JANUARY 2009
WEEK
ENDING JANUARY 3
PRODUCT
Sun Med GreenLine/D Laryngoscope
Blades Compatible with Fiber Optic Green System Handles, Sterile Disposable.
Contents 20,
CODE Lots: Gj; Ha
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sun Med,
Inc., Largo , FL,
Manufacturer: Medical Devices (Pvt) Ltd., Sialkot , Pakistan .
REASON
A breakage
problem of the acrylic bundles at both distal and proximal ends of the light
tube for the MD Laryngoscope Blade GreenLine D Mac 3 has been detected.
VOLUME OF PRODUCT IN COMMERCE
2,682 boxes of 20 each
DISTRIBUTION Nationwide
PRODUCT
a) Stryker Custom Cranial Implant Kit, small. Catalog # 54-00101.
Custom cranial implant designed individually for each patient to correct trauma
and or defects in mandibular, maxillofacial or craniofacial bone,
b) Stryker Custom Cranial Implant Kit, medium.
Catalog # 54-00102. Custom cranial implant designed individually for each
patient to correct trauma and or defects in mandibular, maxillofacial or
craniofacial bone,
c) Stryker Custom
Cranial Implant Kit, large. Catalog #: 54-00103. Custom cranial implant designed
individually for each patient to correct trauma and or defects in mandibular,
maxillofacial or craniofacial bone,
d)
Stryker Custom Cranial Implant Kit, extra large. Catalog #: 54-00104. Custom
cranial implant designed individually for each patient to correct trauma and or
defects in mandibular, maxillofacial or craniofacial bone, CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Leibinger USA , Portage , MI Manufacturer: Contract Medical Manufacturing, Oxford
, CT.
REASON Lack of
assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE 322 units
DISTRIBUTION
VA, HI, KS, AZ, GA,
NY
PRODUCT
a) Terumo Advanced Perfusion System 1;
100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base;
Model 801763,
b) Terumo Advanced Perfusion
System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required)
base; Model 801764 (Not distributed within the United States ),
CODE
a) Serial numbers 0396 through 1049;
b) Serial numbers 0188 through 1027
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems, Corp., Ann Arbor , MI , REASON The power supply may fail to charge the batteries due to various
hardware malfunctions.
VOLUME OF PRODUCT IN COMMERCE 424 units
DISTRIBUTION
Nationwide,
Australia, Belgium, Canada, Colombia, Dominican Republic, Honduras, Hong Kong,
Indonesia, Japan, Jordan, Kuwait, Malaysia, Mexico, Philippines, Saudi Arabia,
Singapore, South Africa, South Korea, Taiwan, Thailand, United Arab Emirates,
and Viet Nam
PRODUCT
Hodogic, Inc., 10 Year Fracture Risk
Questionnaire Option for QDR X-Ray Bone Densitometers Software,
CODE
Software Version: SFW-00700, Rev-002
RECALLING FIRM/MANUFACTURER Hologic, Inc., Bedford , MA
,
REASON Software
error may lead to a high estimate of major fracture probability.
VOLUME OF PRODUCT IN COMMERCE 15 software CD's
DISTRIBUTION CO, MA, MN, NM, NY, NC, OR, OH, PA, TX,
and UK
PRODUCT
a) CASMED 500cc Unifusor Classic with
piston gauge and thumbwheel valve. Model: 903TGA. It is designed for use in
rapid infusion, invasive pressure monitoring and with auto-transfusion devices,
b) CASMED 500cc Unifusor with aneroid gauge
and thumbwheel valve Model: 803FGA. It is designed for use in rapid infusion,
invasive pressure monitoring and with auto-transfusion devices,
c) CASMED 500cc Unifusor with aneroid gauge and
stopcock valve. Model: A803SGA. The letter A refers to a special quantity
designator for a particular customer. The product is designed for use in rapid
infusion, invasive pressure monitoring and with auto-transfusion devices,
d) CASMED 500cc Unifusor II with aneroid gauge and thumbwheel valve Model: 2803SGA. It is designed for use in rapid infusion, invasive pressure monitoring and with auto-transfusion devices,
e) CASMED 500cc Unifusor with aneroid gauge and
stopcock valve. Model: 803SGA. It is designed for use in rapid infusion,
invasive pressure monitoring and with auto-transfusion devices,
f) CASMED 500cc Unifusor Classic with piston gauge
and stopcock valve. Model: A903SGA. The letter A refers to a special quantity
designator for a particular customer. It is designed for use in rapid infusion,
invasive pressure monitoring and with auto-transfusion devices,
g) CASMED 500cc Unifusor Classic with piston gauge
and stopcock valve Model: 903SGA. It is designed for use in rapid infusion,
invasive pressure monitoring and with auto-transfusion devices,
h) CASMED 500cc Unifusor Classic with aneroid gauge
and thumbwheel valve Model:FN-803FGA. Private labeled for Femcare-Nikomed in the
UK . It is designed for use in rapid infusion, invasive pressure monitoring and
with auto-transfusion devices,
i) CASMED
500cc Unifusor with a short tub. Private labeled for King Systems. Model:
P500BAG. It is designed for use in rapid infusion, invasive pressure monitoring
and with auto-transfusion devices,
j)
CASMED 500cc Unifusor II with aneroid gauge and thumbwheel valve. Private
labeled for Transmed in Germany . Model: T2803SGA. It is designed for use in
rapid infusion, invasive pressure monitoring and with auto-transfusion devices,
k) CASMED 500cc Unifusor Classic with
aneroid gauge and thumbwheel valve. Model: D803FGA. Private labeled for P.J.
Dahlhausen in Germany . It is designed for use in rapid infusion, invasive
pressure monitoring and with auto-transfusion devices,
CODE
a) Lot numbers: 21520608, 24710908, 29161308,
29171308, 31151308, 34471608, 2452208, and 43462308;
b) Lot
numbers: 30241308, 22710808, 22720808, 22730808, 23300808, 34391608, 40042008,
41082108, 41752108, 42422208, 44742408, and 45612508;
c) Lot
numbers: 22810808, 24740908, 24750908, 25470908, 25480908, 27271108, 27281108,
31181308, 34511608, 40072008, 41112108, and 41362108, 41802108, 42462208,
42482208, 43472308, 44772408, 44802408, 44812408, 46902508, 46962508, 48692608;
d) Lot numbers: 25380908, 41312108, and 41742108;
e) Lot numbers: 25420908, 27341108, 34411608, 35431608, 41092108, 41322108,
41762108, 42432208, 43432308, 43482308, 44752408, and 44792408;
f) Lot numbers: 25500908, 30281308, 40092008, 42472208, 43502308, 43852308,
44782408, 46032508, and 48262608;
g) Lot numbers: 25460908,
27261108, 31141308, 34441608, 34451608, 41352108, 41782108, 42442208, 43452308,
44762408, and 45642508;
h) Lot numbers: 31281308, 35561608, and
51472808;
i) Lot numbers: 34041608, 36421708, 49342608, 54413008,
and 61753308;
j) Lot number: 42232208;
k) Lot
Numbers: 35541608, 39321908, and 52642908
RECALLING
FIRM/MANUFACTURER
Recalling Firm: CAS Medical Systems, Inc.,
Branford , CT ,
Manufacturer: Statcorp,
Inc., Jacksonville , FL.
REASON Leaks: Infusion Cuffs may exhibit air leakage at the union of the
tube and bag, and not maintain pressure.
VOLUME OF PRODUCT IN
COMMERCE
80,864 pieces
DISTRIBUTION Nationwide, Malaysia , Austria , Belgium , Czech Republic , France
, Germany , Greece , Italy , Norway , Spain , Sweden , Switzerland and the UK
PRODUCT
VASOVIEW 4 Endoscopic Vessel Harvesting System with VASOVIEW
Flexible Endoscopic Tools in the following configuration: a) VH-10242: Uniport
plus dissection cannula, short port blunt tip trocar, flexible endoscopic
scissors; and b) VH-10243: Uniport plus dissection cannula, short port blunt tip
trocar, flexible endoscopic bisector,
CODE
a) Lot numbers: 7100172 to 8081371;
b) Lot numbers: 7100171 to
8081271
RECALLING FIRM/MANUFACTURER CTS, Inc., dba
Guidant Cardiac Surgery, San Jose, CA,
REASON Packaging unsealed:
Sterility of product may be compromised due to packaging issue.
VOLUME OF PRODUCT IN COMMERCE 7,935 devices
DISTRIBUTION Nationwide and Australia
PRODUCT
Insure® Quik Fit™ Developer Kit, Product Numbers: 30025 (InSure
Quik Fit Developer Kit) and 50025 (Insure® Quik Fit™ containing Developer Kit
and Patient Collection Kits. Product Number 30025 - InSure® Quik Fit™ Developer
Kit (1 Box). Each box contains: 25 InSure® Quik Fit™ Test Strips (1 per foil
pack), 1 InSure® Quik Fit™ Conjugate Solution, I InSure® Quik Fit™ Run Buffer,
and 1 InSure® Quik Fit™ Product Instructions. Product 50025 - InSure® Quik Fit™
contains 25 Patient Kits & 1 Developer Kit,
CODE Lot number: B1478, Exp. Date 11/30/2008
RECALLING FIRM/MANUFACTURER Enterix, Inc., Edison , NJ
,
REASON False readings: Reduced sensitivity could affect
the test line area and/or control line on the test strips, which may lead to
inaccurate results.
VOLUME OF PRODUCT IN COMMERCE 45
kits
DISTRIBUTION Nationwide
PRODUCT
FHC microTargeting Platform DBS Measuring Fixture, a component of
the micro-targeting Drive System, Catalog # 66-FA-SF. The device is a
stereotactic instrument used for the placement of recording and stimulating
electrodes in the brain,
CODE Not
coded
RECALLING FIRM/MANUFACTURER FHC, Inc., Bowdoinham
, ME ,
REASON Measuring fixture is incorrectly graduated.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION Nationwide
PRODUCT
Thoratec HeartMate II Left Ventricular Assist System (LVAS).
Model/Catalog Number 1355 and Model/Catalog Number 102139. The HM II LVAS is
intended to provide hemodynamic support in patients with end-stage, refractory
left ventricular heart failure; either for temporary support, such as a bridge
to cardiac transplantation or myocardial recovery, or as permanent destination
therapy. The HeartMate II is intended for use inside or outside the hospital,
C ODE
All serial numbers
RECALLING FIRM/MANUFACTURER Thoratec Corp., Pleasanton
, CA ,
REASON Over time, wear and fatigue of the percutaneous
lead connecting the HeartMate II Left Ventricular Assist System (HM II LVAS)
blood pump with external system controller may result in damage that has the
potential to interrupt pump function and may require a reoperation to replace
the pump.
VOLUME OF PRODUCT IN COMMERCE 2,335 units
DISTRIBUTION Nationwide, Canada, Austria, Italy,
Lithuania, Iceland, Israel, Qatar, Belgium, Bulgaria, Bahamas, Japan, Czech
Republic, Slovenia, Sweden, Switzerland, Saudi Arabia, South Africa, Denmark,
Ecuador, UK, France, Netherlands, Germany, and Greece
PRODUCT
FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 Is a
paramagnetic particle immunoassay for the in vitro quantitative determination of
prostate-specific antigen (PSA) in human serum and plasma as an aid in the
management of patients with prostate cancer. The FastPack(R) Total PSA
immunoassay is designed for use with the FastPack (R) System,
CODE
Lot numbers: 0807002-901, 0807002-903,
0807002-904, 0807002-905, 0807002-906, 0807002-907, 0807002-908, and 0807002-909
RECALLING FIRM/MANUFACTURER Qualigen, Inc., Carlsbad ,
CA ,
REASON Product
was not meeting product performance expectations.
VOLUME OF PRODUCT
IN COMMERCE 720 units
DISTRIBUTION Nationwide, Canada , UK , Italy , Switzerland , Sweden and South
Korea
PRODUCT
IMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) For in vitro diagnostic use with the IMMULITE and IMMULITE 1000
Analyzers - for the quantitative measurement of progesterone in serum, as an aid
in the diagnosis and treatment of disorders of the ovaries or placenta,
CODE
Lot Numbers: 318, 319, 320, 321, 322,
323, 324, 325, 326, and 327
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions Diagnostics, Deerfield ,
IL ,
Manufacturer: Siemens Medical Solutions
Diagnostics, Los Angeles , CA.
REASON Siemens Healthcare Diagnostics has confirmed a
long-standing high bias with LKPG 1, 5. (The bias is approximately 25% at 10 -
20 ng/mL as opposed to approximately 3% at 1-3 ng/mL).
VOLUME OF
PRODUCT IN COMMERCE 12,908 units
DISTRIBUTION Nationwide, Argentina, Aruba, Australia, Austria, Bangladesh,
Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Cyprus, Czech
Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras,
Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Korea,
Kuwait, Lebanon, Mexico, Netherlands, Nicaragua, Pakistan, Peru, Philippines,
Poland, Portugal, Puerto Rico, Republic of Panama, Saudi Arabia, Slovakia,
Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan,
Thailand, Turkey, United Arab Emirates (UAE), United Kingdom, Uruguay, and
Venezuela
PRODUCT
Wallace Oocyte Recovery Needles,
Oocyte Recovery sets, 750mm tube with flushing connector, Product Number:
ONS1633LL-750, and ONS1733LL-750. Retrieval of Oocytes,
CODE Lot numbers: 1270648, exp: 02/10/2013; 1281024,
exp: 02/04/2013; and 1284914, exp: 03/11/2013
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Irvine Scientific Sales Co.,
Inc., Santa Ana , CA ,
Manufacturer:
Smiths Medical, Hythe , Kent , UK . REASON Certain lots of Wallace Oocyte Recovery Sets
have a damaged needle tip.
VOLUME OF PRODUCT IN COMMERCE 71 units
DISTRIBUTION
Nationwide
PRODUCT
Flextome Cutting Balloon Device Over-the-Wire Delivery System,
Coronary Atherotomy System, Over-the-Wire Delivery System, Catalog No.
CB0340006, 4.00mm, Sterile. Made in Ireland . The Flextome Cutting Balloon
Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades)
mounted longitudinally on its outer surface. When the Flextome Cutting Balloon
Device is inflated, the atherotomes score the plaque, creating initiation sites
for crack propagation. This process, referred to as Atherotomy, allows dilation
of the target lesion with less pressure. Indicated for dilatation of stenoses in
coronary arteries for the purpose of improving myocardial perfusion in those
circumstances where a high pressure balloon resistant lesion is encountered,
CODE
Batch/Lot number: EG5577
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston
Scientific Corp., Maple Grove , MN ,
Manufacturer: Interventional Technologies Europe Ltd., A subsidiary of
Boston Scientific Letterkenny, County Donegal, Republic of Ireland.
REASON
An incorrect
compliance chart was packaged inside the sterile pouch of the 4.0mm diameter
Flextome Cutting Balloon device is for a 3.5mm diameter Flextome Cutting Balloon
device. This labeling discrepancy could create a procedural delay as users seek
to explain the discrepancy and/or obtain a replacement unit.
VOLUME
OF PRODUCT IN COMMERCE 75 units
DISTRIBUTION Nationwide
PRODUCT
Genicon 5mm Pyramidal Trocar, Sterile,
Only. Catalog Numbers: 100-005-001 & 100-005-002. Used for incisions made
for positioning the laparoscopic cannula or ports,
CODE
Lot numbers: I1219-K, exp: 11/01/2012; I1220-K,
exp: 11/01/2012; I1278-K, exp: 01/01/2013; I1281-K, exp: 01/01/2013; I1393-K,
exp: 03/01/2013; I1394-K, exp: 03/01/2013; I1415-K, exp: 03/01/2013; I1423-K,
exp: 03/01/2013; I1487-K, exp: 04/01/2013; I1470-K, exp: 04/01/2013; and
I1471-K, exp: 04/01/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Genico, Inc., dba Genicon, Winter Park, FL,
Manufacturer: Unimax Medical Systems, Taipei , Taiwan .
REASON
The stainless steel tips on
the Genicon 5mm Pyramidal Trocar exhibited contamination that resembled rust and
there was also pitting on the tip of the trocar.
VOLUME OF PRODUCT
IN COMMERCE
2,965 Units
DISTRIBUTION Nationwide,
Africa, United Kingdom , Denmark ,
Colombia , Belgium , Italy , Finland , Hong Kong, and Switzerland
PRODUCT
a) Micro Plate EIA Oral Fluid Positive
Control which is a component of the Intercept Micro Plate EIA kit. Product
number 61456,
b) Micro Plate EIA Oral Fluid
Negative Control which is a component of the Intercept Micro Plate EIA kit.
Product Number 61452,
c) Micro Plate EIA
Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro Plate
EIA kit. Product number 61454,
CODE
a) Lot numbers 6604829, 6604836, 6606036, 6606585, and 6606591;
b) Lot numbers 6604827, 6604834, 6606583, 5506589, and 6606034;
c) Lot
numbers: 6604282, 6604835, 6606584, 6606590, and 6606035
RECALLING
FIRM/MANUFACTURER OraSure Technologies, Inc., Bethlehem , PA ,
REASON Results, false-positive test: low % displacement
result of 36.0% (spec 39-60%).
VOLUME OF PRODUCT IN COMMERCE
6,594 units
DISTRIBUTION Nationwide, UK ,
Italy , Germany and Canada
Stryker Craniomaxillofacial Issues Recall of its Custom Cranial Implant Kits
Stryker's Craniomaxillofacial (CMF) business unit announced a recall of the following Stryker CMF's Custom Cranial Implant Kits. Catalogue Numbers 54-00101, 54-00102, 54-00103 and 54-00104, all lots shipped sterile.
Sterilization validation of the product was not performed according to appropriate standards.
Physicians and hospitals who have product that corresponds to the catalogue numbers listed above should stop implanting the product immediately and return it to Stryker CMF. Stryker recommends that patients who have received these implants be monitored by their physicians for signs of infection for at least six months post-implantation.
Physicians and patients with questions related to this issue should contact Stryker CMF at 800-962-6558, Monday – Friday, 8 a.m. to 7 p.m. ET. Patients with questions are encouraged to speak with their surgeon. Any adverse events relating to this product should be reported to Stryker.
Recall of Ophthalmic Surgical Device
A recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif. has been announced.
OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.
AMO recalled all 4,439 units of Healon D lot no. UD30654 of Healon D, due to complaints of inflammation after eye surgery, including Toxic Anterior Segment Syndrome (TASS).
Health care professionals and consumers may contact AMO at 1-877-AMO-4Life to make arrangements for return. The lot number of the device is displayed on the side panel of each unit.
WEEK ENDING JANUARY 10
PRODUCT GE Centricity Ultra Laboratory System Software for recording, reporting and
distribution of lab results,
CODE Software versions 3.3.2.27_P4 and 4.0.1_SP.x
RECALLING
FIRM/MANUFACTURER
Recalling Firm: GE Healthcare Integrated IT
Solutions, Barrington, IL,
Manufacturer:
Triple G Systems Group, Inc., Markham, Canada.
REASON Software computer error: The abnormal result
flag is not being sent in the HL7 messages on results that are lower than the
normal range.
VOLUME OF PRODUCT IN COMMERCE
3
units
DISTRIBUTION Nationwide and
Canada
PRODUCT
a)
Siemens KinetDx 4.2 Workplace, 10090235. Indicated for use by the physician to
aid in diagnosis, and by medical professionals whenever they would require or
desire access to medical images and patient demographic information,
b) Siemens syngo Dynamics Workplace, version 5.0. Intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation,
c) Siemens syngo Dynamics Workplace, version 6.0. Intended for acceptance,
transfer, display, storage, archive and manipulation of digital medical images,
including quantification and report generation,
CODE All units
RECALLING
FIRM/MANUFACTURER Siemens Medical Solutions, USA, Inc., Ann Arbor,
MI,
REASON If the text is manually modified and
additional phrases added as a result of worksheet interactions, some of the
phrases may not populate the report.
VOLUME OF PRODUCT IN
COMMERCE
306 units
DISTRIBUTION Nationwide
PRODUCT
a) Novel PEEK VBR XS 16-22 MM, S-5, 20MM, Part Number: 64733-120. Indicated
for use in the thoracolumbar spine (T1 to L5) for partial or total replacement
of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e.,
fracture). Intended for use with supplemental spinal fixation systems,
b) Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers: 64753-126. Indicated
for use in the thoracolumbar spine (T1 to L5) for partial or total replacement
of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e.,
fracture). Intended for use with supplemental spinal fixation systems,
CODE
a) Lot #: 611884;
b) Lot #:
611881
RECALLING FIRM/MANUFACTURER Alphatec Spine, Inc.,
Carlsbad, CA,
REASON Firm confirmed that two lots were mixed
during manufacturing and were incorrectly labeled with the wrong part number
& lot number. They were incorrectly laser marked with the wrong part numbers
and sizes. Two lots were mixed from the following lot numbers: Part Number
64733-120 Lot Number 611884, and Part Number 64753-126 and Lot Number 611881.
VOLUME OF PRODUCT IN COMMERCE
7
units
DISTRIBUTION Nationwide
PRODUCT MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K, Cordis
Neurovascular. Intended to be used as a mechanism for the infusion of various
diagnostic, embolic, and therapeutic agents into the Neurovascular, Peripheral
Vascular and Coronary Vascular systems and for superselective angiography of
peripheral and coronary vasculature,
CODE Lot #’s: 13358689 and
13350390
RECALLING FIRM/MANUFACTURER Cordis Corp., Miami
Lakes, FL,
REASON Two lots have the potential for sterile
PTFE contamination within the inner lumen of the catheter.
VOLUME OF
PRODUCT IN COMMERCE
27 kits
DISTRIBUTION Nationwide
PRODUCT Stryker Leibinger New Generation/Universal Mandibular System, Mandibular
Recon Plate, Straight, w. Template; REF # 55-28911. A mandibular plate and screw
system intended for stabilization and rigid fixation of mandibular fractures and
reconstruction,
CODE Lot
J8100F1669
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Stryker Leibinger USA, Portage, MI, Manufacturer: Stryker Leibinger
Gmbh, Freiburg, Germany.
REASON A template is supposed to
accompany the product, but it was not included with this lot.
VOLUME
OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION Nationwide
PRODUCT DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental
low flow oxygen therapy. These devices can be used in homes, nursing homes, and
patient care facilities. a) Model 515ADS; b) Model 515ADZ; c) Model 515AKS; and
d) Model 515AKZ,
CODE
a) Serial
number range A561137DS - A562049DS;
b) Serial number range A538908DZ -
A538924DZ;
c) Serial number range A542879KS - A543722KS;
d) Serial number
A501627KZ
RECALLING FIRM/MANUFACTURER Sunrise Medical,
Somerset, PA
REASON Potential for sieve beds to have
been incorrectly assembled.
VOLUME OF PRODUCT IN COMMERCE
428 units
DISTRIBUTION AL, CA, FL ,GA, IN, IL, MA,
MD, MI, MS, NC, NE, NH, NM, NY, PA, SD, TN, TX, VA, WI, Canada, Columbia,
Germany, Mexico, Netherlands, Singapore, and United
Kingdom
PRODUCT Flexi-Seal Fecal Management System Advanced Odor Control Kit. Rx only; 1
silicone catheter tube assembly, 3-1 Liter collection bags with filters, 1 luer-lock syringe, SKU #411104. Made in USA with imported components "For the
fecal management of patients with little or no bowel control and liquid or
semi-liquid stool",
CODE Lot #:
08-TM-51
RECALLING FIRM/MANUFACTURER
Recalling Firm:
CovaTec, Skillman, NJ,
Manufacturer: Vesta,
Inc., Franklin, WI.
REASON A portion of the inner nylon sleeve of the catheter was visible at the
balloon end of a sample device.
VOLUME OF PRODUCT IN
COMMERCE
795 kits
DISTRIBUTION Nationwide
and Canada
PRODUCT
a) Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF
EC1001, Sterile R, individually packaged. This product is indicated for use in
patients undergoing cardiopulmonary bypass. It occludes the ascending aorta,
vents the aortic root and allows delivery of cardioplegia solution to arrest the
heart. The pressure lumen allows monitoring of the aortic root pressure
b) CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic
catheter 100 cm, REF EC1001, Sterile R, individually packaged, Heartport, Inc.,
Somerville, NJ 08876. This product is indicated for use in patients undergoing
cardiopulmonary bypass. It occludes the ascending aorta, vents the aortic root
and allows delivery of cardioplegia solution to arrest the heart. The pressure
lumen allows monitoring of the aortic root pressure,
CODE
a) Lot numbers: MS0408007, MS0508033,
MS0508040, 561241, 562406, 567576, 569133, 569134, 569135, 575695, 579683, and
581317;
b) Lot numbers: MS0208019, MS0208020, MS0208027, MS0208035, MS0208036,
MS0408002, MS0408008, MS1007022, MS1007026, MS1207032, MS1207033, MS1207042,
MS1207043, and MS1207044
RECALLING FIRM/MANUFACTURER
Recalling Firm: Edwards Lifesciences Research Medical, Inc., Midvale, UT,
Manufacturer:
Accellent, Inc., Laconia, NH.
REASON Balloon
rupture: Catheter balloon may rupture during cardiopulmonary bypass
procedure.
VOLUME OF PRODUCT IN COMMERCE
2,230
units
DISTRIBUTION Nationwide, Australia, Canada,
Switzerland and UK
WEEK ENDING JANUARY 17
PRODUCT
GE Healthcare Solar 8000M System, a multiparameter physiological
patient monitoring system intended for use on adult, pediatric and neonatal
patients, within a hospital or facility environment,
CODE Serial numbers: PA1257732, PA1257733, PA1257734, SCZ07200027GA,
SCZ07200028GA, SCZ07200029GA, SCZ07200030GA, SCZ07200031GA, SCZ07200032GA,
SCZ07200033GA, SCZ07200034GA, SCZ07200035GA, SCZ07220036GA, SCZ07220037GA,
SCZ07220038GA, SCZ07220039GA, SCZ07220040GA, SCZ07220041GA, SCZ07220042GA,
SCZ07220043GA, SCZ07220044GA, SCZ07220045GA, SCZ07220046GA, SCZ07220047GA,
SCZ07220048GA, SCZ07220049GA, SCZ07220050GA, SCZ07220051GA, SCZ07220052GA,
SCZ07220053GA, SCZ07220054GA, SCZ07220055GA, SCZ07220056GA, SCZ07220058GA,
SCZ07220059GA, SCZ07220060GA, SCZ07220061GA, SCZ07220067GA, SCZ07220068GA,
SCZ07220069GA, SCZ07220070GA, SCZ07220072GA, SCZ07220073GA, SCZ07220076GA,
SCZ07220077GA, SCZ07220078GA, SCZ07220079GA, SCZ07220080GA, SCZ07220081GA,
SCZ07220082GA, SCZ07220084GA, SCZ07220085GA, SCZ07220086GA, SCZ07220087GA,
SCZ07220088GA, SCZ07220089GA, SCZ07220090GA, SCZ07220091GA, SCZ07220092GA,
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RECALLING
FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Wauwatose, WI,
Manufacturer: General Electric Medical Systems
Information Technology, Milwaukee, WI. F
REASON A software error has been discovered when using
Combination Monitoring with Solar 8000M/I – PDM – Telemetry in combo mode. This
error has only been noted with this particular configuration and mode of
monitoring.
VOLUME OF PRODUCT IN COMMERCE
2,782
units
DISTRIBUTION Nationwide and Australia, Austria,
Belgium, Brazil, Czech Republic, Denmark, Egypt, France, Germany, Indonesia,
Ireland, Italy, Jordan, Korea, Lebanon, Lithuania, Malaysia, Netherlands,
Norway, Pakistan, Saudi Arabia, Spain, Sweden, United Kingdom, and
Venezuela
PRODUCT
a) Somatom Sensation 40 X-Ray System, Model number 8874427. This is
a computed tomography x-ray system which is intended to produce cross-sectional
images of the body by computer reconstruction of x-ray transmission data from
the same axial plane taken at different angles,
b) Somatom Sensation 64 X-Ray System, Model number 8377520. This is a
computed tomography x-ray system which is intended to produce cross-sectional
images of the body by computer reconstruction of x-ray transmission data from
the same axial plane taken at different angles,
CODE
a) Serial numbers: 54016, 54027, 54031,
54033, 54035,54045, 54049, 54050, 54051, 54052, 54056, 54060, 54062, 54064,
54074, 54075, 54085, 54094, 54104, 54108, 54119, 54127, 54129, 54137, 54140,
54144, 54146, 54148, 54154, 54156, 54170, 54172, 54175, 54180, 54186, 54193,
54194, 54198, 54203, 54204, 54219, 54220, 54221, 54222, 54229, 54233, 54248,
54250, 54253, 54254, 54258, 54271, 54306, 54307, 54309 54319, 54325, 54419,
54677, 54684, 54690, 55019, 55022, 55023, 55024, 55035, 55041, 55043, 55047,
55061, 55063,55066, 55070, 55071, 55075, 55080, 55081, 55082, 55090, 55093,
55097, 55100, 55102, 55103, 55110, 55111, 55113, 55115, 55116, 55121, 55122,
55123, 55138, 55141, 55144, 55149, 55156, 55158, 55166, 55172, 55179, 55182,
55183, 55189, 55194, 55207, 55209, 55211, 55230, 55246, 55249, 55250, 55260,
55261, 55265, 55269, 55270, 55274, 55275, 55279, 55283, 55284, 55285, 55286,
55295, 55308, 55309, 55310, 55311, 55316, 55319, 55322, 55325, 55332, 55333,
55336, 55344, 55353, 55357, 55360, 55363, 55369, 55373, 55377, 55385, 55389,
55393, 55398, 55404, 55405, 55406, 55407, 55415, 55416, 55417, 55422, 55423,
55424, 55426, 55428, 55429, 55434, 55440, 55448, 55454, 55455, 55457, 55458,
55466, and 55467;
b) Serial numbers 57084, 57193, 57213, 57261, 57262, 57270, 57272, 57285, and
57298
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens
Medical Solutions USA, Inc., Malvern, PA,
Manufacturer: Siemens AG, Medical Solution,
Forchheim, Germany.
REASON Software error – does
not allow protocol to properly synchronize with ECG triggers.
VOLUME
OF PRODUCT IN COMMERCE
177
units
DISTRIBUTION Nationwide
PRODUCT FS-OMNI, Fusion Omni-Tome, Sterile, Rx only. The Fusion Omni-Tome
is supplied sterile and is a single use device. This device is used in
cannulation of the ductal system and for sphincterotomy,
CODE
Lot: W2501093
RECALLING
FIRM/MANUFACTURER Cook Endoscopy, Winston Salem, NC,
REASON
The wire control port may have been
omitted during manufacture.
VOLUME OF PRODUCT IN
COMMERCE
11
devices
DISTRIBUTION Ireland
PRODUCT ThomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software.
The affected applications include Planning Station, Planned Adaptive, Data
Management System, and TomoPortal. The product is intended for use in radiation
therapy,
CODE
USA 110001 110002
110003 110004 110005 110006 110007 110008 110012 110015 110016 110019 110020
110021 110023 110026 110027 110028 110029 110030 110031 110032 110033 110035
110038 110040 110042 110043 110044 110045 110047 110048 110050 110051 110053
110054 110056 110057 110059 110060 110067 110073 110074 110082 110084 110086
110087 110089 110090 110092 110094 110095 110096 110097 110098 110103 110105
110106 110108 110112 110115 110116 110118 110119 110120 110122 110127 110132
110134 110135 110138 110139 110149 110152 110153 110154 110155 110158 110160
110161 110165 110166 110168 110173 110174 110175 110176 110177 110179 110180
110181 110185 110186 110187 110188 110190 110192 110193 110195 110196 110197
110198 110201 110202 110203 110204 110206 110209 110210 110213 110215 110216
110217 110221 110222 110223 110224 110225 110227 110242 and 110250
Internationally - 110034 110062 110083 110126 110140 110014 110037 110072
110130 110169 110137 110077 110111 110117 110123 110146 110151 110189 110114
110131 110143 110170 110061 110167 110228 110157 110018 110071 110136 110162
110171 110211 110199 110150 110178 110237 110068 110078 110194 110069 110110
110191 110207 and 110240
RECALLING
FIRM/MANUFACTURER
TomoTherapy, Inc., Madison, WI,
REASON
Treatment plans involving very small
structures (volume <2cc), reading in a high dose gradient region, may exhibit
inaccuracies with the DVH curve and the Dose Statistics for the small
structures. The error can result in up to 30% inaccuracy in the DVH curve and
Dose Statistics.
VOLUME OF PRODUCT IN COMMERCE
165
units
DISTRIBUTION Nationwide, Belgium, Canada,
Switzerland, Germany, Spain, France, Great Britain, India, Italy, Japan, Korea,
Netherlands, Turkey, and
Taiwan
PRODUCT
a) GE OEC 9900 Elite ESP fluoroscopic x-ray system. The system is
intended to provide an x-ray display of human anatomy,
b) GE OEC 9900 Elite GSP fluoroscopic x-ray system. The system is intended to
provide an x-ray display of human anatomy,
CODE
a) E2-0033, E2-0060 E2-0077, E2-0101,
E2-0102, E2-0106, E2-0113, E2-0189, E2-0198, E2-0202, E2-0244, E2-0253, E2-0258,
E2-0262, E2-0264, E2-0266, E2-0268, E2-0270, E2-0271 E2-0272, E2-0273, E2-0274,
. E2-0281, E2-0283, E2-0284, E2-0285, E2-0288, E2-0289, E2-0290, E2-0291,
E2-0293, E2-0294, E2-0296, E2-0297, E2-0298, E2-0300, E2-0302, E2-0303, E2-0304,
E2-0305, E2-0308, E2-0310, E2-0311, E2-0312, E2-0314, E2-0315, E2-0317, E2-0317,
E2-0318, E2-0319, E2-0320, E2-0321, E2-0322, E2-0323, E2-0325, E2-0327, E2-0330,
E2-0332, E2-0333, E2-0335, E2-0337, E2-0338, E2-0340, E2-0341, E2-0342, E2-0345
E2-0346, E2-0348, E2-0349, E2-0351, E2-0354, E2-0357, E2-0360, E2-0361, E2-0363,
E2-0364, E2-0365 E2-0366, E2-0368, E2-0369, E2-0370, E2-0371, E2-0372, E2-0373,
E2-0376, E2-0377, E2-0378 E2-0379, E2-0380, E2-0381, E2-0383, E2-0384, E2-0385,
E2-0386, E2-0387, E2-0389, E2-0390, E2-0391, E2-0392, E2-0393, E2-0394, E2-0396,
E2-0398, E2-0399, E2-0400, E2-0401, E2-0402, E2-0403, E2-0404, E2-0405, E2-0406,
E2-0407, E2-0408, E2-0409, E2-0410, E2-0412, E2-0413, E2-0414, E2-0415, E2-0416,
E2-0417, E2-0418, E2-0419, E2-0420, E2-0421, E2-0422, E2-0423, E2-0424, E2-0425,
E2-0426, E2-0427, E2-0428, E2-0429, E2-0430, E2-0431, E2-0432, E2-0433, E2-0434,
E2-0435, E2-0436, E2-0437, E2-0438, E2-0439, E2-0440, E2-0441, E2-0442, E2-0443,
E2-0445, E2-0448, E2-0449 E2-0451, E2-0452, E2-0453, E2-0454, E2-0455, E2-0456,
E2-0457, E2-0458, E2-0459, E2-0461, E2-0462, E2-0463, E2-0465, E2-0466, E2-0467,
E2-0468, E2-0469, E2-0470, E2-0471, E2-0472, E2-0473, E2-0474, E2-0475, E2-0478,
E2-0482, E2-0483, E2-0485, E2-0488, E2-0489, E2-0490, E2-0494, E2-0496, E2-0497,
E2-0498, E2-0499, E2-0502, E2-0503, E2-0504, E2-0507, E2-0509, E2-0512, E2-0513,
E2-0519, E2-0520, E2-0525, E2-0526, E2-0529, E2-0530, E2-0532, E2-0534, E2-0535,
E2-0537, E2-0538, E2-0540, E2-0541, E2-0542, E2-0546, E2-0549, and E2-7022-MH,
E9-0002-G E9-0018, E9-0025, E9-0030, E9-0035-G, E9-0043, E9-0055, E9-0066,
E9-0092, E9-0094, E9-0095, E9-0098, E9-0099, E9-0101, E9-0103, E9-0107, E9-0108,
E9-0109, E9-0110, E9-0119, E9-0121, E9-0124, E9-0129, E9-0137, E9-0138, E9-0140,
E9-0144, E9-0145, E9-0150, E9-0159, E9-0163, E9-0166, E9-0168, E9-0169 E9-0171,
E9-0172, E9-0173, E9-0174, E9-0175, E9-0176, E9-0177, E9-0178, E9-0179, E9-0185,
E9-0186, E9-0187, E9-0190, E9-0191, E9-0192, E9-0194, E9-0195, E9-0197, E9-0198,
E9-0201, E9-0203, E9-0204, E9-0205, E9-0206, E9-0207, E9-0208, E9-0210, E9-0212,
E9-0214, E9-0215, E9-0216, E9-0218, E9-0219, E9-0220, E9-0224, E9-0225, E9-0228,
E9-0231, E9-0232, E9-0233, E9-0234, E9-0235, E9-0236, E9-0237, E9-0238, E9-0239,
E9-0240, E9-0241, E9-0242, E9-0243, E9-0244, E9-0245, E9-0246, E9-0255, E9-0257,
E9-0258, E9-0266, E9-0267, E9-0268, E9-0270, E9-0275, E9-0277, E9-0280, E9-0282,
E9-0283, E9-0284, E9-0285, E9-0289, E9-0290, E9-0292, E9-0294, E9-0300, E9-0301,
E9-0306, E9-0307, E9-0309, E9-0313, E9-0314, E9-0316, E9-0327, E9-0329, E9-0332,
E9-0334, E9-0341, E9-0353, E9-0354, E9-0357, E9-0363, E9-0372, E9-0373, E9-0375,
E9-0384, E9-0388, E9-0390, E9-0391, E9-0393, E9-0394, E9-0396, E9-0398, E9-0400,
E9-0403, E9-0404, E9-0405, E9-0406, E9-0407, E9-0410, E9-0411, E9-0416, E9-0417,
E9-0419, E9-0420, E9-0421, E9-0424, E9-0425, E9-0426, E9-0429, E9-0436, E9-0441,
E9-0443, E9-0444, E9-0445, E9-0446, E9-0447, E9-0448, E9-0449, E9-0450, E9-0452,
E9-0456, E9-0457, E9-0458, E9-0459, E9-0461, E9-0463, E9-0464, E9-0465, E9-0466,
E9-0471, E9-0472, E9-0474, E9-0475, E9-0477, E9-0479, E9-0481, E9-0482, E9-0483,
E9-0486, E9-0488, E9-0492, E9-0494, E9-0495, E9-0497, E9-0499, E9-0501, E9-0502,
E9-0511, E9-0513, E9-0515, E9-0516, E9-0524, E9-0530, E9-0532, E9-0533, E9-0540,
E9-0541, E9-0542, E9-0543, E9-0545, E9-0551, E9-0554, and E9-0557, ES-0013-G,
ES-0019, ES-0050, ES-0054, ES-0103, ES-0110, ES-0113, ES-0114, ES-0115, ES-0117,
ES-0118, ES-0130, ES-0134, ES-0160, ES-0176, ES-0180, ES-0188, ES-0189, ES-0192,
ES-0198, ES-0199, ES-0203, ES-0206, ES-0207, ES-0211, ES-0216, ES-0217, ES-0218,
ES-0219, ES-0220, ES-0224, ES-0225, ES-0226, ES-0227, ES-0228, ES-0234, ES-0236,
ES-0238, ES-0239, ES-0253, ES-0254, ES-0255, ES-0262, ES-0266, ES-0272, ES-0273,
ES-0274, ES-0275, ES-0279, ES-0280, ES-0281, ES-0292, ES-0299, ES-0300, ES-0312,
ES-0316, ES-0321, ES-0322, ES-0326, ES-0332, ES-0335, ES-0336, ES-0337, ES-0342,
ES-0343, ES-0349, ES-0351, ES-0352, ES-0354, ES-0355, ES-0358, ES-0359, ES-0360,
ES-0363, ES-0364, ES-0365, ES-0366, ES-0367, ES-0374, ES-0375, ES-0376, ES-0377,
ES-0378, ES-0379, ES-0380, ES-0381, ES-0382, ES-0383, ES-0384, ES-0385, ES-0387,
ES-0390, ES-0391, ES-0394, ES-0396, ES-0399, ES-0400, ES-0401, ES-0402, ES-0403,
ES-0404, ES-0405, ES-0412, ES-0413, ES-0415, ES-0417, ES-0418, ES-0419, ES-0421,
ES-0422, ES-0423, ES-0425, ES-0427, ES-0428, ES-0429, ES-0430, ES-0431, ES-0433,
ES-0434, ES-0435, ES-0436, ES-0437, ES-0438, ES-0439, ES-0441, ES-0442, ES-0443,
ES-0444, ES-0445, ES-0446, ES-0450, ES-0451, ES-0452, ES-0454, ES-0455, ES-0458,
ES-0459, ES-0460, ES-0462, ES-0463, ES-0464, ES-0465, ES-0467, ES-0468, ES-0469,
ES-0472, ES-0476, ES-0478, ES-0479, ES-0480, ES-0482, ES-0483, ES-0484, ES-0485,
ES-0486, ES-0487, ES-0488, ES-0490, ES-0493, ES-0494, ES-0495, ES-0496, ES-0497,
ES-0498, ES-0499, ES-0500, ES-0501, ES-0502, ES-0509, ES-0510, ES-0513, ES-0514,
ES-0515, ES-0518, ES-0521, ES-0522, ES-0523, ES-0526, ES-0527, ES-0528, ES-0529,
ES-0532, ES-0533, ES-0536, ES-0538, ES-0544, ES-0547, ES-0549, ES-0552, ES-0553,
and ES-0561;
b) E2-0027, E2-0047-RC, E2-0067, E2-0086, E2-0110, E2-0117, E2-0136, E2-0137,
E2-0162, E2-0175, E2-0194, E2-0245, E2-0295, E2-0326, E2-0334, E2-0336, E2-0339,
E2-0343, E2-0344, E2-0347, E2-0350, E2-0353, E2-0355, E2-0356, E2-0358, E2-0359,
E2-0362, E2-0367, E2-0374, E2-0375, E2-0382, E2-0388, E2-0395, E2-0397, E2-0411,
E2-0464, E2-0476, E2-0479, E2-0480, E2-0481, E2-0487, E2-0491, E2-0500, and
E2-0501, E9-0010, E9-0011, E9-0013, E9-0019, E9-0023, E9-0026, E9-0028,
E9-0036-G, E9-0039, E9-0040-G, E9-0045, E9-0048, E9-0049, E9-0057, E9-0058,
E9-0063, E9-0064, E9-0067, E9-0071, E9-0078, E9-0080, E9-0081, E9-0082, E9-0083,
E9-0086, E9-0088, E9-0093, E9-0115, E9-0116, E9-0120, E9-0123, E9-0126, E9-0130,
E9-0141, E9-0143, E9-0149, E9-0153, E9-0155, E9-0156, E9-0156, E9-0157 E9-0158,
E9-0167, E9-0180, E9-0181, E9-0184, E9-0196, E9-0202, E9-0217, E9-0221, E9-0222,
E9-0223, E9-0226, E9-0227, E9-0229, E9-0230, E9-0256, E9-0259, E9-0263, E9-0269,
E9-0271, E9-0272, E9-0273, E9-0274, E9-0276, E9-0278, E9-0279, E9-0281, E9-0286,
E9-0287, E9-0288, E9-0291, E9-0293, E9-0295, E9-0296, E9-0297, E9-0298, E9-0299,
E9-0302, E9-0303, E9-0304, E9-0305, E9-0308, E9-0310, E9-0311, E9-0312, E9-0315,
E9-0317, E9-0318, E9-0319, E9-0320, E9-0321, E9-0322, E9-0323, E9-0324, E9-0325,
E9-0326, E9-0328, E9-0330, E9-0331, E9-0333, E9-0335, E9-0336, E9-0337, E9-0338,
E9-0339, E9-0340, E9-0342, E9-0343, E9-0344, E9-0345, E9-0346, E9-0347, E9-0348,
E9-0349, E9-0350, E9-0351, E9-0352, E9-0355, E9-0356, E9-0358, E9-0359, E9-0360,
E9-0361, E9-0362, E9-0364, E9-0365, E9-0366, E9-0367, E9-0368, E9-0369, E9-0370,
E9-0371, E9-0374, E9-0376, E9-0377, E9-0378, E9-0379, E9-0380, E9-0381, E9-0382,
E9-0383, E9-0385, E9-0386, E9-0387, E9-0389, E9-0392, E9-0397, E9-0399, E9-0401,
E9-0402, E9-0408, E9-0409, E9-0411, E9-0412, E9-0413, E9-0414, E9-0415, E9-0418,
E9-0422, E9-0423, E9-0427, E9-0428, E9-0430, E9-0431, E9-0432, E9-0433, E9-0434,
E9-0435, E9-0437, E9-0438, E9-0439, E9-0440, E9-0442, E9-0451, E9-0454, E9-0455,
E9-0460, E9-0467, E9-0468, E9-0469, E9-0470, E9-0473, E9-0476, E9-0478, E9-0480,
E9-0484, E9-0485, E9-0487, E9-0489, E9-0490, E9-0491, E9-0496, E9-0500, E9-0503,
E9-0508, E9-0510, E9-0512, E9-0517, E9-0518, E9-0520, E9-0521, E9-0526, E9-0528,
E9-0537, E9-0538, E9-0544, E9-0549, and E9-0009, ES-0029-CH ES-0030, ES-0037,
ES-0039, ES-0048, ES-0051, ES-0057, ES-0060-H, ES-0064, ES-0065, ES-0066-CH
ES-0073, ES-0076, ES-0089, ES-0090, ES-0096, ES-0106, ES-0108, ES-0120, ES-0121,
ES-0123, ES-0124, ES-0125, ES-0126, ES-0128, ES-0135, ES-0139, ES-0147, ES-0170,
ES-0172, ES-0181, ES-0183, ES-0187, ES-0197, ES-0208, ES-0213, ES-0214, ES-0215,
ES-0221, ES-0222, ES-0223, ES-0229, ES-0230, ES-0231, ES-0232, ES-0233, ES-0235,
ES-0237, ES-0240, ES-0241, ES-0243, ES-0244, ES-0247, ES-0248, ES-0249, ES-0250,
ES-0251, ES-0252, ES-0256, ES-0257, ES-0258, ES-0259, ES-0260, ES-0261, ES-0263,
ES-0264, ES-0265, ES-0267, ES-0268, ES-0269, ES-0270, ES-0271, ES-0276, ES-0277,
ES-0278, ES-0282, ES-0283, ES-0284, ES-0285, ES-0286, ES-0287, ES-0288, ES-0289,
ES-0290, ES-0291, ES-0293, ES-0294, ES-0295, ES-0296, ES-0297, ES-0298, ES-0301,
ES-0302, ES-0303, ES-0304, ES-0305, ES-0306, ES-0307, ES-0308, ES-0309, ES-0310,
ES-0311, ES-0313, ES-0314, ES-0315, ES-0317, ES-0318, ES-0319, ES-0320, ES-0323,
ES-0324, ES-0325, ES-0327, ES-0328, ES-0329, ES-0330, ES-0331, ES-0333, ES-0334,
ES-0338, ES-0339, ES-0340, ES-0341, ES-0344, ES-0345, ES-0346, ES-0347, ES-0348,
ES-0350, ES-0353, ES-0356, ES-0357, ES-0361, ES-0362, ES-0368, ES-0369, ES-0370,
ES-0371, ES-0372, ES-0373, ES-0386, ES-0388, ES-0389, ES-0392, ES-0393, ES-0395,
ES-0396 ES-0397, ES-0398, ES-0406, ES-0407, ES-0408, ES-0409, ES-0410, ES-0411,
ES-0414, ES-0416, ES-0420, ES-0424, ES-0426, ES-0432, ES-0440, ES-0447, ES-0448,
ES-0449, ES-0453, ES-0457, ES-0466, ES-0470, ES-0471, ES-0473, ES-0474, ES-0475,
ES-0477, ES-0481, ES-0489, ES-0491, ES-0492, ES-0503, ES-0504, ES-0505, ES-0507,
ES-0508, ES-0516, ES-0517, ES-0519, ES-0520, ES-0530, ES-0531, ES-0537, ES-0540,
ES-0542, ES-0543, ES-0546, ES-0548, ES-7002-MH, and
ES-7029-MH
RECALLING FIRM/MANUFACTURER OEC Medical
Systems, Inc., Salt Lake City, UT, .
REASON Under certain conditions, x-ray
system may experience operational impairment.
VOLUME OF PRODUCT IN
COMMERCE
1,017
units
DISTRIBUTION Nationwide
PRODUCT
a) SteriLyte® Liquid Bicarbinate, Formula CL-02; 1 gallon (3.78 L).
This product is used in conjunction with C-Series RenalPure® Liquid Acid
Concentrate or DC-Series Dri-Sate® Dry Acid Concentrate in artificial kidney (hemodialysis) machines,
b) SteriLyte® Liquid Bicarbinate, Formula RL-01; 1 gallon (3.78 L). This
product is used in conjunction with C-Series RenalPure® Liquid Acid Concentrate
or DC-Series Dri-Sate® Dry Acid Concentrate in artificial kidney (hemodialysis)
machines,
CODE
a) Lots: 10442, 10461
and 10462;
b) Lot: 10445
RECALLING
FIRM/MANUFACTURER Rockwell Medical Technologies, Inc., Grapevine,
TX,
REASON Microbial
growth was observed in the retain samples of 4 lots of Liquid Bicarbonate after
products had been distributed.
VOLUME OF PRODUCT IN
COMMERCE
12,452/1 gallon
containers
DISTRIBUTION Nationwide
PRODUCT Homocysteine Reagent Test Kit. The Homocysteine test kits were
manufactured under 2 brand names. The first brand name a) Catch, the label reads
"CATCH Catch Inc., HOMOCYSTEINE REAGENT KIT, Catalog Number A11167, 100 Test
Kit, The kit is made up of 5 individual portions. These include: Homocysteine
Reagent R1 HCY A (28mL), Homocysteine Reagent R2 HCY R2 (13.5 mL), Homocysteine
HCY C (2.8 mL), Homocysteine 0.0 umol/L (2mL) and Homocysteine 27.0 umol/L
(2mL).
b) The second brand name Equal the label reads "EQual DIAGNOSTICS FOR
IN VITRO DIAGNOSTIC USE ONLY HOMOCYSTEINE 3-Part Kit w/calibrators, Catalog
Number E02-058-03, The kit is made up of 5 individual portions. These include:
Homocysteine Reagent R1, Homocysteine Reagent R2, Homocysteine Reagent R3,
Homocysteine Calibrator 0.0 umol/L and Homocysteine Calibrator 27.0 umol/L. All
individual kits are packaged into individual boxes and then packaged into 1 box.
Homocysteine Reagent is intended for in vitro quantitative determination of
total homocysteine in serum and plasma,
CODE
a) Lot Numbers and expiration dates include L05037
2007-05, B06003 2007-08, F06011 2007-12 and H06021 200802;
b) Lot Number and
expiration date include F06011 2007-12. First digit is the month of manufacture,
A = Jan, B = Feb, but I is not used. Second and third digits are the year of
manufacture, 05 = 2005. The remaining digits are sequential numbers for the next
lot
RECALLING FIRM/MANUFACTURER
Recalling Firm: Catch,
Inc., Bothell, WA,
Manufacturer: Intersect
Systems, Inc., Longview, WA.
REASON A high homocysteine level can be reported
as falsely low.
VOLUME OF PRODUCT IN COMMERCE
2,699
kits
DISTRIBUTION CA,
PA
PRODUCT
a) Angiotech, Bone Marrow Aspiration Needle. The device is
intended for use during Bone Marrow Biopsy,
b) Angiotech, Bone Marrow Biopsy Needle. The device is intended for use during Bone Marrow Biopsy,
c) Angiotech, T-Lok Bone Marrow Biopsy Needle. The device is intended for use during Bone Marrow Biopsy,
d) Angiotech, Bone Marrow Harvest Needle. The device is intended for use Bone
Marrow Biopsy,
CODE
a) Lot Number:
81351NDR;
b) Lot Number: 81371NGF and 81081MRM;
c) Lot Number: 81291N9Y;
d) Lot Number: 81431NHL
RECALLING
FIRM/MANUFACTURER Medical Device Technologies, Inc., Gainesville,
FL,
REASON Product packaging for Bone Biopsy
trays/blisters may have a hole in the formed tray.
VOLUME OF PRODUCT
IN COMMERCE
430
units
DISTRIBUTION Nationwide
PRODUCT Cytomics FC 500 Flow Cytometry System with CXP Software, Part
Numbers: 626553, Version 2.2,
CODE Version 2.2
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc.,
Brea, CA,
Manufacturer: Applied Cytometry,
Sheffield, UK. REASON Software error: The CXP User
documentation does not adequately characterize the use of the Live Gate
feature.
VOLUME OF PRODUCT IN COMMERCE
565 units
DISTRIBUTION Nationwide and
Canada
PRODUCT Sinu-Lift(TM) System,
LLC., Model SLS-1, Sterile, Innovative
Implant Technology, The Sinu-Lift(TM) System is intended to: - Facilitate access
to the maxillary sinus, - Lift the sinus membrane from the alveolar ridge of the
maxilla with a minimum height of 5mm, and - Augment the space created by lifting
the maxillary sinus membrane with bone graft to supplement the maxillary
alveolar crest with additional height needed for anchoring an implant,
CODE
Lot number: 162-08
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Innovative Implant
Technology, Weston, FL,
Manufacturer: Sequel Special Products,
LLC,
Waterbury, CT.
REASON Possible device failure: The cutter's
shaft of the Sinu-Drill of the Sinu-Lift System could potentially get stuck
inside the tap, thereby not allowing the cutter to spring out of the tap upon
encountering the sinus membrane, increasing the possibility of perforating the
sinus membrane.
VOLUME OF PRODUCT IN COMMERCE
299
units
DISTRIBUTION Nationwide, Canada, Mexico, Japan,
Australia, Egypt, and
Turkey
PRODUCT
a) Compress Instrument Anchor Plug Holder, stainless steel, REF
32-481006. Non-powered, hand-held device intended for medical purposes for use
with other devices in orthopedic surgery,
b) Compress Instrument 13mm Anchor Plug Holder, stainless steel/TiAIN; REF 32-481091. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery,
c) Compress/Finn Instrument Set Compress Anchor Plug Assembly, stainless steel; REF RD425032. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery,
d) Compress Short Instruments Anchor Plug Holder, 12mm, stainless steel, non-sterile; REF CP460193. Non-powered, hand-held device intended for medical purposes for use with other devices in orthopedic surgery,
e) Compress Short Anchor Plug Holder, 13mm; REF CP461038. Non-powered,
hand-held device intended for medical purposes for use with other devices in
orthopedic surgery,
CODE
a) Lots
913020 and 306010;
b) Lots: 054890, 638720, 622160, 836690, and 599490;
c)
Lots: 281790, 396850, 413850, 881330, and 954810;
d) Lot: 991670;
e) Lot:
991680
RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw,
IN,
REASON The set screw may not fully seat, which
will prevent the handle from mating to the instrument during
use.
VOLUME OF PRODUCT IN COMMERCE
41
units
DISTRIBUTION Nationwide, Australia, Belgium and
Finland
PRODUCT Roche ISE Internal Standard Gen.2 for use on Roche cobas c systems;
Catalog no. 04522320190. Product is an in vitro diagnostic,
CODE
Lot numbers: 60258801, 60258601, 60145701,
60145601, 69921901, 69921801, 69786201, 69922001, 69786101, 69676101, 69509701,
69431901, 69357601, 69342001, 69246501, 68966601 and
68871601
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Roche Diagnostics, Corp., Indianapolis, IN,
Manufacturer: Roche Diagnostics
Gmbh, Mannheim, Germany.
REASON Test results, low: Sodium,
potassium and chloride results on the cobas 6000 ISE unit may exhibit a downward
drift in controls and patient samples within the recommended calibration
interval of 24 hours.
VOLUME OF PRODUCT IN
COMMERCE
7,909
units
DISTRIBUTION Nationwide
PRODUCT Triathlon Total Knee system Primary Tibial Baseplate #5 Beaded
wPA;
Catalog Number 5526-B-500, Cementless use only. Sterile. Made in Ireland. The
Triathlon Total Knee System is intended for use in primary and revision total
knee arthroplasty to alleviate pain and restore function,
CODE
Lot Code: SANMH
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp.,
Mahwah, NJ,
Manufacturer: Howmedica
International S de RL, Limerick, Ireland.
REASON One lot of the Triathlon Primary Beaded
PA Baseplate Size 5 may not have the Peri-Apatite coating.
VOLUME OF
PRODUCT IN COMMERCE
10 units
DISTRIBUTION PA,
GA, AL, WI, UT, and
OR
PRODUCT
a) Synergy Pulse, Powered Flotation Therapy bed, Model number 5609.
Designed to provide enhanced static and pulsation pressure relieving therapies.
Provides sixteen pressure zones for customizing the support surface to each
patient, and is capable of providing pulsation therapy,
b) Synergy Dynamic, Powered Patient Rotation Bed, Model number 5607. Designed to provide enhanced static, pulsation and rotational pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing alternating pressure therapy and lateral rotation up to 45 degrees side to side,
c) Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361. Designed to prevent and treat decubitus ulcers. This is accomplished by achieving interface pressures well below capillary closure during the alternation cycle,
d) Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613
Designed to provide enhanced static and pulsation pressure relieving therapies,
CODE
All serial
numbers
RECALLING FIRM/MANUFACTURER Hill-Rom
Manufacturing, Inc., Charleston, SC,
REASON The devices have
the potential to overheat.
VOLUME OF PRODUCT IN
COMMERCE
2,083
units
DISTRIBUTION Nationwide
PRODUCT Hitachi CXR4 Computed Tomography Scanner. This product is an x-ray
imaging device that produces cross-sectional images of he body at different
angles. The system reconstructs, processes, displays, and stores the collected
images. The device output can provide an aid to diagnosis when used by a
qualified physician and is intended for general purpose CT applications,
CODE
Serial #: CXR46202- CXR46248 (not
inclusive)
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Hitachi Medical Systems America Inc., Twinsburg, OH,
Manufacturer: Hitachi Medical Corp., Tokyo, Japan.
REASON Software error: The device has
a software error that can result in a condition where the displayed image
orientation does not match the display orientation markers (right-left
reversal).
VOLUME OF PRODUCT IN COMMERCE
42
units
DISTRIBUTION Nationwide
PRODUCT ACIST CVi Angiographic Injection System with Interface Cable for
Toshiba Infinix-i cardiovascular X-ray system, Model: CVi Toshiba interface
Cable, Part Number 700318-002. The ACIST injection system is an angiographic
injection system used in interventional cardiology, radiology, and vascular
surgical procedures. The ACIST injection system supplies radiopaque contrast
media to a catheter at a user-determined variable flow rate and volume which can
be instantaneously and continuously varied. The ACIST CVi injection system is
able to synchronize with certain X-ray imaging systems from Siemens, Toshiba, GE
and Philips. Intended to be used for the controlled infusion of radiopaque
contrast media for angiographic procedures,
CODE Not associated with specific serial or lot
numbers.
RECALLING FIRM/MANUFACTURER Acist Medical
Systems, Eden Prairie, MN,
REASON Multiple Injections
may result. It has been determined that when using the ACIST CVi Angiographic
Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray
system there is an injection scenario that may result in multiple injections of
contract media when one injection was intended.
VOLUME OF PRODUCT IN
COMMERCE
18 units
DISTRIBUTION Nationwide,
France, Germany, Italy, Japan, and
Spain
PRODUCT CT syngo Dual Energy Viewer on the syngo Multimodality Work Place
(MMWP) and on the CT workplace, Model number 10094833. Picture Archiving and
Communications System,
CODE
Software versions: syngo MMW 2007C, syngo MMWP
2008A, syngo MMWP 2008B, syngo MMWP 2008C, syngo CT 2007A, and syngo CT
2008G
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens
Medical Solutions USA, Inc., Malvern, PA,
Manufacturer: Siemens AG, Medical Solution, Forchheim, Germany.
REASON
Indicated orientation
does not match actual orientation of the patient.
VOLUME OF PRODUCT
IN COMMERCE
374
units
DISTRIBUTION Nationwide
PRODUCT High-low:x frame for the x:panda mechanical chair,
CODE
Article numbers 8911605-02, 8911605-02E,
8911606-02, 8911615-02, 8911615-02E and 8911616-02. Manufactured between
8/24/2007 and 10/3/2008
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Snug Seat, Inc., Stallings,
NC
Manufacturer: R82 A/S, Gedved, Denmark.
REASON
Breakage in the welds was discovered in a
section of the chair frame.
VOLUME OF PRODUCT IN
COMMERCE
67
units
DISTRIBUTION Nationwide
PRODUCT Measles IgG Enzyme Immunoassay Test Kit,
DIAMEDIX. The assay is
intended for the semi-quantitation of human IgG antibodies to measles virus in
human serum by indirect immunoassay to aid in the assessment of the patient's
immunological response to measles virus, to determine the immune status of
individuals and, when evaluating paired sera, as an aid in the diagnosis of
measles infection,
CODE Lot numbers:
41108 and 41108B
RECALLING FIRM/MANUFACTURER Diamedix
Corp., Miami, FL,
REASON Possible false-negative test
results
VOLUME OF PRODUCT IN COMMERCE
974 Test
Kits
DISTRIBUTION Nationwide and
England
PRODUCT Zimmer Natural-Knee II System Modular Cemented Tibial
Baseplate,
Right, Size 3, For cemented use only, sterile; REF 6420-01-230. The modular
cemented tibial baseplate is indicated for cemented use only in skeletally
mature individuals with conditions of Noninflammatory Degenerative Joint Disease
(NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity
and moderate flexion contracture, or failed previous surgery where pain,
deformity or dysfunction persists. When the primary or N-K II Constrained Knee
System components are used, the medial and collateral ligaments must be intact.
These are single use implantable devices sold sterile, CODE Lot number: 60830979
RECALLING
FIRM/MANUFACTURER Zimmer, Inc., Warsaw, IN,
REASON
Sterility compromised: Lack of assurance
of sterility, as a corner flap of the sterile barrier packaging on the inner
cavity may be trapped in the seal of the barrier packaging for the outer cavity
and the seal integrity of the outer sterile barrier cannot be assured.
VOLUME OF PRODUCT IN COMMERCE
10
units
DISTRIBUTION Nationwide
WEEK ENDING JANUARY 24
PRODUCT Cytomics FC 500 Flow Cytometry System with CXP Software Version
2.2, Part Number: 626553. This product is used for the qualitative and
quantitative measurement of biological and physical properties of cells and
other particles. These properties are measured when the cells pass through one
or two laser beams in single-file,
CODE Software version 2.2
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA,
Manufacturer:
Beckman Coulter, Inc.,
Fullerton, CA. REASON Software error: The CXP software does
not refresh the dataset automatically under certain circumstances. The User
documentation does not clearly state that the user should refresh the dataset
after changes is made.
VOLUME OF PRODUCT IN COMMERCE
594
units
DISTRIBUTION Nationwide and
Canada
PRODUCT
a) Mainline Confirms Strep A, 1) Catalog # 3030-20 and 2) Catalog #
3030-40,
b) Mainline Confirms Strep A DOTS, Catalog # 4040,
c) Mainline Confirms III Serum/Urine control set, Catalog # 3029-CTR,
d) Mainline hCG Accuracy Check, Catalog # 3c1001,
e) Mainline Confirms hCG Serum/Urine III, Catalog # 3029-25,
f) f.y.i. hCG Urine one-step pregnancy test, Catalog # 43065,
g) Mainline Confirms hCG urine pregnancy test, Catalog # 6008C,
CODE
a) 1) Lots: 94355, 94385, 94395, 94415,
94445, 94455, 94485, 94505, 94545, 94585, and 94595; 2) Lots 94350, 94370,
94380, 94410, 94420, 94440, 94450, 94480, 94500, 94510, 94540, 94580, 94590,
94610, 94620, 94630, and 94880;
b) Lots: 92465, 92480, 92525, 92540, 92580, 92600, 92640, 92650, 92680, 92700, 92705, 92720, and 92721;
c) Lot: 06054;
d) Lots: 50074 and 50075;
e) Lots: 96101- 96206, 96218, 96235, 96260, 96295, 96300, 96320, 96360, 96380, and 96381;
f) Lot: 20087;
g) Lots: 19540, 19590, 19914, 20110, 20343, 20537, 20717, 20906, 21060,
21089, 21495, 21733, 21762, 22407, 22408, 22926, 23217, 23525, 23694, 23703,
23994, 24483, and 25080
RECALLING
FIRM/MANUFACTURER
Mainline Technology, Inc., Ann Arbor, MI,
REASON
Lack of assurance of safety and efficacy:
Unapproved for marketing in the U.S., non-compliance with cGMP regulations and
no stability data to support labeled expiration dates.
VOLUME OF
PRODUCT IN COMMERCE
45,330
kits
DISTRIBUTION Nationwide, Belgium and
Switzerland
PRODUCT
a) Depuy DELTA Xtend, Standard humeral PE Cup Dia 38/+3 STD,
sterile, Depuy France; REF 130738203. The device is used as a shoulder implant.
b) Depuy DELTA Xtend, Standard Humerus PE Cup, Dia 38/+6 STD, sterile, Depuy France; REF 130738206. The device is used as a shoulder implant,
c) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+9 STD, sterile, Depuy France; REF 130738209. The device is used as a shoulder implant,
d) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 38/+6R RET, sterile, Depuy France; REF 130738106. The device is used as a shoulder implant,
e) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+3 STD, sterile, Depuy France; REF 130742203. The device is used as a shoulder implant,
f) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+6 STD, sterile, Depuy France; REF 130742206. The device is used as a shoulder implant,
g) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42/+9 STD, sterile, Depuy France; REF 130742209. The device is used as a shoulder implant,
h) Depuy DELTA Xtend, Standard Humeral PE Cup, Dia 42+6R RET, sterile, Depuy
France; REF 130742106. The device is used as a shoulder implant, CODE
All lots
RECALLING
FIRM/MANUFACTURER
Depuy Orthopaedics, Inc., Warsaw, IN,
REASON
Compressed air may become trapped
between the cup and the stem, preventing the tapered walls from engaging and
causing the cup to feel unstable.
VOLUME OF PRODUCT IN
COMMERCE
1,521
devices
DISTRIBUTION Nationwide
PRODUCT
1) Balloon Inflation Device Model #'s: MED15-105 MED15-106 and
SCI04527-01. The reprocessed Balloon inflation device is intended for use with
balloon dilatation catheters to create and monitor pressure in the balloon and
to deflate the balloon.
2) Bed Check Model #'s: BED65815-021 BED65815-025 BED65815-025IT BED65815-030 BED65815-031 BED73000 BED73010 BED74000 BED74010 NURBPP-30A NURBPP-30WC POS8283 RFT1000-1210 RFT1000-1250 RFT1000-1810 and RFT1000-1820. A bed-patient monitor is a battery-powered device placed under a mattress and used to indicate by an alarm or other signal when a patient attempts to leave the bed.
3) Drill Bits Model #'s: DEP14043 MIC8053-019 RIC21-0438 RIC21-0439 RIC21-0441 RIC21-0442 RIC71173504 RIC71173505 RIC71631117 SMI21-0445 STR5800-4-125 STR60-13570 SYN03.010.060 SYN03.010.061 SYN03.010.101 SYN310.19 SYN310.24 SYN310.25 SYN310.288 SYN310.31 SYN310.35 SYN310.431 SYN310.44 SYN310.63 SYN310.65 SYN310.66 SYN310.67 SYN315.28 SYN315.40 SYN315.92 SYN317.861 SYN317.871 SYN356.982 SYN357.407 ZIM00-2318-020-00 and ZIM5056-146. An 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. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.
4) Biopsy Forceps, Hot Model #'s: BAL60110 BAR000852 BAR000854 and MIC1550. Laparoscopic electric instruments are designed for use in minimally invasive procedures and open surgical procedures to facilitate coagulation, transection, resection, mobilization, and dissection of tissue.
5) Burrs Model #'s: ANSL-3SB ANSL-5D ANSQD11-4OVDC HAL5056-118 HAL5056-166 HAL5091-106 HAL5091-112 HAL5091-122 HAL5091-125 HAL5091-136 HAL5091-144 HAL5091-164 HAL5092-120 HAL5092-168 HAL5092-170 KOM04-D0139 LIN5091-101 LIN5091-102 LIN5091-142 LIN5092-132 LIN5092-160 MED874-447 MICZB-228 MICZB-232 MID14CY50 MID14MH30D MIDG6-450 MIDG8-130 MIDMC254 STR1607-2-35 STR1608-6-137 STR1608-6-141 STR1608-6-149 STR277-10-62 STR5120-10-40 STR5120-10-50 STR5120-71-48 STR5300-10-511 STR5300-10-513 STR5300-10-903 STR5300-20-513 STR5300-30-903 XOM31-55641 ZIM5056-116 ZIM5056-117 ZIM5056-118 ZIM5056-125 ZIM5056-140 ZIM5056-150 ZIM5056-159 ZIM5056-161 ZIM5056-162 ZIM5056-164 and ZIM5056-167. Surgical instruments motors 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.
6) Cardiac Imaging Catheter Model #'s: ACU08267996 and ACU55790. Intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. R
7) Colorado Electrodes Model #'s: COLN104A COLN112A and STRN103A. Intended for precision cutting or dissecting and cauterizing soft tissue.
8) Compression Sleeves Model #'s: HUNDVT10-1 and KEN5329. The SterilMed Intermittent Compression Sleeve, 400 series used in conjunction with the Talley DVT-275 pump is indicated for any person that is at risk for deep vein thrombosis or could otherwise benefit from enhanced blood flow and circulation and/or a reduction in post operative pain and swelling.
9) EP Cables Model #'s: BAR560004P BIOC10MR10MSTKS BIOC5-MH/NAVMH-S CORC6-MR10/EPTR-S DAI401972 DAI401976 DAI401977 DAI401981 DAI401983 EPT5454S EPT613 and EPT651. An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.
10) EP Catheter Model #'s: BIOD6-DR-005-RT BIOD6-DR-010-RT DAI401381 DAI401449 DAI401904 DAI401915 and EPT7003D. Intended for temporary use during electrophysiology studies for intracardiac sensing, recording, and stimulation.
11) External Fixation Device Model #'s: ORT99-36501 SYN390.005 SYN390.008 SYN394.84 SYN394.85 and SYN394.86. Intended for use in the construction of an external fixation frame for treatment of a various fracture types that require external fixation.
12) Femoral Compression Device Model #'s: RAD11163 Intended for use in the compression of the femoral artery or vein after cauterization.
13) Guidewires - Endoscopic (Jag Wires) Model #'s: MIC5658 and MIC630-100. Intended to be used for selective cannulization of the billary ducts, including but not limited to, the common bile, cystic, right and left hepatic ducts during endoscopic billary procedures for catheter introduction and exchanges.
14) Harmonic Scalpel Model #'s: ETHACE14S ETHACE23P ETHACE36P ETHCS14C ETHFCS9 ETHHDH05 ETHLCS-C5 and ETHLCSC5HA. Intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired.
15) Lap Instruments/Graspers/Forceps - HOT Model #'s: AUT173016 AUT174301 AUT176643 ETH5DCD ETH5DCS ETHEBF01 ETHPOUCH GYR3000PK GYR3005PK GYR3640 and GYR920005PK. Laparoscopic electric instruments are designed for use in minimally invasive procedures and/or open surgical procedures to facilitate coagulation, transaction, resection, mobilization and dissection of tissue.
16) Lap Instruments/Graspers/Forceps - COLD Model #'s: AUT173030 AUT174233 AUT174317 AUT176613 AUT176647 AUTECATCH10G and ETH5DSG. A manual surgical instrument for general use is a non-powered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures.
17) Laser Probe Model #': SYN55.26.25. Reprocessed laser probes are part of a laser delivery system and are used in ophthalmic procedures where laser energy is the mode of treatment.
18) Masks - Laryngeal Model #'s: AMB321-300-000 AMB321-400-000 AMB321-500-000 LMA12015 LMA12020 LMA12030 LMA12040 LMA12050 LMA12120 LMA12125 LMA12130 LMA12140 and LMA21140. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.
19) Multi-Clip Applier Model #'s: APPCA080 AUT134031 AUT134046 AUT134051 AUT134053 AUT176625 AUT176657 AUTPTACK30 ETHEL5ML ETHER320 ETHMCL20 ETHMCM20 ETHMCM30 ETHMCS20 ETHMSM20 and WEC543965. A manual surgical instrument for general use is a non-powered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures.
20) Phaco Tips Model #'s: ALC30RTS ALC8065740806 ALC8065740809 ALC8065740837 ALC8065740839 ALC8065750852 ALC8065790020 ALC8065790022 and ALLOPOR3020L. Intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.
21) Rasps Model #'s: KOMKM5100-37-113 KOMKM-82 STR1675-115 STR5100-37-113 and STR5100-37-115. A manual surgical instrument for general use is a non-powered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures.
22) Retractors Model #'s: ADE3204 BOS820-175 LON3304 and LON3334-4G. A manual surgical instrument for general use is a non-powered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures.
23) RF Arthroscopy Probe Model #'s: ARTA1325-01 ARTA1335-01 ARTA1345-01 ARTA1730-01 ARTA2630-01 ARTA3625-01 ARTA4330-01 ARTAS1335-01 ARTAS4630-01 ARTASC1335-01 ARTASC2530-01 ARTASC4250-01 ARTASC4830-01 ARTASC5000-01 ARTASC5500-01 ARTEIC4845-01 MIT225203 MIT225301 MIT225302 MIT225305 MIT225350 MIT225360 SMI7209681 SMI7209682 SMI7209683 and STR278-510-500. These devices are designed for general surgical use, including orthopedic and arthroscopic applications or resection, ablation, excision of soft tissue, hemostatis of blood vessels, and coagulation of soft tissue.
24) Saw Blade Model #'s: BIO506112 BIO506113 DEP2555-91-000 DEP5627-11-500 HAL5023-118 HAL5059-32 HAL5071-133 HAL5071-145 HAL5071-163 HAL5071-181 HAL5071-572 HOWHB-NST-6828-7-791 HOWHB-NST-6828-7-792 KOMK-2000-65 KOMKM-004 KOMKM-005 KOMKM-101 KOMKM-101C KOMKM-102 KOMKM-234 KOMKM-275R KOMKM-3101 KOMKM-3107 KOMKM3-225 KOMKM-325R KOMKM-619 KOMKM-660 KOMKM-693 LIN5023-170 MICSO-601 MICSO-610 MICSP-414A MICZO-062 MICZO-7052 MMM5756 STR2108-100 STR2108-102 STR2108-105 STR2108-107-4 STR2108-109 STR2108-110 STR2108-113 STR2108-115 STR2108-118 STR2108-120 STR2108-125 STR2108-140 STR2108-140-6 STR2108-148 STR2108-150 STR2108-150S2 STR2108-151 STR2108-152 STR2108-152-6 STR2108-158 STR2108-160 STR2108-161-2 STR2108-183 STR2108-185 STR2108-189 STR2108-192 STR2108-218 STR2108-302 STR2108-309 STR2108-351 STR2108-356 STR2296-3-103 STR2296-3-105 STR2296-3-111 STR2296-3-115 STR2296-3-125 STR2296-3-212 STR2296-3-225 STR2296-33-105 STR2296-33-111 STR2296-33-125 STR2296-3-412 STR2296-3-414 STR2296-3-511 STR277-88-100 STR277-88-125 STR277-96-250 STR277-96-275 STR277-96-277 STR277-96-325 STR277-96-326 STR298-97-100 STR4111-107-090 STR4125-089-075 STR4125-097-090 STR5100-137-233 STR5301-30-172 STR5301-40-33 STR6113-127-90 STR6125-89-75 SYN11-2217 SYN11-3500 SYN11-3534 TER98-0702-1234-9 ZIM5979-95-35 and ZIM5979-95-41 Surgical instruments motors and accessories are AC-powered, battery-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.
25) Scissor Tips Model #'s: AESPO888 AESPO889 ENCES0102 MIC3112 MIC3122 MIC3142 MIC3152 SNO89-5100 and SNO89-5300. Intended to be used with a reusable hand piece and are designed to use in minimally invasive and open surgical procedures to facilitate coagulation, preparation, mobilization, and cutting tissue.
26) Stone Retrieval Basket Model #': BOS390-10. Used to entrap and remove renal stones and calculi via a rig id or flexible endoscope during transurethral or fluoroscopic percutaneous urologic procedures. R
27) Tourniquet Cuffs Model #'s: INSDT-7024-02 INSDT-7218-01 SMI553322 SMI7010-7002 SMI7010-7006 SMI7010-7007 SMI7010-7008 SMI7010-7010 SMI7010-7011 SMI7010-7012 SMI7010-7015 STR5921-018-136 STR5921-018-235 STR5921-024-135 STR5921-024-136 STR5921-024-146 STR5921-024-235 STR5921-030-135 STR5921-030-235 STR5921-034-135 STR5921-034-136 STR5921-034-235 STR5921-044-135 STR5921-044-136 STR5921-044-235 STR5921-212-135 ZIM60-7070-02 ZIM60-7070-03 ZIM60-7070-04 ZIM60-7070-05 ZIM60-7070-06 ZIM60-7070-07 ZIM60-7070-101 ZIM60-7070-102 ZIM60-7070-103 ZIM60-7070-104 ZIM60-7070-105 ZIM60-7070-106 ZIM60-7070-107 ZIM60-7075-006 ZIM60-7075-03 ZIM60-7075-04 ZIM60-7075-05 ZIM60-7075-06 ZIM60-7075-07 ZIM60-7075-101 ZIM60-7075-102 ZIM60-7075-103 ZIM60-7075-104 ZIM60-7075-106 ZIM60-7075-107 ZIM60-7080-102 and ZIM60-7080-103. A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff,
28) TURP Electrodes Model #'s: CIRMLE-24-012 CIRMLE-24-015 OLYA22205C STO27050F STO27050G and STO27050NK. Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation and/or resection for soft tissue in the prostate and bladder as well as when ablation and coagulation are required in gynecological and urological surgical procedures.
29) Open & Unused Items - This refers to a sterilization service provided by SterilMed, Inc. (devices were not reprocessed) for Class 1 and Class 2 devices that were opened, most likely in O. R. suites, in which for whatever reason the physician elected to select a different type of device, different size of device, or maybe elected to not use the device at all in a procedure. This is not a process regulated by FDA, but is included in the recall process as product would still be considered misbranded and or represent a potential risk to patients. Model #'s: ABB6543-01 ABB6544-01 ACM23116 ACR800-499 ACU014719 ALL2N2704X ALLASC1201 ALLF-5501 ALLSU130-404E ARTAR-6530 ARTAR-6540 ARTAR-6560 ARTAR-6562 ARTAR-6564 ARTAR-6570 AUT054887 AUT059035 AUT059037 AUT174001 AUT8886803712 AUTGIA6025S BAL60417 BAR0043620 BAR0070740 BAR0601110 BAR072231 BARBRD100R BAX2C4005 BER610 BIO418200 BIO631031 BOUTC001NSKA CARASU1510 COD26-1221 CON130309 CON130321 CON134006 CON1412 CON29410 CON29415H CON29496 CON60-6085-100 CON8535 CON9413 CON9448 COO081012 COO081014 COOCTI-512N COOTD-1 COOZSI1151 DAV0035280 DAV0043650 DEN50-7000 DEN50-7500 DER28-0211 DLP10012 EDWDSAFE61 EDWFEMII016A ETH10BB ETH2189 ETH2211 ETH5BB ETH6TB45 ETHBTD05 ETHPMW35 ETHPRW35 ETHPXW35 ETHUV120 FUT4549 GUIOM-9000S GUIXP-4000 GYR240060 GYR240072 GYR70138000 GYR7013-8100 GYR70140257 JOH2214 KEN31140240 KEN31140562 KEN8884720221 KEN8888505172 KIM111 KIM228 kim279 KIM311 KIM330 KIM345 KIM70321 KIM79043 KIM79870 KIM79878 KIM888 KIM89601 KIM95111 KIM95521 KIR10-4000 KIR10-4001 KIR14-3000 KRO6003 LIN9718 LINESA-5333 LINESA-5339 MECEPT03 MED05897/JP2311 MED10001S/JP10001 MED11348/DYNJP2500 MED14184/JP2414 MED14184A/JP2414A MED21394P/JP2302P MED2457S/JP8303 MED2505/JP2510 MED3110A/JP3003A MED3110S/JP3003 MED3130S/JP3008 MED3140S/JP3005 MED3820A/JP3102A MED3820S/JP3102 MED4202S/JP4003 MED6052-53 MED8610S/JP8005 MED91263 MED96570-021 MEDDYNJ01201H MEDDYNJ05933 MEDDYNJO5933 MEDDYNJP8201 MEDSPT-2314/JP2314HD MEG0012 MEG0020 MEG0035H MEG0039H MIC390-310 MIC6131 MIC6237 MIC670-308 MIC710-111 MIC81010 MPS5001689 OLS20-1410KI ORSORS-300 Q2M20-1370 RMITF-3646-0 SMI4116 SMI4615 SMI4616 SMI71111579 SMI7204727 SMI72200195 SPIXDWIK28 STR1608-2-59 STR1608-2-63 STR206-16 STR206-546 STR250-070-530 STR250-070-540 STR275-802-000 STR306-553 STR350-202-000 STR3910-075-500 STR3910-075-501 STR3910-075-650 STR3910-075-651 STR3910-075-800 STR400-800 STR501-140-50 STR5120-103-15 STR606-563 STR620-030-301 STR620-030-407 STR620-30-301 SYN55.36E SYNSDLB TELDP-40K TELMDP-40K TER5842 TERL7328 TEX311033-000 USE00712031 VALE1450-6 VALE1510 VALE2350H VALE2450H VALE2505-10FR VALE2515H VALE2516H WAL909009 WEC528235 WEL24-6001 XOM1014242 XOM10-46001 XOM1850200 XOM31-55631 XOM31-55632 XOM31-55636 XOM31-55637 XOM31-55638 and XOM8225825,
30) Biopsy Forceps, Cold Model #'s: BAR000386 BAR000388 MIC1012 MIC1331 MIC1333 MIC1337 MIC1536 MIC1589 MIC1597 MIC1598 and MIC1599. The Reprocessed Cold Biopsy Forceps are intended to be used during endoscopic procedures of the gastrointestinal tract to collect tissue samples for histologic examination.
31) Taps Model #'s: SYN311.15 SYN311.190 SYN311.39 and SYN311.32. An 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.
32) Reamers Model #'s: HAL5091-144 and ZIMS5979-95-41. An 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, devices individually packaged and sealed within a pouch.
CODE
n/a
RECALLING
FIRM/MANUFACTURER
Sterilmed, Inc., Osseo, MN,
REASON
The
possibility exists that some of the pouches were not properly sealed on one
end.
VOLUME OF PRODUCT IN COMMERCE
7,044
devices
DISTRIBUTION Nationwide and
Canada
PRODUCT ABBOTT Clinical Chemistry Bilirubin Calibrator, List Number
1E66-04. The device is intended for medical purposes for use in a test system to
establish points of reference that are used in the determination of values in
the measurement of substances in human specimens. The product is used to
calibrate assays used to determine bilirubin concentrations in neonate and adult
patient samples, CODE Lot Number:
61388M100, 57919M100, 54754M100, and 52632M100
RECALLING
FIRM/MANUFACTURER
Abbott Laboratories, Inc., South Pasadena, CA
REASON
The matrix of the secondary standard used
in the value assignment of the calibrator is sensitive to the Diazo method. The
matrix of this secondary standard caused a positive bias.
VOLUME OF
PRODUCT IN COMMERCE
7,101
units
DISTRIBUTION
Nationwide, Mexico, Columbia, Uruguay,
Puerto Rico, Canada, Hong Kong, New Zealand, Bahamas, Guatemala, Argentina,
Germany, Thailand, Trinidad/Tobago, Venezuela, Chile, Brazil, El Salvador,
Singapore, Australia, Curacao and Cayman
Island
PRODUCT Dimension EXL Clinical Chemistry System used with software versions
8.5.1 and 8.5.1SP3. The system is a discrete, random-access,
microprocessor-controlled, integrated instrument/chemistry system that measures
a variety of analytes, including enzyme activities, in body fluids for in vitro
diagnostic use.
CODE Software
versions 8.5.1 and 8.5.1SP3
RECALLING
FIRM/MANUFACTURER
Dade Behring, Inc., Newark, DE
REASON
Error messages, "Wash Aspirator Failure"
and "Wash station unable to recover" are not generated when one or both HM wash
probes are totally occluded.
VOLUME OF PRODUCT IN
COMMERCE
57
units
DISTRIBUTION Nationwide
PRODUCT Quantum Pulse machine. The device is used to create light wave
frequencies to effect cellular activity.
CODE All serial numbers
RECALLING
FIRM/MANUFACTURER VIBE Technologies, Greeley, CO,
REASON
Medical Device marketed without marketing
approval for claims that include strengthening, recharging and removing toxins
from cells.
VOLUME OF PRODUCT IN COMMERCE
58
devices
DISTRIBUTION Nationwide and
Internationally
PRODUCT Foot switch, Part Numbers: 1009.81, 1009.81A0, 1009.81A1,
1009.81A2, 1009.81A3, 1009.81B0, 1009.81B1, 1009.81B2, 1009.81C0, 1009.81C1,
1009.81D0, 1009.81D1, 1009.81D2, 1009.81D3, 1009.81D4, 1009.81E0, 1009.81E1,
1009.81E2, 1009.81E3, 1009.81F0, 1009.81F1, 1009.81F2, 1009.81F3, 1009.81G0,
1009.81G1 and 1009.81G2. The foot switches in the 1009.81 series are
accessory components which can be connected to certain MAQUET operating tables.
Several of the table top adjustment motions (depending on the table and foot
switch versions in use) can then be executed by the foot. The foot switch is
equipped with rocker switches. The switching elements are used to initiate the
table top functions.
CODE Product
manufactured between 8/2004 and 9/2008 may be affected.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Maquet, Inc., Bridgewater, NJ,
Manufacturer: Maquet
Aktiengesellschaft, Rastatt,
Germany.
REASON A
bearing point of the pedal of the foot switch may come loose. With continued use
of the foot switch, one or both springs beneath the pedal can fall out of their
mounting, and it is possible the pedal comes to rest on the switch causing an
unintended motion of the operating table during patient use.
VOLUME
OF PRODUCT IN COMMERCE
581
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation
Framework (DCF) 8.2.22, model number H48. Indicated for planning proton
treatment of neoplasms of the eye.
CODE
Serial numbers
H480016, H480051, H480052, H480053, H480054, H480055, H480107, H480133, H480293,
H480346, H480347, H480472, H480652, H480920, H481467, H481510, H481639, H481724,
H481807, H481815, H481816, H481912, H481913, H481914, H481915, H482194, H482195,
H482289, H482793, H482807, H483204, H483407, H484367, H484635, H484636, H484637,
H484638, H484781, H484864, H485100, H485125, H485244, H485346, H485466, H485729,
H486858, H486859, H486860, H486861, H486946, H486947, H486948, H487190, H487212,
H487414, H487580, H487581, H487623, H487640, H487641, H487642, H487700, and
H487757
RECALLING FIRM/MANUFACTURER Varian Medical
Systems Oncology Systems, Palo Alto, CA.
REASON When using the
multiple static segment option, the device may alter dose
delivery.
VOLUME OF PRODUCT IN COMMERCE
64
units
DISTRIBUTION Nationwide, Switzerland and the
Netherlands
PRODUCT RoboCouch Patient Support System, a component of the CyberKnife
Robotic Radiosurgery System. Model number 025007. The CyberKnife is indicated
for treatment planning and image guided stereotactic radiosurgery and precision
radiotherapy of lesions, tumors and conditions anywhere in the body when
radiation treatment is indicated. The RoboCouch Patient Support System is
intended for use in the support and positioning of a patient during Radiosurgery
and radiotherapy procedures and other medical procedures when precise
positioning is required.
CODE
System numbers: C0158,
C0078, C0141, C0160, C0128, C0178, C0179, C0152, C0110, C0113, C0130, C0060, and
C0125
RECALLING FIRM/MANUFACTURER Accuray, Inc.,
Sunnyvale, CA,
REASON Product may not be tensioned properly,
potentially causing unexpected rotation or descent.
VOLUME OF PRODUCT
IN COMMERCE
13 units
DISTRIBUTION Nationwide,
France and
Turkey
PRODUCT Artiste MV Digital Linear Accelerator, when used in combination
with Syngo RT Therapist Version 4.1 build 67 and automatic Motion of Flat Panel,
part number 8139789. Intended use is to deliver x-ray radiation for therapeutic
treatment of cancer. CODE Version
4.1 build 67
RECALLING FIRM/MANUFACTURER
Siemens Medical
Solutions,
REASON Under certain conditions, the flat
panel may move unexpectedly and collide with the patient.
VOLUME OF
PRODUCT IN COMMERCE
31
units
DISTRIBUTION Nationwide, Netherlands, Germany,
Poland, Norway, Australia, Belgium, France, New Zealand, Malaysia, Spain and
Canada
PRODUCT RF Ablation System Foot Switch. (Can be used with Boston Scientific
Maestro 3000 and EPT-1000XP Cardiac Ablation Cardiac Ablation Systems). Catalog
numbers/UPN numbers 21840/M004 218400. Indicated for use in cardiac ablation
procedures.
CODE Serial numbers
starting in 0430200, 0530100, 0606100, 0610000, 0620200, 0623700, 0626500,
0629900, 0634800, and ending in 001-405
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Boston Scientific, Corp., San
Jose, CA,
Manufacturer: Altech, Corp.,
Flemington, NJ.
REASON Product malfunction may result in
delivery of energy without depressing the foot switch that controls delivery.
VOLUME OF PRODUCT IN COMMERCE
322
units
DISTRIBUTION Nationwide, France, Great Britain,
Saudi Arabia, Spain, Canada, Portugal, Germany, Italy, Australia, Russia,
Netherlands, Ireland,
Libya
PRODUCT Triathlon PKR Insert X3 #1
LM/RL - 8mm, Catalog number: 5630-G-108;
Triathlon PKR Insert X3 #1 RM/LL - 12mm, 5630-G-122. Intended Use: - Moderately
disabling joint disease of the knee resulting from painful osteo or post
traumatic arthritis - Revision of previous unsuccessful surgical procedures,
either involving, or not involving, previous use of a unicompartmental knee
prosthesis - As an alternative to tibial osteotomy in patients with
unicompartmental osteoarthritis, where bone stock is of poor quality or
inadequate for other reconstructive techniques as indicted by deficiencies of
the femoral condyle/tibia plateau. These components are intended for
implantation with bone cement.
CODE Lot code
NXDMEE;
Lot code M8JMEE
RECALLING FIRM/MANUFACTURER
Stryker
Howmedica Osteonics Corp., Mahwah, NJ,
REASON Label mix-up: lot mix
up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and
Triathlon PKR Insert X3 #1 RM/LL- 12 mm 5630-G-122 lot code M8JMEE.
VOLUME OF PRODUCT IN COMMERCE
1 unit of 8 mm size; 8
units of 12 mm
size
DISTRIBUTION Nationwide
PRODUCT Centricity Enterprise Web 3.0 software; the software allows
physicians convenient, quick access to medical images and related data they need
via a web browser, password and a standard PC.
CODE Software versions 3.0, 3.0.1, 3.0.1.1, 3.0.2,
3.0.3, and 3.0.4
RECALLING FIRM/MANUFACTURER GE
Healthcare Integrated IT Solutions, Barrington, IL,
REASON Software
error: There are two potential safety situations with Centricity Enterprise Web
software - a forced log off may occur while using the Centricity Enterprise Web
during an open session and Centricity Enterprise Web does not utilize
calibration performed on image measurements in Centricity RA1000 Workstation.
VOLUME OF PRODUCT IN COMMERCE
742
units
DISTRIBUTION Nationwide, Australia, Austria,
Bahrain, Belgium, Canada, China, Denmark, Egypt, France, Germany, Hong Kong,
India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait,
Malaysia, Malta, Martinique, Netherlands, New Zealand, Nigeria, Norway,
Portugal, Reunion, Russia, Saudi Arabia, Slovenia, Singapore, South Africa,
Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab
Emirates, United Kingdom and
Venezuela
PRODUCT
a) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral
Block, 55 mm; REF 32-485150. A manual surgical instrument for general use; a
non-powered, hand-held, or hand-manipulated device; instrument guide.
b) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 57.5 mm; REF 32-485151. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
c) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 60 mm; REF 32-485152. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
d) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 62.5 mm; REF 32-485153. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
e) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 65 mm; REF 32-485154. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
f) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 67.5 mm; REF 32-485155. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
g) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 70 mm; REF 32-485156. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
h) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 75 mm; REF 32-485157. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
i) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 80 mm; REF 32-485158. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
j) Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 72.5
mm; REF 32-485159. A manual surgical instrument for general use; a non-powered,
hand-held, or hand-manipulated device; instrument guide.
CODE
a) Lots 083700 and 132202;
b) Lots
083730 and 132302;
c) Lots: 083760 and 132402;
d) Lots: 083830, 132502 and
132503;
e) Lots 083940 and 132602;
f) Lots: 084280 and 132702;
g)
Lots: 084400 and 132802;
h) Lots: 084520 and 132902;
i) Lots: 084710 and
133002;
j) Lot: 184801
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Biomet, Inc., Warsaw, IN,
Manufacturer: Symmetry Medical USA, Inc.,
Warsaw, IN.
REASON Falling component: The universal pin,
which holds the sliding instrument saw guide in its slot, may loosen during
surgical procedures and fall into the wound.
VOLUME OF PRODUCT IN
COMMERCE
444 units
DISTRIBUTION Nationwide,
Australia, Canada, Japan and UK
PRODUCT
a) Boston Scientific Easy Core Biopsy Device, 18 ga. x 21 cm,
sterile, latex free; UPN 500-104, REF M0065001040 and M0065001041. For use to
endoscopically or percutaneously retrieve tissue samples of soft organs, tumors
or masses for histological analysis. Soft tissue sampling includes, but is not
limited to, organs such as breast, liver, kidney or prostate.
b) Boston Scientific Easy Core Biopsy Device, 18 ga. x 15 cm, sterile, latex free; UPN 500-105, REF M0065001050 and M0065001051. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
c) Boston Scientific Easy Core Biopsy Device, 15 ga. x 15 cm, sterile, latex free; UPN 500-106, REF M0065001060 and M0065001061. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
d) Boston Scientific Easy Core Biopsy Device, 18 ga. x 25 cm, sterile, latex free; UPN 500-107, REF M0065001070 and M0065001071. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
e) Boston Scientific TruPath Biopsy Device, 18 ga. x 25 cm, sterile, latex free; UPN 500-108, REF M0065001080 and M0065001081. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
f) Boston Scientific TruPath Biopsy Device, 18 ga. x 15 cm, sterile, latex free; UPN 500-114, REF M0065001140 and M0065001141. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
g) Boston Scientific TruPath Biopsy Device, 18 ga. x 21 cm, sterile, latex free; UPN 500-115, REF M0065001150 and M0065001151. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
h) Boston Scientific Easy Core Biopsy System, 15 ga. x 15 cm, sterile, latex free; UPN 1213, REF M00512130 and M00512131. For use to endoscopically or percutaneously retrieve tissue samples of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.
i) Boston Scientific Easy Core Biopsy System, 18
ga. x 15 cm, sterile, latex
free; UPN 1215, REF M00512150 and M00512151. For use to endoscopically or
percutaneously retrieve tissue samples of soft organs, tumors or masses for
histological analysis. Soft tissue sampling includes, but is not limited to,
organs such as breast, liver, kidney or prostate.
CODE
a) Lots: 0011520534, 0011539483 and
0011543121;
b) Lots: 0011528037, 0011558750, 0011598779, 0011634769 and 0011712309;
c) Lot 0011524376;
d) Lots 0011523878 and 0011629943;
e) Lot: 0011520533 and 0011575888;
f) Lots 0011520768, 0011539485, 0011579957, 0011583953, 0011628247, 0011633061 and 0011657171;
g) Lots: 0011523876, 0011523877, 0011527254, 0011527255, 0011528021, 0011532165, 0011532166, 0011539493, 0011541089, 0011543122, 0011546133, 0011547761, 0011550536, 0011550537, 0011551878, 0011554904, 0011565663, 0011628245, 0011628246, 0011631838, 0011631839, 0011663060, 0011634768, 0011635389, 0011635870, 0011639103, 0011639104, 0011640138, 0011642791, 0011644188, 0011646497, 0011665362, 0011668986 and 0011671278;
h) Lots 001153216 and 0011537469;
i) Lot 0011537463
RECALLING FIRM/MANUFACTURER
Boston
Scientific Corp., Spencer, IN,
REASON The devices may experience
difficulty cocking and arming, resulting in an inability to use the devices.
VOLUME OF PRODUCT IN COMMERCE
14,249
units
DISTRIBUTION Nationwide, Algeria, Austria,
Australia, Belgium, Canada, Denmark, Egypt, Finland, France, Germany, Great
Britain, Greece, Hong Kong, Ireland, Italy, Japan, Mexico, Netherlands, Norway,
Philippines, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan,
Turkey, Japan and United Arab
Emirates
PRODUCT Custom Waste Management Kit, K10-01756/B, Sterile
EO,
CODE Lot: F622787
RECALLING
FIRM/MANUFACTURER Merit Medical Systems, Inc., South Jordan, UT
REASON
Leak, disposal bag:
A Merit Disposal Depot (MDD) bag contained in certain custom waste management
kits may leak.
VOLUME OF PRODUCT IN COMMERCE
399
kits
DISTRIBUTION Nationwide
PRODUCT BDD l ml Integra TB Syringe with Retracting Precision Glide Needle:
1 ml 27 g ˝ (0.4 mm x 13 mm); Sterile; REF # 305298. Made in USA. Syringes for
use in aspiration and injection of medications.
CODE Lot: 8078251
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co.,
Franklin Lakes, NJ,
Manufacturer: BD
Medical, Diabetes Care, Holdrege, NB.
REASON Expiry date on the shelf carton is
incorrect. It reads 2013-13; it should read 2013-03.
VOLUME OF
PRODUCT IN COMMERCE
334,400
units
DISTRIBUTION GA, KS, OH, MO, FL, PA, KY and NY
WEEK ENDING JANUARY 31
PRODUCT NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System
(software). Whole body x-ray computed tomography scanner which features a
continuously rotating tube-detector system and functions according to the fan
beam principle. The system software is an interactive program used for x-ray
scan control, image reconstruction, and image archive/evaluation. It is intended
to produce cross-section images of head and body by computer reconstruction of
x-ray transmission data taken at different angles. The function of Time Scan is
intended to use in contrast scan include single phase and multi-phase scan, that
is according to different density of contrast in vessels or organs between
different phase to get necessary information to support doctor's diagnosis. CODE
Serial
numbers: 400562, 400563, 400626, NDH009EI, NDH011EI, NDH012EI, NDH013EI,
NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI, NDH030EI, NDH031EI,
NDH034EI, NDHR080001, NDHR080002 and NDHR080003
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, North
America Co. Phillips, Bothell, WA,
Manufacturer:
Philips and Neusoft Medical Systems Co., Ltd, Shenyang, Liaoning, China.
REASON
An issue associated
with the “Timed Scan” application was found. The system does not wait for the
programmed time interval and starts the x-ray after selection of the scan button
when certain criteria is met.
VOLUME OF PRODUCT IN
COMMERCE
19
units
DISTRIBUTION Nationwide
PRODUCT
a) GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System.
The system consists of a monoplane positioner, a vascular or cardiac table, an
X-ray system and a digital detector. The product is indicated for use in
generating fluoroscopic images of human anatomy for vascular angiography
diagnostic and interventional procedures and optionally, rotational imaging
procedures. It is also intended for generating fluoroscopic images of human
anatomy for cardiology, diagnostic and interventional procedures.
b) GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System. The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector. The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.
c) GE Innova 4100 /4100 IQ. , The system consists of a monoplane
positioner,
a vascular or cardiac table, an X-ray system and a digital detector. The product
is indicated for use in generating fluoroscopic images of human anatomy for
vascular angiography diagnostic and interventional procedures and optionally,
rotational imaging procedures. It is also intended for generating fluoroscopic
images of human anatomy for cardiology, diagnostic and interventional
procedures.
CODE
a) 505848CATH1
505848EP 318448INNOVA3 305682IN2 4105502100 410554INNOVA2 208367INNOVA
208381CCL1 2035762100 717217CA10002 843797TCL1 214947MINNOVA 214947MINNOVA2
PRESBYDEP 303839CL2 252384CATH1 303788CL1 4436432100 4107872100 8184092100
864255SFCL2 219932DCL2 305364P2100 954987CL4 713794LAB1 727869CATH3 727869CCL2
727869EP5 208227CATH1 8157412100 816861KCVAI2 308865GIN1 865693CCL 865693CCL2
608775NOVA2 0002507622 310825INNOVA21 516562INNOVA6 516562INNOVA7 865977CCL
217383CCL2A 541732CV2 0002698287 0002698301 251435ICV3 239436CATH4 732776CATH4
212305CATH1 212604INNOVA1 65049321 304424INNOVA 610983INNOVA2 201447LAB1
215453INNOVA21 253627INNOVA1 229228INNOV21C 8053702100 RPINNOVA2100 303425CL3
305682IN2X 317355INNOVA3 318448CA1000 330363LAB3 330375LAB2 336538ARCL1
360456XCL4 405604D2100 408559INV1 410554INNOVA1 414291CL2 414649INNOVA2
417269SCLA 417347FCV4 423495MCATH1 501257VALAB1 508335CA1 508856IN21
509575YM2100 516562INNOVA2A 518243LAB1 518243LAB2 561548ET2 570476INNOVA21
573761SMC2 573815BCR2 573815BCR3 573815BCR4 574535IN21 602239CLAB2 607737CL1
608775NOVA1 610250INNOVA1 610250INNOVA3 610776INNOVA21 612273INNOVA2 615284CV3
615342CV3 615446CV1 617636CL1 630856H2100 650369SV4 651582IN3 661327INNOVA1
661327INNOVA2 706291CLIN1 713375U2100 713375UCA 717217INN21 717544GECATH2
717544GECATH3 718470EP 718780CATH3 727942CATH2 732324INN1 732923INN 770HMCCL1
781340IN1 781340IN3 785354HRTEP 803256PCL5 808547QCV1A 808547QCV3A 812238UN21
813615CL1 813615CL8 813615CL9 813615EP3 814452EP 815741CA1000 815759CARDIAC1
817329BG2100 843724CL1 843724CL2 843724CL3 843724EP1 845368LAB1 845368LAB2
856853IN2100 858554INNOVA2 858554INNOVA3 864255SFCL1 904597CATH 910343EP1
910343EP2 910671INOV21 916781INNOVA2 937208INNOVA2 954735CL2 954987CCL7
954987CCL8 970350CL2 9704CHINNOVA 973579LAB1 985898INNOVAA 985898INNOVAB CM2100
ECXV1406F FHOMEP 508941IN21 508335INNOVA 843692CATH3 828213IN21 901765EP
410554INNOVA4 410554INNOVA3 251435ICV7 262255INNOVA2 303369HCL4 410337INNOVA6
573256MHC 804764CATH2 845365V13 7023602100 9284532100 336832MCCL6 402559UCD
775982INN2100 847316INNOVA1 847316INNOVA2 LVINOV7 0910162009 0910162010
0910162011 0910162012 0910163011 0910163014 0910162013 010120RX44 0002673668
2673668/0002673668 082416100014 082416150002 082416100011 082416130026
082416010005 082416010007 082416030005 082416040011 082416040012 082416040014
082416050003 082416060001 082416070006 082416100009 082416100012 082416100017
082416120008 082416130016 082416130019 082416130023 082416130024 082416160007
082416180003 082416200004 082416210007 082416220010 082416120009 82416030004
82416100007 82416140006 082416ATCINNOVA 82416110005 82449150034 604875AINNOVA1
416480INNOVA 604682INNOVA1 604682INNOVA2 604875AINNOVA2 416864INNOVA 468668XR01
26814ANGI2 2664023INNOVA CS1118VA03 CS1006VA04 HC4348XR02 PC0052XR07 PC0052XR08
507902XR01 HC0222XR35 HC4355XR06 HC4480XR05 DK1066VA02 DZ1006VA01 FEB52055
ME612436 CEE15663 FI1017VA02 FI1017VA03 FI1025VA01 A4166952 B1650215 B5483438
M1334109 M2068110 M2569315 M2844529 M4176519 M4183841 M4200108 M4211066 M4496941
B4192944 M2621511 M4198195 M181374801 00060VAS02 00159VAS04 00192VAS04
00192VAS05 00234VAS01 00282VAS02 00371VAS01 00440VAS02 00440VAS03 00463VAS06
00888VAS02 01065VAS01 05208VAS02 05217VAS02 05451VAS01 10507VAS01 00197VAS01
10086VAS04 H2077VAS27 H17654VAS8 H0002VAS66 0828160007 600010VA01 HU1094VA01
HU1116VA01 HU1205VA01 HU1231VA10 HU1099VA02 0835160017 0835160018 835160021
IE1100VA02 0002644132 08301600206936 083016002101586 083016102100795
083016202101036 083016202101917 083016242100936 083016282101457 083016602101386
083016802100516 083016802100866 083016802100916 083016862101407 083016862101656
083016862101916 83016802100337 83016862100377 083016602101807 083016802101197
083016822101187 8.30168E+12 8.30162E+13 2673438 8.30161E+13 A5333036 A5333037
A147111802 A5125125 A5129025 A5131858 A5155141 A5164510 A5219606 A5220710
A5286803 A5400910 A5605743 A5624112 A5800506 A5807919 A58080104 B5120723
B5219603 C5123625 C5123626 C5323515 A5624127 A5697709 A5764002 B5603933 YV0053
YV0054 YV0057 YV0058 YV0059 YV0060 YV0061 YV0062 YV0063 YV0064 YV0065 YV0066
YV0067 YV0068 YV0069 YV0070 YV0071 YV0072 YV0073 YV0074 YV0075 YV0076 YV0077
YV0078 YV0079 YV0080 YV0081 YV0100 YV0055 YV0056 YX1483 YV0082 0850060723
KW1018VA05 KW1018VA01 KW1018VA02 KW1018VA03 LT4000VA04 LV4000VA02 LV4000VA03
LV4001VA02 MA1004VA02 0002679402 0002684003X 644INNOVA21 83INNOVA2588441
NO1009VA03 NO1064VA03 920169006 600151VA01 600042VA03 0002674834 787844INNOVACL1
787844INNOVACL2 787844INNOVACL3 PER00218 SA1011VA01 SA1054VA02 SD1038VA01
A004RX01 A020RX13 0847160002 0847160003 2682877 SK1110VA01 SY1001VA02 SY2005VA01
06052VAS01 20001VAS02 34009VAS06 34134VAS02 35049VAS01 58010VAS01 80002VAS01
06004VAS03 35021VAS02 0853060191 853060197, and 853060193;
b) 215576INNOVA1 760242CATH1 404686CRI3 281420LAB23100 541382CV3 205783BCL5 2035763100 508941IN1 843797TCL2 361980INNOVA2 214590PH3100 303629CL4 303629EP 3027443100 7018573100 303788CL2 239939CLA 850862IN3100 352333CATH1 352333CATH2 8184093100 919731WMINOV 305364P3100 205877CCL1 281440CL3 208227CATH2 2014183100 7028533100 865693CCL1 609757IN3100 6619483100 219326IN31 7022333100 816969LSCATH 209334LINNOVA1 310319SM3100 502587LAB1 219877IN31 9734293100 215335INNOVA1 239436CATH3 239513CRLAB1 8053703100 615222H 812858GWLAB1 812858GWLAB2 8014793100 270688INN 65049331 850747BR3100 6106483100 8508573100 850469BCV1 207662CL4 207879CL131 951788INNOVA3 951788INNOVA2 541677MINNOVA1 5033703100 253968INNOVA 254742KDCL1 662377CV4 412437INNOVA 9202623100 303425CL4 2197573100 0002595303 228818VASC 316651INNOVA31 316962WCVC1 316962WCVC2 325428CATH1 325428CATH3 336832MCPV 360456XCL3 361857CATH1 405272SCL2 405372S3100 405604D3100 405840OIC3100 406447VAIN3 406543IN3 413582C3100 414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 417885JCL7 417885JCL8 423495MCL6 423844CCL1 478274CTH1 502852INNOVA 510797INV8 512901NI3100 516562INNOVA8 516562INNOVA9 516663INNOVA1A 530244XC106 561548CL4 570476INNOVA31 573458CL1 573632CRC2 6012883100CV2 603421PCL 610595CL1 610770INNOVA31 610983INNOVA1 616392INNOVA 617732IN9 618241GSI3100 620225INNOVA31 631968INNOVA2 631968INNOVA3 662377CV2 671GMHAINVA 708WESTSUB3100 713359INC 713948INA 717782INNOVA31A 718245UNITY 718470INNOVA2 718780CATH2 732776CATH6 770991CL1 772LWCL1 775982CATH2 781340IN2 803255CL1 804285CATH1 814676C1 815344CARDIAC3 815756KCHSPEC 816478MC1 816861KCVAI1 816943STJIC1 816985NKCI 847362CONCATH4 856596IN3100 864255SFCL3 901516R3 903UT3100 904276CTH1 909464IN3 909825VAINNOVA 910343NHIN4 913345MI1 940626DCH3100 954987CCL9 956698INN31 970350CL1 970945CL1 973877LAB4 ECXV1406B FHORLCL7 580548B3100 941798CLAB2 760323DRINNOVA 718270INNOVA1 603580ECL1 410740CV MARTINSVILLE310 480728LAB2 865481CCL2 405610NW3100 8157413100 251633PROV 907562CATH1 919784REP1 601883CL1 650369SV3 610954INNOVA1 760242CATH2 314768SMCL1A 2035763100A 402559UCB 561694IN1 2036883100 201996LAB1 205877CCL2 207351YCL1 251435ICV6 281420LAB1 314525STACL2 334418CL 412623LAB2 479441SP3100 480821IN2 508856IN2 541MWHINNOVA 573882UMC1 610447CL1 610526LAB1 610526LAB2 610891CL1 617789IN1 631376EP 704384CATH2 706481CCL 706774CCL4 706774CCL5 713776M3100 717782INNOVA31 803256PCL1 812450CATH1 815226INN2 863687CL31 916781INNOVA1 918494IN31A 952993INNOVA5 BPINNOVA1 845365V19 918333JPIN1 909788INNOVA1 516663INNOVA2 2652143 8185023100 0002686429X 312STMNAZ3100 630312B31 717782INNOVA31B 727725CATH2 785354S3100 918333JPIN2 378INV31 0910064009 0910163012 0910163013 0910163015 910064007 910064008 910162006 910162008 910163006 910163007 910163009 BA4080VA01 140024RX09 BG4549VA02 2573329 2667313 2676587 BE5003VA02 082416040018 082416140004 082416290001 082416140003 082416130018 082416080001 082416010006 082416020004 082416020005 082416030006 082416040015 082416040019 082416100013 082416110002 082416110003 082416120010 082416140002 082416150001 082416160008 082416160009 082416160013 082416180004 082416190004 082416190001 082416190002 082416190003 082416210006 082416210008 082416220008 082416270002 082416300001 082416310003 082416310006 082449100050 082416160011 082416170002 82416030003 82416030008 82416030010 82416100006 82416100010 82416100019 82416120007 82416120011 82416130015 82416160003 82416160006 82416210003 82416210004 82416310007 082416220009 82416130017 82416030009 82416120012 82416180005 82416310008 2625365INNOVA 2645993INNOVA CS1006VA03 HC4348XR01 0002655786 MPX82206 FPG86403 FPG93008 DPM32143 DPN88402 FPA99414 FI1064VA01 M2030709 M4163030 M4166988 M5480755 M6083613 A6017504 M2848425 M2970614 M4016034 M40480151 A9190149 M40480167 00203VAS01 01367VAS02 GE1005VA01 HU1099VA04 A5127281 A5112597 A5162256 A5333035 A5812244 B5274834 B5332001 B5810907 A5125119 JO1000VA01 YV0162 YV0048 YV0163 XF0250 YV0033 YV0034 YV0035 YV0038 YV0039 YV0040 YV0042 YV0043 YV0044 YV0045 YV0046 YV0047 YV0049 YV0050 YV0051 YV0023 YV0024 YV0025 YV0027 YV0028 YV0029 YV0030 YV0031 YV0032 YV0037 0850060719 0850060724 0850060726 0850060727 0850060728 KW1055VA01 52XVINN2565367 818INNOVAHM2 477XVIN2553211 0834160003 NO1005VA05 0920169007 2048000INNOVA 2664627INNOVA 2685467INNOVA PL1082VA01 600098VA01 RU1482VA02 RU1475VA01 RU1142VA01 RU2581VA01 SA1010VA02 01012VAS01 41018VAS01 58002VAS01 60001VAS01 34268VAS01 0853060194, and 388567772VASMET;
c) "0002651236A 813745INTV" 0002701957A 3184734100 706774USP3 6309784100
6616324100 304256INNOVA 2035764100 352596SPEC 423495MSPEC2 5135844100
719560INN41 303320OR41 303399IR 303436ANGIO 3027444100 574294IN41 239939INNOVA
252847PRS3 864255SF4100 305823IN4100 7137764100 3016094100 414649CL2 812858GWSP
212639ACT1 8014794100 304424CCINOVA 309655FSP1A 4134474100 5033704100 509474SH41
201541SP1 281401T4100 918744JR4100 22925941V2 586573SP1 SHOWCASE4100
314569SJRM12 314966DPHSP 317887INNOVAPV 330489SPEC9 352333INVOR 386254HS1
386254HS2 386HPOS1 404466SF41A 404GHSIR1 410337INNOVA2 412647OR10 414649DVI
419696LAB1 505848CATH2 505848V4100 508650IN41 509482HFI 512901NI4100
530888ANG206 541686SPR1 561548VAS2 570321LAB2 605333RM10 610988INNOVA4 617636IN1
619229INNOVA1 623848SP 630275G41 630275G41B 650493ANGIOCT 662244GTSP 678EJCIR1
706291RINN2 706651SP1 706733SP1 708783CL4100 708783SP4100 713375U4100
718630LIBERTY 727791INNOVA 770535N4100 803256SP 804594ANGIO 812238UN41
812825INNOVA1 813615CL10 815740SC4100 817465AR4100 817922BA4100 843577CL2
845368RM10 850747IN4100 863687INV24 864573LAB2 865373SP 865481SUR 908522SP1
915577SP1 918682IN41 954MW4100 970247INNOVA COR359867 DR4100 FHORL4100
PEMBROKE4100 RADNETXV1 RHD4100 480512SP 8458584100 770736SP1 423495M4100E
423493I4100 8593134100 313343SP1 708202VA41 708WESTSUB4100 509575YM4100 80140841
80180741 2194654100 4082594100 4105434100 4137484100 5094744100 5417684100
5703214100 5705224100 6082634100 7023604100 7028804100 219326IN41 229228INNOV41C
22925941V 251435I12 252816INNOVA 269226IN1 269226IN2 269983IN41 303839CL1
308534ANG 309672M4100 312792R4100 313876SP41 316651INNOVA41 317338PV3
360754INNOVA 401274IN41 412623LAB1 412623LAB3 414328INN4100 419251LAB1
508383IN4100 512528CPCL1 541282CV2 603650ANG1 608263ACT 608263XMR 608324DAL
610954INNOVA41 617525IN1 617726RF2Y6 626359INNOVA 650369SV5 706291RINN
718206LIBERTY1 760633IR1 773878SWGANGIO1 801268INNOVA 804285CATH2 804764CATH3
810342A41 813558INTV 816943SP1 817433HSW4100 828298VASC 847842GS4100 856365ANGIO
903GS4100 904202SP1 904BSSP 913317SLS4100 952993INNOVA2 972335LIB 972487ANGIO1
972566INNOVA3 985867INNOVA2 ECXV1406E MIRAMAR41 WCATHLAB41 334286BSP
757889INNOVA 706278INNOVA1 561747IN4 252847PRS2 918744JC4100 5136864100
850494WSP1 FWANG3217 0002520549AX 252816INNOVA 309343CSP1A 309655FSP3A
802295VALCA 190020RX09 082406070010 082406310005 082416030007 082416040020
082416100016 082416130020 082416130021 082416130025 082416220006 82406040022
82406120016 82416130010 82416130011 82416130013 82416140005 82416160005
82416160010 514842AINNOVA 613548INNOVA3 4163694100 250370INNOVA 306766INNOVA
416756INNOVA 514376INNOVA 514934BANGIO 519663INNOVA2 519685INNOVA 204787INNOVA1
CS1054VA01 HC0220XR07 407953XR01 487692XR01 UC1129XR33 FI1015VA02 FI1015VA01
M1230007 N4192927 R4211476 M4505274 00490VAS02 01278VAS01 10091VAS01 00095VAS07
00137VAS01 00171VAS01 00860VAS01 HU1039VA02 IE1100VA01 IL1043VA01
083006202101017 A5102671 A5163317 A5605732 A5105151 C5603903 XF0150 XF0151
XF0152 XF0153 XF0154 XF0155 XF0200 YV0006 YV0007 XF0156 YV0009 XF0022 XF0149
YV0001 YV0002 YV0004 0850060718 0850060720 0850060721 0850060722 0850060725
850060707 KW1001VA03 KW1001VA04 KW1018VA04 KW1013VA01 LB1037VA01 MA1020VA01
BRD0411 NO1015VA04 600042VA02 787620IN4100 787653INNOVA 600152VA01 RU2714VA01
RU2992VA01 RU1050VA03 RU1018VA03 RU1106VA02 SA1005VA06 E001RX08 0002603739
0002603828 06004VAS02, and 853060187
RECALLING
FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha,
WI,
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France.
REASON Software error, computer: GE Healthcare has
become aware of an issue with Error Management affecting the Innova 2100,
3100/3100 IQ & 4100/4100IQ. It was reported that when the foot switch was
pressed, the live monitor screen was blank and it looked like there were no
X-rays being emitted. But the message "Acquisition in progress" was displayed on
the DL monitor, even after the foot switch was released. The operator had to
reset the system to clear the message. This issue raises potential safety
concerns in particular in the X RAY and motion controls if the error management
does not work properly. No injury was reported. However, the patient received a
low, unnecessary x-ray dose.
VOLUME OF PRODUCT IN
COMMERCE
1,129 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT Hill-Rom 70 Semi-Electric Bed; Model HS-968. The bed is a general
purpose bed for use with low to medium acuity patients in the home care
environment.
CODE Serial numbers:
HC100001 through HC101261
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Hill-Rom, Inc.,
Batesville, IN,
Manufacturer:
Power Metal Industry Kunshan Co., Lt, Kunshankunshan, China. F
REASON
Failure, mechanical:
If the bed mechanism is cranked downward when the bed is already in its lowest
position, the springs may cause the bed to rise suddenly if the bed is empty,
more slowly if occupied by a patient, or when the patient exits the bed.
VOLUME OF PRODUCT IN COMMERCE
597
beds
DISTRIBUTION Nationwide
PRODUCT
a) Quantimetrix QuanTscopics Urine Microscopics Control.
QuanTscopics is a plastic bottle liquid urine microscopic quality control. It is
a bi-level control with stabilized human blood cells provide a means to validate
the processing and is centrifugation of urine prior to microscopic analysis in
compliance with CLIA regulations.
b) Quantimetrix Dip and Spin Control Urine Dipstick/Microscopics Control. The intended use is to validate the performance of the Multistix, Chemstrip, Uriscan, QuickVue, Diascreen and other urinalysis reagent strips, and as a control for confirmatory tests such as Acetest, Clinitest, and Icotest reagent tablets, and as a control for hCG methods. In addition, the Dip and Spin Control is intended as a means of validating the processing and centrifugation of patient urine samples prior to the microscopic evaluation of urine sediment.
c) Quantimetrix SpinalScopics Spinal Fluid Cell Count Control. Spinalscopics is a plastic bottle liquid spinal fluid cell count control. This product is intended for monitoring cell counts in patient cerebrospinal fluid samples performed manually using a hemocytometer.
d) Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a
plastic bottle Synovial fluid cell count control. It is a control for monitoring
total cell counts in patient Synovial fluid samples performed manually using a
hemocytometer. It is also an aid for identifying the crystals which may indicate
a pathological condition present in the Synovial fluid. This control is used as
a third party control to confirm proper functioning of the analysis by
microscopic evaluation. CODE
a) Lot
Numbers: 48170, 48171, 48172, 48180, 48181 and 48182;
b) Lot Numbers: 47160, 47170, 47180, 47190, 47200 and 47210;
c) Lot Numbers: 46130, 46131, 46132, 46140, 46141, 46142, 46150, 46151, 46152, 46160, 46161, 46162, 46170, 46171 and 46172;
d) Lot Numbers: 38050 and 38060
RECALLING
FIRM/MANUFACTURER
Quantimetrix Corp., Redondo Beach, CA,
REASON
This recall was initiated due to
efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes
contained in this product group.
VOLUME OF PRODUCT IN
COMMERCE
24,937 sets for all
products
DISTRIBUTION Nationwide
PRODUCT Vertical drive brake on patient supports. Used on certain Philips
Medical Systems MX series and Brilliance series CT scanners. The device is a
vertical drive brake that controls the vertical position of a patient support
system or couch. The patient support system is intended to be used to place the
patient in the correct horizontal and vertical position in order to be scanned.
The couch is an accessory product to a computed tomography scanner.
CODE
Assembly number: 4535 664
98912
RECALLING FIRM/MANUFACTURER
Philips Medical Systems
(Cleveland) Inc., Cleveland, OH,
REASON The
patient support may travel downwards without being commanded to
move.
VOLUME OF PRODUCT IN COMMERCE
559
units
DISTRIBUTION Nationwide, and countries of
Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Canada, China,
Colombia, Costa Rica, Czech Republic, Denmark, Egypt, England, France, Germany,
Greece, China, India, Indonesia, Ireland, Iraq, Italy, Japan, Jordan, Korea,
Lebanon, Libya, Lithuania, Malaysia, Malta, Mexico, Netherlands, New Zealand,
Norway, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi
Arabia, South Africa, South Korea, South Africa, Spain, Sweden, Switzerland,
Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and
Venezuela
PRODUCT
a) Alimed Gait Belt (Transfer Aid), Antimicrobial Plastic buckle,
54" Model: 72108.
b) Alimed Gait Belt (Transfer Aid), Antimicrobial Plastic buckle, 70" Model:
72109.
CODE
a) Lot Numbers:
Y8739, Y8296, Y7619, Y7004, Y5966 and Y3169;
b) Lot Numbers: Y3356 and
Y3170
RECALLING FIRM/MANUFACTURER AliMed Corp., Dedham,
MA,
REASON Misassembled gait (transfer aid) belt.
VOLUME OF PRODUCT IN COMMERCE
993
units
DISTRIBUTION Nationwide
PRODUCT
a) Esmark Elastic Bandage, 3” x 4” yards, sterile, for single use
only, latex free. Catalog number: 23580-034. The device is used to promote blood
flow from the extremities by compressing the superficial vessels.
b) Esmark Elastic Bandage, 4” x 3” yards, sterile, for single use only, latex
free. Catalog number: 23580-043. The device is used to promote blood flow from
the extremities by compressing the superficial vessels, CODE
a) Work order numbers: 304696 and
312977;
b) Work order numbers: 310652, 316815, 324060 and
327413
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Cardinal Health, McGaw Park, IL,
Manufacturer: Convertors De Mexico,
S.A. De C.V., Ciudad, Juarez,
Mexico.
REASON The
natural rubber latex bandages were mislabeled as latex free.
VOLUME
OF PRODUCT IN COMMERCE
9,521
units
DISTRIBUTION Nationwide, Guam and
Korea
PRODUCT Stryker Vision 3 Flat Panel Shroud, Part #0682-000-414 (Individual
Flat Panel Shroud, Ver. 2, Reworked), 0682-000-415 (SV3 Shroud Retro Fit Kit)
and 0682-000-416 (Flat Panel Retro Fit Kit); The 0682-000-414 (FP Shroud version
2 reworked) is a shroud designed to cover the cabling necessary on a Stryker
Version 3 Monitor when mounted on the Flat Panel Arm.
CODE
All product shipped between 06/05/06 and
01/31/08
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Stryker Communications Corp., Flower Mound, TX,
Manufacturer: Ondal Indust
Gmbh, Hunfeld, Germany.
REASON Paint chips: Shroud used to cover
cables on the Stryker Vision 3 flat panel monitor (monitor used in surgery rooms
during procedures) was not manufactured/painted to specification, resulting in
the possibility that paint chips could fall off and fall into non-sterile and/or
sterile fields during surgery.
VOLUME OF PRODUCT IN
COMMERCE
116 units
DISTRIBUTION Nationwide,
Canada, Spain and the
UK
PRODUCT Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant.
Product is used to lubricate vulvar and vaginal tissues to facilitate entry of
diagnostic or therapeutic devices. Pre' Lubricant is acceptable for use to
facilitate insertion of diagnostic or therapeutic devices during fertility
interventions such as: embryo transfer, transvaginal collection of oocytes,
intrauterine insemination and post coital testing. In addition, product may be
used as a personal lubricant to supplement the body's own natural lubricating
fluids.
CODE Lot
number: 5213
RECALLING FIRM/MANUFACTURER
Recalling
Firm: INGfertility, LLC, Valleyford, WA,
Manufacturer: Unicep Packaging, Inc., Sandpoint, ID.
REASON
Product contaminated with
bacteria (Brachybacterium rhamnosum, a non pathogen gram positive cocci).
VOLUME OF PRODUCT IN
COMMERCE
Unknown
DISTRIBUTION Nationwide and
Ireland
PRODUCT TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or
3.2.1 software. The affected applications include Planning Station, Planned
Adaptive, Data Management System, and TomoPortal. TomoTherapy HI-ART Systems is
intended to be used as an integrated system for the planning and delivery of
intensity modulated radiation therapy (IMRT). The HI-ART System provides precise
delivery of radiation to tumors or other targeted tissues while minimizing the
delivery of radiation to vital health tissue. The HI-Art system's planning
station or operator station is intended to be used by the physician/oncologists
to prescribe a radiation therapy plan for a particular patient,. The HI-ART
System then calculates the treatment plan which the physician reviews and
approves. The HI-ART system's operator station and status console is then
intended to be used by the therapist to select and implement the patient's
treatment plan. The treatment process will begin by performing a TomoImage (MVCT) scan (a CT using the on board linear accelerator as the radiation
source). This TomoImage (MVCT) will confirm that the patient's position is
correct for the radiation therapy as well as assist in patient re-positioning
when necessary. The TomoImage (MVCT) image is not for diagnostic use. When
patient positioning is complete, the HI-ART System i sthen intended to be used
by the therapist to treat the patient using the selected treatment plan. The
HI-ART System delivers the radiation therapy, stereotactic radiotherapy or
stereotactic radiosurgery treatment in accordance with the physician approved
plan delivered in a helical tomographic pattern.
CODE
Domestic Customer Information Serial number: 110001
110002 110003 110004 110005 110006 110007 110008 110012 110013 110015 110016
110017 110019 110020 110021 110022 110023 110024 110025 110026 110027 110028
110029 110030 110031 110032 110033 110035 110038 110039 110040 110041 110042
110043 110044 110045 110047 110048 110050 110051 110053 110054 110056 110057
110059 110060 110066 110067 110073 110074 110080 110081 110082 110084 110086
110087 110089 110090 110091 110092 110094 110095 110096 110097 110098 110100
110103 110104 110105 110106 110108 110112 110115 110116 110118 110119 110120
110122 110127 110132 110134 110135 110138 110139 110141 110144 110145 110148
110149 110152 110153 110154 110155 110158 110160 110161 110165 110166 110168
110173 110174 110175 110176 110177 110179 110180 110181 110185 110186 110187
110188 110190 110192 110193 110195 110196 110197 110198 110201 110202 110203
110204 110206 110209 110210 110213 110214 110215 110216 110217 110221 110222
110223 110225 110227 110238 110242 110224 and 110250; International Customer
Information Serial number: 110009 110014 110018 110034 110036 110037 110046
110049 110052 110055 110058 110061 110062 110063 110064 110065 110068 110069
110071 110072 110075 110076 110077 110078 110079 110083 110085 110088 110093
110107 110109 110110 110111 110113 110114 110117 110123 110124 110126 110128
110129 110130 110131 110133 110136 110137 110140 110142 110143 110146 110150
110151 110156 110157 110159 110162 110164 110167 110169 110170 110171 110172
110178 110182 110183 110189 110191 110194 110199 110200 110207 110211 110228
110237 and 110240
RECALLING
FIRM/MANUFACTURER
TomoTherapy, Inc., Madison, WI,
REASON
A potential issue with the Hi-Art system
during the course of ongoing testing. The Operator Station Calibration panel
provides access to view and modify machine specific configuration settings.
Access to these settings has always been restricted to individuals with
appropriate security rights, being limited to only the "Superuser" and "Field
Service engineer" categories. Other security level users, including "Therapist",
cannot modify these settings. In the calibration panel, it is possible for
"Superuser" and "Field Service Engineer" user types to manually disable the
front and back jaw potentiometer interlock. This interlock is always correctly
enabled prior to factory shipment of systems from TomoTherapy, and there are no
service procedure that requires the interlock to be disabled. If this setting
were to be manually disabled, the jaw would not perform a verification of the
pre-procedure homing routine. In the unlikely event that this verification
routine failed in a rare and very specific manner, the jaws could position
incorrectly for that procedure without a system interlock occurring. This
positioning error could only result in a field width that is smaller than
planned. Fractions that would be affected would only be those incurring the
unusual chain of events outlined above. Regardless, overdose in not a possible
outcome.
VOLUME OF PRODUCT IN COMMERCE
215
units
DISTRIBUTION Nationwide, and countries of Belgium,
Canada, Switzerland, China, Germany, Spain, France, Great Britain Hong Kong,
Italy, Japan, Korea, Netherlands, Singapore, Taiwan and Turkey
PRODUCT Cyberknife Robotic Radiosurgery System. A radiation therapy device,
MultiPlan (MP) Treatment Planning Software and Iris Variable Aperture
Collimator, Software version 3.0. Product is indicated for treatment planning
and image guided stereotactic radiosurgery and precision radiotherapy of
lesions, tumors and conditions anywhere in the body when radiation treatment is
indicated.
CODE All units that have
MP software version 3.0 and the Iris Collimator in clinical use at the same
time.
RECALLING FIRM/MANUFACTURER
Accuray, Inc.,
Sunnyvale, CA,
REASON System may use random incorrect data to
calculate dose. Resulting dose calculation can exceed 100% of correct
dose.
VOLUME OF PRODUCT IN COMMERCE
4
units
DISTRIBUTION Nationwide
PRODUCT Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing,
Model number 0350600006, for use with the FloControl Arthroscopy Pump.
CODE
Lot number: 08E0451
RECALLING
FIRM/MANUFACTURER Stryker Endoscopy, San Jose, CA,
REASON Unable to pump fluids. Silicone tubing is stiffer
than usual, resulting in motor defect message, leading to inability to pump
saline through tubes for surgery.
VOLUME OF PRODUCT IN
COMMERCE
1,440
devices
DISTRIBUTION Nationwide
PRODUCT
a) Tornier AFFINITI Humeral Stem Standard 10mm, Catalog No.
0020010. Sterile. Tornier's Affiniti Shoulder System is a non-constrained
glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement
system. The total shoulder consists of a metal humeral stem, a metal humeral
head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder
consists of a metal humeral stem and a metal humeral head.
b) Tornier AFFINITI Humeral Stem Standard 14mm, Catalog No. 0020014. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
c) Tornier AFFINITI Humeral Head Eccentric 44mm x 18mm, Catalog No. 0020025. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
d) Tornier AFFINITI Humeral Head Eccentric 44mm x 21mm, Catalog No. 0020026. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
e) Tornier AFFINITI Humeral Head Eccentric 48mm x 21mm, Catalog No. 0020030. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
f) Tornier AFFINITI Humeral Head Eccentric 52mm x 21mm, Catalog No. 0020034. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
g) Tornier AFFINITI Humeral Head Eccentric 56mm x 21mm, Catalog No. 0020038. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
h) Tornier AFFINITI Humeral Head Standard 44mm x 15mm, Catalog No. 0020044. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
i) Tornier AFFINITI Humeral Head Standard 44mm x 18mm, Catalog No. 0020045. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
j) Tornier AFFINITI Humeral Head Standard 44mm x 21mm, Catalog No. 0020046. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
k) Tornier AFFINITI Humeral Head Standard 48mm x 15mm, Catalog No. 0020048. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
l) Tornier AFFINITI Humeral Head Standard 48mm x 18mm, Catalog No. 0020049. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
m) Tornier AFFINITI Humeral Head Standard 48mm x 21mm, Catalog No. 0020050. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
n) Tornier AFFINITI Humeral Head Standard 52mm x 15mm, Catalog No. 0020052. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
o) Tornier AFFINITI Humeral Head Standard 52mm x 18mm, Catalog No. 0020053. Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
p) Tornier AFFINITI Humeral Head Standard 52mm x 21mm, Catalog No. 0020054.
Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral
prosthesis intended for use as a total or hemi-shoulder replacement system. The
total shoulder consists of a metal humeral stem, a metal humeral head and an
ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a
metal humeral stem and a metal humeral head.
q) Tornier AFFINITI Humeral Head Standard 56mm x 21mm,
Catalog No. 0020057. Sterile. Tornier's Affiniti Shoulder System is a
non-constrained glenohumeral prosthesis intended for use as a total or
hemi-shoulder replacement system. The total shoulder consists of a metal humeral
stem, a metal humeral head and an ultrahigh molecular weight polyethylene
glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral
head.
r) Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020058.
Sterile. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral
prosthesis intended for use as a total or hemi-shoulder replacement system. The
total shoulder consists of a metal humeral stem, a metal humeral head and an
ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a
metal humeral stem and a metal humeral head.
CODE
a) Lot No: AA1234;
b) Lot No: AA1434;
c)
Lot No’s: AA1157C, and AA1435;
d) Lot No’s: AA1158C, and AA1436;
e) Lot
No: AA1303;
f) Lot No’s: AA1305, and AA1214;
g) Lot No: AA1307;
h)
Lot No: AA1437;
i) Lot No’s: AA1146C, and AA1438;
j) Lot No:
AA1290;
k) Lot No: AA1291;
l) Lot No: AA1292;
m) Lot No:
AA1293;
n) Lot No: AA1294;
o) Lot No’s: AA1295, and AA1439;
p) Lot No:
AA1440;
q) Lot No: AA1298;
r) Lot No’s: AA1208, and
AA1442
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Tornier, Stafford, TX,
Manufacturer: Micropulse, Inc., Columbia City, IN.
REASON Tornier, Medical has received a report of
a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to
voluntarily recall the potentially affected lots, including two (2) lots of
AFFINITI Stems.
VOLUME OF PRODUCT IN COMMERCE
401
units
DISTRIBUTION AR, CA, FL, NC, NE, OH, PA, TN, TX,
WA, and
WI
PRODUCT
Dri-Lok Disposable Cannula, Part numbers 3910-075-500,
3910-075-501, 3910-075-502, 3910-075-650, 3910-075-651, 3910-075-652,
3910-075-800, 3910-075-801, 3910-075-802, 3910-090-500, 3910-090-502,
3910-090-650, 3910-090-652, 3910-090-800, and 3910-090-802. The obturator is
used to create an opening into the patient's joint and is removed after the
cannula is inserted. The cannula then allows instruments and scopes access to
the joint while maintaining a seal against the loss of saline fluid used to keep
the joint clean. The seal is formed by two elastomeric valves. The first
controls loss of water when there is no instrument or scope therein, while the
second provides a seal when the cannula is in use. The valves operate
automatically.
CODE Lot numbers:
08135AG2 through 08294AG2
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Stryker Endoscopy, San Jose, CA,
Manufacturer:
Stryker, Arroyo, PR.
REASON Leak-resistant barrier may not properly seal and
leak when an instrument is inserted, and keep leaking after instrument is
removed.
VOLUME OF PRODUCT IN COMMERCE
4,914 boxes
(24,570 units)
DISTRIBUTION
Nationwide, Australia,
Brazil, Canada, Chile, China, France, Germany, Greece, India, Italy, New
Zealand, Poland, Portugal, Sweden, Spain, Singapore, Switzerland, and UK.