290309 H290370 H290508 H291007 H291068
H291130 H272940 H273002 H273065 H273128 H273197 H290164 H290242 H290310
H290371 H290509 H291008 H291069 H291131 H272941 H273003 H273066 H273130
H273198 H290165 H290243 H290311 H290372 H290510 H291009 H291070 H291132
H272942 H273004 H273067 H273131 H273199 H290166 H290244 H290312 H290373
H290511 H291010 H291071 H291133 H272943 H273005 H273068 H273132 H273200
H290168 H290246 H290313 H290374 H290512 H291011 H291072 H291134 H272944
H273006 H273069 H273133 H273201 H290171 H290247 H290314 H290375 H290513
H291012 H291073 H291135 H272946 H273007 H273070 H273134 H273202 H290173
H290248 H290315 H290376 H290514 H291013 H291074 H291136 H272947 H273008
H273071 H273135 H273203 H290175 H290249 H290316 H290377 H290515 H291014
H291075 H291137 H272948 H273010 H273072 H273136 H273204 H290176 H290250
H290317 H290378 H290516 H291015 H291076 H291138 H272949 H273011 H273074
H273137 H273206 H290180 H290253 H290318 H290379 H290517 H291016 H291077
H291139 H272950 H273012 H273075 H273138 H273208 H290181 H290254 H290319
H290380 H290518 H291017 H291078 H291140 H272951 H273013 H273077 H273140
H273209 H290182 H290255 H290320 H290381 H290519 H291018 H291079 H291141
H272952 H273014 H273078 H273141 H273210 H290183 H290256 H290321 H290382
H290520 H291019 H291080 H291142 H272953 H273016 H273079 H273142 H290001
H290185 H290257 H290322 H290383 H290521 H291020 H291081 H291143 H272954
H273017 H273080 H273143 H290003 H290186 H290258 H290323 H290384 H290522
H291021 H291082 H291144 H272955 H273018 H273081 H273144 H290021 H290187
H290259 H290324 H290385 H290523 H291022 H291083 H291145 H272956 H273019
H273082 H273145 H290026 H290189 H290260 H290325 H290386 H290524 H291023
H291084 H291146 H272957 H273020 H273083 H273147 H290027 H290191 H290261
H290326 H290387 H290525 H291024 H291085 H291147 H272958 H273021 H273084
H273148 H290030 H290192 H290262 H290327 H290388 H290526 H291025 H291086
H291148 H272959 H273022 H273085 H273149 H290031 H290193 H290263 H290328
H290389 H290527 H291026 H291087 H291149 H272960 H273023 H273086 H273150
H290032 H290194 H290264 H290329 H290390 H290528 H291027 H291088 H291150
H272961 H273024 H273087 H273151 H290033 H290195 H290265 H290330 H290392
H290529 H291028 H291089 H291151 H272962 H273025 H273088 H273152 H290034
H290196 H290266 H290331 H290393 H290530 H291029 H291090 H291152 H272963
H273026 H273089 H273153 H290103 H290197 H290267 H290332 H290394 H290531
H291030 H291091 H291153 H272964 H273027 H273090 H273155 H290104 H290198
H290268 H290333 H290395 H290532 H291031 H291092 H291154 H272965 H273028
H273091 H273156 H290105 H290201 H290269 H290334 H290396 H290533 H291032
H291093 H291155 H272966 H273029 H273092 H273157 H290108 H290202 H290271
H290335 H290397 H290534 H291034 H291094 H291156 H272967 H273030 H273093
H273158 H290109 H290203 H290272 H290336 H290398 H290535 H291035 H291095
H291157 H272968 H273031 H273094 H273159 H290110 H290205 H290273 H290337
H290399 H290536 H291036 H291096 H291158 H272969 H273032 H273095 H273160
H290111 H290206 H290274 H290338 H290400 H290537 H291037 H291097 H291159
H272970 H273033 H273097 H273162 H290113 H290208 H290275 H290339 H290401
H290538 H291038 H291098 H291160 H272971 H273034 H273098 H273163 H290114
H290209 H290276 H290340 H290402 H290539 H291039 H291099 H291161 H272972
H273035 H273099 H273164 H290116 H290210 H290277 H290341 H290403 H290540
H291040 H291101 H291162 H272973 H273036 H273100 H273165 H290118 H290211
H290278 H290342 H290404 H290541 H291041 H291102 H291163 H272974 H273037
H273101 H273166 H290121 H290212 H290279 H290343 H290405 H290542 H291042
H291103 H291164 H272975 H273038 H273102 H273167 H290122 H290213 H290280
H290344 H290406 H290543 H291043 H291104 H291165 H272976 H273039 H273103
H273170 H290123 H290214 H290281 H290345 H290408 H290544 H291044 H291105
H291166 H291167 H291227 H293310 H293370 H293432 H293492 H293554 H293616
H293677 H293739 H293800 H293861 H293921 H291168 H291228 H293311 H293371
H293433 H293493 H293555 H293617 H293678 H293740 H293801 H293862 H293922
H291169 H291229 H293312 H293372 H293434 H293494 H293556 H293618 H293679
H293741 H293802 H293863 H293923 H291170 H291230 H293313 H293373 H293435
H293495 H293557 H293619 H293681 H293742 H293803 H293864 H293924 H291171
H291231 H293314 H293374 H293436 H293496 H293558 H293620 H293682 H293743
H293804 H293865 H293925 H291172 H291232 H293315 H293375 H293437 H293497
H293559 H293621 H293683 H293744 H293805 H293866 H293926 H291173 H291233
H293316 H293376 H293438 H293498 H293560 H293622 H293684 H293745 H293806
H293867 H293927 H291174 H291234 H293317 H293377 H293439 H293499 H293561
H293623 H293685 H293746 H293807 H293868 H293928 H291175 H291235 H293318
H293378 H293440 H293500 H293562 H293624 H293686 H293747 H293808 H293869
H293929 H291176 H291236 H293319 H293379 H293441 H293501 H293563 H293625
H293687 H293748 H293809 H293870 H293930 H291177 H291237 H293320 H293380
H293442 H293502 H293564 H293626 H293688 H293749 H293810 H293871 H293931
H291178 H291238 H293321 H293381 H293443 H293503 H293565 H293627 H293689
H293750 H293811 H293872 H293932 H291179 H291239 H293322 H293382 H293444
H293504 H293566 H293628 H293690 H293751 H293812 H293873 H293933 H291180
H291240 H293323 H293383 H293445 H293505 H293567 H293629 H293691 H293752
H293813 H293874 H293934 H291181 H291241 H293324 H293384 H293446 H293506
H293568 H293630 H293692 H293753 H293814 H293875 H293935 H291182 H291242
H293325 H293385 H293447 H293507 H293569 H293631 H293693 H293754 H293815
H293876 H293936 H291183 H291243 H293326 H293386 H293448 H293508 H293570
H293632 H293694 H293755 H293816 H293877 H293938 H291184 H291244 H293327
H293387 H293449 H293509 H293571 H293633 H293695 H293756 H293817 H293878
H293940 H291185 H291245 H293328 H293388 H293450 H293510 H293572 H293634
H293696 H293758 H293818 H293879 H293941 H291186 H291246 H293329 H293389
H293451 H293511 H293573 H293635 H293697 H293759 H293819 H293880 H293942
H291187 H291247 H293330 H293390 H293452 H293512 H293574 H293636 H293698
H293760 H293820 H293881 H293943 H291188 H291248 H293331 H293391 H293453
H293513 H293575 H293637 H293699 H293761 H293821 H293882 H293944 H291189
H291249 H293332 H293393 H293454 H293514 H293576 H293638 H293700 H293762
H293822 H293883 H293945 H291190 H291250 H293333 H293394 H293455 H293515
H293577 H293639 H293701 H293763 H293823 H293884 H293946 H291191 H291251
H293334 H293395 H293456 H293516 H293578 H293640 H293702 H293764 H293824
H293885 H293947 H291192 H291252 H293335 H293396 H293457 H293517 H293579
H293641 H293703 H293765 H293825 H293886 H293948 H291193 H291253 H293336
H293397 H293458 H293518 H293581 H293642 H293704 H293766 H293826 H293887
H293949 H291194 H291254 H293337 H293398 H293459 H293519 H293583 H293643
H293705 H293767 H293827 H293888 H293950 H291195 H291255 H293338 H293399
H293460 H293520 H293584 H293644 H293706 H293768 H293828 H293889 H293951
H291196 H291256 H293339 H293401 H293461 H293521 H293585 H293645 H293707
H293769 H293829 H293890 H293952 H291197 H291257 H293340 H293402 H293462
H293522 H293586 H293646 H293708 H293770 H293830 H293891 H293953 H291198
H291258 H293341 H293403 H293463 H293523 H293587 H293648 H293709 H293771
H293831 H293892 H293954 H291199 H291259 H293342 H293404 H293464 H293524
H293588 H293649 H293710 H293772 H293832 H293893 H293955 H291200 H291260
H293343 H293405 H293465 H293525 H293589 H293650 H293712 H293773 H293833
H293894 H293956 H291201 H291261 H293344 H293406 H293466 H293527 H293590
H293651 H293713 H293774 H293834 H293895 H293957 H291202 H291262 H293345
H293407 H293467 H293528 H293591 H293652 H293714 H293775 H293835 H293896
H293958 H291203 H291263 H293346 H293408 H293468 H293529 H293592 H293653
H293715 H293776 H293836 H293897 H293959 H291204 H291264 H293347 H293409
H293469 H293530 H293593 H293654 H293716 H293777 H293837 H293898 H293960
H291205 H291265 H293348 H293410 H293470 H293531 H293594 H293655 H293717
H293778 H293838 H293899 H293961 H291206 H291266 H293349 H293411 H293471
H293532 H293595 H293656 H293718 H293779 H293839 H293900 H293962 H291207
H291267 H293350 H293412 H293472 H293533 H293596 H293657 H293719 H293780
H293840 H293901 H293963 H291208 H291268 H293351 H293413 H293473 H293534
H293597 H293658 H293720 H293781 H293841 H293902 H293964 H291209 H291269
H293352 H293414 H293474 H293535 H293598 H293659 H293721 H293782 H293842
H293903 H293965 H291210 H291270 H293353 H293415 H293475 H293536 H293599
H293660 H293722 H293783 H293843 H293904 H293966 H291211 H291271 H293354
H293416 H293476 H293537 H293600 H293661 H293723 H293784 H293844 H293905
H293967 H291212 H291272 H293355 H293417 H293477 H293538 H293601 H293662
H293724 H293785 H293845 H293906 H293968 H291213 H291273 H293356 H293418
H293478 H293539 H293602 H293663 H293725 H293786 H293846 H293907 H293969
H291214 H292832 H293357 H293419 H293479 H293540 H293603 H293664 H293726
H293787 H293847 H293908 H293970 H291215 H293009 H293358 H293420 H293480
H293541 H293604 H293665 H293727 H293788 H293848 H293909 H293971 H291216
H293207 H293359 H293421 H293481 H293542 H293605 H293666 H293728 H293789
H293849 H293910 H293972 H291217 H293300 H293360 H293422 H293482 H293543
H293606 H293667 H293729 H293790 H293850 H293911 H293974 H291218 H293301
H293361 H293423 H293483 H293544 H293607 H293668 H293730 H293791 H293851
H293912 H293975 H291219 H293302 H293362 H293424 H293484 H293545 H293608
H293669 H293731 H293792 H293852 H293913 H293976 H291220 H293303 H293363
H293425 H293485 H293546 H293609 H293670 H293732 H293793 H293854 H293914
H293977 H291221 H293304 H293364 H293426 H293486 H293548 H293610 H293671
H293733 H293794 H293855 H293915 H293978 H291222 H293305 H293365 H293427
H293487 H293549 H293611 H293672 H293734 H293795 H293856 H293916 H293979
H291223 H293306 H293366 H293428 H293488 H293550 H293612 H293673 H293735
H293796 H293857 H293917 H293980 H291224 H293307 H293367 H293429 H293489
H293551 H293613 H293674 H293736 H293797 H293858 H293918 H293981 H291225
H293308 H293368 H293430 H293490 H293552 H293614 H293675 H293737 H293798
H293859 H293919 H293982 H291226 H293309 H293369 H293431 H293491 H293553
H293615 H293676 H293738 H293799 H293860 H293920 H293983 H293984 H294045
H294107 H294169 H294229 H294291 H294352 H294413 H294477 H294537 H294604
H294666 H294730 H293985 H294046 H294108 H294170 H294230 H294292 H294353
H294414 H294478 H294538 H294605 H294667 H294731 H293986 H294047 H294109
H294171 H294231 H294293 H294354 H294415 H294479 H294539 H294606 H294668
H294732 H293987 H294048 H294110 H294172 H294232 H294294 H294355 H294416
H294480 H294540 H294607 H294669 H294733 H293988 H294049 H294111 H294173
H294233 H294295 H294356 H294417 H294481 H294541 H294608 H294670 H294734
H293989 H294050 H294112 H294174 H294234 H294296 H294357 H294418 H294482
H294542 H294610 H294671 H294735 H293990 H294051 H294113 H294175 H294235
H294297 H294358 H294419 H294483 H294543 H294611 H294672 H294736 H293991
H294052 H294114 H294176 H294236 H294298 H294359 H294420 H294484 H294544
H294612 H294673 H294737 H293992 H294053 H294116 H294177 H294237 H294299
H294360 H294421 H294485 H294545 H294613 H294674 H294738 H293993 H294054
H294117 H294178 H294238 H294300 H294361 H294422 H294486 H294546 H294614
H294675 H294739 H293994 H294055 H294118 H294179 H294239 H294301 H294362
H294423 H294487 H294547 H294615 H294676 H294740 H293995 H294056 H294119
H294180 H294240 H294302 H294363 H294424 H294488 H294548 H294616 H294677
H294741 H293996 H294057 H294120 H294181 H294241 H294303 H294364 H294425
H294489 H294549 H294617 H294678 H294742 H293997 H294058 H294121 H294182
H294242 H294304 H294365 H294426 H294490 H294550 H294618 H294679 H294743
H293998 H294059 H294122 H294183 H294243 H294305 H294366 H294427 H294491
H294551 H294619 H294680 H294744 H293999 H294060 H294123 H294184 H294244
H294306 H294367 H294428 H294492 H294552 H294620 H294681 H294745 H294000
H294061 H294124 H294185 H294245 H294307 H294368 H294429 H294493 H294553
H294621 H294682 H294746 H294001 H294062 H294125 H294186 H294246 H294308
H294369 H294430 H294494 H294554 H294622 H294683 H294747 H294002 H294063
H294126 H294187 H294247 H294309 H294370 H294431 H294495 H294555 H294623
H294684 H294748 H294003 H294064 H294127 H294188 H294248 H294310 H294371
H294432 H294496 H294556 H294624 H294685 H294749 H294004 H294065 H294128
H294189 H294249 H294311 H294372 H294433 H294497 H294557 H294625 H294686
H294750 H294005 H294066 H294129 H294190 H294250 H294312 H294373 H294434
H294498 H294564 H294626 H294687 H294751 H294006 H294067 H294130 H294191
H294252 H294313 H294374 H294435 H294499 H294565 H294627 H294688 H294752
H294007 H294068 H294131 H294192 H294253 H294314 H294375 H294436 H294500
H294567 H294628 H294689 H294753 H294008 H294069 H294132 H294193 H294254
H294315 H294376 H294437 H294501 H294568 H294629 H294690 H294754 H294009
H294070 H294133 H294194 H294255 H294316 H294377 H294438 H294502 H294569
H294630 H294691 H294755 H294010 H294071 H294134 H294195 H294256 H294317
H294378 H294439 H294503 H294570 H294631 H294692 H294756 H294011 H294072
H294135 H294196 H294257 H294318 H294379 H294440 H294504 H294571 H294632
H294693 H294757 H294012 H294073 H294136 H294197 H294258 H294319 H294380
H294442 H294505 H294572 H294633 H294694 H294758 H294013 H294074 H294137
H294198 H294259 H294320 H294381 H294443 H294506 H294573 H294634 H294695
H294759 H294014 H294075 H294139 H294199 H294260 H294321 H294382 H294444
H294507 H294574 H294635 H294696 H294760 H294015 H294076 H294140 H294200
H294261 H294322 H294383 H294445 H294508 H294575 H294636 H294697 H294761
H294016 H294077 H294141 H294201 H294262 H294323 H294384 H294446 H294509
H294576 H294637 H294698 H294762 H294017 H294078 H294142 H294202 H294263
H294324 H294385 H294447 H294510 H294577 H294638 H294700 H294763 H294018
H294079 H294143 H294203 H294264 H294325 H294386 H294448 H294511 H294578
H294639 H294701 H294764 H294020 H294080 H294144 H294204 H294265 H294326
H294387 H294449 H294512 H294579 H294640 H294702 H294765 H294021 H294081
H294145 H294205 H294266 H294327 H294388 H294450 H294513 H294580 H294641
H294704 H294766 H294022 H294083 H294146 H294206 H294267 H294328 H294389
H294451 H294514 H294581 H294642 H294705 H294767 H294023 H294084 H294147
H294207 H294268 H294329 H294390 H294452 H294515 H294582 H294643 H294706
H294768 H294024 H294085 H294148 H294208 H294269 H294330 H294391 H294454
H294516 H294583 H294644 H294707 H294769 H294025 H294086 H294149 H294209
H294270 H294331 H294392 H294457 H294517 H294584 H294645 H294708 H294770
H294026 H294087 H294150 H294210 H294271 H294332 H294393 H294458 H294518
H294585 H294646 H294709 H294771 H294027 H294088 H294151 H294211 H294272
H294333 H294394 H294459 H294519 H294586 H294647 H294710 H294772 H294028
H294089 H294152 H294212 H294273 H294334 H294395 H294460 H294520 H294587
H294648 H294711 H294773 H294029 H294090 H294153 H294213 H294274 H294335
H294396 H294461 H294521 H294588 H294649 H294712 H294774 H294030 H294091
H294154 H294214 H294275 H294336 H294397 H294462 H294522 H294589 H294650
H294713 H294775 H294031 H294092 H294155 H294215 H294276 H294337 H294398
H294463 H294523 H294590 H294651 H294714 H294776 H294032 H294093 H294156
H294216 H294277 H294338 H294399 H294464 H294524 H294591 H294652 H294715
H294777 H294033 H294094 H294157 H294217 H294278 H294339 H294401 H294465
H294525 H294592 H294653 H294716 H294778 H294034 H294095 H294158 H294218
H294279 H294340 H294402 H294466 H294526 H294593 H294654 H294717 H294779
H294035 H294097 H294159 H294219 H294280 H294341 H294403 H294467 H294527
H294594 H294655 H294718 H294780 H294036 H294098 H294160 H294220 H294281
H294342 H294404 H294468 H294528 H294595 H294656 H294719 H294781 H294037
H294099 H294161 H294221 H294283 H294343 H294405 H294469 H294529 H294596
H294657 H294720 H294782 H294038 H294100 H294162 H294222 H294284 H294345
H294406 H294470 H294530 H294597 H294658 H294721 H294783 H294039 H294101
H294163 H294223 H294285 H294346 H294407 H294471 H294531 H294598 H294659
H294723 H294784 H294040 H294102 H294164 H294224 H294286 H294347 H294408
H294472 H294532 H294599 H294660 H294724 H294785 H294041 H294103 H294165
H294225 H294287 H294348 H294409 H294473 H294533 H294600 H294661 H294726
H294786 H294042 H294104 H294166 H294226 H294288 H294349 H294410 H294474
H294534 H294601 H294663 H294727 H294787 H294043 H294105 H294167 H294227
H294289 H294350 H294411 H294475 H294535 H294602 H294664 H294728 H294788
H294044 H294106 H294168 H294228 H294290 H294351 H294412 H294476 H294536
H294603 H294665 H294729 H294789 H294790 H294854 H294917 H294984 H295049
H295120 H295203 H294791 H294855 H294918 H294986 H295050 H295121 H295206
H294792 H294856 H294919 H294987 H295051 H295122 H295207 H294793 H294857
H294920 H294988 H295053 H295125 H295209 H294794 H294858 H294921 H294989
H295054 H295126 H295211 H294795 H294859 H294922 H294990 H295056 H295127
H295212 H294796 H294860 H294923 H294991 H295057 H295128 H295213 H294797
H294861 H294924 H294992 H295058 H295129 H295216 H294798 H294862 H294925
H294993 H295059 H295130 H295217 H294799 H294863 H294926 H294995 H295060
H295131 H295224 H294800 H294864 H294927 H294996 H295061 H295132 H295225
H294801 H294865 H294928 H294997 H295062 H295133 H295226 H294802 H294866
H294929 H294998 H295063 H295134 H295227 H294803 H294867 H294930 H294999
H295064 H295135 H295231 H294804 H294868 H294931 H295000 H295065 H295136
Hcx3582 H294806 H294869 H294932 H295001 H295066 H295138 Hcx4019 H294807
H294870 H294933 H295002 H295067 H295139 Hcx4138 H294808 H294871 H294934
H295003 H295068 H295140 Hcx4344 H294809 H294872 H294935 H295004 H295069
H295141 Hcx4400 H294810 H294874 H294936 H295006 H295070 H295142 Hcx4566
H294811 H294875 H294937 H295008 H295071 H295143 Hcx4662 H294812 H294876
H294938 H295009 H295072 H295144 Hcx4703 H294813 H294877 H294940 H295010
H295073 H295145 Hcx4849 H294814 H294878 H294941 H295011 H295074 H295146
Hcx4852 H294815 H294879 H294942 H295012 H295075 H295147 Hcx4973 H294816
H294880 H294943 H295013 H295076 H295148 Hcx4994 H294817 H294881 H294945
H295014 H295077 H295149 Hcx5055 H294818 H294882 H294946 H295015 H295078
H295150 Hcx5088 H294820 H294883 H294947 H295016 H295080 H295151 Hcx5113
H294821 H294884 H294949 H295017 H295081 H295152 H294822 H294885 H294950
H295018 H295082 H295155 H294823 H294886 H294951 H295019 H295083 H295156
H294824 H294887 H294952 H295020 H295084 H295157 H294825 H294888 H294953
H295021 H295085 H295158 H294826 H294889 H294954 H295022 H295087 H295159
H294827 H294890 H294955 H295023 H295089 H295160 H294828 H294891 H294956
H295024 H295090 H295161 H294829 H294892 H294957 H295025 H295093 H295162
H294830 H294893 H294958 H295026 H295094 H295169 H294831 H294894 H294959
H295027 H295095 H295170 H294832 H294895 H294960 H295028 H295096 H295171
H294833 H294896 H294961 H295029 H295097 H295172 H294834 H294897 H294962
H295030 H295099 H295173 H294835 H294898 H294963 H295031 H295100 H295174
H294836 H294899 H294965 H295032 H295101 H295176 H294837 H294900 H294966
H295033 H295102 H295177 H294838 H294901 H294967 H295034 H295103 H295178
H294839 H294902 H294969 H295035 H295105 H295179 H294840 H294903 H294970
H295036 H295106 H295182 H294841 H294904 H294971 H295037 H295107 H295183
H294842 H294905 H294972 H295038 H295108 H295184 H294843 H294906 H294974
H295039 H295109 H295185 H294844 H294907 H294975 H295040 H295110 H295186
H294845 H294908 H294976 H295041 H295111 H295188 H294846 H294910 H294977
H295042 H295112 H295193 H294847 H294911 H294978 H295044 H295114 H295195
H294848 H294912 H294979 H295045 H295116 H295196 H294850 H294914 H294980
H295046 H295117 H295199 H294851 H294915 H294981 H295047 H295118 H295201
H294853 H294916 H294982 H295048 H295119 H295202
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology
Systems, Palo Alto, CA,
REASON Varian
has received reports in which a user has remotely rotated the gantry into
contact with the couch or with the patient, in both the manual mode and the
automate mode.
VOLUME OF PRODUCT IN COMMERCE
5823 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
1) Stryker Modular Dual Mobility (MDM)
Liner and X3 Acetabular Insert; The MDM Liner and X3 Acetabular Inserts is a
sterile single-use device intended for use in primary and revision total hip
arthroplasty to alleviate pain and restore function. This device is intended
to be used only with any currently available Howmedica Osteonics 22.2 mm and
28 mm diameter femoral heads. Catalog No. 626-00-XXY (XXY= 36C, 38D, 42E, 46F,
48G, 52H, 54I, 58J).
2) Stryker Restoration ADM System X3
Acetabular Insert. The Restoration ADM System X# Acetabular Insert is a
sterile, single-use device intended for use in primary and revision total hip
arthroplasty to alleviate pain and restore function. This device is intended
to be used only with any currently available Howmedica Osteonics 28mm diameter
femoral heads. Catalog No.: 1236-2-8XX (XX=46, 48, 50, 52, 54, 56, 58, 60, 62,
64).
3) Stryker Restoration ADM System; The
Restoration ADM is a sterile, single-use device intended for use in primary
and revision total hip arthroplasty to alleviate pain and restore function.
This device is intended to be used only with any currently available Howmedica
Osteonics 22.2 mm and 28 mm diameter femoral heads. Catalog No: 1235-2-8XX
(XX+48, 50, 52, 54, 56, 58, 60, 63, 64).
CODE
1) All Lots K103233;
2) All Lots K093644;
3) All Lots K0272020
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica
Osteonics Corp., Mahwah, NJ, .
Manufacturer: Stryker Ireland,
Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland.
REASON There
is the potential for interpretation of the product labeling which may lead to
an incorrect implant being used.
VOLUME OF PRODUCT IN COMMERCE
16,891 units
PRODUCT
1) SUPER TORQUE MB Angiographic Catheter
product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97
mm)***PIG***Max. 1200 psi (8274 kPa)***Markers***Open End 6 Sideholes***Angiographic
Catheter*** REF Cat No.***Lot***Use By***Assembled in Mexico,
USA***EC***REP*** Cordis Cashel, ***Cordis***a Johnson&Johnson
company***" UPN H739532598A3, Cat No 532-598A, No. MB 10, French Size 5,
Shape (PIG), Length cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN
H739532598B3, Cat No 532-598B, No. MB 20, French Size 5, Shape (PIG), Length
cm 110, Flow Rate, ml/sec, 18, Sideholes 6. UPN H73953298C3, Cat No 532-598C,
No MB 20 French Size 5, Shape (PIG), Length, cm 65, Flow Rate, ml/sec, 30,
Side Holes 6. UPN H73953298D3, Cat No 532-598D, No MB 2 French Size 5, Shape
(PIG), Length , cm 70, Flow Rate, ml/sec, 30, Side Holes 10. Cordis SUPER
TORQUE MB angiographic catheters with Market Bands are designed to provide
angiographic visualization and linear measurement of the vasculature when
combined with the delivery of radiopaque contrast media to selected sites in
the vascular system. Catalog No. 532-598A and 532-598B.
2) SUPER TORQUE MB Angiographic Catheter
product is labeled in part: "***5F (1.65 mm)***110 cm .038" (0.97
mm)***MULTIPURPOSE A SUPER TORQUE MB***Max. 1200 psi (8274 kPa)***Markers***OPEN
end***Sideholes***SPECIAL***Angiographic Catheter*** REF Cat No.***Lot***Use
By***STERIAL EO***Assembled in Mexico***EC***REP*** Cordis Cashel, Cahir Road
Cashel, Co Tipperary, Ireland***Cordis***a Johnson&Johnson
company***" UPN SRD5724MB, No MB 2, Length, cm 100, Sideholes 2. UPN
SRD5727MB, No MB 4, Length, cm 80, Sideholes 4. Cordis SUPER TORQUE MB
angiographic catheters with Market Bands are designed to provide angiographic
visualization and linear measurement of the vasculature when combined with the
delivery of radiopaque contrast media to selected sites in the vascular
system. Catalog No. 532-598A and 532-598B.
CODE Not
Lot Specific.
RECALLING FIRM/MANUFACTURER
Cordis Corp., Miami Lakes. FL,
REASON Marker
bands dislodged during a procedure.
VOLUME OF PRODUCT IN COMMERCE
119,000 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Varian
brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or
Build 10.0.34), An Eclipse Treatment Planning System used with ARIA Radiation
Oncology (RT Chart module), Reference/FSCA Identifier: CP-05277, Model Number:
H48. The Eclipse Treatment Planning System (Eclipse TPS) is used to plan
radiotherapy treatments for patients with malignant or benign diseases.
Eclipse TPS is used to plan external beam irradiation with photon, electron
and proton beams, as well as for internal irradiation (brachytherapy)
treatments. In addition, the Eclipse Proton Eye algorithm is specifically
indicated for planning proton treatment of neoplasms of the eye.
CODE All
codes from H480005 through H48C896.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology
Systems, Palo Alto, CA,
REASON An
anomaly has been identified with Varian Eclipse and RT Chart where adding a
reference point in RT Chart and editing the field dose contributions may
change the Prescribed Dose Per Fraction in Eclipse.
VOLUME OF PRODUCT IN COMMERCE
2472 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Synthes
Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical
instrument motor and accessories are AC-powered, battery-powered or
air-powered devices intended for use during surgical procedures to provide
power to operate various accessories or attachments to cut hard tissue or bone
and soft tissue. Accessories or attachments may include a bur, chisel (osteotome),
dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw
blade. Catalog number: 532.026.
CODE All
lots
RECALLING FIRM/MANUFACTURER
Synthes USA (HQ), Inc., West Chester,
PA,
REASON The
potential exists for the Large Oscillating Saw Attachment to disengage from
the Small Battery Drive handpiece. If the attachment disengages from the
handpiece, there is a potential for injury to the patient and/or user.
VOLUME OF PRODUCT IN COMMERCE
5 units
PRODUCT Crystalens
Accommodating Posterior Chamber Intraocular Lens, AT-50AO. Crystalens
Accommodating Posterior Chamber Intraocular Lens PMA No.: P030002. The
Crystalens is intended for primary implantation in the capsular bag of the eye
for the visual correction of aphakia secondary to the removal of a cataractous
lens in adult patients with and without presbyopia.
CODE Serial
No.: Expiration Date: 11-699865 to 11-699951 01/14/2016 11-699952 to 11-700027
01/14/2016
RECALLING FIRM/MANUFACTURER
Bausch and Lomb, Inc., Aliso Viejo.
CA,
REASON Bausch
+ Lomb voluntary initiated the recall due to a physician complaint of haze on
the Crystalens AO which was visualized using an angled beam from a slit lamp
during the post-operative examination.
VOLUME OF PRODUCT IN COMMERCE
62 units
PRODUCT
1) Microcyn Solution with Preservatives
(Rx), a) Part number: 84798, 16.9 fl oz (500 mL) and b) Part number: 84781; 33.5
fl oz. (990 mL) Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl)
(230 mg/L) and preservatives: Sodium Hypochlorite (Na0Cl) (40 mg/L),
Hypochlorous acid (H0CL) (30 mg/L) -Non Foaming -Does not contain antibiotics
- Does not facilitate resistance - No known drug/treatment interactions or
contraindications -laboratory proven in solution inactivation of bacteria,
viruses, fungi and spores. Performance testing: Microcyn Solution with
Preservatives has been evaluated by the USP <51> antimicrobial
Effectiveness Test and in Time-Kill studies. It has demonstrated effectiveness
by reducing the microorganisms listed below and passed the USP antimicrobial
Effectiveness test for a category 1 product. Intended to be used by health
care professionals in the management in wounds.
2) Puracyn OTC; Wound & Skin Care
Solution with Preservatives; a) Part number: 6000; 80003 (8 oz trigger spray);
b) Part number: 6002; 80001, (8 oz finger pump); c) Part number: 6004; 80005,
(16 fl oz pump with insert). Kills 99.99% of Staph, MRSA, Strep and other
Infectious Germs in 30 seconds in solution. Does not contain Antibiotics,
Steroids or Alcohol. -Cleans infected wounds in one step - Safe to use around
eyes, nose, m mouth and open wounds - Accelerated healing of minor wounds by
keeping the wound clean -Non-toxic and non-irritating. Made in USA. Intended
for OTC use for the management of skin abrasions, lacerations, minor
irritations, cuts, and intact skin.
3) Microcyn Dermatology Spray with germ
killing Preservatives (Rx); Part number: 84866 - 8 fl oz spray bottle. 99.999%
Reduction In-solution in 30 seconds. MRSA - Staphylococcus aureus VFR -
Enterococcus faecalis Acinetobacter baumannii Pseudomonas aeruginosa. Microcyn
Dermatology Spray has been evaluated by the USP <51> Antimicrobial
Effectiveness Test and in Time Kill studies. It has demonstrated effectiveness
by reducing the microorganisms listed below and passed the USP antimicrobial
Effectiveness test for a Category 1 product. Safe to use around eyes, nose and
mouth. Oculus Innovative Sciences . Petaluma, CA 94954. Intended for use by
health care professionals in management via debridement of wounds.
4) Microcyn Dermatology HydroGel, Spray,
a) Part number: 84811 - 1.76 oz. and b) Part number 84828, 4 oz. Provided Pain
Relief, Relieve Itch, Reduces symptoms of inflammation due to irritation,
Provide a protective shield against contamination. Antibiotic-free,
steroid-free and biodegradable. Intended for use by health care professionals
in management of wounds including itch and pain relief associated with dermal
irritation, sore, injuries and ulcers or dermal tissue. Microcyn Skin and
Wound hydrogel is intended for use on first and second degree burns, excluding
wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the
management of mechanically or surgically debrided wounds.
CODE
1) a) Lot numbers: OIS00011-01, exp
1/12; OIS00011-02, exp 1/12; 10l0119, exp 8/12; 10J0145, exp 8/12; 10K0158,
exp 8/12; 10K0159, exp 8/12; 10K0160, exp 8/12; 1C0130, exp 2/13; b) lot
numbers: OIS00012-01, exp 1/12; OIS00012-02, exp 1/12; 10E0086-01, exp 5/12;
10l0120, exp 8/12; 10J0145, exp 8/12; 11A0042, exp 1/13; 11B0056, exp 2/13;
11B0081-01, exp 2/13; 11B0082-02, exp 2/13; 11E0192, exp 6/13; 11F0197, exp
6/13;
2) a) Lot numbers: 10E0084-01, exp
11/11; 10F0099, exp 12/11; 10F0105, exp 12/11; 041311-01, exp 5/12; b) lot
number s: 041311-01, exp 5/12; 081710-01, exp.9/11; 120810-01, exp 2/2012;
073010-02, exp 11/11; c) lot number: 061511-02, exp 12/12;
3) Lot numbers: 11G0108, exp 1/12;
10H0113-01, exp 2/12; 10H0118-01, exp 8/12; 10l0122-03, exp 3/12; 10l0125-01,
exp 3/12; 10J0137-03, exp 4/12; 10K0164, exp 5/12; 11B0068-01, exp 8/12;
4) a) Lot numbers: 10C0030-03, exp 3/12;
10C0034-03, exp 3/12; 10D0051-01, exp 4/12; 10D0059-02, exp 4/12; 10E0076-01,
exp 5/12; 10H0112-03, exp 8/12; 10H0116-03, exp 8/12; 10J0143-02, exp 10/12;
11B0051-01, exp 2/13; b) lot number: 10C0032, exp 3/12
RECALLING FIRM/MANUFACTURER
Oculus Innovative Sciences Inc.,
Petaluma, CA,
REASON Unapproved
drug claims and those not approved under 510K clearance.
VOLUME OF PRODUCT IN COMMERCE
18397 total units
PRODUCT
1) Urine Reagent Strips (URS) 10
Parameters URS-l0-1OOW 510(K) number: K970250 Devise Listing number: D072377.
Each device consists of 100 strips of Urine Reagent Strips 10 parameters
packed with a desiccant pouch inside a gray bottle with Teco Diagnostics Label
on the bottle and the bottle placed inside a Teco Diagnostics Box. For the
semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone,
Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in
urine.
2) Urine Reagent Strips (URS) 10
Parameters URS-l0-1OOW 510(K) number: K970250 Devise Listing number: D072377
Each device consists of 100 strips of Urine Reagent Strips 10 parameters
packed with a desiccant pouch inside a gray bottle with Teco Diagnostics Label
on the bottle and the bottle placed inside a Teco Diagnostics Box. For the
semi-quantitative and qualitative detection of Glucose, Bilirubin, Ketone,
Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, Leukocytes in
urine. URS-II-I00G-00I i. 3.
CODE
1) Lot Number: 35264 ii. Expiration
Date: 0112014;
2) Lot Number: 35224 ii. Expiration
Date: 08/2013
RECALLING FIRM/MANUFACTURER
Teco Diagnostics, Anaheim, CA,
REASON This
recall was initiated in response to findings during a FDA inspection of the
firm. The firm's recall has been initiated due to improper manufacture of
sub-component nitrite paper Lot 35134, Expiration Date: 01/2014. Discrepancies
were found on the information recorded on formulation sheet and manufacturing
log sheets (Refer to next paragraph). Sampling size submitted for QC testing
was insufficient based upon number of rolls manufactured.
VOLUME OF PRODUCT IN COMMERCE
1) 550 kits; 2) 200 kits
PRODUCT The
IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE
rebreathing systems. Intended use: GE Healthcare anesthetic machines: S5
Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air,
oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and
sevoflurane.
CODE
Lot # Expiration Date 2194 1101240
2013-04 2194 1101425 2013-05 2194 1101426 2013-05 2194 1101902 2013-06 2195
1102927 2013-08 2195 1102596 2013-07 2195 1101423 2013-05 2195 1102596 2013-07
2196 1100392 2013-02 2196 1101241 2013-04 2196 1101426 2013-05 2196 1103379
2016-01 2197 1101281 2013-05 2197 1102597 2013-08 2198 1101107 2013-04 2198
1101427 2013-05 2198 1101428 2013-05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Intersurgical
Inc., Liverpool, NY,
Manufacturer: Intersurgical Ltd.
– Guernsey, Guernsey, UK.
REASON Intersurgical
Incorporated has issued a voluntary recall of the IS Cans Carbon Dioxide
Absorber due to a possibility that loose granules may enter the inspiratory
path of the breathing system.
VOLUME OF PRODUCT IN COMMERCE
2216 cans
DISTRIBUTION Nationwide
and Canada
PRODUCT Smith
& Nephew, SPIDER2 Limb Positioner, including accessories Battery, foot
pedal and charger Catalog Number: 72203299. Table, Operating-room,
Pneumatic.
CODE
Serial Numbers: VAL07,
VAL08,VAL11,VAL15, VAL16, VAL19, VAL20, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12,
13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 30, 31, 32,
33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51,
52, 53, 54, 55, 56, 58, 59, 60, 61, 62, 63, 66, 71, 73, 76, 77, 79, 80, 81,
82, 88, 90, 92, 93, 94, 95, 97, 98, 99, 100, 101, 102, 103, 104, 106, 107, 110
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith &
Nephew, Inc. Endoscopy Division, Andover, MA,
Manufacturer: Tenet Medical
Engineering, Calgary, Canada.
REASON SPIDER2
may unlock (loss of traction) resulting in potential movement of the patient
when the device is within close proximity to an RF source. Loss of traction
can potentially result in the unintended repositioning of the extremity and
potential for tissue or cartilage damage.
VOLUME OF PRODUCT IN COMMERCE
52 units
DISTRIBUTION Nationwide,
Canada and France
PRODUCT Agfa
Computed Radiography Systems with DX-G Digitizer. DX-G Digitizers have the
same intended use as the predicate devices. They are intended to use in
providing diagnostic images to aid the physician with diagnosis. DX-G
Digitizers provide the ability to use both standard needle phosphor image
plates and can be used with either Musica or Musica 2. In the US, Agfa's
Computed Radiography Systems with DX-G Digitizers are not intended for use in
mammography. Model No. 5170/100.
CODE None
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp.,
Greenville, SC,
Manufacturer: Agfa-Gevart NV,
Mortsel, Belgium.
REASON Occasionally
images can be lost or sent to an incorrect folder or the digitizer may stop
either during startup or during a cassette scan cycle.
VOLUME OF PRODUCT IN COMMERCE
124 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT 0.9%
Sodium Chloride Injection, USP, pre-filled flush solution, for IV Flush only,
sterile fluid path; 10 mL Single-Use Syringe with Male Luer Lock, 100 syringes
per pack, 4 packs per case; list no. 1978-20 lock flush solution.
CODE Lots:
91-100-5E, 91-102-5E, 91-106-5E, 91-114-5E, 91-116-5E and 91-118-5E
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc.,
Lake Forest, IL,
Manufacturer: Hospira Holdings
de, Costa Rica Ltd., La Aurora de Heredia, Costa Rica
REASON There
is particulate matter in the fluid pathway, which has been identified as the
same material as the rubber tip of the syringe plunger.
VOLUME OF PRODUCT IN COMMERCE
1,277,600 syringes
PRODUCT ETCO2
Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707
7-7-24. Salter Labs Nasal Cannula (Adult), Salter Style with modified nasal
prongs. w/7' O2 line and 7' CO2 line with male luer lock connector.
CODE Lot:
090610
RECALLING FIRM/MANUFACTURER
Salter Labs, Arvin, CA,
REASON Mis-labeling:
report of cases labeled as 4707 (cannulas with male luer lock connector)
actually contained 4707F (with female luer lock connectors).
VOLUME OF PRODUCT IN COMMERCE
240 cases, 24 to be part of the recall
PRODUCT Eius
Unicompartmental Knee System. Intended for use in Unicompartmental Knee
Arthroplasty (UKA). Surgeon users have identified the following potential
advantages of UKA procedures versus Total Knee Arthroplasty procedures
generally: conservation of the opposite compartment, preservation of ligaments
and patellofemoral articulation, reduced loss of bone stock and lower implant
cost. The EIUS UKA is a Resurfacing device that requires the removal of a thin
condylar cross-section intended to replace the diseased cartilage only. This
allows the surgeon to conserve good quality subchondral bone.
CODE K052917,
K9922887 6636-2-001 002,003, 004, 005, 011, 012, 013, 014, 015, 308, 309, 310,
312, 318, 319, 320, 322, 408, 409, 410, 412, 418, 419, 420, 422, 508, 509,
510, 512, 518, 519, 520, 522, 608, 609, 610, 612, 618, 619, 620, 622, 708,
709, 710, 712, 718, 719, 720, and 722 - ALL LOTS
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp.,
Mahwah, NJ,
REASON Two
National Joint Registries suggest that the EIUS Unicompartmental System is
associated with a higher revision rate then the unicompartmental devices.
VOLUME OF PRODUCT IN COMMERCE
26,348 units
PRODUCT SKYLight
Imaging Systems, Model 882050; Intended to produce images depicting the
anatomical distributions of single photon and positron emitting radioisotopes
within the human body for interpretation by medical personnel.
CODE
Code numbers: K01110023 K02040041,
K02050049 K03050121 K02030032 K01070004 K02080079 K02100095 K02030033
K02030034 K01070003 K02070068 K02080075, K02080082 K01090015 K01080005
K02080077 K01080009 K01100016 K02050058 K02070065 K02080078 K02030035
K02070070 K01100019 K01110027 K01110021 K02100092 K02090087 K02060061
K03060124 K02040040 K02030037 K02100094 K02070063 K01100017 K01110025
K02050052 K03080132 K02040043 K01090012 K03030112 K01100020, K02070064
K03070128 K03040115 K01080008 K02090084, K03030108 K02100098 K01110022
K01110024 K02050048 K02090088 K03050119 K03030107 K02050055 K01090011
K03060122 K02070062 K02040047 K01090010 K02050059 K03040116 K02050054
K03030109 K03080134 K02030038 K03080133 K02070072, K02080081 K02100091
K02060050 K02020029 K03030114 K02100096 K02070071 K03040117 K03060123
K01080006 K03030135 K03080135 K01080007 K02020030, K02040045 K02070067
K02020031 K03070125 K02030036 K02070066 K02090083 K02100090 K02090089
K02110097 K02120104 K02120106 K03070129 K03070130 K02080074 K02120105
K02040042 K03040118 K02110101 K02120103 K03050120 K02110102 K02110001
K03070131 K02050053 K03070126 K02040044 K03030113 K03030110 K03030111
K02070073 K02050056 K02110100 K02050050 K02040046 K01090013 K03070127
K01110028 K02050051 K02030039 K02080076 K02050057 K02090085
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical
Systems, San Jose, CA, .
Manufacturer: Philips Medical
Systems (Cleveland) Inc., Cleveland, OH.
REASON During
preventative maintenance, a crack was discovered in the lower portion of the
old style, non-common arm for the detector assembly, which could result in the
detector dropping in an uncontrolled manner.
VOLUME OF PRODUCT IN COMMERCE
129 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
1) STAT 2 I.V. Controller, Catalog/REF
No. S2, ASSEMBLED IN MEXICO. This is a disposable device with a sterile,
nonpyrogenic fluid path. For controlling the infusion of Intravenous fluids
into the human body.
2) STAT 2 Extension Set Gravity Flow
Controller, 12" length, Catalog/REF No. S2-12, STERILE, ASSEMBLED IN
MEXICO. This is a disposable device with a sterile, nonpyrogenic fluid path.
The STAT 2 Extension sets are for use in conjunction with commonly available
I.V. administration sets for controlling the infusion of I.V. fluids into the
human body.
3) STAT 2 Extension Set Gravity Flow
Controller (Needle-Free), 12" length, Catalog/REF No. S2-12N, STERILE,
ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic
fluid path. The STAT 2 Extension sets are for use in conjunction with commonly
available I.V. administration sets for controlling the infusion of I.V. fluids
into the human body.
4) STAT 2 Primary Administration Set
Gravity Flow Controller, 20 Drops/cc, 84" length, Catalog/REF No. S2V-20,
STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile,
nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets
are for use in attachment to an I.V. bag and patient catheter inserted into a
vein to control the infusion of intravenous fluids into the human body.
5) STAT 2 Primary Administration Set
Gravity Flow Controller (Needle-Free), 20 Drops/cc, 84" length,
Catalog/REF No. S2V-20 N, STERILE, ASSEMBLED IN MEXICO. This is a disposable
device with a sterile, nonpyrogenic fluid path. The STAT 2 Secondary and
Primary Administration Sets are for use in attachment to an I.V. bag and
patient catheter inserted into a vein to control the infusion of intravenous
fluids into the human body.
6) STAT 2 Secondary Set Gravity Flow
Controller, 20 Drops/cc, 13" length, Catalog/REF No. S2-20 MD, STERILE,
ASSEMBLED IN MEXICO. This is a disposable device with a sterile, nonpyrogenic
fluid path. The STAT 2 Secondary and Primary Administration Sets are for use
in attachment to an I.V. bag and patient catheter inserted into a vein to
control the infusion of intravenous fluids into the human body.
7) STAT 2 Primary Administration Set
Gravity Flow Controller, 60 Drops/cc, 84" length, Catalog/REF No. S2V-60,
STERILE, ASSEMBLED IN MEXICO. This is a disposable device with a sterile,
nonpyrogenic fluid path. The STAT 2 Secondary and Primary Administration Sets
are for use in attachment to an I.V. bag and patient catheter inserted into a
vein to control the infusion of intravenous fluids into the human body.
8) STAT 2 Primary Administration Set
Gravity Flow Controller (Needle-Free), 60 Drops/cc, 84" length,
Catalog/REF No. S2V-60 N, STERILE, ASSEMBLED IN MEXICO. This is a disposable
device with a sterile, nonpyrogenic fluid path. The STAT 2 Secondary and
Primary Administration Sets are for use in attachment to an I.V. bag and
patient catheter inserted into a vein to control the infusion of intravenous
fluids into the human body.
CODE
1) Beginning Lot Code 1007195, Ending
Lot Code 1010085;
2) Beginning Lot Code 1006214, Ending
Lot Code 1103304;
3) Beginning Lot Code 1006284, Ending
Lot Code 1103294;
4) Beginning Lot Code 1006094, Ending
Lot Code 1103214;
5) Beginning Lot Code 1006304, Ending
Lot Code 1103284;
6) Beginning Lot Code 1006304, Ending
Lot Code 1103114;
7) Beginning Lot Code 1006284, Ending
Lot Code 1103104;
8) Beginning Lot Code 1007054, Ending
Lot Code 1011104
RECALLING FIRM/MANUFACTURER
Recalling Firm: ConMed Corp.,
Utica, NY,
Manufacturer: Consolidated
Medical Equipment Co., Chihuahua, Mexico.
REASON Certain
units were assembled with an incorrect component which could result in the
devices exhibiting a different flow rate and might reduce the ability of the
user to regulate the device at low flow rates.
VOLUME OF PRODUCT IN COMMERCE
265,540 sets: Nationwide - 225,192;
Internationally - 40,348
DISTRIBUTION Nationwide
and Internationally
PRODUCT
1) Zee Clear Vinyl Medical Examination
Gloves, Powder Free, Medium, Non-Sterile; 100 gloves per box, 10 boxes per
case; Made in China; Zee Part No.: 3061 Single Use, medical exam glove worn on
the hand to provide a barrier against potentially infectious materials and
other contaminants.
2) Zee Clear Vinyl Medical Examination
Gloves, Powder Free, Large, Non-Sterile; 100 gloves per box, 10 boxes per
case; Made in China; Zee Part No.: 3062 Single Use, medical exam glove worn on
the hand to provide a barrier against potentially infectious materials and
other contaminants.
3) Zee Clear Vinyl Medical Examination
Gloves, Powder Free, X-Large, Non-Sterile; 100 gloves per box, 10 boxes per
case; Made in China; Zee Part No.: 3063 Single Use, medical exam glove worn on
the hand to provide a barrier against potentially infectious materials and
other contaminants
CODE Lot
number CZA04-22
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cypress Medical
Products LLC, McHenry, IL,
Manufacturer: QINGDAO LANGHUI
Import and Export Co, LTD, Qingdao, China.
REASON The
gloves fail to meet the performance requirements of 21 CFR 800.20 for leakage
defects.
VOLUME OF PRODUCT IN COMMERCE
680 cases
PRODUCT
1) Biomet Series A Thin Patella size
25mm, three pegs, Part 184780, Sterile. For use with Vanguard, Maxim, Ascent
& AGC Knee Systems. Knee joint patellofemorotibial, cemented, polymer
/metal/polymer, semi-constrained. Knee joint replacement prosthesis, intended
for patella replacement of the knee joint in conjunction with a femoral and
tibial component.
2) Biomet Series A Standard Patella size
25mm, one peg, Part 184700, Sterile. Knee joint patellofemorotibial, cemented,
polymer/metal/polymer, semi-constrained. For use with Vanguard, Maxim, Ascent
& ACG knee system. Knee joint replacement prosthesis, intended for patella
replacement of the knee joint in conjunction with a femoral and tibial
component.
3) Biomet Series A Standard Patella size
28mm, one peg – 184702. For use with Vanguard, Maxim, Ascent & ACG Knee
system. Knee joint patellofemorotibial, cemented, polymer/metal/polymer,
semi-constrained. Knee joint replacement prosthesis, intended for patella
replacement of the knee joint in conjunction with a femoral and tibial
component.
4) Biomet Series A Thin Patella size
25mm, one peg - 184720 Sterile. For use with Vanguard, Maxim, Ascent & AGC
Knee Systems Knee joint patellofemorotibial, cemented, polymer/metal/polymer,
semi-constrained. Knee joint replacement prosthesis, intended for patella
replacement of the knee joint in conjunction with a femoral and tibial
component.
5) Biomet Series A Thin Patella size
25mm, one peg - 184720, Sterile. For use with Vanguard, Maxim, Ascent &
AGC Knee Systems Knee joint patellofemorotibial, cemented,
polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis,
intended for patella replacement of the knee joint in conjunction with a
femoral and tibial component.
6) Biomet Series A Standard Patella size
25mm, three pegs - 184760, Sterile. For use with Vanguard, Maxim, Ascent &
AGC Knee Systems Knee joint patellofemorotibial, cemented,
polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis,
intended for patella replacement of the knee joint in conjunction with a
femoral and tibial component.
7) Biomet Series A Standard Patella size
28mm, three pegs - 184762, Sterile. For use with Vanguard, Maxim, Ascent &
AGC Knee Systems Knee joint patellofemorotibial, cemented,
polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis,
intended for patella replacement of the knee joint in conjunction with a
femoral and tibial component.
8) Biomet Series A Thin Patella size
28mm, three pegs - 184782, Sterile. For use with Vanguard, Maxim, Ascent &
AGC Knee Systems Knee joint patellofemorotibial, cemented,
polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis,
intended for patella replacement of the knee joint in conjunction with a
femoral and tibial component.
9) Biomet Series A Asymmetrical Patella
size 25mm, three pegs - 184790, Sterile. For use with Vanguard, Maxim, Ascent
& AGC Knee Systems Knee. Joint patellofemorotibial, cemented,
polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis,
intended for patella replacement of the knee joint in conjunction with a
femoral and tibial component.
10) Biomet Series A Asymmetrical Patella
size 28mm, three pegs – Part 184791, Sterile. For use with Vanguard, Maxim,
Ascent & AGC Knee Systems Knee. Joint patellofemorotibial, cemented,
polymer/metal/polymer, semi-constrained. Knee joint replacement prosthesis,
intended for patella replacement of the knee joint in conjunction with a
femoral and tibial component.
CODE
1) Lot 357470, 438780, 527760, 633870,
684140, and 710230;
2) Lot 079520, 118810, 136470,
190350, 232400, 248190, 332290, 517200, 572130, 732770;
3) Lot 107600, 136480, 136490,
190360, 248230, 312420, 312430, 344660, 413600, 413610, 485560, 517210,
517240, 614990, 644400, 678050, and 732780;
4) Lot 079520, 136540, 332320,
506170, 678090;
5) Lot 079530, 190400, 344670, 423400,
474010, 619850, and 740130;
6) Lot 190410, 369920, 423430,
572150, 633870, 721650;
7) Lot 107610, 136550, 205940,
205950, 205960, 205970, 248270, 248280, 248290, 344680, 344690, 344700,
369940, 369950, 403040, 423440, 423450, 474020, 184762 474030, 474040, 498270,
527680, 527690, 527700, 527710, 572160, 312080, 572170, 572180, 572190,
572200, 687900, 687910, 687920, and 687930;
8) Lot 098970, 144970, 190440, 232540,
274550, 357320, 397810, 397820, 438790, 438800, 498310, 539710, 599220,
644430, 710240;
9) Lot 219180, 219190, 219200;
10) Lot 098760, 143320, 143480, 247410,
247420, 283590, 311990
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN,
REASON Correcting
language on product labeling which incorrectly states patella buttons are
intended for use with the AGC knee system.
VOLUME OF PRODUCT IN COMMERCE
1757 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT U-Joint
Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup
System. Driver is included in Part Number 270-9004-Escalade Acetabular Prep
Kit and Part Number 228-9001-Triplus Acetabular Instrument Kit. The Acetabular
Cup System is indicated for use in total hip arthroplasty procedures where the
means of cup fixation is uncemented, biological fixation. The Hex Head Drive
is used to place the screw that affixes the acetabular cup to the hip
acetabulum.
CODE Lot
numbers: 1365304, 1365305
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho Development
Corp., Draper, UT, .
Manufacturer: Symmetry Medical
USA, Inc., Warsaw, IN. .
REASON Tip
of hex-head screwdriver may break off during use in hip replacement procedure.
VOLUME OF PRODUCT IN COMMERCE
37 units
PRODUCT Olympus
Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used in
conjunction with cutting and coagulation electrosurgical devices intended for
use in electrosurgery procedures during flexible gastrointestinal endoscopy.
CODE
Serial numbers 11053P230001,
11053P230002, 11053P230003, 11053P230004, 11053P230005, 11060P230001,
11160P230002, 11060P230003, 11160P230004, 11160P230005, 11081P230001,
11081P230003, 11081P230004, 11081P230005, 11081P230006, 11081P230007,
11081P230008, 11081P230009, 11081P230010, 11094P230006, 11094P230007,
11094P230008, 11094P230009, 11094P230010, 11096P230007, 11096P230008,
11096P230009, 11096P230010, 11102P230001, 11102P230002, 11102P230003,
11102P230004, 11102P230005, 11109P230002, 11109P230003, 11109P230004,
11109P230005, 11110P230001, 11110P230002, 11110P230003, 11110P230004,
11110P230005, 11116P230001, 11116P230002, 11116P230003, 11116P230004,
11116P230005, 11117P230001, 11117P230002, 11117P230003, 11117P230004,
11117P230005, 11132P230001, 11132P230002, 11132P230003, 11132P230004,
11132P230005, 11133P230001, 11133P230002, 11133P230003, 11138P230002,
11138P230003, 11138P230004, 11139P230001, 11139P230002, 11139P230005,
11167P230001, 11167P230004, 11180P230003, 11180P230005, 11201P230005,
11201P230010, 11202P230001, 11202P230005, 25456W23-101, 25456W23-102,
25456W23-107, 25456W23-108, 25456W23-109, 25522W23-101, 25522W23-102,
25522W23-103, 25522W23-104, 25522W23-105, 25553W23-105, 25553W23-107,
25553W23-108, 25553W23-109, 25553W23-110, 25565W23-102, 25565W23-103,
25565W23-105, 25565W23-106, 25565W23-108, 25565W23-109, 25565W23-110,
25593W23-101, 25593W23-102, 25593W23-103, 25593W23-104, 25593W23-105,
25593W23-107, 25593W23-109, 25593W23-110, 25607W23-101, 25607W23-102,
25607W23-103, 25607W23-104, 25607W23-105, 25607W23-106, 25607W23-107,
25607W23-108, 25607W23-110, 25613W23-101, 25613W23-102, 25613W23-103,
25613W23-104, 25613W23-105, 25613W23-106, 25613W23-107, 25613W23-108,
25613W23-109, 25613W23-110, 25686W23-102, 25719W23-105, 25719W23-106,
25736W23-101, 25736W23-102, 25736W23-103, 25736W23-104, 25736W23-105,
25736W23-106, 25736W23-107, 25736W23-108, 25736W23-109, 25752W23-101,
25752W23-102, 25752W23-103, 25752W23-104, 25752W23-105, 25752W23-106,
25752W23-107, 25776W23-101, 25776W23-102, 25776W23-103, 25776W23-105,
25776W23-106, 25776W23-107, 25776W23-108, 25776W23-109, 25776W23-110,
25869W23-101, 25869W23-102, 25869W23-103, 25869W23-104, 25869W23-105,
25869W23-106, 25869W23-107, 25869W23-108, 25869W23-109, 25869W23-110,
25978W23-104, 25978W23-105, 25978W23-106, 25978W23-107, 26052W23-109,
26052W23-110, 26085W23-101, 26085W23-102, 26085W23-103, 26085W23-104,
26085W23-105, 26085W23-106, 26085W23-107, 26085W23-108, 26085W23-109,
26136W23-101, 26136W23-103, 26136W23-104, 26136W23-105, 26136W23-107,
26136W23-108, 26136W23-109, 26136W23-110, 26162W23-108, 26162W23-109,
26162W23-110, 26227W23-102, 26227W23-103, 26227W23-104, 26227W23-105,
26227W23-106, 26227W23-107, 26227W23-108, 26227W23-109, 26227W23-110,
26456W23-101, 26456W23-102, 26456W23-103, 26456W23-104, 26456W23-105,
26456W23-106, 26456W23-107, 26456W23-108, 26456W23-109, 26456W23-110,
26559W23-101, 26559W23-103, 26559W23-104, 26559W23-105, 26559W23-108,
26559W23-109, 26559W23-110, 26710W23-108, 26710W23-109, 26770W23-101,
26770W23-102, 26770W23-103, 26770W23-104, 26770W23-105, 26770W23-106,
26770W23-107, 26770W23-108, 26770W23-109, 26770W23-110, 26878W23-101,
26878W23-102, 26878W23-103, 26878W23-104, 26878W23-105, 26879W23-102,
26879W23-103, 26879W23-104, 26879W23-105, 26917W23-101, 26917W23-102,
26917W23-103, 26917W23-105, 26917W23-106, 26917W23-107, 26917W23-108,
26917W23-109, 26917W23-110, and 26992W23-110
RECALLING FIRM/MANUFACTURER
Recalling Firm: Olympus America
Inc., Center Valley, PA, .
Manufacturer: Celon AG Medical
Instruments, Teltow, Germany.
REASON
Investigations of customer complaints revealed a counterfeit capacitor was
used in the manufacture of some lots of the ESG-100
VOLUME OF PRODUCT IN COMMERCE
245 units
PRODUCT MORPHEUS
CT PICC with STYLET, 5F Dual Lumen 65 cm Insertion Kit, Catalog No./REF
1200923, STERILE, COMMON/USUAL NAME: Percutaneous, implanted, long-term
intravascular catheter; CLASSIFICATION NAME: Percutaneous, implanted,
long-term intravascular catheter; Device Listing # D095274. PICC Catheters are
utilized for Short or Long Term peripheral access to the Central Venous system
for intravenous therapy and power injections of contrast media.
CODE Lot
Number 974842; exp. 10/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Angiodynamics
Worldwide Headquarters, Latham, NY,
Manufacturer: Angiodynamics,
Inc., Queensbury, NY.
REASON AngioDynamics
distributed the affected PICC catheters that were beyond their expiration
date.
VOLUME OF PRODUCT IN COMMERCE
16 units
PRODUCT MAQUET
QUADROX iD PEDIATRIC -OXYGENATOR: BEQ-HMOD 3000; Made In Germany The diffusion
membrane oxygenator Quadrox iD pediatric is intended for use in an
extracorporeal perfusion system. The oxygenator is designed for a blood flow
rate of 0.2 -2.8 I/min and is intended for the treatment of pediatric
patients. Within the specified flow rate range, the device oxygenates the
blood, removes carbon dioxide and regulates the blood temperature.The
utilization period for this device is restricted to six hours.
CODE 510(k)
numbers: 1<100278 (Bioline coated) Device Listing No. 0098004 BEQ-HMOD
30000 70064002-28 units 70064004-140 units
RECALLING FIRM/MANUFACTURER
Maquet Cardiovascular Us Sales, LLC,
Wayne, NJ,
REASON There
are reports of leakage in the Leuer connector of the blood outflow connector
of the Quadrox-iD pediatric oygenator.
VOLUME OF PRODUCT IN COMMERCE
168 units
PRODUCT GE
LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and
R3.1.1. The device is intended for use by a qualified physician for ultrasound
evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes,
thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric);
Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology
(including prostate); Transrectal; Transvaginal; Transesophageal and
Intraoperative (abdominal, thoracic, vascular and neurosurgical)
CODE
Serial Number 103674US8 105837US9
104914US7 104936US0 105527US6 104692US9 102751US5 104924US6 103932US0
100901US8 100461US3 104253US0 104257US1 105521US9 104943US6 104252US2
104941US0 98527US5 106276US9 106324US7 104669US7 104217US5 106966US5 105488US1
96282US9 106381US7 105373US5 100021US5 106341US1 105068US1 104909US7 104956US8
104933US7 106512US7 103928US8 106450US0 106380US9 105704US1 106571US3
106570US5 106574US7 105222US4 106378US3 100434US0 100443US1 102760US6
105827US0 105519US3 106379US1 103908US0 102853US9 103458US6 94284US7 102454US6
97788US4 105740US5 105128US3 103810US8 100304US5 103395US0 96382US7 95471US9
105744US7 99804US7 104366US0 106563US0 103820US7 105329US7 105350US3 105339US6
95985US8 95965US0 95961US9 105461US8 107078US8 107154US7 103741US5 104776US0
107075US4 107079US6 106180US3 105608US4 106958US2 106843US6 106954US1
106977US2 105469US1 106846US9 107026US7 107110US9 107137US2 102952US9 96866US9
99107US5 99104US2 96812US3 106946US7 106472US4 105278US6 107044US0 107086US1
106829US5 107061US4 107035US8 107152US1 107196US8 107030US9 107096US0
107133US1 96791US9 107124US0 107010US1 106908US7 104889US1 107192US7 107117US4
100084US3 106405US4 94348US0 103772US0 106730US5 96232US4 96173US0 102281US3
105948US4 105940US1 104938US6 102276US3 106771US9 99287US5 103768US8 100297US1
97785US0 106302US3 105691US0 106294US2 104086US4 106776US8 104797US6 105362US8
106535US8 104198US7 104877US6 105721US5 105850US2 104278US7 104616US8
104831US3 106839US4 104875US0 105760US3 105122US6 106853US5 106851US9
104817US2 97344US6 98846US9 94943US8 98739US6 103697US9 105124US2 106815US4
105736US3 105931US0 106810US5 106629US9 105670US4 103028US7 94125US2 105076US4
102183US1 99937US5 98975US6 102918US0 103923US9 105231US5 105223US2 104828US9
106484US9 105150US7 106090US4 106956US6 106168US8 106803US0 100984US4
105617US5 95409US9 103086US5 105123US4 106035US9 106715US6 106757US8 100362US3
100369US8 102728US3 103895US9 105415US4 97263US8 106568US9 102591US5 106824US6
96607US7 106669US5 106818US8 95665US6 105393US3 105490US7 97209US1 100946US3
105282US8 104307US4 106667US9 105680US3 105976US5 105116US8 105141US6
105576US3 105565US6 104282US9 105573US0 105432US9 106799US0 105382US6
106627US3 101665US8 106666US1 103093US1 105385US9 100452US2 103662US3 99060US6
103792US8 105616US7 95197US0 95131US9 104426US2 104203US5 103971US8 105860US1
106982US2 106968US1 103668US0 103637US5 103642US5 106234US8 105614US2
100897US8 107004US4 105719US9 105672US0 106980US6 99159US6 101537US9 101530US4
105874US2 105902US1 105623US3 105889US0 104091US4 103633US4 100490US2
104354US6 105893US2 99284US2 106494US8 105682US9 99663US7 104564US0 102013US0
99007US7 97914US6 106903US8 107051US5 105601US9 99080US4 103854US6 107206US5
104854US5 104486US6 105730US6 103146US7 103875US1 101171US7 97917US9 103935US3
105830US4 105795US9 95729US0 99062US2 100829US1 98804US8 99641US3 104285US2
106872US5 106893US1 102799US4 101909US0 104858US6 104876US8 103016US2
105143US2 97740US5 96113US6 95696US1 103825US6 102125US2 103230US9 100836US6
103259US8 103252US3 104027US8 103247US3 102718US4 103142US6 104638US2
104762US0 103909US8 105592US0 105556US5 104713US3 104712US5 104191US2
102218US5 106489US8 106509US3 103821US5 106479US9 106990US5 107202US4
105118US4 103437US0 105066US5 97779US3 107153US9 103663US1 106481US5 101542US9
105534US2 98089US6 106671US1 106772US7 102707US7 105655US5 106960US8 106959US0
106421US1 104085US6 106634US9 106636US4 106637US2 106857US6 106699US2
106847US7 106700US8 106845US1 106712US3 106858US4 107073US9 94783US8 106227US2
106835US2 106782US6 106773US5 106882US4 106350US2 106351US0 106096US1
106953US3 101305US1 100925US7 99993US8 107000US2 107034US1 107002US8 107007US7
105553US2 107006US9 107015US0 107021US8 107020US0 106888US1 98980US6 102415US7
103801US7 98709US9 104552US5 106686US9 102927US1 103831US4 104661US4 95507US0
100466US2 97243US0 105681US1 107005US1 106364US3 106354US4 106462US5 106340US3
104107US8 103109US5 101408US3 101410US9 99175US2 100958US8 105495US6 96963US4
105661US3 106569US7 106445US0 104765US3 104766US1 104691US1 105751US2
106848US5 103191US3 98449US2 105675US3 102978US4 98814US7 97329US7 98516US8
106382US5 105866US8 105676US1 105852US8 106399US9 106392US4 105854US4 97720US7
97722US3 105737US1 106511US9 106844US4 105858US5 104458US5 104456US9 104451US0
106501US0 107062US2 106646US3 107163US8 107071US3 106766US9 107159US6
107170US3 107105US9 107103US4 103856US1 106989US7 106995US4 107143US0
106961US6 106969US9 106658US8 99561US3 107055US6 106614US1 106623US2 106935US0
106861US8 106880US8 104326US4 104622US6 104518US6 104502US0 100888US7
105658US9 106203US3 104799US2 104880US0 103944US5 106920US2 106926US9
106933US5 106900US4 106918US6 106929US3 101454US7 106923US6 102057US7
104927US9 106558US0 106157US1 99206US5 99208US1 105938US5 105896US5 105839US5
104586US3 101928US0 106019US3 105752US0 105805US6 100932US3 101026US3
102197US1 105294US3 104019US5 105500US3 105496US4 105514US4 96050US0 104076US5
106204US1 98952US5 98478US1 102447US0 102419US9 105975US7 105862US7 105980US7
105952US6 105692US8 105937US7 105817US1 105782US7 105811US4 105820US5
105792US6 105939US3 105930US2 104025US2 101929US8 103988US2 106029US2
106545US7 106179US5 105784US3 105808US0 105798US3 105814US8 105801US5
105602US7 105605US0 105599US5 93694US8 93697US1 104214US2 105569US8 105869US2
105707US4 105711US6 104213US4 104866US9 106914US5 106306US4 106564US8
104689US5 102529US5 103979US1 106652US1 106645US5 104808US1 106552US3
104834US7 102037US9 105733US0 102461US1 104919US6 104920US4 104911US3
105129US1 104978US2 104890US9 104929US5 104917US0 105659US7 99309US7 105526US8
104688US7 105112US7 104497US3 105923US7 105911US2 106553US1 104505US3
106377US5 106677US8 106673US7 105261US2 104979US0 106554US9 105105US1
106741US2 106746US1 105579US7 104678US8 105643US1 105879US1 106383US3
103681US3 104925US3 104908US9 104975US8 106655US4 105422US0 106608US3
105701US7 106122US5 104980US8 102460US3 106451US8 106292US6 104028US6
105987US2 106151US4 106154US8 106690US1 106477US3 106463US3 106460US9
106474US0 106469US0 106468US2 106457US5 106466US6 106455US9 105584US7
105686US0 105325US5 106701US6 106704US0 106135US7 106448US4 96796US8 96723US2
106644US8 105957US5 105804US9 106118US3 106146US4 106141US5 106109US2
105158US0 105954US2 106243US9 105265US3 106365US0 104942US8 106372US6
106370US0 104954US3 106246US2 104823US0 99381US6 99380US8 95340US6 95338US0
95343US0 105789US2 103238US2 106160US5 102458US7 106510US1 99487US1 106796US6
99621US5 98695US0 102022US1 105632US4 105660US5 106447US6 106152US2 106156US3
106898US0 106892US3 105436US0 101887US8 106042US5 100136US1 100139US5
104215US9 104874US3 104928US7 104156US5 104865US1 105108US5 105645US6
106347US8 106073US0 106081US3 106140US7 105109US3 105103US6 105125US9
106488US0 106601US8 104477US5 104607US7 105160US6 106312US2 105183US8
105136US6 106974US9 104030US2 106208US2 106193US6 106075US5 106213US2
106209US0 106590US3 106588US7 104910US5 106507US7 104913US9 102426US4
104873US5 105304US0 105567US2 106155US5 104912US1 104867US7 105286US9
106565US5 106585US3 106162US1 106161US3 107001US0 102501US4 104885US9
104926US1 106374US2 102506US3 101393US7 106215US7 106219US9 104020US3
105280US2 105316US4 105634US0 105709US0 106651US3 106631US5 105291US9
106201US7 106060US7 105115US0 106181US1 105741US3 105753US8 106593US7
102505US5 105107US7 105003US8 105001US2 106176US1 106139US9 95304US2 95905US6
106304US9 104221US7 102117US9 102383US7 102090US8 104218US3 104029US4
106153US0 106163US9 99630US6 105964US1 105219US0 104633US3 104962US6 105145US7
106045US8 94579US0 94580US8 106779US2 101880US3 102526US1 103392US7 104666US3
104181US3 106299US1 104907US1 105005US3 106527US5 106842US8 100988US5
105582US1 106326US2 104684US6 104682US0 102391US0 103946US0 106513US5
105450US1 105218US2 104959US2 104887US5 105625US8 105004US6 104918US8
104921US2 105857US7 99351US9 104811US5 104861US0 106376US7 102364US7 104538US4
103203US6 102457US9 106483US1 106482US3 107072US1 105300US8 104888US3
103631US8 104598US8 104805US7 101381US2 105668US8 104273US8 106938US4
103587US2 104558US2 104862US8 104510US3 106859US2 106790US9 96396US7 96559US0
96565US7 104977US4 104026US0 104998US0 105945US0 105000US4 100636US0 105283US6
106692US7 106171US2 106125US8 106108US4 104018US7 104868US5 102311US8
104711US7 104976US6 104903US0 106534US1 106082US1 106277US7 106720US6
106777US6 106647US1 106616US6 106600US0 106732US1 106769US3 106597US8
106520US0 106642US2 106638US0 106530US9 106595US2 106602US6 106598US6
106538US2 106544US0 106780US0 104999US8 104660US6 105377US6 104690US3
102673US1 106710US7 104966US7 102049US4 102102US1 102528US7 102358US9
104667US1 105114US3 104021US1 105633US2 105665US4 106128US2 106210US8
103945US2 104778US6 104881US8 104968US3 105268US7 106279US3 106127US4
106435US1 106426US0 106278US5 106438US5 102041US1 103752US2
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare,
LLC, Waukesha, WI,
Manufacturer: GE Medical Systems
Information Tecnology, Wauwatosa, WI.
REASON GE
Healthcare has recently become aware of a potential safety issue associated
with the data of your LOGIQ E9 system that may impact patient safety. 1 User
may notice an image from a different patient, or an image from the current
patient with title information from a different patient. 2 Incorrect
measurements/calculations on images, when viewed on the off-line review
station. As a result imaging may need to be repeated due to the confusion in
the image information.
VOLUME OF PRODUCT IN COMMERCE
894 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Outer
Carton labeled in part: "1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH
LACREON FOR ASTIGMATISM***Contact Lenses for Daily Wear***D -1.50***-1.25
100***2016/07***BC 8.5***DIA 14.5***Made in USA***" Individual Lenses
labeled in part: "***1-DAY ACUVUE MOIST FOR ASTIGMATISM WITH LACREON***BC
8.5***DIA 14.5***AXIS -1.75 -0.75***080***2016/06***" It is intended for
daily wear for the correction of refractive ametropia (myopia and hyperopia)
in aphakic or non-aphakic persons with not diseased eyes who may have 1.00D or
less of astigmatism.
CODE External
carton Lot Number B00BVTN -1.50 -1.25cyl. 100 (30 primary packages per
secondary carton Internal package Lot Number B00BSBH -1.75 -0.75cyl. 80 (30
primary packages per secondary carton)
RECALLING FIRM/MANUFACTURER
Johnson & Johnson Vision Care, Inc.,
Jacksonville, FL,
REASON Johnson
& Johnson Vision Care, Inc. recalled their 1-DAY ACUVUE MOIST Brand
Contact Lenses for ASTIGMATISM due to a lot being mixed. The secondary carton
lot number and power are not the same as on the primary package inside the
carton.
VOLUME OF PRODUCT IN COMMERCE
152 cartons
DISTRIBUTION Nationwide
and Internationally
PRODUCT
1) Varian brand 4D Integrated Treatment
Console (4DITC) v10.2.3, Reference/FSCA Identifier: CP-06873, Model Number:
H51. The 4D Integrated Treatment Console [4DITC] is designed to interface to
the Varian Clinac Treatment Control System [TCS] for the purpose of providing
verification of treatment parameters, imaging and providing a record of
treatment. The general function of the 4D Integrated Treatment Console is to
allow treatment plans and images to be retrieved from the Oncology Information
System [OIS] and sent to the TCS, planned treatment plan parameters to be
verified against the TCS delivery parameters for accuracy and treatment
history to be recorded in the OIS for use and display. The Barcode Conical
Collimator Verification [BCCV] device assists operators of radiation therapy
devices by preventing irradiation until the conical collimator required by the
treatment plan is in place.
2) Varian brand Barcode Conical
Collimator Verification (BCCV) v1.0, Reference/FSCA Identifier: CP-06873,
Model Number: HB. The 4D Integrated Treatment Console [4DITC] is designed to
interface to the Varian Clinac Treatment Control System [TCS] for the purpose
of providing verification of treatment parameters, imaging and providing a
record of treatment. The general function of the 4D Integrated Treatment
Console is to allow treatment plans and images to be retrieved from the
Oncology Information System [OIS] and sent to the TCS, planned treatment plan
parameters to be verified against the TCS delivery parameters for accuracy and
treatment history to be recorded in the OIS for use and display. The Barcode
Conical Collimator Verification [BCCV] device assists operators of radiation
therapy devices by preventing irradiation until the conical collimator
required by the treatment plan is in place.
CODE
1) Units: HBC0001 H512022 H511551
H511275 HBC0004 H512993 H513292 H515900 HBC0007 H512781 H513115 H511691
HBC0018 H512241 H515092 H513533 HBC0021 H513561 H514438 H515524 HBC0024
H510889 H512278 H513927 HBC0028 H515461 H515076 H514202 HBC0048 H510126
H513080 H515780 HBC0069 H515541 H512967 H515068 HBC0070 H511840 H513262
H510732 HBC0075 H514160 H513701 H511593 HBC0079 H513117 H513551 H514018
HBC0083 H511663 H511565 H512454 HBC0090 H513989 H515570 H515064 HBC0097
H512618 H512464 H515737 HBC0106 H514439 H515943 H515696 HBC0111 H515691
H511821 H515523 HBC0115 H515998 H514402 H514521 HBC0174 H515387 H514403
H513548 HBC0210 H513769 H514080 HBC0211 H515262 H513002 HBC0348 H514488
H512998
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology
Systems, Palo Alto, CA,
REASON When
multiple conical collimator treatment plans are scheduled to be treated in a
session, the Plan Label should be displayed on the BCCV dialog box should
match the Plan Label on the 4DITC. However, the name of the plan is not being
updated correctly
VOLUME OF PRODUCT IN COMMERCE
64 units
DISTRIBUTION Nationwide,
Canada, Germany, Japan and Qatar
Covidien
Contraindicates the Use of Duet TRS for Thoracic Surgery, Implements a Recall
Covidien (NYSE: COV), a leading global
provider of healthcare products, today announced that it is conducting a recall
of all production lots for the Duet TRS Universal Straight and Articulating
Single Use Loading Units, with respect to the use of this product family in the
thoracic cavity.
The Company has concluded that Duet TRS has the potential to injure adjacent
anatomical structures within the thorax, which may result in life-threatening,
post-operative complications.
The affected product codes and descriptions are as follows:
DUET4535
DUET4535A
DUET4548
DUET4548A
DUET6035
DUET6035A
DUET6048
DUET6048A
DUET TRS 45 3.5MM STRAIGHT SULU
DUET TRS 45 3.5MM ARTICULATING SULU
DUET TRS 45 4.8MM STRAIGHT SULU
DUET TRS 45 4.8MM ARTICULATING SULU
DUET TRS 60 3.5MM STRAIGHT SULU
DUET TRS 60 3.5MM ARTICULATING SULU
DUET TRS 60 4.8MM STRAIGHT SULU
DUET TRS 60 4.8MM ARTICULATING SULU
Customers have been notified of this
recall by letter on January 12, 2012. Product intended for thoracic use
must be returned. Please return the affected product by contacting Customer
Service at SDFeedback@Covidien.com
or 1-800-722-8772, option 1, to obtain a Return Goods Authorization prior to
returning the affected units. Alternatively, customers may choose to retain the
product for uses other than thoracic.
WEEK ENDING JANUARY 14
PRODUCT
1) St. Jude Medical Riata (8Fr), Models:
1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Product
Usage: These Silicone transvenous high voltage (HV) leads connect an
implantable cardioverter-defibrillator (lCD or CRT-D) to cardiac tissue to
monitor and regulate a patients heart rate by providing pacing therapy and/or
tachyarrhythmia therapy.
2) St. Jude Medical Riata ST Silicone
Endocardial Defibrillation Leads Riata (7Fr), Models: 7000, 7001, 7002, 7010,
7011, 7040, 7041, 7042 Product Usage: These Silicone transvenous high voltage
(HV) leads connect an implantable cardioverter-defibrillator (lCD or CRT-D) to
cardiac tissue to monitor and regulate a patients heart rate by providing
pacing therapy and/or tachyarrhythmia therapy.
CODE None
RECALLING FIRM/MANUFACTURER
St Jude Medical CRMD, Sylmar, CA
REASON The
recall was initiated because St. Jude Medical has confirmed the failures
associated with all cause insulation failure on the St. Jude Medical Riata and
Riata ST Silicone Endocardial Defibrillation Leads with specific emphasis on
externalized conductors.
VOLUME OF PRODUCT IN COMMERCE
128,000 units
PRODUCT AVEA
Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide
continuous respiratory support in an institutional health care environment
(e.g. hospitals). It may be used on neonatal through adult patients. It should
only be operated by properly trained clinical personnel, under the direction
of a physician. Prescription Use: Federal law restricts the sale of this
device except by or on order of a physician. Each of the affected devices is
individually serialized.
CODE None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carefusion 211
Inc., Yorba Linda, CA,
Manufacturer: Carefusion 207,
Inc., Palm Springs, CA.
REASON The
recall was initiated because Carefusion has identified a potential risk
associated with certain AVEA ventilators and affected replacement parts
manufactured between March 1, 2009 and June 30, 2011. Carefusion is
voluntarily initiating a field correction of the affected devices to preclude
the possibility of this risk.
VOLUME OF PRODUCT IN COMMERCE
6797 (1891 in the US)
DISTRIBUTION Nationwide
and Internationally.
PRODUCT
1) "***BIOMET 3i***REF
AC4425***Conical 25 ANGLED ABUTMENT***4.1mm (D) X 4mm (H)***Abutment; Pilier:
Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i Dental
Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1' ***". Attach an implant to
an implant restoration.
2) "***BIOMET 3i***REF
SWCA62***Conical Abutment Gold Standard ZR***6mm(D) X 2mm(H)***Abutment;
Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i
Dental Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1'***". Attach an
implant to an implant restoration.
CODE
1) Lot 887628-5;
2) Lot 848478
RECALLING FIRM/MANUFACTURER
Biomet 3i, LLC, Palm Beach Gardens,
FL,
REASON The
packaging for the referenced products may not have been completely sealed
prior to shipment.
VOLUME OF PRODUCT IN COMMERCE
122 Conical Angled... and 8 Standard
Conical
DISTRIBUTION Nationwide
and Chile, Italy, Japan, Korea, Spain, and Sweden
PRODUCT Synthes
Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer
system. Transforaminal posterior atraumatic lumbar spacer system. Synthes
T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD)
at one or two contiguous levels from L2 to S1 whose condition requires the use
of interbody fusion combined with supplemental fixation. The interior of the
T-PAL Spacer should be packed with autogeneous bone graft (i.e. autograft).
DDD is defined as back pain of discogenic origin with degeneration of the disc
confirmed by history and radiographic studies. These patients should be
skeletally mature and have had six months of non-operative treatment.
Part number 01.812.001 - T-PAL
Instrument and Implant Set.
CODE None
RECALLING FIRM/MANUFACTURER
Synthes USA (HQ), Inc., West Chester,
PA,
REASON LABELING
CORRECTION for Medical Device - previous labeling and promotional materials
associated with the T-PAL Spacer system reference the use of T-PAL spacer with
allograft material. T-PAL Spacer is currently indicated for use with autograft
material. All accounts with record of receiving T-PAL Implant will receive
notification of the labeling correction and a copy of the updated brochure.
All Synthes Spine Sales Consultants will receive notification of the labeling
correction and a copy of the updated brochure.
VOLUME OF PRODUCT IN COMMERCE
N/A - Labeling Correction
DISTRIBUTION Nationwide,
Canada and Japan
PRODUCT Extended
Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H,
1.5.1A and 2.0Q -Field Test Period A nuclear medicine image display and
processing application suite that provided software applications used to
process analyze and display medical images/data. Model Number 882488: EBW NM
Special Model Number 882489: Extended Brilliance Workspace NM Model number
728260: Extended Brilliance Workspace.
CODE
Serial numbers: 66762, 66790 66146
66001, 66002 66235, 66812, 66820 67160 12344, 66393, 66398, 66418, 66422
12502, 66351 66193, 66223, 66921 66208, 66213, 66217 66952, 66959, 67056 66016
66564 66590, 66591, 66595 66065 66895 66685, 66733, 66735, 66736 66098 66553
66673 66257, 66260 66660, 67126 C66319 67319 66362, 66370 66558 12510 67123
66683 12718 14312 66800 66481 66042, 66194, 66727 66953 66662 12540 66579
66107, 66168 66551 67009, 67014 66077 66641, 66643 66212 C66326 66295 66140,
66379 66088 66097 66367 67274 66674 66723 66778 66599 66196, 66863, 66899
66114 66020, 66021, 66170 C66507 67004 66661 66716 66406 66821 66040 66242,
66244 67065 66687, 66701 67064 66070 66402 67140 66222, 66354 67308 66729,
66741, 66751, 66913 67204, 67208 66104 66782, 66788 66882 67122, 66818A,
66819A 66421 66721 66835 67206 66456 66695, 66699 67285 66209, 66504 66932
66652 67191 66602, 66658 C66331 67217 66901 66468 66697, 66700, 67180 66363,
66369 66382, 66384, 66464, 666112 66717 66575 67280, 67315 66409 66286 67055
66237 66902 66448 66872 12334 66839 66709 66905 67125 66671, 66711, 66726
66621 C66513 67046 66412 66019 66436, 66615, 66710 67057, 67172 66843 67109
66912 66025 66136, 66137, 66252, 66259, 66263, 66306, 66307, 66310, 66311
66400 C66502 66167 66440, 66659 67213, 67214 66452 66636, 66663, 67184, 67187,
C66327, C66341 66268, 66555, 67157, 67162, 67167 66761 12624, 12639 66582
66483 67216, 67237 12606 67003, 67059 66004, 66006 67005, 67013, 67170 67255
66649 66570 66844 66926, 66928, 66936 66890 66132, 66728 66494, 66946 66078,
66081 66879 66381 66497 66737 67006 66229 66285 66598, 66600, 66601 67271
66688 66298, 66350, 66360 66038, 66051, 66052 66227 66067 66383 66055, 67212
66186 66753, 66008, 66012 66607 67230, 67234 66180 66568 66813, 66837 66900
66493, 66498 66487, 66489, 67158 66931 66183 66732 67176, 67269 66619 12266,
12269 66686 C66320 C66509, C66510 66754, C66500 66757, 66763, 66764 66552
66707 66438 66884 66950, 66954 66130, 66131, 66133, 66945 66560 66787 66791,
66795, C66342, C66344 66368 67151, 67231 66182 66608, 66609 66634 66109, 66152
67288, 67294 66403, 66405, 66466 66410, 66496 12131 66894, 66935 66429, 66476
66876, 67021, 67022, 67030 66625 66958, 66960 66148, 66154, 67070 C66339
66450, 67233 66829 66749 67264 66846 66877 66783 12355 66197 66583 12334,
12335, 12340, 66393, 66395, 66404, 66414, 66425, 66427, 66435, 66444, 66445,
66449, 66453, 6645566462, 66462 66809 66123, 66127 66224, 66718 13174, 13176,
66144, 66394, 66480 66240, 66613 66887, 66889 66574, 66585 66740, 66744 66893,
66896, 66907,67185, 67198, 66106, 66230 66645 66115 67020, 67023, 67024, 67028
66680 C66349 66747, 66748 66108, 66850 67053 66647, 66691 66376, 66387 12825
67111, 67113, 67134, 67169 66799, C66345, C66346 66245, 66784 66102, 66105
66702 66039 66218 66927, 66933 66916, 66918, 66957 66703, 66705 66071, 66074,
66075 67232 12517, 12519, 66177, 66202 66266, 66282, 66807 66554 66411, 66415,
66469 C66512 66041, 66054 12437, 66014, 66015, 66018, 66022, 66031, 66035,
66420, 66441, 66575, 66593, 66603, 67044 67000, 67017, 67054, 67142 66848,
66851, 67084, 67092 66231, 66233, 66249, 66267, 66271, 66355 66299 66397,
67026, 67040 66808 67007, 67011 66169, 66175, 66767, 66768, 66769, 66770
66565, 66586, 66589 66471, 66477 66875, 66898, 66947, 66948 66801, 66802
66597, 66604, 66606 66232, 66234, 66955, 66962 66189, 66377 67175 66236,
66246, 66269, 66275 66084, 66089, 66092 67268, 67257 66796, C66511 66883
66903, 66914 12516, 66017, 66024, 66592 66592 66437, 66439 66353, 66380 66648,
66656, 66666, 66096 66296, 66357 66143, 66184, 66199, 66283, 66287, 66364
66047, 66053, 66057, 66068, 66069, 66099, 66100, 66118, 66121, 66125, 66126,
66149, 66156 67190, 67192 66103, 66159, 66191, 66192, 66198 66644, 66670,
66672, 66681, 67226 66712, 66713, 66888, 66904, 66956 67200, 67201 67077,
67002 9300 66805, 66823, 66832, 66833, 66840, 66841, 66842 66029, 66033, 66044
66704 66443 66792, 66734, 66906 11728, 11774, 66000 66793 66689, 66690 66794,
66798, 66836 66365 66049, 66190 67183 11875, 11876 66490, 66492 8689 66073
66056, 66059, 66451 66569 66550, 67182, 67292, 67286 67174, 67177 66488 67220
67272, 67276 67293 12635, 12642, 66467 C66314, C66315 66881, 66944 67195
12736, 12737, 12738 C66300 12433, 66220 12368, 12371 12728, 12729 11799, 66200
66797 66584 66007, 66096, 66101, 66484 66618, 66730 66082 66390 66389, 66482
66239 66358, 66485, 66614, 66633 66627, 666113 66214 66622 66961, 67088 12404
66164, 66165 66171, 66204 66682, 66815 66824 13442, 13554, 13555 12715, 67146,
66284 66675 67079 66566 66562, 66572, 66573 66720 67278, 67282 66580 66859
67082 66086, 66909, 66911, 66930 66495 67145, 67165 66826 67062 67043 66715
67090 67263 67001, 67012 66201 66172, 66251 66878 66273, 66290 67211 12357,
66816, 66830, 66834 66392 66979, 66980 66966 66773, 66810 66662 66852, 66855,
67076 67093 67080 66215 67015 66247 67246 66776 66288 66920, 66925 66083 66746
66861 67130 66775 66974, 66975, 66977 66588 66873, 66922, 67283 66581 13193,
66243, 66698 66692, 66719 66766, 66770 66027, 66036, 66043, 66045 67039 66312
12607 66258 66653, 66678, 67018 12613, 12615, 66076 67210 66860 66113 66915
66473 66502 66630 66623 66009, 66011 66058, 66060 66866, 66870 67254 66973
66620 C66323 66640, 66642, 67029, 67221, 67225, 67227 66771 66187, 66248 66868
66090 67085 66428 67238 13040, 66371, 66374 66201, 66228 66085, 66093, 66094
66447, 66454 67036 66155, 66160 67189, 67338 66458 66417, 66419 66651, 66667
66270, 66276 66226, 66274 66862 67164 66122, 66162 13126, 13144 67188 66386,
66388 C66328 66929 67281 66869, 67236, C66324 66777 C66334 C66317 66759, 66867
C66325 66446 66871 66738 66091, 66128, 66129 67194, 67229, 67265, 67277,
67279, 67168F 66655 67025, 67049, 67066 66509 66460 67193 66561 66279, 66472,
66677 66976, 66978 67139 C66342 C66340, C66503 C13070 66173 66206 C66329
C66322 67222 66141, 66145 12975, 12977 67069, 67166, 67173 66768, 66769,
66785, 67179 66938 66724 66157, 66161, 66293 67124 66506 66571 C66348, C66508
67041 66254 66664 66845, 66847, 66849, 66856, 12964, 12978 66116 12644 66124,
66163 67197 66828 66941 C66301 66087, 66111, 66923 66188 66650 66743 66305
66668 66475 12721 66062, 66063 66818, 66819, 67008, 67016 67186 66461 12779,
12785 12375 66706, 66745 66864 66238, 66142 C66313 66361 67108 66147, 66158
66665 66080, 66117 66211 66765 67034, 67118 66563 66166, 66838, 66806A 66611,
66612 66865 66265, 66277 13346, 13347, 13354 66297 C66504 66066, 66151 66178
66289 67052, 67178 66886 66216 66857 67154 66858 66262 67137 12878 66825 66512
66399 13263 66241 66372, 66375 13364 12877, 66510 13264 66939, 66940 13175
66880, 66892 67273 66359 67031, 67050, 67058 12982, 12993 66731 66817, 66822,
66908, 66910, 67027 66626 66594 67270, 66352 66714 12372 66617 66610 12575
12566, 12572, 12576, 12577 67063 66205, 66219, 66416, 66423, 66432, 66654,
66679, 66676 66046 67252 66272, 66278 66030, 66032 66684 66657 67138 66378
67037 66261 67148 66853 66804, 66814, 66827 66153 66972 C66316 12532 12362
66005 C66304, C66309 C66321 66174, 66179 C66333 66023 C66501 13216 67019
66037, 66291, 66292 66739 66253, 66255, 66628, 66629, 66631, 66635, 66638,
67083 66806, 66811, 67087, 67094 66280 66176 66181 66003, 66072, 66366 12387
66391 66491 66119 66470 66185 66772, 66774 C66303 12910 66616 67074 66708
66587 67239 66781 66478, 66576 66250, 66256 66897, 67091 66207, 66373 66578,
66596 11331 C66332, C66335 66624, 66632, 66654 67181 66885 66110, 66112,
66221, 66225, 66457, 66459, 66474 66356, C66505 66750 12508, 66026 66203 66891
67033, 67042, 67117, 67127 66064 66079 C66337 66722 12378, 12384, 12395 66637
66969
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips
Medical Systems, San Jose, CA,
Manufacturer: Philips Medical
Systems (Cleveland) Inc., Cleveland, OH.
REASON A
problem related to a software error has been detected. A false negative
interpretation due to a falsely elevated ejection fraction or a false positive
interpretation due to a false low ejection fraction could occur.
VOLUME OF PRODUCT IN COMMERCE
1,181 systems
DISTRIBUTION Nationwide
and Canada
PRODUCT PDI
Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads, 100/box.
Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit;
or Hemosense INRatio 2 Prothrombin Time/INR Testing Kit, Self-Test System;
Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombin Time/INR
Testing Kit, Self-Test System; Alcohol Prep Pads, packaged in the INRatio
Starter Kit Product Model Number: 0200086, 0200432, 0100007, 0100072 The Alere
INRatio2 PT/INR Home Monitoring System is used for the quantitative
measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The
Alere INRatio2 PT/INR Home Monitoring System is intended for use outside the
body (in vitro diagnostic use) by people taking warfarin and other oral
anticoagulant (blood thinning) therapy who need to monitor the clotting time
of their blood. The Alere INRatio2 PT/ INR Home Monitoring System is not
intended to be used for screening purposes. The Alere INRatio2 PT/INR Home
Monitoring System should only be used with a prescription from your physician.
The INRatio2 PT Monitoring system is used for the quantitative measurement of
Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio2 PT
Monitoring system is intended for use outside the body (in vitro diagnostic
use) by people taking warfarin and other oral anticoagulant (blood thinning)
therapy who need to monitor the clotting time of their blood. The INRatio2 PT
Monitoring System is not intended to be used for screening purposes. The
INRatio2 PT Monitoring system should only be used with a prescription from
your physician. The INRatio system performs Prothrombin Time (PT) testing on
fresh, capillary whole blood. The PT test is the principle assay used to
monitor warfarin therapy. Patients taking warfarin and other oral
anticoagulants should consult with their healthcare provider before adjusting
their dosage. The thromboplastins used in performing PT tests can vary
substantially causing differences in results between methods. The
International Normalized Ratio (INR) is a mathematical correction of the PT
result that adjusts for differences in thromboplastins. Consult your physician
for the appropriate therapeutic range for you.
CODE
Lot/Unit Codes: 245765R, 245763R,
245766R, 245768, 245769, 252549, 245770, 252020, 252021, 252530, 252532,
252533, 256080, 256081, 256082, 256083, 256084, 256085, 260082, 256086,
256087, 256088, 256089, 256090, 256091, 256092, 261879, 261880
RECALLING FIRM/MANUFACTURER
Alere San Diego, San Diego, CA
REASON Alere
has initiated a recall due to the potential presence of low levels of the
microorganism Bacillus cereus.
VOLUME OF PRODUCT IN COMMERCE
14,248 total units
PRODUCT EHEC
Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X
II 100.0ml.Lot# 2607EXP.2-EHEC Detection Antibody 10.0ml Lot#
8603EXP.3-EHEC-Enzyme Conjugate 10.0ml Lot# 8604EXP.4-Substrate II 12.5ml Lot#
1601EXP.5-Stop-Solution II 10.0 ml Lot# 1601EXP.6-EHEC Positive Control 3.4 ml
Lot# 8601EXP.7-EHEC Negative Control 3.4 ml Lot# 1603EXP.8-96 transfer
pipettes-1 Microwell holder-3 Microwell strip sealers The Premier EHEC test
kit is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and
II (verotoxins) in stool specimens, broth cultures, from individual colonies
or colony sweeps of agar plates. The Premier EHEC test is intended for use as
an aid in the diagnosis of enterohemorrhagic E. Coli (EHEC) infections.
CODE Lot
# 608096, Lot# 8602 EXP.1, Lot # 2607 EXP.2, Lot # 8603 EXP.3, Lot # 8604
EXP.4, Lot # 1601 EXP.5, Lot # 1601 EXP.6, Lot # 8601 EXP.7, Lot # 1603 EXP.8
RECALLING FIRM/MANUFACTURER
Meridian Bioscience Inc., Cincinnati, OH
REASON Internal
testing has shown that the indicated kits produce false negative results when
tested with some direct stool specimens. These false negative reactions are
not observed for all devices tested, however, the rate of occurrence will
likely impact clinical sensitivity as defined by product registration and
associated instructions for use.
VOLUME OF PRODUCT IN COMMERCE
3,236 kits
DISTRIBUTION Nationwide
and Internationally
PRODUCT VNS
Therapy Aspire HC Generator and VNS, Model 105 For implantation in humans to
treat Epilepsy and Depression.
CODE None
RECALLING FIRM/MANUFACTURER
Cyberonics, Inc., Houston, TX,
REASON The
devices are being recalled because the output current delivered to the vagus
nerve is less than the design intent and there is a potential charge imbalance
at the lead cathode and generator-can during stimulation.
VOLUME OF PRODUCT IN COMMERCE
346 units
DISTRIBUTION Nationwide
and Norway
PRODUCT IMPAX
Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM
7.8 SU2.
CODE Software
Versions: RM2.04.37.04 to RM 7.8 SU2 (RM 2.04.37.04 is a version prior to CV
7.2 release).
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp.,
Greenville, SC,
Manufacturer: AGFA HealthCare
Corp., Westerly, RI.
REASON Improper
merging of IMPAX Cardiovascular Results Management (RM) reports causes the
signed report to become unavailable.
VOLUME OF PRODUCT IN COMMERCE
323 units
DISTRIBUTION Nationwide
and Canada
PRODUCT PDI
Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They
are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4
pieces of PDI Electrode Prep Pads. Hook-up kits that contain the affected
alcohol prep pads are as follows: Aria, Kit Part number 23189-010, Kit, Basic
hookup, AA; CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall;
Aria, Kit Part number 23189-106, Kit, Aria Hookup; Aria, Kit Part number
23189-110, Kit, Aria Hookup; Flashcorder, Kit Part number 23189-111, Kit,
Flashcorder Hookup; Aria, Kit Part number 23189-113, Holter Hookup Kit 7
electrode; LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12,
Multilingual; Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA;
LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard; 483, Kit
Part number 23189-117, Kit, Holter Hookup 483; Aria, Kit Part number
23189-153, Holter Hookup Kit, 7 electrode; Aria VLC, Kit Part number
23189-207, Kit, Aria Hookup, VLC; EVO, Kit Part number 50-0048, 4 electrode
hookup kit without pouch; EVO, Kit Part number 50-0049, 4 electrode hookup kit
with pouch; EVO, Kit Part number SK10456, Sample Kit, Disposables. A surgical
skin degreaser or an adhesive tape solvent is a device that consists of a
liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane;
and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve
surface skin oil or adhesive tape.
CODE No
lot #’s
RECALLING FIRM/MANUFACTURER
Del Mar Reynolds Medical, Ltd.,
Hertford, United Kingdom,
REASON The
non-sterile alcohol prep pads (B339) are included in Spacelabs Healthcare
hook-up kits may have the presence of a bacterium, Bacillus cereus. These
alcohol prep pads were manufactured and recalled by Professional Disposables
International (PDI).
VOLUME OF PRODUCT IN COMMERCE
25,000 pieces of PDI alcohol pads-total
15 different Spacelabs Hook up kits
DISTRIBUTION Nationwide
and Internationally
PRODUCT
1) Brilliance Big Bore Computed
Tomography X-Ray System, 510(k) #K033357, Model Number: 728243. The recalled
device systems are equipped with Version 3.5 Beta 1 software.
2) Brilliance 64 Computed Tomography
X-Ray System, 510(k) #K033326, Model Number: 728231. The recalled device
systems are equipped with Version 3.5 Beta 1 software.
CODE
1) Serial Numbers: 7298, and 7060;
2) Serial Numbers: 9745, 90169, and
95414
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland)
Inc., Cleveland, OH,
REASON Software
errors. A number of non-conformances were found for the Brilliance Big Bore
and Brilliance 64 Computed Tomography X-ray Systems equipped with software
version; 3.5 Beta1. The non-conformances stem from software errors identified
in the operating software.
VOLUME OF PRODUCT IN COMMERCE
five 5) system units
DISTRIBUTION Nationwide,
Italy, India and China
PRODUCT Odyssey
A radiation treatment planning system.
CODE Versions
4.4 through 4.7
RECALLING FIRM/MANUFACTURER
PerMedics, Inc., San Bernardino, CA,
REASON Anomaly
1 - Invalid Export of Beam Table and or Collimator Angle for DICOM RT Ion,
DICOM Image and RTP Link export files: During PerMedics' internal code reviews
for lEC 61217 compliance verification, an issue was identified by PerMedics
engineers in three export files: D1COM RT Ion Plan, D1COM RT Image and RTP
Link. In some cases, this issue can result in table and/or collimator angle
values to be exported that are not in compliance with either the lEC 61217
standard or the PerMedics D1COM Conformance Statement. Within Odyssey, the
table angle increases counterclockwise (when viewed from Odyssey's
"Beam's Eye View" feature) in compliance with the IEC 61217 Patient
Support coordinate system. Likewise, within Odyssey, the collimator angle
increases counterclockwise (when viewed from Odyssey's "Beam's Eye
View" feature) in compliance with the IEC 61217 Beam Limiting Device
coordinate system. Through its internal investigation, PerMedics discovered
that Odyssey does not export the correct table and/or collimator angles to
DICOM RT Ion Plan, DICOM RT Image and RTP Link when the treatment machine's
table angle and/or collimator angle increase in the clockwise
direction--opposite of the IEC 61217 and Odyssey's internal angle systems. In
these cases, Odyssey converts the table and collimator angles to the treatment
machine's angle system, which does not match IEC 61217. This conversion should
never be performed for these files. Because Odyssey's DICOM and RTP Link
exports are supposed to express angles in IEC 61217 coordinates, this
conversion results in incorrect table and collimator angle values when the
table and collimator angle systems of the beam's machine do not match
Odyssey's internal angle systems. Note: If the actual treatment machine's
table angle and collimator angle increases in the same direction as Odyssey's
internal table angle and collimator angle system, then the conversion is not
performed, and these files contain the correct table and collimator angle
values. The following conditions must all be present in order for an invalid
table angle to be exported for a beam: “The internal table angle of the beam
displayed in Odyssey is not equal to zero. " The table angle system for
the beam's machine is defined in Odyssey's MakeLib to increase in the
clockwise direction when viewed in "Beam's Eye View". "The beam
is exported to a DICOMRT Ion Plan, DICOMRT Image, or RTP Linkfile. If anyone
of these conditions is not met, then the anomaly does not occur for table
angles exported for a beam. The following conditions must all be present in
order for an invalid collimator angle to be exported for a beam: “The
internal collimator angle of the beam displayed in Odyssey is not equal to
zero.” The collimator angle system for the beam's machine is defined in
Odyssey's MakeLib to increase in the clockwise direction when viewed in
"Beam's Eye View". “The beam is exported to a DICOMRT Ion Plan or
RTP Linkfile. If anyone of these conditions is not met, then the anomaly does
not occur for collimator angles exported for a beam. Anomaly 2 - Incorrect
Monitor Unit Values when Changing Treatment Start Date: If the treatment start
date is changed for a patient's fully computed IMRT plan, IMAT plan or a plan
containing a "Region DVH" prescription, then Odyssey automatically
re-computes the treatment schedule. However, this automatic re-computation
also changes the monitor unit values in the schedule so they are no longer
correct. In these cases it is necessary to manually perform a full
re-computation of the plan to calculate the correct monitor unit values for
the treatment schedule; however, Odyssey does not provide indication to the
user of this anomaly, and allows export of the plan with these incorrect
monitor unit values.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION Nationwide,
Hungary, Brazil, China, India, Italy, and Mexico
PRODUCT
1) Product is labeled in part - Pouch
label: "***ORTHOFIX***Description: Origen***DBM
Paste***Size***REF:***ID***Expiration***STERILE R***Donated Human Tissue
Allograft***SINGLE PATIENT USE ONLY***Rx Only***" Product is labeled in
part - Carton label: "***Origen DBM with Bioactive Glass***REF***ID***
Expiration*** Rx Only***ONE EACH***" Origen DBM with Bioactive Glass
Catalog #: a) 22-2002 (2cc size); b) 22-2005 (5cc size); c) 22-2010 (10cc
size) "Bone void filler comprised of a gelatin carrier, bioactive glass
(45s5), and human demineralized bone matrix (DBM) intended for
transplantation." Indicated to be gently placed into bony voids or gaps
of the skeletal system that are not intrinsic to the stability of the bony
structure (e.g. the extremities and pelvis).
2) Product is labeled in part - Pouch
label: "***NanoFUSE***DBM*** Description: NanoFUSE DBM***Size***Order
No.:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE
PATIENT USE ONLY***Rx Only*** nanotherapeutics***" Product is labeled in
part - Carton label: "***NanoFUSE DBM***Order No:***ID***Expiration***nanotherapeutics***Rx
Only***ONE EACH***" NanoFUSE DBM Catalog #:a) NAN109-02 (2cc size); b)
NAN109-05 (5cc size); c) NAN109-10(10cc size) "Bone void filler comprised
of a gelatin carrier, bioactive glass (45s5), and human demineralized bone
matrix (DBM) intended for transplantation." Indicated to be gently placed
into bony voids or gaps of the skeletal system that is not intrinsic to the
stability of the bony structure (e.g. the extremities and pelvis).
CODE
1) a) Lot #: 070281P, 070591P, 073221P,
073434P, 073504P, 073577PA, 073761PA, 073761PB, 074349P, 075075PA, 075128P,
075245PA, 075255P, 075259P, 077870PA, 078093PB, 078268PB; b)Lot #: 067559PA,
067559PB, 0700869, 070281P, 070546PA, 070546PB, 070552P, 070591P, 070743P,
070884PA, 070884PB, 073221P, 073222P, 073346PB, 073434P, 073496P, 073504P,
074032P, 075075PB, 075259P, 075481P, 075637PA, 075637PB, 075660P, 077642PA,
077870PB, 078048P, 078268PB, 078309PA, 079002PA; c) Lot #: 060095P, 067484P,
070203P, 070281P, 070512P, 070521P, 070603PA, 070607P, 070629P, 070703P,
070704P, 070755P, 070831P, 070916P, 071043PB, 071045PA, 071053PA, 071053PB,
073221P, 073319PB, 073346PA, 073346PB, 073411PB, 073434P, 073494PA, 073494PB,
073502P, 073590P, 073695P, 073751P, 073828P, 073879P, 075050PA, 075058P,
075167PB, 075230PA, 075230PB, 075245PB, 075338PA, 075338PB, 075492PA, 075629P,
077390P, 077715PA, 077715PB, 077863PA, 078093PA, 078268PA, 078268PB, 078344PB;
2) a) Lot #: 074349P; b) Lot #:
073995PA, 077870PB; c) Lot #: 071045PB, 071043PA, 070916P
RECALLING FIRM/MANUFACTURER
Nanotherapeutics, Inc., Alachua,
FL,
REASON The
products were manufactured without an approved 510k. Direct accounts were
notified of the recall on 04/08/2011.
VOLUME OF PRODUCT IN COMMERCE
6,407 units
PRODUCT Synthes
Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical
instrument motor and accessories are AC-powered, battery-powered or
air-powered devices intended for use during surgical procedures to provide
power to operate various accessories or attachments to cut hard tissue or bone
and soft tissue. Accessories or attachments may include a bur, chisel (osteotome),
dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw
blade. Catalog number: 532.026.
CODE All
lots
RECALLING FIRM/MANUFACTURER
Synthes USA (HQ), Inc., West Chester,
PA,
REASON The
potential exists for the Large Oscillating Saw Attachment to disengage from
the Small Battery Drive handpiece. If the attachment disengages from the
handpiece, there is a potential for injury to the patient and/or user.
VOLUME OF PRODUCT IN COMMERCE
5 units
PRODUCT P/N
801-01-013 Foundation Tibial Broach to be used in conjunction with the Tibial
Sizing Template and Tibial Broach Guide to prepare the resected Tibial plateau
for acceptance of a keeled Tibial Baseplate stem.
CODE Lot
#'s: 35149L02, 36204L06, 37990L06, 38272L13, and 50479L12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Encore Medical,
LP, Austin, TX,
Manufacturer: Encore Medical, LP,
Austin, TX.
REASON The
strike plate may dislodge from the broach stem handle during impaction of the
device.
VOLUME OF PRODUCT IN COMMERCE
30 Units
DISTRIBUTION Nationwide,
UK and Italy
PRODUCT SoftReports
version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. SoftReports is a
web-based report launching tool to be used in a hospital or laboratory
environment by knowledgeable, trained, and experienced personnel. SoftReports
enables the user to schedule and generate reports for the purpose of viewing
and printing data stored in SCC product databases.
CODE SoftReports
version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL,
REASON When
SoftReports Designer opened a layout, the system did not load the layout with
the previously saved value in the NewPage property. This caused multiple
patient records to be printed on the same page.
VOLUME OF PRODUCT IN COMMERCE
5 units
PRODUCT
1) VenaCure EVLT NeverTouch PROCEDURE
KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Kit 45CM Internal Sheath,
Catalog No./REF 11402001, STERILE. Product Usage: The AngioDynamics, Inc.
VenaCure Procedure Kit is indicated for endovascular coagulation of the Great
Saphenous Vein (GSV) in patients with superficial vein reflux, for the
treatment of varicose veins and varicosities associated with superficial
reflux of the Great Saphenous Vein (GSV), and for the treatment of
incompetence and reflux of superficial veins of the lower extremity.
2) VenaCure EVLT NeverTouch PROCEDURE
KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Kit 65CM Internal Sheath,
Catalog No./REF 11402002, STERILE. Product Usage: The AngioDynamics, Inc.
VenaCure Procedure Kit is indicated for endovascular coagulation of the Great
Saphenous Vein (GSV) in patients with superficial vein reflux, for the
treatment of varicose veins and varicosities associated with superficial
reflux of the Great Saphenous Vein (GSV), and for the treatment of
incompetence and reflux of superficial veins of the lower extremity.
3) VenaCure EVLT NeverTouch - FRS
PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch 45cm Kit
w/Gripper and RFID T, Catalog No./REF 11403001, STERILE. Product Usage: The
AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular
coagulation of the Great Saphenous Vein (GSV) in patients with superficial
vein reflux, for the treatment of varicose veins and varicosities associated
with superficial reflux of the Great Saphenous Vein (GSV), and for the
treatment of incompetence and reflux of superficial veins of the lower
extremity.
4) VenaCure EVLT NeverTouch - FRS
PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch 65cm Kit
w/Gripper and RFID T, Catalog No./REF 11403002, STERILE. Product Usage: The
AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular
coagulation of the Great Saphenous Vein (GSV) in patients with superficial
vein reflux, for the treatment of varicose veins and varicosities associated
with superficial reflux of the Great Saphenous Vein (GSV), and for the
treatment of incompetence and reflux of superficial veins of the lower
extremity.
5) VenaCure EVLT NeverTouch - FRS
.018" System PROCEDURE KIT Featuring Gold-Tipped Fiber, 25 cm, VC EVLT
NeverTouch-FRS 0.18 25 cm Kit, Catalog No./REF 11403003, STERILE. Product
Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for
endovascular coagulation of the Great Saphenous Vein (GSV) in patients with
superficial vein reflux, for the treatment of varicose veins and varicosities
associated with superficial reflux of the Great Saphenous Vein (GSV), and for
the treatment of incompetence and reflux of superficial veins of the lower
extremity. ;
6) VenaCure EVLT NeverTouch - FRS
PROCEDURE KIT Featuring Gold-Tipped Fiber, 90 cm, VC EVLT NeverTouch-FRS 90cm
Kit, Catalog No./REF 11403004, STERILE. Product Usage: The AngioDynamics, Inc.
VenaCure Procedure Kit is indicated for endovascular coagulation of the Great
Saphenous Vein (GSV) in patients with superficial vein reflux, for the
treatment of varicose veins and varicosities associated with superficial
reflux of the Great Saphenous Vein (GSV), and for the treatment of
incompetence and reflux of superficial veins of the lower extremity.
7) VenaCure EVLT NeverTouch - FRS w/19Ga
Needle PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NT FRS 45cm Kit
w/19Ga Needle, Catalog No./REF 11403005, STERILE. Product Usage: The
AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular
coagulation of the Great Saphenous Vein (GSV) in patients with superficial
vein reflux, for the treatment of varicose veins and varicosities associated
with superficial reflux of the Great Saphenous Vein (GSV), and for the
treatment of incompetence and reflux of superficial veins of the lower
extremity.
8) VenaCure EVLT NeverTouch - FRS w/19Ga
Needle PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NT FRS 65cm Kit
w/19Ga Needle, Catalog No./REF 11403006, STERILE. Product Usage: The
AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular
coagulation of the Great Saphenous Vein (GSV) in patients with superficial
vein reflux, for the treatment of varicose veins and varicosities associated
with superficial reflux of the Great Saphenous Vein (GSV), and for the
treatment of incompetence and reflux of superficial veins of the lower
extremity.
9) VenaCure EVLT NeverTouch - FRS .018
" System PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, 45cm
NeverTouch FRS .018 Procedure Kit, Catalog No/REF 11403012, STERILE. Product
Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for
endovascular coagulation of the Great Saphenous Vein (GSV) in patients with
superficial vein reflux, for the treatment of varicose veins and varicosities
associated with superficial reflux of the Great Saphenous Vein (GSV), and for
the treatment of incompetence and reflux of superficial veins of the lower
extremity.
10) VenaCure EVLT NeverTouch - FRS .018
" System PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, 65cm
NeverTouch FRS .018 Procedure Kit, Catalog No./REF 11403013, STERILE. Product
Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for
endovascular coagulation of the Great Saphenous Vein (GSV) in patients with
superficial vein reflux, for the treatment of varicose veins and varicosities
associated with superficial reflux of the Great Saphenous Vein (GSV), and for
the treatment of incompetence and reflux of superficial veins of the lower
extremity.
11) VenaCure EVLT NeverTouch PROCEDURE
KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Procedure Kit 45cm, Catalog
No./REF 51402007, STERILE. This is a Special Order. Product Usage: The
AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular
coagulation of the Great Saphenous Vein (GSV) in patients with superficial
vein reflux, for the treatment of varicose veins and varicosities associated
with superficial reflux of the Great Saphenous Vein (GSV), and for the
treatment of incompetence and reflux of superficial veins of the lower
extremity.
12) VenaCure EVLT NeverTouch PROCEDURE
KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Procedure Kit 65cm, Catalog
No./REF 51402008, STERILE. This is a Special Order. Product Usage: The
AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular
coagulation of the Great Saphenous Vein (GSV) in patients with superficial
vein reflux, for the treatment of varicose veins and varicosities associated
with superficial reflux of the Great Saphenous Vein (GSV), and for the
treatment of incompetence and reflux of superficial veins of the lower
extremity.
13) VenaCure EVLT NeverTouch-FRS
PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, VenaCure NeverTouch FRS 45cm
Clear Needle, Catalog No./REF 51403001, STERILE. This is a Special Order.
Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for
endovascular coagulation of the Great Saphenous Vein (GSV) in patients with
superficial vein reflux, for the treatment of varicose veins and varicosities
associated with superficial reflux of the Great Saphenous Vein (GSV), and for
the treatment of incompetence and reflux of superficial veins of the lower
extremity.
14) VenaCure EVLT NeverTouch-FRS
PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VenaCure NeverTouch FRS 65cm
Clear Needle, Catalog No./REF 51403002, STERILE. This is a Special Order.
Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for
endovascular coagulation of the Great Saphenous Vein (GSV) in patients with
superficial vein reflux, for the treatment of varicose veins and varicosities
associated with superficial reflux of the Great Saphenous Vein (GSV), and for
the treatment of incompetence and reflux of superficial veins of the lower
extremity.
15) VenaCure EVLT NeverTouch-FRS
PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VC NT FRS 65cm Clear
Non-Echo Needle, Catalog No./REF 51403005, STERILE. This is a Special Order.
Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for
endovascular coagulation of the Great Saphenous Vein (GSV) in patients with
superficial vein reflux, for the treatment of varicose veins and varicosities
associated with superficial reflux of the Great Saphenous Vein (GSV), and for
the treatment of incompetence and reflux of superficial veins of the lower
extremity.
CODE
1) Batch/Lot Numbers: 549594, 549802;
2) Batch/Lot Numbers: 549019, 549040,
549041, 549599, 549600, 549601, 549602, 549603, 549803, 549804, 549805,
551095, 551096, 551097;
3) Batch/Lot Numbers: 549604, 549605,
549607, 549806, 549991, 550848, 551098, 551099, 551100, 551101, 551102,
551503, 551970, 551971, 551972, 551973, 551974, 552939, 552960, 553299,
553300, 553301, 553302, 553583, 553605, 553937, 553938, 553939, 554040,
554041, 554267, 554268, 554269, 554270, 554624;
4) Batch/Lot Numbers: 549045, 549046,
549047, 549609, 549610, 549611, 549612, 549613, 549614, 549807, 549808,
549809, 549810, 551103, 551104, 551105, 551504, 551505, 551506, 551975,
551976, 551977, 551978, 551979, 552961, 552962, 552963, 553303, 553304,
553305, 553306, 553584, 553585, 553586, 554271, 554272, 554273, 554274,
554275, 554276, 554630, 554631, 554632, 554636;
5) Batch/Lot Numbers: 549811, 550576,
552000, 552964, 552965, 554277, 554278;
6) Batch/Lot Numbers: 549745, 549746;
7) Batch/Lot Numbers: 552001, 553679;
8) Batch/Lot Numbers: 549759, 549780,
549781, 549782, 549783, 550822, 551106, 551107, 552967, 553307;
9) Batch/Lot Numbers: 549616, 550415,
552004, 553309, 553589, 554285;
10) Batch/Lot Numbers: 549595, 549617,
550212, 551109, 552005, 552052, 552968, 553310, 554282, 554283, 554642;
11) Batch/Lot Number: 553311;
12) Batch/Lot Numbers: 551252, 551840,
556175;
13) Batch/Lot Number: 554047;
14) Batch/Lot Numbers: 551253, 553312,
554789;
15) Batch/Lot Numbers: 550483, 552969,
554284
RECALLING FIRM/MANUFACTURER
Recalling Firm: Angiodynamics
Worldwide Headquarters, Latham, NY,
Manufacturer: Angiodynamics,
Inc., Queensbury, NY.
REASON During
an in-process inspection the hemostasis sidearm assemblies were identified to
have the potential for flash to exist on the housing at the base of the
threads. This flash has the potential to break off and relocate within the
fluid path.
VOLUME OF PRODUCT IN COMMERCE
Nationwide: 11,036 units;
Internationally: 1230 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT MAXLOCK
EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product
Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates
are indicated for fractures, fusions and osteotomies for small bones in the
hand, wrist, foot and ankle in both pediatric and adult patients. Variable
Angle Technology in MXL and CLA plates are indicated for the fractures,
fusions, and osteotomies of the clavicle and small bones in the hand, wrist,
foot and ankle. a) Model # VAR-031-35-10, Model # VAR-031-35-12, Model #
VAR-031-35-14, Model # VAR-031-35-16, Model # VAR-031-35-18, Model #
VAR-031-35-20, Model # VAR-031-35-22, Model # VAR-031-35-24, Model #,
VAR-031-35-26, Model # VAR-031-35-28, Model # VAR-031-35-30 &, b) Model #,
MXL-032-35 and Model # VAR-032-35.
CODE a)
Lot # 1364, 1731, 1862; b) Lot # 1365011, 1365012
RECALLING FIRM/MANUFACTURER
Orthohelix Surgical Designs Inc.,
Medina, OH,
REASON The
firm discovered a testing protocol error, in both dynamic and static
cantilever comparative testing, during the initial comparative testing.
VOLUME OF PRODUCT IN COMMERCE
2,722 units
PRODUCT
1) HOTLlNE Disposable Administration
Sets, Product Codes L-70 Product Usage: Single patient use Sets designed for
use by trained medical professionals, in conjunction with HOTLlNE Routine Flow
Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of
blood and I.V. solutions, at normothermic flow rates of 50 - 5,000
ml/hr.
2) HOTLlNE Disposable Administration
Sets, Product Codes L-70NI Product Usage: Single patient use Sets designed for
use by trained medical professionals, in conjunction with HOTLlNE Routine Flow
Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of
blood and I.V. solutions, at normothermic flow rates of 50 - 5,000
ml/hr.
3) HOTLlNE Disposable Administration
Sets, Product Code L-270 Product Usage: Single patient use Sets designed for
use by trained medical professionals, in conjunction with HOTLlNE Routine Flow
Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of
blood and I.V. solutions, at normothermic flow rates of 50 - 5,000
ml/hr.
4) HOTLlNE Disposable Administration
Sets, Product Code L-370 Product Usage: Single patient use Sets designed for
use by trained medical professionals, in conjunction with HOTLlNE Routine Flow
Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of
blood and I.V. solutions, at normothermic flow rates of 50 - 5,000
ml/hr.
5) HOTLlNE Disposable Administration
Sets, Product Code L-80 Product Usage: Single patient use Sets designed for
use by trained medical professionals, in conjunction with HOTLlNE Routine Flow
Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of
blood and I.V. solutions, at normothermic flow rates of 50 - 5,000
ml/hr.
6) Level 1 Normothermic I.V. Fluid
Administration Sets, Product Code D-60HL , Product Usage: Single patient use
sets designed for use by trained medical professionals, in conjunction with
Level 1® Fast Flow Fluid Warmers (H1000, H-1025, H-1028, and H-1200), for the
warming and delivery of blood and I.V. solutions, at flow rates of 75ml/min -
530 ml/min.
7) Level 1 Normothermic I.V. Fluid
Administration Sets, Product Code DI-60HL , Product Usage: Single patient use
sets designed for use by trained medical professionals, in conjunction with
Level 1® Fast Flow Fluid Warmers (H1000, H-1025, H-1028, and H-1200), for the
warming and delivery of blood and I.V. solutions, at flow rates of 75ml/min -
530 ml/min.
CODE
1) Lot Numbers: 1961565 1967233 1967234
1967235 1967236 1967237 1967238 1967239 1967240 1973118 1973119 1982938
1982939 1983243 1983244 1983246 1989241 1989242 1989243 1989244 1989245
1995431 1995554 1995555 1995556 1995698 1995699 1995700 1995701 1995702
2007275 2007276 2007277 2007278 2019640 2019641 2019642 2019643 2019644
2025123 2025125 2025126 2025127 2025128 2025129 2025130 2025131 2025133
2025134 2025135 2033081 2033082 2033083 2033084 2033085 2033086 2042613
2042614 2042615 2042617 2042618 2049316 2049317 2049318 2049437 2049438
2055173 2055174 2055175 2055176 2059473 2059474 2059475 2064014 2064015
2064017 2064018 2068138 2068139 2068140 2068141 2068142 2077203 2077204
2077205 2077206 2077207 2083507 2083508 2084305 2090782 2090783 2093663
2093664 2095298 2095300 2101204 2101205 2101206 2101207 2101208;
2) Lot Numbers: 1967243 1967244 1973126
1979964 1979965 1979966 1981255 1981256 1981257 1981258 1981259 1995557
2007279 2007280 2007281 2007282 2019645 2019646 2025136 2025137 2025138
2025140 2025143 2025144 2025145 2042619 2042620 2042621 2042622 2042623
2042624 2042625 2049440 2049441 2049442 2059476 2059477 2059478 2059479
2064019 2064020 2064021 2068143 2068144 2068145 2068146 2077341 2077342
2083509 2087640 2090784 2090785 2090786 2095293 2095294 2099545 2099546
2105392;
3) Lot Numbers: 1947531 1952652 1957058
1957059 1967245 1967246 1979007 1995553 1995693 1998983 1998984 2019637
2019638 2019639 2025120 2025121 2038143 2038144 2038146 2038147 2049439
2059469 2059470 2064010 2068137 2077198 2077199 2077200 2090779;
4) Lot Numbers: 1995695 1995696 2038150
2038151 2038152 2047423 2061923 2061924 2061929 2061930 2061931 2061932
2061933 2077201 2077202 2090780 2090781 2095295 2095302 2095306;
5) Lot Numbers: 1974580 2007256 2064012
2089416 2093985;
6) Lot Numbers: 1974580 2007256 2064012
2089416 2093985;
7) Lot Numbers: 2033447 2039136 2046398
2046400 2047961 2047963 2064528 2064529 2064530 2077404 2077405 2077406
2077407 2087667 2099050 2099766 2102361
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Rockland, MA,
REASON Disconnected/
loose Luer connectors at the patient end of the triple lumen tubing of the
HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV
Administration Sets.
VOLUME OF PRODUCT IN COMMERCE
805,506 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT UniCel
DxC and Synchron LX Clinical Systems 100 L Sample Syringe, 100UL-PKGD, Part
Number 474171 Product Usage: The UniCel DxC and LX Synchron Clinical Systems
are fully automated, computer-controlled clinical chemistry analyzers designed
for the in vitro determination of a variety of general chemistries,
therapeutic drugs, and other chemistries. Analysis can be performed on serum,
plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is
chemistry dependent).
CODE Lot/Serial
Numbers: All
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA,
REASON The
Modular Chemistry (MC) and Cartridge Chemistry (CC) 100 uL sample syringes may
experience premature wear as indicated by brown discoloration on the plunger
and/or inside the glass syringe barrel. Excessive wear of the 100 uL sample
syringe barrel and plunger could lead to leaking and may affect results.
VOLUME OF PRODUCT IN COMMERCE
3278 total (3083 Nationwide, 195 in
Canada)
DISTRIBUTION Nationwide
and Canada
PRODUCT Artiste
Maverick Tint, Part Number: N36TB, Product Description and Intended Use: The
intended use of this device is for internal color characterization and
includes 3 opaques for blocking out deep staining or metal substrates. Product
Usage: The intended use of this device is for internal color characterization
and includes 3 opaques for blocking out deep staining or metal
substrates.
CODE Lot/Serial
Numbers: 3416180
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kerr Corp.,
Orange, CA,
Manufacturer: Pentron Clinical
Dental Material, Villa Park, CA.
REASON The
resin material separates when the product is extruded from the syringe.
Although there are no safety issues related with this situation, please
refrain from using the affected product.
VOLUME OF PRODUCT IN COMMERCE
One hundred (100) units
DISTRIBUTION Nationwide
and Armenia, Russia and Ukraine
PRODUCT SPOT-Light"
HER2 CISH Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Product
Usage: The SPOT-Light HER2 CISH Kit is intended to quantitatively determine
HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast
carcinoma tissue sections and is indicated as an aid in the assessment of
patients for whom Herceptin (trastuzumab) treatment is being considered.
CODE Lot
1029335, Exp. August 31, 2012
RECALLING FIRM/MANUFACTURER
Life Technologies Corp., Frederick, MD,
REASON In
vitro diagnostic reagent may be contaminated with a fungal contaminant.
VOLUME OF PRODUCT IN COMMERCE
29 kits
DISTRIBUTION Nationwide,
Canada, Venezuela, and the UK
PRODUCT SoftLab
GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21;
4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16;
4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8. Product Usage: SoftLab is a laboratory
information system to be used in a medical research or clinical laboratory by
knowledgeable, trained, and experienced personnel. SoftLab enables the user to
handle data-processing and laboratory activities, for the purpose of storing,
managing, querying, and reporting laboratory data.
CODE SoftLab
GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21;
4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16;
4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL,
REASON A
client reported that results were not flagged correctly. This can occur when a
test is ordered in Order Entry, then collected, received, and resulted from
the Order Entry results tab in the same session in Order Entry, within a very
short time frame. The patient results are accurate, but if the result
interpretation flags are missing, an abnormal test result could be overlooked
by a physician when reviewing the patient report. Also, if the abnormal flags
are missing, the results will not qualify to the Call list.
VOLUME OF PRODUCT IN COMMERCE
220 units
DISTRIBUTION Nationwide
and Canada
PRODUCT Lifescreen
Apnea is Lifescreen ECG Screening System, Version 3.31. Lifescreen Apnea is
indicated for screening adults for the probability that they suffer from
obstructive sleep apnea, mixed apnea or hypopnea, in order to evaluate the
necessity for a polysomonographic examination. The ECG recording may be
obtained at any location specified by a physician including home, hospital or
clinic. Subjects screened for sleep apnea should have periods of sleep of at
least 4 hours duration during which the ECG is predominantly sinus rhythm in
nature.
CODE
There is no Serial Numbers for 169 Kits.
Serial Numbers for 519 units: 12038, 32288, 32300, 32302, 32327, 32329, 32330,
32389, 32410, 32411, 32415, 32417, 32418, 32470, 32471, 32472, 32473, 32474,
32475, 32476, 32478, 32479, 32480, 32481, 32482, 32483, 32484, 32485, 32486,
32487, 32488, 32532, 32546, 32547, 32548, 32549, 32550, 32551, 32552, 32553,
32554, 32557, 32558, 32561, 32567, 32568, 32569, 32570, 32648, 32649, 32650,
32651, 32652, 32653, 32655, 32656, 32657, 32658, 32659, 32676, 32677, 32678,
32679, 32680, 32681, 32682, 32683, 32684, 32686, 32687, 32712, 32713, 32714,
32715, 32716, 32717, 32718, 32719, 32720, 32721, 32722, 32723, 32726, 32742,
32759, 32790, 32791, 32797, 32798, 32799, 32800, 32801, 32802, 32803, 32804,
32805, 32806, 32814, 32821, 32822, 32823, 32824, 32860, 32861, 32862, 32863,
32864, 32865, 32866, 32867, 32868, 32869, 32870, 32871, 32872, 32873, 32877,
32878, 32880, 32881, 32944, 32945, 32946, 32947, 32948, 32949, 32950, 32951,
32952, 32954, 32955, 32956, 32957, 32958, 32959, 32960, 32961, 32963, 32977,
32979, 32980, 32982, 32983, 32984, 32986, 32987, 32989, 32990, 32991, 32992,
32993, 32994, 32995, 33015, 33017, 33058, 33095, 33096, 33097, 33098, 33099,
33100, 33101, 33102, 33103, 33104, 33105, 33106, 33107, 33108, 33113, 33114,
33115, 33116, 33117, 33118, 33119, 33120, 33121, 33122, 33123, 33124, 33132,
33135, 33158, 33159, 33160, 33161, 33162, 33164, 33165, 33166, 33167, 33184,
33185, 33186, 33188, 33189, 33190, 33200, 33201, 33213, 33219, 33221, 33240,
33241, 33242, 33243, 33244, 33245, 33254, 33255, 33257, 33258, 33259, 33260,
33261, 33262, 33263, 33264, 33265, 33267, 33268, 33269, 33270, 33322, 33323,
33324, 33326, 33327, 33328, 33329, 33330, 33336, 33337, 33338, 33339, 33343,
33347, 33348, 33352, 33355, 33386, 33387, 33388, 33391, 33392, 33393, 33394,
33396, 9310, 9520, 9885, 9933, 9934, IMP-002054, IMP-005010, IMP-005011,
IMP-005013, IMP-005025, IMP-005027, IMP-005028, IMP-005029, IMP-005030,
IMP-005031, IMP-005035, IMP-005036, IMP-005038, IMP-005039, IMP-005042,
IMP-005043, IMP-005045, IMP-005046, IMP-005048, IMP-005049, IMP-005050,
IMP-005062, IMP-005063, IMP-005065, IMP-005066, IMP-005068, IMP-005073,
IMP-005077, IMP-005078, IMP-005087, IMP-005090, IMP-005091, IMP-005092,
IMP-005094, IMP-005102, IMP-005108, IMP-005110, IMP-005111, IMP-005115,
IMP-005141, IMP-005147, IMP-005151, IMP-005152, IMP-005160, IMP-005162,
IMP-005165, IMP-005176, IMP-005218, IMP-005219, IMP-005237, IMP-005238,
IMP-005253, IMP-005254, IMP-005258, LIFE-025878, LIFE-027365, LIFE-027527,
LIFE-027528, LIFE-027866, LIFE-028314, LIFE-029149, LIFE-029150, LIFE-029718,
LIFE-029719, LIFE-032784, LIFE-033181, LIFE-033791, PATH-000100, PATH-000101,
PATH-000102, PATH-000103, PATH-000104, PATH-000105, PATH-000106, PATH-000107,
PATH-006004, PATH-006005, PATH-006006, PATH-006007, PATH-006018, PATH-006019,
PATH-006020, PATH-006039, PATH-006040, PATH-006041, PATH-006042, PATH-006043,
PATH-006044, PATH-006045, PATH-006068, PATH-006069, PATH-006070, PATH-006071,
PATH-006072, PATH-006073, PATH-006074, PATH-006075, PATH-006077, PATH-006099,
PATH-006101, PATH-006102, PATH-006103, PATH-006104, PATH-006105, PATH-006106,
PATH-006108, PATH-006109, PATH-006110, PATH-006112, PATH-006113, PATH-006114,
PATH-006115, PATH-006120, PATH-006132, PATH-006158, PATH-006159, PATH-006160,
PATH-006161, PATH-006162, PATH-006163, PATH-006164, PATH-006165, PATH-006166,
PATH-006175, PATH-006182, PATH-006183, PATH-006184, PATH-006186, PATH-006188,
PATH-006190, PATH-006237, PATH-006238, PATH-006239, PATH-006250, PATH-006251,
PATH-006252, PATH-006253, PATH-006254, PATH-006255, PATH-006256, PATH-006258,
PATH-006259, PATH-006299, PATH-006300, PATH-006301, PATH-006302, PATH-006306,
PATH-006309, PATH-006314, PATH-006315, PATH-006316, PATH-006317, PATH-006318,
PATH-006319, PATH-006320, PATH-006321, PATH-006322, PATH-006323, PATH-006324,
PATH-006325, PATH-006326, PATH-006327, PATH-006328, PATH-006329, PATH-006332,
PATH-006333, PATH-006344, PATH-006350, PATH-006351, PATH-006353, PATH-006382,
PATH-006407, PATH-006409, PATH-006410, PATH-006447, PATH-006448, PATH-006451,
PATH-006452, PATH-006471, PATH-006485, PATH-006486, PATH-006487, PATH-006488,
PATH-006489, PATH-006490, PATH-006502, PATH-006505, PATH-006506, PATH-006522,
PATH-006523, PATH-006524, PATH-006525, PATH-006526, PATH-006527, PATH-006528,
PATH-006531, PATH-006533, PATH-006537, PATH-006538, PATH-006542, PATH-006543,
PATH-006544, PATH-006545, PATH-006572, PATH-006573, PATH-006574, PATH-006602,
PATH-006603, PATH-006604, PATH-006605, PATH-006606, PATH-006607, PATH-006608,
PATH-006609, PATH-006610, PATH-006611, PATH-006612, PATH-006613, PATH-006614,
PATH-006615, PATH-006630, PATH-006631, PATH-006632, PATH-006638, PATH-006650,
PATH-006651, PATH-006652, PATH-006662, PATH-006663, PATH-006664, PATH-006665,
PATH-006666, PATH-006667, PATH-006698, PATH-006712, PATH-006713, PATH-006714,
PATH-006715, PATH-006716, PATH-006717, PATH-006735, PATH-006736, PATH-006738,
PATH-006739, PATH-006740, PATH-006741, PATH-006742, PATH-006743, PATH-006744,
PATH-006774, PATH-006830, PATH-006831, PATH-006853, PATH-006858, PATH-006859,
PATH-006860, PATH-006861, PATH-006862, PATH-006872, PATH-006873, PATH-006874,
PATH-006877, PATH-006878, PATH-006984
RECALLING FIRM/MANUFACTURER
Del Mar Reynolds Medical, Ltd.,
Hertford, UK,
REASON When
Lifescreen is left open and a new recording is loaded from Sentinel Cardiology
Information Management System, customers can get corruption in the data or a
wrong ECG after the first 32 hours. Both recordings have to be longer than 32
hours for this to happen.
VOLUME OF PRODUCT IN COMMERCE
519 units and 16 9 kits (34 units and 7
kits Nationwide; 485 units and 162 kits Internationally)
DISTRIBUTION Nationwide
and Internationally
PRODUCT Therakos
Cellex Photopheresis System CellexUSA & Cellex. The photopheresis system
is indicated for use in the ultraviolet-A (UVA) irradiation in the presence of
the photoactive drug 8-methoxypsoralen (8-MOP) of extracorporeally circulating
leukocyte-enriched blood in the palliative treatment of the skin manifestation
of cutaneous T-cell lymphoma (CTCL) in person who have not been responsive to
other forms of treatment. The Cellex procedural kits are designed to interface
with the Cellex Photopheresis System to perform cell separation and photo
activation in a single closed and sterile circuit. This is accomplished by use
of an integrated centrifuge bowl and associated tubing for separation of whole
blood into red blood cells, plasma, and buffy coat (leukocyte-enriched blood).
All blood components are returned to the patient. The procedural kits are
fully assembled as received by the customer and the customer is only required
to place the components in the Cellex System to enable the system for
use.
CODE
Lot Numbers and Expiration Dates
CELLEXUSA 40115 20091201 CELLEXUSA 40117 20090707 CELLEXUSA 40122 120090713
CELLEXUSA 40129 120090618 CELLEXUSA 40130 20091103 40133 20091014 CELLEXUSA
40134 20091014 ICELLEXUSA 40136 20091019 ICELLEXUSA CELLEXUSA 40137 20091021
CELLEXUSA 40141 20091201 20091104 40142 ICELLEXUSA 40143 20091208 ICELLEXUSA
CELLEXUSA 40151 20091215 - 40152 20100114 CELLEXUSA 40154 20100112 CELLEXUSA
40156 20100112 CELLEXUSA 40158 20100209 CELLEXUSA 40159 - 20100209 CELLEXUSA
40160 40161 20100128 CELLEXUSA 20100209 CELLEXUSA 40162 40163 20100128
CELLEXUSA 40165 20100322 CELLEXUSA 20100401 CELLEXUSA 40166 20101006 CELLEXUSA
40170 40171 20100623 CELLEXUSA 20101022 CELLEXUSA 40172 20100625 CELLEXUSA
40173 40174 20100625 CELLEXUSA 40175 20101029 CELLEXUSA 40176 20101026
CELLEXUSA 40177 20101029 CELLEXUSA 40178 20101130 CELLEXUSA 40179 20100625
CELLEXUSA 40180 20100927 CELLEXUSA 20101130 CELLEXUSA 40181 20101201 CELLEXUSA
40182 20101201 CELLEXUSA 140183 CELLEX 40111 20090327 CELLEX 40112 2009 1005
CELLEX 40113 20090327 CELLEX 40114 20090326 I CELLEX 40116 20090330 CELLEX
40118 20090522 CELLEX 40119 20090423 CELLEX 40120 20090522 CELLEX 40121
20090522 CELLEX 40124 200906 12 CELLEX 40125 20090603 CELLEX 40126 20090612
CELLEX 40127 20090604 CELLEX 40128 2009 1028 CELLEX 40131 20091002 CELLEX
40132 2009 10 15 CELLEX 40135 2009 10 15 CELLEX 40138 2009 11 10 CELLEX 40139
2009 1029 CELLEX 40140 2009 1026 CELLEX I 40144 2009 1029 CELLEX 40145
20091029 CELLEX 40147 2009 12 18 CELLEX 140148 2009 12 18 CELLEX 40149 2009
:12 18 CELLEX 40150 2009 12 18 CELLEX 40153 1201002 19 CELLEX 40155 201002 i9
CELLEX 40157 20100219 CELLEX 40164 20100323 CELLEX 40167 20100528 CELLEX 40184
20100920 CELLEX 40185 20100929 CELLEX 40186 2010 1021 CELLEX 40187 2010 10 26
CELLEX 40188 2010 1029 CELLEX 40190 20101223 CELLEX 40191 2010 1223 CELLEXUSA
40189 20100625 CELLEXUSA 40207 20110517 20110531 20101229 20110615 20110809
20110810 20110818 I CELLEXUSA 40208 CELLEXUSA 140209 ICELLEXUSA 40210
CELLEXUSA 40211 CELLEXUSA 40212 CELLEXUSA 40213 CELLEXUSA 40215 CELLEXUSA
40216 CELLEXUSA 40224
RECALLING FIRM/MANUFACTURER
Therakos, Inc., Raritan, NJ,
REASON There
have been three confirmed reports of post reinfusion hemolysis or
hemoglobinuria in patients treated on the Therakos Cellex Photopheresis
System.
VOLUME OF PRODUCT IN COMMERCE
49 Nationwide, 65 Internationally
DISTRIBUTION Nationwide
and Internationally
PRODUCT Midmark
M11 Ultra Steam Sterilizer. Sterilize reusable equipment that is heat and
moisture stable. Model #'s: M11-001, M11D-001, M11-001R, M11D-002, M11-002,
M11-002R, M11-003, M11-004, M-005, and M11-006.
CODE None
RECALLING FIRM/MANUFACTURER
Midmark Corp., Versailles, OH,
REASON During
and FDA inspection on 8/23/2011, it was discovered that the firm received
numerous reports of the steam sterilizer malfunctioning.
VOLUME OF PRODUCT IN COMMERCE
30,255 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
1) OPUS Magnum 2 Plus Implant Product
Number OM-1502 is a bone anchor Intended for rotator cuff repair in the
shoulder.
2) OPUS Magnum 2 Plus Implant Product
Number OM-9026 is one of two kits Intended for rotator cuff repair.
3) OPUS Magnum 2 Plus Implant Product
Number OM-9027 is one of two kits with product number OM-1502 Intended for
rotator cuff repair.
4) OPUS SpeedStitch Product Number
OM-8086 is a suture cartridge. For use in approximation and/or ligation of
soft tissues, including use of allograft tissue for orthopedic
surgeries.
5) OPUS SmartStitch Product Number
OM-8178 is a suture cartridge; for use in approximation and/or ligation of
soft tissues, including use of allograft tissue for orthopedic surgeries.
6) OPUS SmartStitch M-Connector Product
Number OM-8007 is a suture passer.
7) OPUS SpeedScrew Implant Product
Number OM-6500 is a bone anchor intended to be used for fixation of soft
tissue to bone.
8) 3.0mm 45 Degree Beval with cable
Product Number AC2430-01 is an ablation wand.
9) SideWinder Hip Wand Product Number
AC2340-01 is an ablation wand intended for resection, ablation, and
coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic
and orthopedic procedures.
10) MultiVac Tristar 50 Product Number
AS4630-01 is an ablation wand Intended for resection, ablation, and
coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic
and orthopedic procedures.
11) CoVac 50 Product Number AS2530-01 is
an ablation wand intended for resection, ablation, and coagulation of soft
tissue, and hemostasis of blood vessels in arthroscopic and orthopedic
procedures.
12) CoVac 70 Product Number AS3730-01 is
an ablation wand intended for resection, ablation, and coagulation of soft
tissues and hemostasis of blood vessels in arthroscopic procedures.
13) 3.0mm 45 Degree bevel Part Number
A2430-01 is an ablation wand intended for resection, ablation, and coagulation
of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic
procedures.
14) 3.5mm 90 Degree Part Number A1335-01
is an ablation wand intended for resection, ablation, and coagulation of soft
tissue, and hemostasis of blood vessels in arthroscopic and orthopedic
procedures.
15) Saber 30 Part Number A4330-01 is an
ablation wand Indicated for resection, ablation, and coagulation of soft
tissue, and hemostasis of blood vessels in arthroscopic and orthopedic
procedures.
16) Turbo Vac 90 with Cable Part Number
ASC1335-01 is an ablation wand Indicated for resection, ablation, and
coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic
and orthopedic procedures.
17) Lancelot 90 Degree with Cable Part
Number ASC4145-01 is an ablation wand.
18) 90 Degree LoPro with Cable Part
Number AC1336-01 is an ablation wand Intended for resection, ablation, and
coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic
and orthopedic procedures.
19) 3.0 60 Degree wand Part Number
A2530-01 is an ablation wand Intended for resection, ablation, and coagulation
of soft tissue, and hemostasis of blood vessels.
20) 5.0 mm Parafix Part Number 22-5011
is a suture anchor metal Intended for rotator cuff repair.
21) OPUS Minimagnum Implant Part Number
OM-2500 is a bone anchor Intended for rotator cuff repair.
CODE
1) Lot Numbers 120761, 120570, 120760,
120010, 1191150, and 120755;
2) Lot Number 114499;
3) Lot Number 114516;
4) Lot Numbers 1000044 and 1000162;
5) Lot Number 121748;
6) Lot Numbers 113086, 107304, 110511,
and 112473;
7) Lot Number 1004579;
8) Lot Number Q833660-A;
9) Lot Number M305780-A;
10) Lot Numbers 5604941-2 and 5600411;
11) Lot Numbers 3018831-2 and 3014221;
12) Lot Number 3526250-A;
13) Lot Number 1324341-2;
14) Lot Numbers 0933831-2, 093534102,
and 5L14150-A;
15) Lot Numbers 2711631, 2715201, and
2726711;
16) Lot Numbers 4C05970-A and 4C03160-C;
17) Lot Number N009660-A;
18) Lot Number Q732460-A;
19) Lot Number 1424970-A;
20) Lot Number 205091;
21) Lot Numbers 110730, 110874, 110400,
119256 and 117489
RECALLING FIRM/MANUFACTURER
Recalling Firm: Innovatech
Medical Resources L.P., Midlothian, TX,
Manufacturer: ArthroCare Corp.,
Sunnyvale, CA.
REASON Product
is being removed from the field due to an over-label issue.
VOLUME OF PRODUCT IN COMMERCE
150 units
PRODUCT Octopus
900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5),
Model Number: Octopus 900. Product Usage: The OCTOPUS 900 Perimeter is
designed for the examination, analysis and documentation of the field of
sight, especially the light difference sensitivity and other functions of the
human eye.
CODE
S/N's: 159, 231, 279, 313, 314, 315,
336, 338, 478, 479, 484, 485, 559, 560,561, 562, 563, 642, 644, 645, 646, 647,
648, 649, 650, 651, 772, 773, 774, 775, 776, 777, 797, 798, 804, 805, 806,
807, 808, 813, 814, 839, 840, 841, 842, 843, 844, 868, 869, 870, 871, 872,
873, 874, 903, 904, 905, 907, 908, 909, 910, 911, 956, 957, 958, 959, 975,
983, 984, 985, 986, 987, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1034, 1035,
1036, 1037, 1038, 1059, 1060, 1061, 1062, 1063, 1064, 1065, 1066, 1117, 1118,
1119, 1120, 1140, 1141, 1143, 1152, 1162, 1163, 1164, 1166, 1199, 1200, 1201,
1202, 1239, 1240, 1241, 1262, 1263, 1286, 1287, 1288, 1307, 1308, 1401, 1402,
1403, 1404, 1405, 1424, 1425, 1426, 1458, 1459, 1460, 1480, 1481, 1482, 1483,
1484, 1543, 1545, 1546, 1550, 1552, 1553, 1554, 1555, 1556, 1560, 1561, 1562,
1563, 1564, 1579, 1580, 1581, 1582, 1583, 1586, 1587, 1588, 1589 and 1591
RECALLING FIRM/MANUFACTURER
Recalling Firm: Haag-Streit USA
Inc., Mason, OH,
Manufacturer: Haag Streit Ag,
Koeniz, Switzerland.
REASONCurrently
there is a possibility, at the start of the perimetry examination, for the
background illumination of the cupola not to turn on. If no illumination of
cupola occurs, data obtained from the examination could provide the doctor
with results that would appear to be better than actual.
VOLUME OF PRODUCT IN COMMERCE
158 units
DISTRIBUTION Nationwide
and Mexico
PRODUCT
1) Dimension(R) Vista(R) V-LYTE(R)
Standard A (K820) Product Usage: V-LYTE(R) Standard A is for the calibration
of NA, K, and CL on the Dimension Vista(R) system.
2) Dimension(R) Vista(R) V-LYTE(R)
Standard B/Salt Bridge (K825) Product Usage: V-LYTE(R) Standard B/Salt Bridge
is for the calibration and measurement of NA, K, and CL on the Dimension
Vista(R) system.
3) Dimension(R) Vista(R) V-LYTE(R)
Diluent (K835) Product Usage: V-LYTE(R) Diluent is for the automatic dilution
of samples processed in the V-LYTE(R) Integrated Multisensor on the Dimension
Vista(R) system.
CODE
1) Lot number KA1G01, KA1H01, and
KA1J01;
2) Lot number KB1G02, KB1J01, and
KB1K01;
3) Lot number KE1H01, KE1J01, and KE1K01
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc.,
Newark, DE,
REASON Firm
has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced
V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by
increases in: Urine sodium QC results within 48 hours after installation of a
new IMT sensor. The results can be elevated approximately 10-20% which may
cause QC recovery being out of acceptable ranges. Patient Urine sodium results
may also be significantly affected. Serum sodium QC may show an upward trend
of up to 6 mmol/L for the serum QC.
VOLUME OF PRODUCT IN COMMERCE
19,524 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Synthes
Drill Bit for 5.0mm Recon Screws with Large Quick Coupling. This orthopedic
manual surgical instrument is a non powered hand-held device intended for
medical purposes to manipulate tissue or for use with other devices in
orthopedic surgery. Model number 03.010.228.
CODE All
lot numbers.
RECALLING FIRM/MANUFACTURER
Synthes USA (HQ), Inc., West Chester,
PA,
REASON Synthes
is initiating a recall of the Drill Bit for 5.0mm Recon Screws with large
Quick Coupling due to the potential for the drill stop to slip on the drill
bit.
VOLUME OF PRODUCT IN COMMERCE
577 units
PRODUCT Step
2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic
bottle. The Step 2, 3000-2000 GPD chemical is used in the cleaning procedures
for the Isopure MD400 Series Reverse Osmosis System.
CODE Lot
# 11IC002, Serial #'s: 11IC00210 - 11IC002294
RECALLING FIRM/MANUFACTURER
Recalling Firm: Isopure Corp.,
Simpsonville, KY,
Manufacturer: Di-Chem Inc.,
Champlin, MN.
REASON The
cleaning solution Step 2, 3000-22000 GPD labeled bottles (NaOH) were filled
with Step 1, 3000-22000 GPD chemical (HCl).
VOLUME OF PRODUCT IN COMMERCE
91 cs/12/4 oz plastic bottles
PRODUCT TUM-E-VAC
Ethox International. Intended use: gastric lavage.
CODE LOT
031123255
RECALLING FIRM/MANUFACTURER
Ethox International, Inc., Buffalo,
NY,
REASON Ethox
Tum-E-Vac Gastric Lavage Kit #2075 is labeled with expiration date symbol and
date of 2010/10 on the unit product label. The carton is labeled with a
manufacturing date symbol and date of 2010/10. The Ethox Tum-E-Vac Gastric
Lavage Kit #2075 does not have an expiration date.
VOLUME OF PRODUCT IN COMMERCE
130 units
DISTRIBUTION Nationwide
WEEK ENDING JANUARY 7
PRODUCT INOmax DS (Delivery System) Model 10003
& 10007. The INOMAX DS Delivery System delivers INOMAX (nitric oxide for
inhalation) therapy gas into the inspiratory limb of the patient breathing
circuit in a way that provides a constant concentration of nitric oxide (NO),
as set by the user, to the patient throughout the inspired breath. It uses a
specially designed injector module, which enables tracking of the ventilator
waveforms and the delivery of a synchronized and proportional dose of NO. It
may be used with most ventilators. The INOMAX DS provides continuous
integrated monitoring of inspired O2, NO2, and NO, and a comprehensive alarm
system.
CODE
Serial Number DS20070005 DS20070006
DS20070007 DS20070008 DS20070009 DS20070010 DS20070011 DS20070012 DS20070013
DS20070014 DS20070015 DS20070016 DS20070017 DS20070018 DS20070019 DS20070020
DS20070021 DS20070022 DS20070023 DS20070024 DS20070025 DS20070026 DS20070027
DS20070028 DS20070029 DS20070030 DS20070031 DS20070032 DS20070033 DS20070034
DS20070035 DS20070036 DS20070037 DS20070038 DS20070039 DS20070040 DS20070041
DS20070042 DS20070043 DS20070044 DS20070045 DS20070046 DS20070047 DS20070048
DS20070049 DS20070050 DS20070051 DS20070052 DS20070053 DS20070054 DS20070055
DS20070056 DS20070057 DS20070058 DS20070059 DS20070060 DS20070061 DS20070062
DS20070063 DS20070064 DS20070065 DS20070066 DS20070067 DS20070068 DS20070069
DS20070070 DS20070071 DS20070072 DS20070073 DS20070074 DS20070075 DS20070076
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DS20100395 DS20100396 DS20100397 DS20100398 DS20100399 DS20100400 DS20100401
DS20100402 DS20100403 DS20100404 DS20100405 DS20100406 DS20100407 DS20100408
DS20100409 DS20100410 DS20100411 DS20100412 DS20100413 DS20100414 DS20100415
DS20100416 DS20100417 DS20100418 DS20100419 DS20100420 DS20100421 DS20100422
DS20100423 DS20100424 DS20100425 DS20100426 DS20100427 DS20100428 DS20100429
DS20100430 DS20100431 DS20100432 DS20100433 DS20100434 DS20100435 DS20100436
DS20100437 DS20100438 DS20100439 DS20100440 DS20100441 DS20100442 DS20100443
DS20100444 DS20100445 DS20100446 DS20100447 DS20100448 DS20100449 DS20100450
DS20100451 DS20100452 DS20100453 DS20100454 DS20100455 DS20100456 DS20100457
DS20100458 DS20100459 DS20100460 DS20100461 DS20100462 DS20100463 DS20100464
DS20100465 DS20100466 DS20100467 DS20100468 DS20100469 DS20100470 DS20100471
DS20100472 DS20100473 DS20100474 DS20100475 DS20100476 DS20100477 DS20100478
DS20100479 DS20100480 DS20100481 DS20100482 DS20100483 DS20100484 DS20100485
DS20100486 DS20100487 DS20100488 DS20100489 DS20100490 DS20100491 DS20100492
DS20100493 DS20100494 DS20100495 DS20100496 DS20100497 DS20100498 DS20100499
DS20100500 DS20100501 DS20100502 DS20100503 DS20100504 DS20100505 DS20100506
DS20100507 DS20100508 DS20100509 DS20100510 DS20100511 DS20100512 DS20100513
DS20100514 DS20100515 DS20100516 DS20100517 DS20100518 DS20100519 DS20100520
DS20100521 DS20100522 DS20100523 DS20100524 DS20100525 DS20100526 DS20100527
DS20100528 DS20100529 DS20100530 DS20100531 DS20100532 DS20100533 DS20100534
DS20100535 DS20100536 DS20100537 DS20100538 DS20100539 DS20100540 DS20100541
DS20100542 DS20100543 DS20100544 DS20100545 DS20100546 DS20100547 DS20100548
DS20100549 DS20100550 DS20100551 DS20100552 DS20100553 DS20100554 DS20100555
DS20100556 DS20100557 DS20100558 DS20100559 DS20100560 DS20100561 DS20100562
DS20100563 DS20100564 DS20100565 DS20100566 DS20100567 DS20100568 DS20100569
DS20100570 DS20100571 DS20100572 DS20100573 DS20100574 DS20100575 DS20100576
DS20100577 DS20100578 DS20100579 DS20100580 DS20100581 DS20100582 DS20100583
DS20100584 DS20100585 DS20100586 DS20100587 DS20100588 DS20100589 DS20100590
DS20100591 DS20100592 DS20100593 DS20100594 DS20100595 DS20100596 DS20100597
DS20100598 DS20100599 DS20100600 DS20100601 DS20100602 DS20100603 DS20100604
DS20100605 DS20100606 DS20100607 DS20100608 DS20100609 DS20100610 DS20100611
DS20100612 DS20100613 DS20100614 DS20100615 DS20100616 DS20100617 DS20100618
DS20100619 DS20100620 DS20100621 DS20100622 DS20100623 DS20100624 DS20100625
DS20100626 DS20100627 DS20100628 DS20100629 DS20100630 DS20100631 DS20100632
DS20100633 DS20100634 DS20100635 DS20100636 DS20100637 DS20100638 DS20100639
DS20100640 DS20100641 DS20100642 DS20100643 DS20100644 DS20100645 DS20100646
DS20100647 DS20100648 DS20100649 DS20100650 DS20100651 DS20100652 DS20100653
DS20100654 DS20100655 DS20100656 DS20100657 DS20100658 DS20100659 DS20100660
DS20100661 DS20100662 DS20100663 DS20100664 DS20100665 DS20100666 DS20100667
DS20100668 DS20100669 DS20100670 DS20100671 DS20100672 DS20100673 DS20100674
DS20100675 DS20100676 DS20100677 DS20100678 DS20100679 DS20100680 DS20100681
DS20100682 DS20100683 DS20100684 DS20100685 DS20100686 DS20100687 DS20100688
DS20100689 DS20100690 DS20100691 DS20100692 DS20100693 DS20100694 DS20100695
DS20100696 DS20100697 DS20100698 DS20100699 DS20100700 DS20100701 DS20100702
DS20100703 DS20100704 DS20100705 DS20100706 DS20100707 DS20100708 DS20100709
DS20100710 DS20100711 DS20100712 DS20100713 DS20100714 DS20100715 DS20100716
DS20100717 DS20100718 DS20100719 DS20100720 DS20100721 DS20100722 DS20100723
DS20100724 DS20100725 DS20100726 DS20100727 DS20100728 DS20100729 DS20100730
DS20100731 DS20100732 DS20100733 DS20100734 DS20100735 DS20100736 DS20100737
DS20100738 DS20100739 DS20100740 DS20100741 DS20100742 DS20100743 DS20100744
DS20100745 DS20100746 DS20100747 DS20100749 DS20100750 DS20100751 DS20100752
DS20100753 DS20100754 DS20100755 DS20100756 DS20100757 DS20100758 DS20100759
DS20100760 DS20100761 DS20100762 DS20100763 DS20100764 DS20100765 DS20100766
DS20100767 DS20100768 DS20100769 DS20100770 DS20100771 DS20100772 DS20100773
DS20100774 DS20100775 DS20100776 DS20100777 DS20100778 DS20100779 DS20100780
DS20100781 DS20100782 DS20100783 DS20100784 DS20100785 DS20100786 DS20100787
DS20100788 DS20100789 DS20100790 DS20100791 DS20100792 DS20100793 DS20100794
DS20100795 DS20100796 DS20100797 DS20100798 DS20100799 DS20100800 DS20100801
DS20100802 DS20100803 DS20100804 DS20100805 DS20100806 DS20100807 DS20100808
DS20100809 DS20100810 DS20100811 DS20100812 DS20100813 DS20100814 DS20100815
DS20100816 DS20100817 DS20100818 DS20100819 DS20100820 DS20100821 DS20100822
DS20100823 DS20100824 DS20100825 DS20100826 DS20100827 DS20100828 DS20100829
DS20100830 DS20100831 DS20100832 DS20100833 DS20100834 DS20100835 DS20100836
DS20100837 DS20100838 DS20100839 DS20100840 DS20100841 DS20100842 DS20100843
DS20100844 DS20100845 DS20100846 DS20100847 DS20100848 DS20100849 DS20100850
DS20100851 DS20100852 DS20100853 DS20100854 DS20100855 DS20100856 DS20100857
DS20100858 DS20100859 DS20100860 DS20100861 DS20100862 DS20100863 DS20100864
DS20100865
RECALLING FIRM/MANUFACTURER
Ino Therapeutics. Madison WI,
REASON Through the review and monitoring of its
complaint data, Ikaria identified a product anomaly with the INOmax DS Model
1003. Ikaria concluded the anomaly risk to the patient safety was low and non
reportable (4/23/10). During a subsequent Level 3 inspection by FDA, it was
concluded that the action should have been reported under 21 CFR & 806.10.
VOLUME OF PRODUCT IN COMMERCE
2446 units
DISTRIBUTION Nationwide and Malaysia
PRODUCT Rapid Strand Rx; the RAPID Strand Rx kit
consists of custom loaded absorbable seeding spacers and I-125 radionuclide
brachytherapy sources (seeds) spaced at prescribed distance and configuration
within a sleeve (tube) made of absorbable suture material, stiffened, loaded
into prostate seeding needles, packaged and then sterilized by Gamma
sterilization method, accompanied by a calibration strand, a sealed source
calibration certificate (100% assay report), a radiograph of the loaded
needles in the needle-holding card, and a source certification technical data
sheet.; Products Provided by: Oncura, Prescription Filled by: AnazaoHealth,;
product identifier: I125RSRX, model 7000. RA PID Strand Rx is indicated for
permanent interstitial implantation of selected localized tumors that are of
low to moderate radio sensitivity. It may be used either as primary treatment
(such as prostate cancer or unresectable tumors) or for the treatment of
residual disease after excision of the primary tumor. RAPID Strand Rx may be
indicated for use concurrent with or at the completion of other treatment
modalities such as external beam radiation therapy.
CODE Oncura order numbers 85342, 85778,
85897, 87430, 87433, 87479, 87547, 87801, 87849, 87851, 87992, 87993, 88070,
88081, 88093, 88426, 88562, 88690, 88798, 88819, 88823, 88830 and 88844
RECALLING FIRM/MANUFACTURER
Medi-Physics Inc. dba GE Healthcare,
Arlington Heights, IL,
REASON There is a potential brachytherapy over
or under dose with the RAPID Strand Rx kit that may impact patient therapy.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION Nationwide, Canada and the UK
PRODUCT Suction Handle (Sterile) Part Number:
1990S. For use in open heart procedures, Autologus blood recovery or blood
suction. Product is a component of Blood Recovery Systems.
CODE Lot # IBC 041811-2065, Exp date:
18/APR/2015
RECALLING FIRM/MANUFACTURER
International Biophysics Corp., Austin,
TX,
REASON Potential for the sterility to be
compromised.
VOLUME OF PRODUCT IN COMMERCE
1,200 units
PRODUCT cobas c 311 Analyzer, Part Number:
04826876001 In-vitro diagnostic analyzer capable of performing clinical
chemistry, specific protein and electrolyte tests. Analytes are measured
photometrically or turbidimetrically; the analyzer also has an optional ISE
module for measuring sodium, potassium and chloride.
CODE
Serial Numbers:1050-16, 1040-08,
1041-06, 0927-16, 0918-05, 1048-02, 0812-12, 1058-09, 0925-20, 1044-19,
1041-05, 1043-15, 1056-18, 0812-09, 1038-07, 0814-10, 1041-19, 1170-04,
0929-08, 0919-16, 0814-03, 0926-11, 1035-01, 1034-19, 1035-10, 1174-19,
1176-03, 1067-02, 0919-17, 0920-05, 0927-13, 1060-17, 1060-05, 0927-17,
1044-18, 0812-10, 0811-20, 1041-20, 1174-04, 0925-05, 1060-01, 1062-09,
1066-20, 1174-07, 0814-15, 0814-17, 1053-16, 1054-02, 1034-02, 1052-16,
1052-19, 0918-06, 1052-13, 1052-20, 1052-15, 1034-07, 1043-10, 0811-15,
1054-03, 1061-08, 1043-06, 0926-10, 1044-06, 1034-03, 1052-09, 1043-12,
1055-01, 0929-09, 1038-05, 1034-01, 0810-19, 1054-20, 1062-07, 1059-20,
0814-16, 1043-14, 1062-08, 1054-01, 0929-07, 1038-06, 1056-19, 1057-03,
1169-20, 0926-19, 1067-01, 1038-04, 0925-06, 1043-08, 1043-13, 0812-11,
1057-05, 1060-06, 0926-16, and 1034-06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics
Operations, Inc., Indianapolis, IN, .
Manufacturer: MHitachi High-Technologies
Corp., Tokyo, Japan.
REASON The cobas c 311 analyzer software may
incorrectly calculate the volume of the ISE Reference Electrolyte solution
remaining on the analyzer. In some cases the incorrect results obtained will
not be flagged with any data alarms.
VOLUME OF PRODUCT IN COMMERCE
940 units
DISTRIBUTION Nationwide and Internationally
PRODUCT SoftMic GUI versions: 4.0.3.0-4.0.3.15,
4.0.4.1-4.0.4.7. SoftMic is a laboratory information system to be used in
medical research, clinical, and public health laboratories by knowledgeable,
trained, and experienced personnel. SoftMic enables the user to handle data
processing and laboratory activities for microbiology and serology testing,
for the purpose of storing, managing, querying, and reporting laboratory data.
CODE SoftMic GUI versions: 4.0.3.0-4.0.3.15,
4.0.4.1-4.0.4.7.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL,
REASON When a certain series of keystrokes on
the test grid are performed while entering results and statusing a test, the
test status may not be maintained upon saving. The status may be removed or
copied from another test on the order upon saving.
VOLUME OF PRODUCT IN COMMERCE
144 units
DISTRIBUTION Nationwide and Canada
PRODUCT Siemens Healthcare Diagnostics,
Dimension Vista(R) Cardiac Troponin I Calibrator (KC678), in vitro diagnostic.
CODE Lot # 1DD085
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc.,
Newark, DE,
REASON Siemens Healthcare Diagnostics has
confirmed positive bias on QC and Patients.
VOLUME OF PRODUCT IN COMMERCE
2,281 units
DISTRIBUTION Nationwide and Internationally
PRODUCT Baxter Colleague CX Infusion Pump,
Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.
CODE Serial Number 12050019CC
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp.,
Round Lake, IL,
Manufacturer: Baxter Healthcare SA,
Singapore, Singapore.
REASON There was no documentation to show the
required tests were performed following the replacement of the battery and
battery harness.
VOLUME OF PRODUCT IN COMMERCE
1 pump
PRODUCT
1) Coulter LH500 Series Analyzer, Part
number: 178832, 178833, 178834. LH 500 Series System Instructions for Use, PN
624602 Rev BA. The COULTER LH 500 Analyzer is a quantitative, automated
hematology analyzer and leukocyte differential cell counter For In Vitro
Diagnostic Use in clinical laboratories. The LH500 Analyzer also provides a
semi-automated reticulocyte analysis.
2) Coulter HmX Hematology Analyzer,
Part number: 6605522, 6605523, 6605524. HmX Hematology Analyzer / HmX
Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX
Hematology Analyzer is a quantitative, automated hematology analyzer and
leukocyte differential cell counter for In Vitro Diagnostic Use in clinical
laboratories.
3) Coulter HmX Hematology Analyzer
with Autoloader, Part number: 6605525, 6605526, 6605527. HmX Hematology
Analyzer / HmX Hematology Analyzer with Autoloader PN 4237523 Rev C. The
COULTER HmX Hematology Analyzer is a quantitative, automated hematology
analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use
in clinical laboratories.
4) COULTER MAXM Hematology Analyzer/MAXM
Hematology Analyzer with Autoloader Part number: 6705995, 6705996, 6705997/
Part number: 6705998, 67059999, 6706000. HmX Hematology Analyzer / HmX
Hematology Analyzer with Autoloader PN 4237523 Rev C. The COULTER HmX
Hematology Analyzer is a quantitative, automated hematology analyzer and
leukocyte differential cell counter for In Vitro Diagnostic Use in clinical
laboratories.
CODE N/A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc.,
Brea, CA,
Manufacturer: Beckman Coulter, Inc.,
Miami, FL.
REASON The recall was initiated because Beckman
has identified a problem with Integrated Circuit chips used in different
boards throughout the analyzer.
VOLUME OF PRODUCT IN COMMERCE
222 units
DISTRIBUTION Nationwide and Internationally
PRODUCT The GSP 2021-0010 (Genetic Screening
Processor) instrument is a fully automated, high throughput batch analyzer for
time- resolved and prompt fluorescence analysis of samples in microtitration
plates. It is intended for in vitro quantitative / qualitative determination
of analytes in body fluids. The chemistries running on the GSP instrument are
used to test blood specimens dried on filter paper as an aid in screening
newborns for congenital disorders.
CODE None
RECALLING FIRM/MANUFACTURER
Recalling Firm: PerkinElmer LAS, Inc.,
Waltham, MA,
Manufacturer: PerkinElmer Life and
Analytical Sciences, Wallac, OY, Turku, Finland.
REASON Malfunction of the GSP disk remover unit
may cause a punched disc to remain in the well during the measurement of the
plate. This may cause a false negative screening result being reported for
17-OHP, resulting in failure to identify cases of congenital adrenal
hyperplasia (CAH).
VOLUME OF PRODUCT IN COMMERCE
52
DISTRIBUTION Nationwide and Internationally
PRODUCT CDI 101
Hematocrit/Oxygen Saturation
Monitoring System. The CDI 101 Hematocrit/Oxygen Saturation Monitoring System
is intended for use during cardiopulmonary bypass procedures where continuous
monitoring of the blood's oxygen saturation, hematocrit and hemoglobin levels
is needed.
CODE
Serial Numbers: 1070, 1071, 1076, 1077,
1080, 1083, 1104, 1107, 1108, 1115-1117, 1124, 1127, 1128, 1132-1134, 1136,
1137, 1139-1144, 1148, 1151, 1152, 1154-1156, 1160-1162, 1166, 1168-1173,
1182,1185,1186,1190,1192, 1193, 1195, 1239-1241, 1243-1245, 1247,
1249-1257,1261, 1264-1266, 1268-1277,1279, 1280, 1282-1289, 1297,1299-1301,
1306-1311, 1313-1318, 1321-1324, 1337-1339, 1350-1355, 1357-1363, 1365-1377,
1382, 1386, 1406-1409, 1411, 1413,1414, 1417-1422, 1428-1436, 1440, 1441,
1443-1447, 1450-1453, 1455-1458, 1460, 1463, 1469-1482, 1484, 1486, 1488,
1492,1503-1511 ,1513, 1515-1520, 1532-1534, 1537, 1540, 1542, 1543, 1547,
1548, 1550, 1551, 1555, 1560-1563, 1568-1574, 1578, 1579, 1585-1596, 1598,
1614, 1615, 1617-1622, 1625-1629, 1632-1647, 1653, 1655, 1660, 1666, 1667,
1669-1676, 1679, 1681, 1682, 1690, 1693, 1694, 1696, 1699, 1705-1709, 1713,
1714, 1726, 1729-1734,1738, 1745-1750,1752-1756,1760, 1764-1768, 1771,
1773-1777,1785,1787,1788,1790-1794,1797-1799,1801-1808,1816,1818-1821, 1823,
1826, and 1839
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann
Arbor, MI,
REASON Terumo is recalling the CDI 101
Hematocrit/Oxygen Saturation Monitoring System because they have not yet
submitted a 510(k) to FDA to market the device.
VOLUME OF PRODUCT IN COMMERCE
366 units
DISTRIBUTION Nationwide
PRODUCT Curix Opthos H, size 35x43 cm A
radiographic medical x-ray film designed to optimize diagnostic chest imaging
by providing complete diagnostic information including superbly visualized
lung detail along with a high level of retro-cardiac, sub-diaphragmatic and
mediastinal information.
CODE Unit: 79890049
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville,
SC,
Manufacturer: Agfa Materials Corp.,
Goose Creek, SC.
REASON The film notch was located in the wrong
position.
VOLUME OF PRODUCT IN COMMERCE
125 units
DISTRIBUTION IN, KS, MI, MN, MO, NC, NE, NY, OH, TN
and Canada