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U.S. Department of Health and Human Services

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Enforcement Report for December 31, 2008

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

December 31, 2008
08-52

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II 
___________________________________ 
PRODUCT 
Argatroban Injection, 100mg/mL, 2.5mL vials, Rx only, NDC 0007-4407-01. Recall # D-141-2009
CODE 
Lots: C343898, exp. 12/09; C343899, exp. 12/09; C346397, exp. 12/09; C347627, exp. 12/09; C355925, exp. 4/10; C355926, exp. 4/10; C356943, exp. 4/10; C356944, exp. 4/10; C363375, exp. 5/10; C363376, exp. 5/10; C363380, exp. 5/10; and C366042, exp. 5/10.
RECALLING FIRM/MANUFACTURER 
Recalling Firm: GlaxoSmithKline, Inc., Zebulon ,  NC , by letters beginning on November 4, 2008.
Manufacturer: Glaxo Operations UK Limited, Barnard Castle , UK . Firm initiated recall is ongoing.
REASON 
Lack of Assurance of Sterility, some vials may have shoulder cracks that could result in non-sterility and leakage.
VOLUME OF PRODUCT IN COMMERCE 
60,436 units
DISTRIBUTION 
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III 
___________________________________ 
PRODUCT 
(Packaged under a) Preferred Plus label): Earwax Removal Aid, Carbamide Peroxide 6.5%, non USP, Cleanses Ear with Microfoam Action, 0.5 fl. oz. (15 mL), NDC 66879-915-01; Also labeled as b) Pharmacist Recommended, Earwax Removal Aid, Carbamide Peroxide 6.5%, non USP, Cleanses Ear with Microfoam Action, 1 fl. oz. (30 mL), NDC 11383-172-01, Recall # D-140-2009
CODE 
a) Lot H07070, Exp. 8/09; b) Lot : 07080A1, Exp. 8/09
RECALLING FIRM/MANUFACTURER 
Medico Labs, Inc., Hamilton , NJ , by letters on December 1, 2008. Firm initiated recall is ongoing.
REASON 
Failing results for pH of stability samples.
VOLUME OF PRODUCT IN COMMERCE 
11,784 bottles
DISTRIBUTION 
NY, IA
___________________________________ 
PRODUCT 
ZiNGO (lidocaine hydrochloride monohydrate) powder intradermal injection system, 0.5 mg, Rx only. This is a single use product, NDC 28000-105-12, Recall # D-146-2009
CODE 
Lot # A000057 (Exp: 4/10), A000058 (Exp: 5/10)
RECALLING FIRM/MANUFACTURER 
Anesiva, South San Francisco , CA , by letter and fax on November 11, 2008. Firm initiated recall is ongoing.
REASON 
Product may not deliver full dosage as indicated, as testing for emitted dose shows that products do not deliver full dose after 3 months.
VOLUME OF PRODUCT IN COMMERCE 
15,504 intradermal injection systems
DISTRIBUTION 
Nationwide
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0333-09
CODE 
Unit: 1411995
RECALLING FIRM/MANUFACTURER 
Community Blood Council of New Jersey, Inc., Trenton , NJ , by telephone on August 12, 2008. Firm initiated recall is complete.
REASON 
Blood product, which tested positive for Cytomegalovirus (CMV), but was labeled as negative for CMV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
NJ
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0338-09
CODE 
Unit: 9061630
RECALLING FIRM/MANUFACTURER 
Carter BloodCare, Bedford , TX , by telephone on February 19, 2008 and by letter on February 21, 2008. Firm initiated recall is complete.
REASON 
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
TX
___________________________________ 
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0339-09
CODE 
Unit: 4046579 (part 1 and part 2)
RECALLING FIRM/MANUFACTURER 
Carter BloodCare, Bedford , TX , by telephone on March 27, 2008 and by letter on April 8, 2008. Firm initiated recall is complete.
REASON 
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
TX
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0333-09
CODE 
Unit: 72H373764
RECALLING FIRM/MANUFACTURER 
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville , FL , by facsimile on August 7, 2008.
Manufacturer: LifeSouth Community Blood Centers, Inc., Mobile , AL. Firm initiated recall is complete.
REASON 
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
AL
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0341-09
CODE 
Unit: 72F261562
RECALLING FIRM/MANUFACTURER 
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville , FL , by facsimile on June 16, 2008.
Manufacturer: LifeSouth Community Blood Centers, Inc., Brooksville, FL. Firm initiated recall is complete.
REASON 
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
FL
___________________________________ 
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0342-09
CODE 
Unit: 72F682645
RECALLING FIRM/MANUFACTURER 
LifeSouth Community Blood Centers, Inc., Gainesville , FL , by facsimile on June 24, 2008.
REASON 
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
FL
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0353-09
CODE 
Units: W11916, W08504
RECALLING FIRM/MANUFACTURER 
Northern Illinois Blood Bank dba Rock River Valley BC, Rockford, IL, by facsimile on July 31, 2008 and by letter dated July 31, 2008, Firm initiated recall is ongoing.
REASON 
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
2 units
DISTRIBUTION 
IL and NC
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0337-09
CODE 
Unit: 6614642
RECALLING FIRM/MANUFACTURER 
BloodNet USA, Inc., Lakeland , FL , by facsimile on August 16, 2005. Firm initiated recall is complete.
REASON 
Blood product, which was labeled with an incorrect expiration date and product code, was distributed.
VOLUME OF PRODUCT IN COMMERCE 
1 unit
DISTRIBUTION 
FL
___________________________________ 
PRODUCT 
a) Fresh Frozen Plasma, Recall # B-0350-09;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0351-09
CODE 
a) Units: 2541733, 2541736, 2541737, 2541738, 2541741, 2541758, 2541759;
 
b) Units : 2541731, 2541732, 2541733, 2541734, 2541735, 2541736, 2541737, 2541738, 2541739, 2541740, 2541742, 2541743, 2541744, 2541745, 2541746, 2541747, 2541748, 2541749, 2541750, 2541753, 2541754, 2541755, 2541756, 2541757, 2541758, 2541759, 2541760, 2541761, 2541762, 2541763, 2541764, 2541765, 2541767, 2541768
RECALLING FIRM/MANUFACTURER 
Medic, Inc., Knoxville , TN , by telephone on April 10, 2007 and by letter dated April 13, 2007. Firm initiated recall is complete.
REASON 
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
41 units
DISTRIBUTION 
TN and KY
___________________________________ 
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-0352-09
CODE 
Units: 4458387, 4458421, 4458445
RECALLING FIRM/MANUFACTURER 
LifeShare Blood Centers , Baton Rouge , LA , by telephone on December 7, 2007. Firm initiated recall is complete.
REASON 
Blood products, collected from an unsuitable donor due to a history of hemochromatosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 
3 units
DISTRIBUTION 
LA
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I 
___________________________________ 
PRODUCT 
Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic Green System Handles, Sterile Disposable. Contents 20, Recall # Z-0459-2009
CODE 
Lots: Gj; Ha
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Sun Med, Inc., Largo , FL, by letter on April 27, 2007 and by press release on December 12, 2008.
Manufacturer: Medical Devices (Pvt) Ltd., Sialkot , Pakistan . Firm initiated recall is ongoing.
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, Recall # Z-0509-2009;
 
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, Recall # Z-0510-2009;
 
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, Recall # Z-0511-2009;
 
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, Recall # Z-0512-2009;
CODE 
All units
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Stryker Leibinger USA , Portage , MI , by letter dated October 24, 2008.
Manufacturer: Contract Medical Manufacturing, Oxford , CT. Firm initiated recall is ongoing.
REASON 
Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE 
322 units
DISTRIBUTION 
VA, HI, KS, AZ, GA, NY
 
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II 
___________________________________ 
PRODUCT 
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763, Recall # Z-0445-2009;
 
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 ), Recall # Z-0446-2009
CODE 
a) Serial numbers 0396 through 1049;
b) Serial numbers 0188 through 1027
RECALLING FIRM/MANUFACTURER 
Terumo Cardiovascular Systems, Corp., Ann Arbor , MI , by letter dated April 17, 2008. Firm initiated recall is ongoing.
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, Recall # Z-0449-2009
CODE 
Software Version: SFW-00700, Rev-002
RECALLING FIRM/MANUFACTURER 
Hologic, Inc., Bedford , MA , by telephone on September 23-24, 2008 and by letter on September 25, 2008. Firm initiated recall is complete.
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, Recall # Z-0461-2009;
 
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, Recall # Z-0462-2009;
 
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, Recall # Z-0463-2009;
 
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, Recall # Z-0464-2009;
 
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, Recall # Z-0465-2009;
 
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, Recall # Z-0466-2009;
 
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, Recall # Z-0467-2009;
 
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, Recall # Z-0468-2009;
 
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, Recall # Z-0469-2009;
 
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, Recall # Z-0470-2009;
 
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, Recall # Z-0471-2009
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 , by letter dated September 19, 2008.
Manufacturer: Statcorp, Inc., Jacksonville , FL. Firm initiated recall is ongoing.
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, Recall # Z-0476-2009
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, by letter on September 9, 2008. Firm initiated recall is ongoing.
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 FitT Developer Kit, Product Numbers: 30025 (InSure Quik Fit Developer Kit) and 50025 (Insure® Quik FitT containing Developer Kit and Patient Collection Kits. Product Number 30025 - InSure® Quik FitT Developer Kit (1 Box). Each box contains: 25 InSure® Quik FitT Test Strips (1 per foil pack), 1 InSure® Quik FitT Conjugate Solution, I InSure® Quik FitT Run Buffer, and 1 InSure® Quik FitT Product Instructions. Product 50025 - InSure® Quik FitT contains 25 Patient Kits & 1 Developer Kit, Recall # Z-0480-2009
CODE 
Lot number: B1478, Exp. Date 11/30/2008
RECALLING FIRM/MANUFACTURER 
Enterix, Inc., Edison , NJ , by letters on October 3, 2008. Firm initiated recall is ongoing.
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, Recall # Z-0486-2009
CODE 
Not coded
RECALLING FIRM/MANUFACTURER 
FHC, Inc., Bowdoinham , ME , by letter on October 8, 2008. Firm initiated recall is ongoing.
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, Recall # Z-0496-2009
C ODE 
All serial numbers
RECALLING FIRM/MANUFACTURER 
Thoratec Corp., Pleasanton , CA , by letter dated October 21, 2008. Firm initiated recall is ongoing.
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, Recall # Z-0500-2009
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 , by letter dated September 29, 2008 and by telephone beginning September 30, 2008. Firm initiated recall is ongoing.
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, Recall # Z-0524-2009
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 , by letter on July 22, 2008.
Manufacturer: Siemens Medical Solutions Diagnostics, Los Angeles , CA. Firm initiated recall is ongoing.
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, Recall # Z-0593-2009
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 , by letter dated October 22, 2008.
Manufacturer: Smiths Medical, Hythe , Kent , UK . Firm initiated recall is ongoing.
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, Recall # Z-0621-2009
CODE 
Batch/Lot number: EG5577
RECALLING FIRM/MANUFACTURER 
Recalling Firm: Boston Scientific Corp., Maple Grove , MN , by letter dated November 21, 2008.
Manufacturer: Interventional Technologies Europe Ltd., A subsidiary of Boston Scientific Letterkenny, County Donegal, Republic of Ireland. Firm initiated recall is ongoing.
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, Recall # Z-0622-2009
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, by letter dated September 19, 2008 and by e-mail and fax on September 25, 2008.
Manufacturer: Unimax Medical Systems, Taipei , Taiwan . Firm initiated recall is ongoing.
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
  
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III 
___________________________________ 
PRODUCT 
a) Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro Plate EIA kit. Product number 61456, Recall # Z-0477-2009;
 
b) Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro Plate EIA kit. Product Number 61452, Recall # Z-0478-2009;
 
c) Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro Plate EIA kit. Product number 61454, Recall # Z-0479-2009
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 , by letter dated September 8, 2008. Firm initiated recall is ongoing.
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
  
END OF ENFORCEMENT REPORT FOR DECEMBER 31, 2008

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