FEBRUARY 2007
WEEK ENDING FEBRUARY 3
PRODUCT
a) Cyberonics VNS
Therapy System, Model 250-'HAND HELD'
programming software v6.1, v6.1.7,
v7.0 and v7.1.3,
b) Handhelds-Cyberonics VNS
Therapy System, Model 2500-'Handhelds'
preprogrammed with software v6.0,
v6.1, v6.1.7, v7.0 and v7.1.3,
CODE
a) For
Software v6.1: 10-005-9400 and 10-006-0900; For Software v6.1.7:
10-0007-2400 and 10-0007-2500; For Software v7.0: 10-0007-4100
and
10-0007-2500; For Software v7.1.3: 10-0007-8400 and 10-0007-8500;
b) For
Handheld v6.0: 99-0000-3000; For Handheld v6.1: 10-0006-4300;
For Handheld
v6.1.7: 10-0007-2700, 10-0007-3600, 10-0007-2609
and 77-0000-7000; For
Handheld v7.0: 10-0007-4300;
For Handheld v7.1.3:
10-0007-8600.
RECALLING FIRM/MANUFACTURER Cyberonics, Inc.,
Houston, TX
REASON During programming, pulse generator may be
inadvertently set to 8.0 mA output, regardless of the mA range selected by the
clinician
VOLUME OF PRODUCT IN COMMERCE 3,538 Software; 7,404
Handheld PCs
DISTRIBUTION Nationwide and Internationally
PRODUCT Jostra Heater Cooler Unit
HCU30, system version 1.02-Low voltage machin, Article number: 0704629,
CODE
Serial numbers: 101006, 101007, 101008, 101009,
101010, 101011, 101013, 101015, 101016, 101018, 101019, 101020, 101022, 101023,
101024.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet,
Inc., Bridgewater, NJ,
Manufacturer:
Maquet Critical Care AB, Solna, Sweden.
REASON The HCU 30 system potentially will not be have the
power capacity to run the compressor when the heaters are on during operation.
This may lead to a situation where the user may not be able to cool the patient
and/or cardioplegia sufficiently.
VOLUME OF PRODUCT IN COMMERCE 15
units
DISTRIBUTION CA, NC, FL, WY, NY and WV
PRODUCT Salicylate-SL, in vitro
diagnostic, Cat. No.511-20,
CODE Lot number:
29892
RECALLING FIRM/MANUFACTURER Diagnostic Chemicals, Ltd.,
Charlottetown Prince Edward Island, Canada,
REASON Upon subsequent testing on
different instruments (as required by other customers), DCL detected a
non-linear response on certain analyzers. A decision was made to recall the
product due to the fact that DCL customers sell the product to different end
users, DCL cannot be certain which instruments the end users employ in their
laboratories.
VOLUME OF PRODUCT IN COMMERCE 55
kits
DISTRIBUTION PA
PRODUCT Suros ATEC Breast Biopsy
System handpiece (9 gauge cannula 12 centimeters in length with a 20 millimeter
aperture) for use with the ATEC Breast Biopsy and Excision System, disposable,
sterile, Part no. 0912-20,
CODE Lot:
611018
RECALLING FIRM/MANUFACTURER Suros Surgical Systems, Inc.,
Indianapolis, IN,
REASON The handpiece package may have an incorrect part
number on the inner package. Error could result in over-penetration of the
biopsy needle.
VOLUME OF PRODUCT IN COMMERCE 1,249
handpieces
DISTRIBUTION Nationwide
PRODUCT Electronic Otto Bock
Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the
exoprosthetic fitting of amputations of the lower limb.
Microprocessor-controlled prosthetic knee joint used by lower extremity
amputees,
CODE
Material number 3C85, serial
numbers: 200547006, 200547007, 200547008, 200547009, 200547034, 200547035,
200547036, 200547037, 200547038, 200547039, 200548022, 200548023, 200548037,
200548038, 200548039, 200548040, 200548041, 200548042, 200604015, 200604016,
200604017, 200604021, 200604022, 200604024, 200604064, 200605002, 200613003.
Material number 3C95, serial numbers: 200531057, 200531058, 200531059,
200531060, 200547003, 200547004, 200547005, 200547024, 200547049, 200547050,
200547051, 200547052, 200547053, 200547054, 200547055, 200547056, 200547057,
200548007, 200548008, 200548009, 200548010, 200548011, 200548012, 200548013,
200548014, 200548015, 200548016, 200548017, 200548018, 200548019, 200548020,
200548034, 200548035, 200548036, 200548044, 200548045, 200548046, 200548047,
200548048, 200548049, 200548051, 200548052, 200548053, 200548054, 200548055,
200548056, 200548058, 200548059, 200548060, 200548061, 200548062, 200548063,
200548064, 200548065, 200548067, 200548068, 200604001, 200604002, 200604003,
200604004, 200604005, 200604006, 200604007, 200604008, 200604009, 200604010,
200604012, 200604013, 200604014, 200604026, 200604027, 200604028, 200604029,
200604030, 200604032, 200604033, 200604034, 200604035, 200604036, 200604038,
200604039, 200604040, 200604041, 200604042, 200604043, 200604044, 200604045,
200604053, 200604054, 200604055, 200604056, 200604057, 200604058, 200604059,
200604062, 200604063, 200605003, 200605004, 200605005, 200605006, 200605008,
200605009, 200605010, 200605018, 200605019, 200605020, 200605021, 200605022,
200605023, 200605054, 200605055, 200605057, 200605058, 200605059, 200605060,
200605061, 200612015, 200612016, 200612017, 200612018, 200612019, 200612020,
200612021, 200612024, 200612029, 200612045, 200612047, 200612050, 200612051,
200612052, 200612053, 200612054, 200612056, 200613034, 200613035, 200613038,
200613039, 200613041, 200613042, 200613043, 200613044, 200613045, 200613054,
200613055, 200613056, 200613057, 200613061, 200613062,
200613063.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bock,
Otto, Orthopedic Ind., Inc., Minneapolis MN
Manufacturer: Otto Bock Austria,
Wien, Austria.
REASON A correction of the Otto Bock Compact
prosthetic knee joint, material numbers 3C93 and 3C85, is being conducted. A
limited number of Compacts have a defective solder connection between the
contact wires and battery terminals. If exposed to strong vibrations these
Compact knee joints have an increased probability of malfunction and a resultant
risk to the Compact wearer.
VOLUME OF PRODUCT IN COMMERCE 176
systems
DISTRIBUTION Nationwide
PRODUCT i-STAT PT/INR Cartridge
prothrombin time test in vitro diagnostic. Product list #’s 04J50-01 and
04J50-02, catalog # 420200; Ref 04J50-01 24, Recall # Z-0364-2007
CODE Lot numbers: N06227, N06175A, N06176, N06179, N06181, N06186,
N06188,, N06194, N06195A, N06200A, N06201A, N06201B, N06201C, N06202, N06206,
N06206B, N06208, N06208A, N06209, N06222, N06222A, N06222B, N06223, N06227,
N06227A, N06227B, N06235, N06235A, N06236A, N06236B, N06237, N06241, N06241A,
N06241B, N06243, N06244, N06251, N06254, N06256, N06258C, N06262, N06263,
N06265, N06265A, N06265B, N06265C, N06265D, N06265E, N06266, N06266A, N06267,
N06268, N06268A, N06269, N06269A, N06273, N06274, N06274A, N06274B, N06274C,
N06275, N06275A, N06275B, N06275C, N06276, N06277, N06277A, N06277B, N06282,
N06285, N06285B, N06285C, N06290A, N06294, N06294A, N06295, N06298, N06298A,
N06298B, N06301A, N06303, N06304, N06308, N06309, N06310A,
N06311
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott
Point of Care Inc., East Windsor NJ
Manufacturer: Abbott Point Of Care I Stat, Kanatakanata Ontario,
Canada. REASON Patients treated
with the antibiotic CUBICIN can cause a concentration dependent false
prolongation of prothrombin time (PT) and elevation of INR (International
Normalized Ratio) when using the i-STAT PT/INR cartridges.
VOLUME OF
PRODUCT IN COMMERCE 14,045 boxes of
24
DISTRIBUTION Nationwide
PRODUCT Sterile Neolon 2G
Latex-Free Powder-Free Neoprene Surgical Gloves, Does Not Contain Natural Rubber
Latex; 1 pair of gloves per package, 100 packages per case; Item number
MDS207060,
CODE Lot number T502554397, size
6
RECALLING FIRM/MANUFACTURER Terang Nusa Sdn Bhd, Kota Bharu,
Malaysia,
REASON Some of the packages
labeled as latex-free actually contain latex gloves.
VOLUME OF PRODUCT IN
COMMERCE 43 cases
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Philips Integris Allura
x-ray systems angiographic - Allura 9 F/C
(floor and ceiling models). A
mono-plane analog Allura with a
9" Image Intensifier,
b) Allura Mono X-Ray System, angiographic - monoplane, analog
Allura
with a 12" and 15" Image Intensifier,
c)
Allura FD 10 FC, X-Ray System, angiographic - a monoplane,
digital Allura FD
(flat detector) with a 10" Image Intensifier (II),
d) Allura FD20 x-ray system,
angiograph, monoplane, digital
Allura FD
with a 20" detector FD,
e) FD 10/10 X-Ray
System, Angiograph, bi-plane digital Allura FD,
10" detector,
f) FD 20/10 X-Ray System,
Angiograph, biplane, digital Allura
FD, 10"
and 20" detectors,
CODE
a) thru f)
Site numbers: 534928, 545964, 532207, 545365, 538387, 543397, 543398, 543399,
546572, 544581, 544728, 548147, 547005, 539456, 543953, 547234, 547364, 545838,
545839, 545840, 544395, 547952, 530393, 545799, 540790, 547431, 544122, 541659,
546060, 543433, 545604, 543198, 545921, 545640, 545966, 541590, 540456, 546201,
541572, 544130, 544635, 534665, 542963, 535303, 541783, 544631, 540930, 544610,
544506, 546456, 544989, 544990, 544992, 543984, 543759, 546906, 543873, 543087,
543108, 547279, 546908, 544750, 545518, 545052, 545539, 543799, 543411, 547660,
543229, 544371, 548288, 546668, 545714, 537604, 541046, 544513, 545583, 540808,
545280, 548039, 544489, 544120, 540275, 540284, 540952, 544637, 547855, 545941,
545753, 541597, 545025, 536030, 544543, 546693, 548140, 546025, 545752, 547976,
543971, 543972, 539634, 545749, 546119, 545750, 547642, 544433, 545069, 545073,
547777, 547321, 547628, 545733, 547392, 545293, 545296, 547908, 541880, 543386,
546013, 548061, 545282, 533398, 541588, 541589, 540374, 545357, 542486, 545443,
546012, 545090, 545037, 538432, 532226, 540407, 103281, 104950, 531926, 104953,
530653, 520630
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Philips Medical Systems North America Co. Philips, Bothell, WA,
Manufacturer: Philips Medical Systems
Nederlands,
Best, Netherlands.
REASON Movement of the AD5 table or Lateral C-arm (LARC).
The table and/or LARC will not move upon request, will move slowly when movement
is requested or will not stop moving when requested.
VOLUME OF PRODUCT IN
COMMERCE 140 devices
DISTRIBUTION Nationwide
PRODUCT GE Centricity PACS RA 1000
Workstation; for diagnostic image analysis; Software versions 2.1.XX. and
3.0.XX. used in combination with the GE Senographe 2000D, Senographe DS or
Senographe Essential,
CODE Versions 2.1.X.X.
and 3.0.X.X.
RECALLING FIRM/MANUFACTURER GE Healthcare Integrated
IT Solutions, Barrington, IL,
REASON The Centricity PACS RA1000 Workstation
Software may manifest certain mammography image display problems only if the
images were acquired through GE Senographe versions 2000D, DS or
Essential.
VOLUME OF PRODUCT IN COMMERCE 198
units
DISTRIBUTION Nationwide and Internationally
PRODUCT BIo-Rad D-10 Dual Program
Calibrator Diluent, a component of the Bio-Rad D10 Dual Program diagnostic test.
This is a specific part of the kit, and only the calibrator diluent is
defective. It comes in two kits,
CODE Diluent
lot number AA61508, Catalog number for recalled diluent: 220-0119, expiration
date 11/30/07 Catalog number for whole kit: 220-0201. Reorder pack lot numbers
2006 1537, 2006 1555, 2006 1561, 2006 1557, 2006 1597, 2006 1600, 2006 1745,
2006 2007. Expiration dates on hte above catalog numbers: 04/30/2007, except for
2006 1557, which is 2/28/07. The diluent is packaged with either HbA1c
Calibrators (cat number 220-0128, lot number S61409, exp. date 5/31/2007), or
HbA2/F/A1c calibrators (cat number 220-218, exp date 5/31/07. Calibrator diluent
that comes with the kit has an expiration date of AA61408
RECALLING
FIRM/MANUFACTURER Bio-Rad Laboratories, Inc., Hercules, CA,
REASON The Diluent in the D-10 Dual Program Calibrator reorder
packs is defective, and can cause early calibration failure or elevated control
and sample recovery results.
VOLUME OF PRODUCT IN COMMERCE 900 kits
plus 43 sets of diluent
DISTRIBUTION Nationwide and
Internationally
PRODUCT Cook Flexor DL Dual Lumen
Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL,
CODE
Lot: U1546391
RECALLING
FIRM/MANUFACTURER Cook Urological, Inc., Spencer, IN,
REASON
Lack of
assurance of sterility, as the packages may not have been sealed.
VOLUME
OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION MA, ME, NH, and
PR
PRODUCT Medtronic Intersept
Custom Tubing Pack. Do Not Reuse. The design and components of this product were
specified by the user from an array of components and designs offered by the
manufacturer. Any change in the cardiopulmonary bypass procedure that
compromises the function of this Custom Tubing Pack is the responsibility of the
user. The tubing is made of polyvinyl chloride (PVC). Portions of the tapered
tubing are used in the vent, suction and arterial roller heads of the heart lung
machine,
CODE Model / Lot Number: CB4W39R1 /
4876667; 0A84R2 / 4531036; 1708R18 / 4627100; 0V68R4 / 4212182; 1P07R6 /
4433014; 1P07R6 / 4678134; 2Y91R / 4628170; 2Y91R / 4800224; 2Y91R / 4902036;
CB0Q49R14 / 4800849; 4D87R2 / 4184927
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Medtronic Perfusion Systems,
Brooklyn Park, MN,
Manufacturer:
Medtronic Mexico, S. De R. L. De C. V., Tijuana, Baja California, Mexico.
REASON
An out of specification
condition exists with the tapered tubing found in some Custom Tubing Packs. The
wall thickness is undersized and does not meet specifications.
VOLUME OF
PRODUCT IN COMMERCE 146 packs
DISTRIBUTION CA, FL, IL, IN,
LA and TN
PRODUCT Bivona Laryngectomy Tube,
Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, REF BOSL1L,
CODE
Lots 1055779, 1245930, 1263830, 1302670, 1310500,
1324570, 1351420, 1351480, G654810, G689730 and G726388
RECALLING
FIRM/MANUFACTURER Smiths Medical ASD, Inc., Gary, IN,
REASON
The
label incorrectly states the outer diameter of the tube is 20.0 mm when it is
actually 12.0 mm.
VOLUME OF PRODUCT IN COMMERCE 117
devices
DISTRIBUTION Nationwide and Internationally
WEEK ENDING FEBRUARY 10
PRODUCT
a) Davol Salute
Fixation System, 38cm Reusable Shaft (Laparoscopic) with Handle. To attach
mesh to the abdominal wall. Reference Number 0113036 or
9113036
(refurbished),
b) Davol Salute Fixation System, 18cm
Reusable Shaft (Short/Open) with Handle.
To attach mesh to the abdominal
wall. Reference Number 0113037 or 9113037
(refurbished),
CODE
All serial numbers
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Davol, Inc., Sub. C. R. Bard,
Inc., Cranston, RI,
Manufacturer: Bard
Shannon Limited, Humacao, PR.
REASON Inadequate directions for use in the Salute System.
Labeling -Revised to provide updated instructions for use and proper
servicing.
VOLUME OF PRODUCT IN COMMERCE 4,787
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Terumo Advanced Perfusion
System 1 Integrated Centrifugal System Control Unit; Catalog number 801046,
CODE
Serial numbers: 0119, 0123, 0124, 0128,
0135, 0136, 0139, 0140, 0146, 0147, 0148, 0151, 0152, 0157, 0171, 0196, 0197,
0214, 0232, 0241, 0271, 0305, 0310, 0315, 0316, 0318, 0323, 0345, 0346, 0372,
0375, 0376, 0377, 0378 and 0380
RECALLING FIRM/MANUFACTURER Terumo
Cardiovascular Systems Corp., Ann Arbor, MI,
REASON Following installation of software version 1.30 in
October 2006, the firm confirmed a complaint that the new software caused a
discrepancy in the pump speed calculation and caused the pump to stop during
clinical use and a ''connect motor'' message to be displayed.
VOLUME OF
PRODUCT IN COMMERCE 35 units
DISTRIBUTION Nationwide
PRODUCT
a) ACS Rotating
Hemostatic Valve, 0.096 inch, for use with a dilatation catheter –
Reference
Number 23242,
b) ACS DUOSTAT® Rotating Hemostatic
Valve, 0.096 inch, for use with a
dilatation catheter - Reference Number
23244,
CODE
a) 6090751, 6090752, 6091151,
6091152;
b) 6090551
RECALLING FIRM/MANUFACTURER Abbott
Vascular-Cardiac Therapies dba Guidant Corp., Temecula, CA
REASON Specific
lots of the .096' and .115' Rotating Hemostatic Valves (RHV) and the Duostat
.096' Rotating Hemostatic Valve (RHV) potentially have an incomplete seal in the
packaging pouch.
VOLUME OF PRODUCT IN COMMERCE 3,153
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) G2 Filter System -
Jugular/Subclavian Delivery Kit, for use in the
prevention of recurrent
pulmonary embolism. Catalog Number RF-320J,
b)
Recovery G2 Filter System - Jugular/Subclavian Delivery Kit, for use in
the
prevention of recurrent pulmonary embolism. Catalog Number RF-220J
***For
Canada & Australia only***,
CODE
Lot
numbers: GFPK4733, GFPK4734, GFPL4229, GFPL4230, GFPL4231,
GFQA1497,
GFQA1498, GFQA1499, GFQA1500, GFQA1501, GFQA1502,
GFQA1503, GFQA1504,
GFQA1505, GFQA1506, GFQA2794, GFQA2795,
GFQA2796, GFQA2797, GFQA2798,
GFQA2994, GFQA2995, GFQA2996,
GFQA2997, GFQA2998, GFQA2999, GFQB1909,
GFQB1910, GFQB1911,
GFQB1912, GFQB1913, GFQB1914, GFQB1915, GFQB1916,
GFQC1489,
GFQC1490, GFQC1491, GFQC3088, GFQC3089, GFQC3090, GFQD0153,
GFQD0154, GFQD0155, GFQD0156, GFQD0157, GFQD0158, GFQD0159,
GFQD0160,
GFQD2046, GFQD2047, GFQD2048, GFQD3730, GFQD3731,
GFQD3732, GFQD3733,
GFQD3734, GFQD3735, GFQD3736, GFQD3737,
GFQE4635, GFQE4636, GFQF0398,
GFQF0399, GFQF0626, GFQF0627,
GFQF3344, GFQF3345, GFQF3346, GFQF3348,
GFQF3349, GFQF3350,
GFQF4295, GFQF4298, GFQF4299, GFQF4300, GFQG2804,
GFQG3632,
GFQG3633, GFQG4404, GFQH1231, GFQH1232, GFQH1233, GFQH1234,
GFQH1235, GFQH3834, GFQH3835, GFQH3836, GFQI0220, GFQI0221,
GFQI0222,
GFQI0223, GFQI0224, GFQI0225, GFQI0226, GFQI0227,
GFQI0228, GFQI3991,
GFQI3993 & GFQI3996;
b) Lot numbers: GFPK3279, GFPK3280, GFPK3281 &
GFPK3282
RECALLING FIRM/MANUFACTURER Bard Peripheral Vascular,
Inc., Tempe, AZ,
REASON This action is being taken because BPV has recently
received three complaints for the device that involve reports of introducer
sheath tip damage. The damage may result in loss of tip integrity.
VOLUME
OF PRODUCT IN COMMERCE 5,885 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Boston Scientific
brand iLab™ Ultrasound Imaging System, for intravascular use; Model Number(s):
iLab120lNS, iLab2401NS,
CODE All serial
numbers.
RECALLING FIRM/MANUFACTURER Boston Scientific Target,
Fremont, CA,
REASON The product fails to comply with applicable
electronic product performance standard, in that the electromagnetic energy is
in excess of the labeled conformance standards for radiated
emissions.
VOLUME OF PRODUCT IN COMMERCE 25
units
DISTRIBUTION Nationwide and Portugal
PRODUCT Portrait® PSR3
System, an electro-surgical device used in dermatological applications,
CODE
Software versions prior to Version
V2.0A
RECALLING FIRM/MANUFACTURER Rhytec, Inc., Waltham, MA
REASON
Inadequate Directions for Use: Software Upgrade to
set maximum pulse rate to 2.5 Hz.
VOLUME OF PRODUCT IN COMMERCE 234
units
DISTRIBUTION Canada, Australia, Brazil, and Korea
PRODUCT ev3 Protege GPS
Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120,
CODE
Lot: 1772812
RECALLING
FIRM/MANUFACTURER Ev3, Inc., Plymouth, MN
REASON Two individual ev3
Protege GPS Biliary Stent System devices were incorrectly labeled as
SERB65-09-60-120 and the actual device is SERB65-12-60-80. Length is shorter
than expected.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION IL, PA
HoMedics Announces Recall of Certain of its Heating Pads Produced in 2001 and Shipped by HoMedics within the United States in 2001 and 2002
HoMedics, Inc announced a recall, to the consumer level of approximately 292,108 of its heating pads which were produced in 2001 and subsequently shipped to retailers in 2001 and 2002.
These heating pads were sold nationwide to Walgreens as well as to drug stores, discount stores and department stores.
It has been determined that some of the heating pads contained an inadequate connector crimp, which lead to a high resistance connection that generated excessive heat, thereby posing a risk of burn injuries, fire or damage to the heating pad itself or to materials (like bedding and furniture) that could come into contact with the pad.
Models involved in this recall include:
Each HoMedics heating pad is marked with a unique 4-digit date code located both on the back of the hand control as well as on the bottom panel of the color box. ONLY 4-DIGIT DATE CODES ENDING IN "01" ARE SUBJECT TO THIS VOLUNTARY RECALL.
Consumers whom have any of these particular heating pads should discontinue the use of the product immediately and return it to the retailer of purchase for a full refund. HoMedics is currently contacting the retailers of these heating pads to communicate return instructions. Further information can be obtained by going to http://www.homedics.com/.
Consumers with questions may contact the company at 1-800-466-3342.
WEEK ENDING FEBRUARY 17
PRODUCT
a) Boston Scientific
Mach 1 Guide Catheter Femoral Approach, 6F, 0.070',
Internal Mammary Curve,
UPN # H74934356260, Catalog # 34356-26.
Made in Mexico, R
b) Boston Scientific Mach 1 Guide Catheter Femoral Approach, 6F,
0.070',
Voda Left Curve, UPN # H74934356710, Catalog # 34356-71. Made in
Mexico,
c) Boston Scientific Mach 1 Guide Catheter
Femoral Approach, 7F, 0.081',
Multipurpose Curve, UPN # H74934357380,
Catalog # 34357-38. Made in
Mexico,
d) Boston
Scientific Mach 1 Guide Catheter Femoral Approach, 8F, 0.091',
Amplatz Right
Curve, UPN # H74934358180, Catalog # 34358-18. Made in
Mexico,
e) Boston Scientific Mach 1 Guide Catheter Femoral Approach, 8F,
0.091',
Amplatz Left Curve, UPN # H74934358190, Catalog # 34358-19. Made in
Mexico,
f) Boston Scientific Mach 1 Guide Catheter
Femoral Approach, 7F, 0.081',
Voda Left Curve, UPN # H74934357730, Catalog #
34357-73. Made in Mexico,
g) Boston Scientific Mach
1 Peripheral Guide Catheter, 6F, 55cm, LIMA Tip Shape, UPN # M001196620,
Catalog # 19-662. Made in Mexico,
CODE
a)
Batch / Lot # 687532;
b) Batch / Lot #: 687586, 687593, 687596;
c) Batch /
Lot # 687654;
d) Batch / Lot # 687753;
e) Batch / Lot # 687754;
f)
Batch / Lot # 688035;
g) Batch / Lot #: 687877, 687878, 687879,
688002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston
Scientific, Maple Grove, MN
Manufacturer: Pacific Device De Mexico S A De C V, Tijuana B C
Mex, Mexico.
REASON Excess
strands of resin may exist in the lumen near the hub of certain batches/lots of
the Mach 1 Guide Catheters. If this excess resin is present in the catheter,
there is the potential of an embolization resulting from the excess resin
detaching from the device during the procedure.
VOLUME OF PRODUCT IN
COMMERCE 51 units
DISTRIBUTION Nationwide
PRODUCT Perry-Kolberg
Titanium Motility/Support System (Threaded Sleeve and Flat Peg), for use in
ocular implants, Model Number 100045 The threaded sleeve and flat peg are two
components of the P-K Titanium Motility/Support System. The threaded sleeve is
an externally threaded cylinder and an internal drilled hole designed to receive
a peg. It is placed in the Bioeye Hydroxyapatite Implant with the use of the P-K
Titanium threaded sleeve wrench after a hole has been prepared in the implant by
drilling with a series of hypodermic needles of gradually increasing sizes.
After the threaded sleeve is placed in the implant, any of the P-K Pegs can be
inserted. The affected model which is the subject of this recall comes with the
flat peg. Product is not serialized. Note: Lot code assigned by the contract
manufacturing firm
CODE
Lot number: M-50021
RECALLING FIRM/MANUFACTURER
Recalling Firm: Integrated Orbital
Implants Inc., San Diego, CA,
Manufacturer: Kolberg Ocular Products Inc., San Diego, CA.
REASON
The threads on the threaded
sleeve were manufactured with left-handed threads, requiring a modification to
the surgical technique for proper insertion. Failure to properly identify the
affected components and apply the modified insertion technique will result in an
inability to insert the sleeve into the implant.
VOLUME OF PRODUCT IN
COMMERCE 234 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Mucotrol
Concentrated Oral Gel Wafer contained in HDPE Bottle, CODE Batch/Lot numbers 65AB, 97AB, and 99
AB
RECALLING FIRM/MANUFACTURER Belcher Pharmaceuticals, Inc.,
Largo, FL,
REASON Processing and cleaning process validation were not
completed before production. Product had some GMP failures related to the
quality system.
VOLUME OF PRODUCT IN COMMERCE 1,097 bottles (21
& 45 count / bottles)
DISTRIBUTION Nationwide
PRODUCT
a) Triathlon X3 CR
Tibial Bearing Insert for knee prosthesis Size #2 - 11MM,
Ref # 5530-G-211
2011-09,
b) Triathlon X3 CR Tibial Bearing Insert for
knee prosthesis Size #7 - 11MM
Ref # 5530-G-711 2011-09,
CODE
a) Lot code G9XF6 LAF974;
b) Lot G9XF7
LAF978
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker
Howmedica Osteonics, Corp., Mahwah, NJ,
Manufacturer: Stryker
Orthopaedi, Limerick, Ireland.
REASON A product mix -up in which the
labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM,
however, the device inside the package is actually a Triathlon X3 CR Tibial
Bearing insert Size # 7 - 11MM and vice versa.
VOLUME OF PRODUCT IN
COMMERCE 47 units
DISTRIBUTION Nationwide and Canada
PRODUCT
a) BD Beaver™
Mini-Blade, Blade Mini Orthopedic 1.255 in,
Catalog Number: 374562,
b) BD Beaver™ Mini-Blade, Blade Mini Orthopedic 1.31 in,
Catalog Number: 376100,
c) BD Beaver™ Mini-Blade,
Blade Sharp Two Sides Pointed,
Catalog Number: 376300,
d) BD Beaver™ Mini-Blade, Blade Mini RND Tip Sharp One Side,
Catalog Number: 376400,
e) BD Beaver™ Mini-Blade,
Blade Mini Pointed Tip S/SU,
Catalog Number: 376500,
f) BD Beaver™ Mini-Blade, Blade Mini Curved Sharp on One,
Catalog Number: 376700,
g) BD Beaver™ Mini-Blade,
Blade Mini Sharp All Around S/SU,
Catalog Number: 376900,
h) BD Beaver™ Mini-Blade, Mini/Bulk 64, Catalog Number: 374820,
i) BD Beaver™ Mini-Blade, Mini/Bulk 67, Catalog
Number: 374822,
j) BD Beaver™ Mini-Blade, Mini/Bulk
69, Catalog Number: 374823,
CODE
a) Lot
Numbers: 6164130, 6233130, 6265005;
b) Lot Numbers: 6158640, 6215941,
6258011
c) Lot Number: 6159927;
d) Lot Numbers: 6138940, 6146142, 6156739,
6166196, 6167300, 6172592, 6177437, 6186449, 6191356, 6193323, 6195540,
6200787, 6205116, 6212332, 6215951, 6222023, 6228063, 6233806, 6241023,
6255156, 6262012, 6269131, 6278501 6296135* 6300614* 6312509* 6331680*
6338257* 6346693*;
e) Lot Numbers: 6136891, 6158973, 6164128, 6167321,
6172845, 6179889, 6186623, 6198098, 6213333, 6248635, 6251884 6265045*
6275006* 6297349* 6321708*
f) Lot Numbers: 6143495, 6153297, 6160837,
6167304, 6173905, 6179920, 6230311, 6236605, 6244982, 6251826, 6257987,
6264189, 6272049 6279648* 6289452* 6311753* 6321505*;
g) Lot Numbers:
6137932, 6142435, 6158382, 6180374, 6187250, 6192282, 6194468, 6198656,
6209256, 6220182, 6223296, 6234908, 6240871, 6243911, 6248083, 6261021, 6271650, 6276887 6283485* 6289455* 6304844* 6317038* 6333608* 6338256*
6342185*;
h) Lot Numbers: 6166194, 6180373, 6222021, 6249826, 6278493;
i)
Lot Numbers: 6159386, 6293719;
j) Lot Numbers: 6151098, 6202027, 6216915,
6227071, 6237675, 6276883 6293717*
RECALLING FIRM/MANUFACTURER BD
Opathalmic Systems, Waltham, MA
REASON Product sterility
may be compromised due to incomplete package seal.
VOLUME OF PRODUCT IN
COMMERCE 664,050 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth
or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length,
CODE
94724 95261 104057 94853 95272 104217 94893 100062
104335 94894 102389 104337 94897 102394 104343 94953 102681 104584 94957 102851
105517 94962 103100 94964 103103 95024 103200 95026 103288 95029 103293 95069
103297 95135 103566 95259 103570
RECALLING FIRM/MANUFACTURER Ascent
Healthcare Solutions, Inc., Lakeland, FL,
REASON The tip of the
trocars may separate before and while in use. In some instances the trocars have
been found with exposed blades upon opening the packaging.
VOLUME OF
PRODUCT IN COMMERCE 1,566
units
DISTRIBUTION Nationwide
PRODUCT
a)
ARCHITECT i2000 Processing Module, for in vitro diagnostics,
List Number
08C89-01; Temperature Controller Board Part #78560-109;
b) ARCHITECT i2000SR Processing Module, for in vitro
diagnostics,
List Number 3M74-01; Temperature Controller Board Part
#78560-109;
CODE
a) Serial numbers:
1202790, 1202804, 1202805, 1202806, 1202807, 1202808, 1202809, 1202810, 1202811,
1202812, 1202813, 1202814, 1202815, 1202816, 1202817, 1202818, 1202819, 1202820,
1202821, 1202822, 1202823, 1202824, 1202825, 1202826, 1202827, 1202828, 1202829,
1202830, 1202831, 1202832, 1202833, 1202834, 1202835, 1202836, 1202837, 1202838,
1202839, 1202840, 1202841, 1202842, 1202843, 1202844, 1202845, 1202846, 1202847,
1202848, 1202849, 1202850, 1202851, 1202852, 1202853, 1202854, 1202855, 1202856,
1202857, 1202858, 1202859.
b) Serial numbers: 1SR03771 1SR03653 1SR03823
1SR03720 1SR03565 1SR03839 1SR03835 1SR03708 1SR04077 1SR03719 1SR03621 1SR03626
1SR04030 1SR03618 1SR03570 1SR04031 1SR03891 1SR04033 1SR03562 1SR04048 1SR03698
1SR03567 1SR03813 1SR03868 1SR03747 1SR03615 1SR03826 1SR04032 1SR03752 1SR03772
1SR03983 1SR03623 1SR03520 1SR03553 1SR03680 1SR03713 1SR03725 1SR03746 1SR03757
1SR03168 1SR03530 1SR03533 1SR03537 1SR03538 1SR03569 1SR03676 1SR03862 1SR03832
1SR03678 1SR03679 1SR03819 1SR03484 1SR03588 1SR03778 1SR03673 1SR03518 1SR03510
1SR03825 1SR03767 1SR03754 1SR03659 1SR03844 1SR03809 1SR03880 1SR03882 1SR03705
1SR03596 1SR03549 1SR03590 1SR03514 1SR03571 1SR03513 1SR03612 1SR03859 1SR03489
1SR03524 1SR03522 1SR03852 1SR03853 1SR03740 1SR03662 1SR03564 1SR03517 1SR03741
1SR03663 1SR03830 1SR03884 1SR03576 1SR03768 1SR03786 1SR03769 1SR03774 1SR03775
1SR03886 1SR03531 1SR03577 1SR03486 1SR03821 1SR03541 1SR03759 1SR03921 1SR03671
1SR03760 1SR03692 1SR03501 1SR03582 1SR03583 1SR03516 1SR03723 1SR03528 1SR03790
1SR03700 1SR03896 1SR03608 1SR03729 1SR03487 1SR03593 1SR03632 1SR03620 1SR03619
1SR03464 1SR03597 1SR03598 1SR03600 1SR03482 1SR03485 1SR03601 1SR03827 1SR03674
1SR03745 1SR03779 1SR03807 1SR03818 1SR03883 1SR03890 1SR03242 1SR03481 1SR03499
1SR03503 1SR03525 1SR03547 1SR03559 1SR03568 1SR03594 1SR03595 1SR03603 1SR03605
1SR03606 1SR03622 1SR03625 1SR03629 1SR03633 1SR03634 1SR03677 1SR03707 1SR03712
1SR03721 1SR03770 1SR03777 1SR03782 1SR03783 1SR03789 1SR03795 1SR03801 1SR03808
1SR03840 1SR03842 1SR03848 1SR03849 1SR03850 1SR03854 1SR04063 1SR04064 1SR04065
1SR04066 1SR04068 1SR04069 1SR04070 1SR04071 1SR04072 1SR04074 1SR04084 1SR04085
1SR04086 1SR04087 1SR04091 1SR04092 1SR04093 1SR04094 1SR04098 1SR04101 1SR04102
1SR04112 1SR04116 1SR04119 1SR04120 1SR04122 1SR04123 1SR04124 1SR04126 1SR04127
1SR04128 1SR04129 1SR04130 1SR04131 1SR04132 1SR04134 1SR04137 1SR04138 1SR04139
1SR04140 1SR04141 1SR04145 1SR04149 1SR04111 1SR04121 1SR04125 1SR04133 1SR03544
1SR03578 1SR03924 1SR03946 1SR03953 1SR04136 1SR04146 1SR04147 1SR04148 1SR04153
1SR04154 1SR03627 1SR03952 1SR03997 1SR03766 1SR03534 1SR03806 1SR04023 1SR03695
1SR03664 1SR03976 1SR03580 1SR04055 1SR03816 1SR03684 1SR03773 1SR03631 1SR03824
1SR03628 1SR03505 1SR03682 1SR03515 1SR03507 1SR03820 1SR03498 1SR03765 1SR04045
1SR03967 1SR04089 1SR03828 1SR03846 1SR04028 1SR04002 1SR04076 1SR03635 1SR03660
1SR04113 1SR04114 1SR03793 1SR04001 1SR03656 1SR04034 1SR03694 1SR03874 1SR04118
1SR03589 1SR04150 1SR03714 1SR03738 1SR03909 1SR04081 1SR03800 1SR03805 1SR03756
1SR04097 1SR03502 1SR03906 1SR04151 1SR03555 1SR03607 1SR03617 1SR03812 1SR03814
1SR03831 1SR03152 1SR04156 1SR04162 1SR04166 1SR04155 1SR04160 1SR03554 1SR03558
1SR03560 1SR03591 1SR03613 1SR03655 1SR03717 1SR03718 1SR03722 1SR03726 1SR03727
1SR03735 1SR03776 1SR03791 1SR03794 1SR03799 1SR03822 1SR03836 1SR03841 1SR03843
1SR03845 1SR03851 1SR03855 1SR03857 1SR03894 1SR03904 1SR03962 1SR03971 1SR03982
1SR03986 1SR03994 1SR03998 1SR04012 1SR04013 1SR04018 1SR04019 1SR04021 1SR04024
1SR04035 1SR04052 1SR04067 1SR04073 1SR04075 1SR04079 1SR04080 1SR04090 1SR04104
1SR04107 1SR03731 1SR03661 1SR03743 1SR03834 1SR03733 1SR03734 1SR03585 1SR03490
1SR03811 1SR03748 1SR03810 1SR03804 1SR03654 1SR03637 1SR03732 1SR03523 1SR03636
1SR03860 1SR03792 1SR03614 1SR03798 1SR03552 1SR03667 1SR03657 1SR03847 1SR03683
1SR03497 1SR03545 1SR03701 1SR03574 1SR03575 1SR03630 1SR03535 1SR03892 1SR03803
1SR03458 1SR03573 1SR03536 1SR03761 1SR03493 1SR03561 1SR03864 1SR03867 1SR03572
1SR03556 1SR03960 1SR03675 1SR03581 1SR03539 1SR03763 1SR03641 1SR03665 1SR03604
1SR03699 1SR03829 1SR03557 1SR03500 1SR03670 1SR03511 1SR03526 1SR03579 1SR03703
1SR03755 1SR03509 1SR03750 1SR03586 1SR03587 1SR03666 1SR03669 1SR03611 1SR03551
1SR03616 1SR03638 1SR03642 1SR03643 1SR03644 1SR03645 1SR03646 1SR03647 1SR03648
1SR03649 1SR03650 1SR03651 1SR03658 1SR03728 1SR03730 1SR03817 1SR03833 1SR03838
1SR03863 1SR03865 1SR03869 1SR03870 1SR03873 1SR03879 1SR03897 1SR03899 1SR03900
1SR03856 1SR03858 1SR03866 1SR03872 1SR03876 1SR03877 1SR03878 1SR03887 1SR03888
1SR03889 1SR03907 1SR03908 1SR03910 1SR03916 1SR03920 1SR03922 1SR03923 1SR03926
1SR03927 1SR03945 1SR03957 1SR03958 1SR03961 1SR03972 1SR03973 1SR03974 1SR03978
1SR09803 1SR03981 1SR03989 1SR03995 1SR04000 1SR04004 1SR04005 1SR04006 1SR04007
1SR04008 1SR04011 1SR04015 1SR04016 1SR04017 1SR04025 1SR04026 1SR04027 1SR04029
1SR04036 1SR04039 1SR04040 1SR04041 1SR03764 1SR03542 1SR03668 1SR03690 1SR03903
1SR03762 1SR03788 1SR03913 1SR04106 1SR03563 1SR04056 1SR03685 1SR03527 1SR03521
1SR03895 1SR04022 1SR03912 1SR04053 1SR04105 1SR03918 1SR03901 1SR04096 1SR03893
1SR03610 1SR03984 1SR03744 1SR04038 1SR04044 1SR04014 1SR03992 1SR03751 1SR03780
1SR03691 1SR03702 1SR03693 1SR03787 1SR03686 1SR03602 1SR03975 1SR03546 1SR03736
1SR03529 1SR03932 1SR03672 1SR03711 1SR03599 1SR03977 1SR03540 1SR03881 1SR03739
1SR03715 1SR03709 1SR03724 1SR03543 1SR03696 1SR03688 1SR03689 1SR03697 1SR03710
1SR03784 1SR03797 1SR03917 1SR03942 1SR03987 1SR04009 1SR04020 1SR04043 1SR04050
1SR04082 1SR04083 1SR04088 1SR04095 1SR04099 1SR04115 1SR04135 1SR03753 1SR04117
1SR03914 1SR03749 1SR03758 1SR03898 1SR03875 1SR03532 1SR03550 1SR03796 1SR03802
1SR03592 1SR03624 1SR03742 1SR04037 1SR04010 1SR04046 1SR04100 1SR04042 1SR04060
1SR03979 1SR03999 1SR03885 1SR03566 1SR03491 1SR03492 1SR03504 1SR03506 1SR03512
1SR03704 1SR03508 1SR03815 1SR03609 1SR03687 1SR03781 1SR03584 1SR03496 1SR03985
1SR03991 1SR03519 1SR03639 1SR03640 1SR03706 1SR03716 1SR03737 1SR04047 1SR04049
1SR04051 1SR04057 1SR04058 1SR04059 1SR04061 1SR04062 1SR03652 1SR03993 1SR04003
1SR04054 1SR04103 1SR04108 1SR04109 1SR04110 1SR03785 1SR03871 1SR03919 1SR03988
1SR03990 1SR03488 1SR03495 1SR03681 1SR03480
RECALLING
FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX,
REASON
The re-designed ARCHITECT Temperature Controller
Board has been identified as being susceptible to electromagnetic interference
(EMI) in the laboratory. This can cause a board reset condition, stopping
temperature control function of the board. Situation does not stop analyzer
operation and does not generate an error condition alerting operator when
condition occurs.
VOLUME OF PRODUCT IN COMMERCE 701
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Cytomics FC 500
with CXP software, Versions 2.0 & 2.1: Part #722645,
Software Kit; CXP
version 2.1 New User; Part #723113 Software Kit;
CXP version 2.1 Upgrade;
Part #629637 Software Kit; CXP version 2.0
New User; Part #629636 Software
Kit; CXP version 2.0 Upgrade.
The Cytomics FC 500 is a system for the
qualitative and quantitative
measurement of biological and physical
properties of cells and other
particles,
b( Cytomics
FC 500 MPL with MXP software, Versions 2.0 & 2.1:
Part #731419 KIT; FOC
MXP 2.0 UPGRADE KIT; Part #731418
SWRE KIT; MXP 2.0 NEW USER; Part #772145
MXP 2.1 FOC
Upgrade Kit; 771938 MXP 2.1 Software; Part #771952 FOC MXP 2.1
Upgrade Kit; Part #771953 New User MXP 2.1 Kit. The Cytomics
FC 500 is a
system for the qualitative and quantitative measurement
of biological and
physical properties of cells and other particles,
c) CXP Analysis Software, Versions 2.0 & 2.1: Part #722396 CXP
Analysis Software Kit V2.1, Single User; Part #722395 CXP Analysis
Software Kit V2.1, Single User Upgrade; Part #722397 CXP Analysis
Software Kit V2.1, 3 User Pack; Part #722398 CXP Analysis Software
Kit
V2.1, 5 User Pack; Part #722399 CXP Analysis Software Kit V2.
1, 15 User
Pack; Part # 722593 CXP Analysis Software Kit V2.1,
5 Network User Pack Part
#722594 CXP Analysis Software Kit V2.1,
10 Network User Pack; Part #722595
CXP Analysis Software Kit V2.1,
15 Network User Pack; Part #629640 CXP
Analysis Software Kit V2.0,
Single User; Part #629639 CXP Analysis Software
Kit V2.0, Single User
Upgrade; Part #629641 CXP Analysis Software Kit V2.0, 3
User Pack;
Part #629642 CXP Analysis Software Kit V2.0, 5 User Pack; Part
#629643
CXP Analysis Software Kit V2.0, 15 User Pack; Part #629644 CXP
Analysis
Software Kit V2.0, 5 Network User Pack; Part #629645 CXP Analysis
Software Kit V2.0, 10 Network User Pack; Part #629646 CXP Analysis
Software Kit V2.0, 15 Network User Pack. The Cytomics FC 500 is a system
for the qualitative and quantitative measurement of biological and physical
properties of cells and other particles,
CODE Versions 2.0 & 2.1
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc, Brea, CA,
Manufacturer:
Applied Cytometry,
Sheffield, UK.
REASON Two
workflow scenarios associated with renaming regions may produce incorrect
results.
VOLUME OF PRODUCT IN COMMERCE 423 units, 200
pieces
DISTRIBUTION Nationwide and
Canada
PRODUCT iE33 Ultrasound
System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed
echo, ultrasonic),
CODE
Base id numbers:
02RCZW, 02KHVQ, 02L57V, 02L5HV, 02KG8D, 02LJ5B, 02LJBB, 02RC00, 02HWQJ, 02BV73,
02LFMR, 02HXCQ, 02KHQ7, 02HWRH, 02HWT2, 02LJ1R, 02RC92, 02KHWF, 02LHZT, 02L6Y3,
02L6Z7, 02RC8Y, 02KHMD, 02LJ85, 02KHXP, 02KHWK, 02KHZH, 02HXP2, 02HXPN, 02D391,
02KJ47, 02L54X, 02RC0Y, 02RC11, 02L598, 02KHQQ, 02RC7B, 02LJBC, 02KHLC, 02KHJ1,
02KHMX, 02LFKV, 02LFKW, 02LFMB, 02LFML, 02LFMP, 02LJP0, 02RCFT, 02RCY3, 02RCXZ,
02RCQL, 02RCXC, 02D38B, 02BV74, 02DPCL, 02LJ56, 02LJ47, 02LJL3, 02RD0X, 02HWQ5,
02D3VM, 02RCXG, 02L4TW, 02RCHN, 02L5KG, 02RC0Q, 02LJ5L, 02L6B4, 02L6F6, 02L5RZ,
02LJPL, 02KH91, 02KH87, 02KHG5, 02HXKQ, 02HXL5, 02HWV9, 02RCXX, 02HXBW, 02HXN6,
02KJ3L, 02L6W7, 02L552, 02HXFX, 02RCV6, 02KHPD, 02KHNW, 02KHPT, 02KHNQ, 02L6YX,
02L5NP, 02DPL9, 02DPK5, 02KJ5Y, 02DPMN, 02KHMY, 02L51R, 02L57W, 02KHHH, 02KHHW,
02LJJH, 02LJK8, 02L6CD, 02L559, 02KHKM, 02RCX6, 02RCWB, 02RCX7, 02RCPJ, 02LJ0M,
02L50F, 02KHVH, 02BVM0, 02L5XW, 02RCHP, 02RCW8, 02RCW5, 02RCW6, 02RCJN, 02RCY1,
02LJ0J, 02RCV8, 02KHG1, 02L5L9, 02KH9J, 02L52X, 02LJ8K, 02LJ91, 02BV6Z, 02LJ0V,
02LJ0P, 02LJ08, 02L4XN, 02RC10, 02RC1W, 02RC27, 02RC28, 02KH8C, 02LJ09, 02D28Y,
02HXJR, 02KHVK, 02KHQX, 02KHX4, 02LJ4D, 02LJC1, 02LJB6, 02LJ96, 02LJBD, 02LJBG,
02L6CC, 02HWRJ, 02L5X0, 02L6QV, 02L5MF, 02HXL7, 02L66Y, 02L66Z, 02L6M9, 02L4Z8,
02RCTK, 02DQBF, 02HWRK, 02LJC5, 02LJG1, 02LJDD, 02LJKC, 02LJKZ, 02LFJB, 02BVJ6,
02LJ3F, 02LJ1N, 02L603, 02L5WJ, 02L6FL, 02L6F5, 02LJKT, 02RCZX, 02D4BK, 02DPFV,
02L6NP, 02D4C2, 02DQ10, 02RD05, 02RCHQ, 02HX8L, 02LJM6, 02L6H9, 02RD01, 02RCZY,
02RCZR, 02LJ0K, 02LJ0Z, 02LJ1G, 02LJ1K, 02LK02, 02LK09, 02RCWC, 02RCW9, 02KHB1,
02LHYK, 02LHYG, 02DPXK, 02BV72, 02HWQ0, 02RCCF, 02RCMW, 02RCM8, 02RCZZ, 02RCBC,
02RCM5, 02L56K, 02L6NQ, 02RCZP, 02L4XH, 02L51Q, 02HXTK, 02HXTN, 02HWW9, 02DR1W,
02KHVX, 02LJ1Y, 02LJ2R, 02HWPT, 02RCTG, 02KHBL, 02KHBM, 02KHC3, 02DPMV, 02DQNF,
02DPMR, 02RCPL, 02LJ1C, 02L70Z, 02DQP4, 02DQNX, 02HXR3, 02HXQK, 02HXR4, 02HXTG,
02HXTV, 02DPDT, 02KH5M, 02L6R5, 02L6RR, 02DPPW, 02KHY8, 02L51K, 02L70R, 02KHDT,
02KHPW, 02RCX8, 02RCX9, 02L57J, 02L4Z1, 02DPPT, 02DR25, 02HWTF, 02LHZV, 02DP8Q,
02L6N8, 02DP9T, 02DPB7, 02DPB9, 02DPPD, 02DPP8, 02DP8P, 02DP86, 02RCRR, 02HXD9,
02HXDD, 02HXDH, 02HXF0, 02LFNR, 02RC16, 02RCW3, 02KHT4, 02RCB3, 02RC88, 02KJ6F,
02KG8F, 02KHJL, 02HX54, 02HX55, 02HX5B, 02HX7H, 02HX7V, 02HXHQ, 02LJCR, 02LJDR,
02L5G5, 02L5CK, 02RCF4, 02RCMX, 02RCMY, 02RCM2, 02L4YM, 02L57X, 02L591, 02L6LX,
02L50Y, 02KHXB, 02KH71, 02L4YG, 02BVLZ, 02DQNJ, 02HX7X, 02HXJH, 02RCZN, 02RCWY,
02RCVB, 02D413, 02RD06, 02HXBY, 02RCXB, 02RCY2, 02DQJH, 02L6N0, 02L6MD, 02DR27,
02HXC0, 02L6MZ, 02L6BP, 02HXBG, 02HX7Y, 02L5QK, 02LJ1J, 02LJC0, 02LJ1H, 02LHZ2,
02L5RY, 02LJ2Q, 02LJ38, 02L6QT, 02HXPL, 02L6YM, 02LHYH, 02KHVW, 02RCG8, 02LFMX,
02L706, 02KJ1V, 02RD00, 02HXN0, 02HWT3, 02KHTM, 02HXKL, 02L5Z8, 02L6R3, 02KHT8,
02LFMW, 02RC0P, 02KHQZ, 02RCN0, 02RCXD, 02DPDP, 02L6J9, 02LFH9, 02LK0Y, 02LK10,
02RCRQ, 02HWZV, 02HX8B, 02L50K, 02KJ0H, 02KJ0N, 02LJNM, 02LJM4, 02LJK9, 02LJKX,
02HXMG, 02HXMB, 02HXKK, 02HXKN, 02LHYD, 02KG8C, 02HXHW, 02L4XG, 02KHRN, 02HXP5,
02KHRH, 02DPWZ, 02RCLF, 02BTMJ, 02HWPZ, 02RCX3, 02KHJH, 02HXFP, 02KHMF, 02KH9H,
02KHM5, 02KHM7, 02HXD5, 02LJH4, 02LJKJ, 02LJKH, 02LJM5, 02L6GX, 02RD10, 02HXR2,
02LJF8, 02L6TB, 02LJH3, 02LJG7, 02D3VK, 02HXHN, 02HWXL, 02RCXH, 02LFHB, 02L67L,
02L61D, 02HWV8, 02HXBV, 02LJDN, 02LJH2, 02LJ1Z, 02LJ9R, 02LK0X, 02LJ8Q, 02RCRP,
02RCV9, 02L6G9, 02L6Y6, 02L6QW, 02LJ88, 02RCQJ, 02KHM2, 02RCJB, 02L4XJ, 02L56N,
02L55C, 02HXBH, 02L6GY, 02KH5L, 02RC01, 02DPP9, 02L6KX, 02HXK9, 02RCZT, 02L4Y7,
02L6C4, 02KHXL, 02L4YH, 02L6V2, 02L6V3, 02L6MY, 02RC7Q, 02RC7P, 02RC5N, 02RC7Y,
02LFMD, 02LFMM, 02LFNL, 02RC08, 02RC0V, 02RC14, 02KHHR, 02L699, 02L68J, 02L68F,
02L6B2, 02L70N, 02LJ1V, 02LJCY, 02LJ5N, 02L5G6, 02D4C3, 02DP9Q, 02DPQP, 02KHW0,
02KHQ3, 02HWTX, 02KHNR, 02RCJJ, 02RC29, 02RCTD, 02HXHP, 02LJJG, 02LJ5M, 02KHQ9,
02LJP1, 02L6BG, 02L5FY, 02KG8H, 02KHVL, 02RCC1, 02RCFW, 02L5P8, 02LFMK, 02L5VC,
02L5PP, 02RCZQ, 02RCTC, 02L605, 02L60X, 02RD0Z, 02DPRK, 02DPTZ, 02RD04, 02RD12,
02RD13, 02L6ZN, 02LJC9, 02RCM4, 02DPQR, 02HWRG, 02KHPZ, 02DPVB, 02KHXN, 02KHWJ,
02RC5J, 02KJ42, 02RCT7, 02LK0B, 02L5FH, 02RCX4, 02L71D, 02L70T, 02LHZ4, 02L5TC,
02L6V6, 02HXF5, 02HXPT, 02L602, 02RCPP, 02LFMC, 02KHP9, 02KHRM, 02RCY4, 02RCY5,
02RCXY, 02RD0Y, 02RCHM, 02RCTN, 02RCW7, 02RCVC, 02RD03, 02L6Q6, 02L681, 02LFMZ,
02LFMG, 02LFMJ, 02LFM9, 02LFMV, 02LFN2, 02HXBM, 02HWZF, 02L6K9, 02L6KW, 02L6Y9,
02LJ4B, 02L6NX, 02L6LV, 02KJ5X, 02RCZV, 02RCPR, 02L6NB, 02HX53, 02HXNL, 02D4BG,
02HWT0, 02L6GB, 02L6FT, 02L5MP, 02L69C, 02L6B0, 02L6GD, 02L6MB, 02L6LY, 02L6KC,
02RCRV, 02RCRT, 02KHD5, 02HXL2, 02RC7T, 02DPQ6, 02L4WW, 02DPZV, 02L6BF, 02L6BC,
02L69B, 02L68N, 02L68G, 02L662, 02L64N, 02L64Z, 02L64P, 02HWQ6, 02LJKK, 02LJ2N,
02KJ0G, 02RCB1, 02RCXF, 02RCTP, 02KJ5P, 02L4VC, 02L4VH, 02L667, 02L663, 02L64Y,
02L64Q, 02L682, 02L683, 02L67X, 02L67N, 02L63T, 02L61F, 02DQ3N, 02KH89, 02LFMT,
02HXNK, 02RCY0, 02HXJG, 02LFMN, 02RC17, 02RC2B, 02RC2Q, 02L6XC,
02L6NC
RECALLING FIRM/MANUFACTURER Phillips Ultrasound, Inc.,
Bothell, WA,
REASON Acoustic output intensity may exceed maximum
specified limits and the patient contact temperature may exceed 43 degree C
(when the system is used with the S12-4 transducer in CW-mode).
VOLUME OF
PRODUCT IN COMMERCE 1,429 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Desktop Pro™ R6.0
& R6.1, Linear Medical Accelerator, Model number MRT 9871/ MRT 10601,
CODE
This issue affects all Desktop Pro 6.0 and 6.1
users with a 3rd party R & V System, with the exception of Sigma Micro
Users.
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Elekta,
Inc. Norcross GA,
Manufacturer:
Elekta Oncology, Sussex, UK.
REASON Unexpected Diaphragm movement when manual field
size modifications are not saved.
VOLUME OF PRODUCT IN COMMERCE 37
units
DISTRIBUTION Nationwide and Canada
WEEK ENDING FEBRUARY 24
PRODUCT Rocker Reducer, part
of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty:
1 ea, non-sterile,
CODE Lot numbers: MH05F006
and MH05J015
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Medtronic Sofamor Danek Instrument Manufacturing, Bartlett, TN,
Manufacturer:
Marson Medical, Inc., Paramus, NJ.
REASON Due to a manufacturing
error, the proximal end may deform causing the protrusions that engage the
associated implant to break off of the instrument during use.
VOLUME OF
PRODUCT IN COMMERCE 58 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Access® Immunoassay
Systems Thyroglobulin Antibody Reagent Kit, in vitro diagnostic, Part Number
33890,
CODE 518729 (expires 10/31/06); 520617
(expires 12/31/06); 612764 (expires 12/31/06); 613481 (expires 3/31/07); 614541
(expires 5/31/07); 616787 (expires 8/31/07)
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea CA
Manufacturer: Beckman Coulter, Inc.,
Chaska, MN.
REASON Low end
imprecision affecting both S0 calibrators and patient samples which can lead to
inaccurate low level patient results when using the Access Thyroglobulin
Antibody assay.
VOLUME OF PRODUCT IN COMMERCE 474
units
DISTRIBUTION Nationwide and Canada