Enforcement Report

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.

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March 8, 2006
06-10

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
a) Carbidopa and Levodopa Extended-Release Tablets,
50 mg/ 200 mg, Rx only, 310 (10x31) unit-dose
tablets. The product is packaged as 10 packages/31
packs per package (310 total tablets) in a clear
plastic bag. Only the outer bag is labeled,
Recall # D-172-6;
b) Carbidopa and Levodopa Extended-Release Tablets,
50 mg/ 200 mg, Rx only, 30 tablet unit dose
blister pack. NDC 0615 4568 39, Recall # D-173-6;
c) Carbidopa and Levodopa Extended-Release Tablets,
50 mg/ 200 mg, Rx only, 31 tablet unit dose
blister pack. NDC 0615 4568 31, Recall # D-174-6
CODE
a) Lot #4568-5003, 4568-5004, 4568-5006, 4568-5008,
4568-5009;
b) Lot #4568-5003, 4568-5004, 4568-5005, 4568-5006,
4568-5007, 4568-5010, 4568-5011, 4568-5012;
c) Lot #4568-5003, 4568-5004, 4568-5005, 4569-5006,
4568-5008, 4568-5009
RECALLING FIRM/MANUFACTURER
Recalling Firm: NCS Healthcare of Kentucky Inc, Glasgow, KY, by letter on February 8, 2006.
Manufacturer: Mylan Pharmaceuticals Inc., Morgantown, WV. Firm initiated recall is ongoing.
REASON
The incorrect stability test method was used to assure that the product meets its specifications throughout its shelf life.
VOLUME OF PRODUCT IN COMMERCE
142/10 x 31 count cards, 7,875/31 count cards, 45,054/30 count cards
DISTRIBUTION
Nationwide

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PRODUCT
a) Carbidopa and Levodopa Extended-Release
Tablets, 50 mg/200 mg. The product is
packaged as 250 tablets per bag, NDC
#61392-647-25, Recall # D-175-6;
b) Carbidopa and Levodopa Extended-Release
Tablets, 50 mg/200 mg. The product is
packaged as 30 tablets per box, NDC
#61392-647-30, Recall # D-176-6;
c) Carbidopa and Levodopa Extended-Release
Tablets, 50 mg/200 mg. The product is
packaged as 60 tablets per box, NDC
#61392-647-60, Recall # D-177-6
CODE
a) Lot K36341R25, U37262B25, U38484C25, U36886A25,
U38484A25, U38484D25, U39499B25;
b) K36341R30, K38972B30, U36886A30, U37725A30,
U38484B30, U39499A30, K38972A30, K39542A30,
U37262A30, U37947A30, U38484E30;
c) K36341R60
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland Repack Services LLC, Toledo, OH, by letter on February 8, 2006.
Manufacturer: Mylan Pharmaceuticals Inc., Morgantown, WV. Firm initiated recall is ongoing.
REASON
The incorrect stability test method was used to assure that the product meets its specifications throughout its shelf life.
VOLUME OF PRODUCT IN COMMERCE
13,252/30 count boxes, 983/60 count boxes, 619/250 count bags
DISTRIBUTION
Nationwide

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PRODUCT
Citalopram Hydrobromide 20 mg, 100 Tablets, Rx only, NDC 0172-4741-60, Recall # D-178-6
CODE
Lot 136715D Exp. Date 12/2007
RECALLING FIRM/MANUFACTURER
Ivax Pharmaceuticals, Inc., Cidra, PR, by telephone, on February 1, 2006. Firm initiated recall is ongoing.
REASON
Mislabeling: incorrect expiration date on the label.
VOLUME OF PRODUCT IN COMMERCE
7,032 bottles (100 count)
DISTRIBUTION
Nationwide

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PRODUCT
a) Carbocaine 1.5% mepivacaine hydrochloride
injection USP, 15 mg/mL in 30 mL single dose
vial, Rx only, Sterile Injection For peripheral
nerve block, caudal and epidural anesthesia,
NDC 0074-1041-30, Recall # D-179-6;
b) Carbocaine 2% mepivacaine hydrochloride
injection USP, 20 mg/mL in 20 mL single dose
vial and 50 mL multiple dose vials, Rx only,
Sterile Injection, For peripheral nerve block,
caudal and epidural anesthesia, 20 mL vial:
NDC 0074-1067-20, 50 mL vial: NDC 0074-2047-50,
Recall # D-180-6;
c) Trimethobenzamide HCl Injection, USP, 200
mg/2 mL (100 mg per mL), 2 mL Carpuject
Sterile Cartridge Unit with Luer Lock,
10 units per carton, Rx only, For Intramuscular
Use Only, NDC 0074-1952-32, Recall # D-181-6;
d) Labetalol Hydrochloride Injection, USP,
100 mg/20 mL (5 mg/mL), 20 mL Multidose Vial,
Rx only, Sterile Solution For Intravenous
Injection Only, NDC 0074-2267-20,
Recall # D-182-6;
e) Cefazolin for Injection (lyophilized), equivalent
to 1 gram cefazolin; Single-dose ADD-Vantage
Vial, 25 vials per carton, Rx only, For I.V.
Infusion Only, Note: For use only with ADD-Vantage
Flexible Diluent Container; NDC 0074-4732-03,
Recall # D-183-6;
f) Ketorolac Tromethamine Injection, USP, 60 mg
(30 mg/mL, Rx only, packaged in a) 2 mL
single-dose Carpuject Sterile Cartridge Unit
with Luer Lock -- NDC 0409-2287-61 and
b) Amerinet Choice, 2 mL single-dose fliptop
vials, NDC 0409-3796-61, 25 vials per carton,
Sterile Injectable Anti-Inflammatory, For I.M.
Use Only, Recall # D-184-6;
g) Dobutamine Injection, USP, each mL contains
12.5 mg dobutamine, as the hydrochloride, 250
mg per 20 mL, 20 mL single-dose fliptop vial,
10 vials per carton, must be diluted prior to
use, For I.V. Use Only, Rx only, Sterile
Cardiotonic; NDC 0409-2344-02,
Recall # D-185-6;
h) Clindamycin Injection, USP, 900 mg/6 mL (150
mg/mL), 6 mL single dose fliptop vial, 25 vials
per carton, Rx only, For I.M. or I.V. Use,
dilute before I.V. use; NDC 0409-4052-01,
Recall # D-186-6
CODE
a) Lot 29-245-3A, exp 11/1/2007;
b) Lot 21-335-3A, exp 3/1/2007,
Lot 26-220-3A, exp 8/1/2007;
c) Lot 32-510-3B, exp 8/1/2006;
d) Lot 34-065-3A, exp 8/1/2007;
e) Lot 29-203-DA, exp 3/1/2007;
f) Lot 26-546-LL, exp 2/1/2006,
Lot 33-289-DK, exp 7/1/2007;
g) Lot 33-272-DK, exp 3/1/2007;
h) Lot 33-428-DK, exp 3/1/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc., Lake Forest, IL, by letter on January 24, 2006.
Hospira, Inc., Rocky Mount, NC, firm initiated recall is ongoing.
REASON
Lack of Efficacy; the affected lots were initially received in a frozen state. The labeling claim for these products does not support their use when frozen.
VOLUME OF PRODUCT IN COMMERCE
2,240 units
DISTRIBUTION
OH

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PRODUCT
a) Dollar General Night Time Original Flavor
Multi-Symptom Cold/Flu Relief, Part Number
FP-05-103-41310, Recall # D-188-6;
b) Dollar General Night Time Cherry Flavor
Multi-Symptom Cold/Flu Relief, Part Number
FP-05-103-71210, Recall # D-189-6
CODE
a) Lot numbers(expiration dates): 2932(08/2007),
22933(08/2007), 23180(08/2007), 24179(10/2007),
24222(10/2007), 24306(11/2007), 24361(11/2007),
24479(11/2007), 24753(12/2007), & 24848(01/2008);
b) Lot numbers(expiration dates): 22935 (08/2007),
23183(08/2007), 23496(08/2007), 24129(10/2007),
24224(10/2007), 24308(11/2007), 24484(11/2007),
24608(12/2007), 24689(12/2007), & 24776(12/2007)
RECALLING FIRM/MANUFACTURER
Aaron Industries, Inc., Lynwood, CA, by letter on January 30, 2006. Firm initiated recall is ongoing.
REASON
Misbranding: The identified lots are misbranded in that the Principal Display Panel (PDP) of each of the products' label identifies the Antihistamine contained within the product as Chlorpheniramine Maleate whereas the Antihistamine actually contained within the product as well as identified within the Drug Facts portion of the labeling is Doxylamine Succinate.
VOLUME OF PRODUCT IN COMMERCE
253,746
DISTRIBUTION
Nationwide

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PRODUCT
TriNessa (Norgestimate and Ethinyl Estradiol) Tablets, Oral Contraceptive, packaged in unit dose PVC blisters with an aluminum foil backing, Rx only, NDC 52544-935-28, Recall # D-190-6
CODE
Lot -- Exp: 4CM613 -- MARCH 2006;
4CM614 -- MARCH 2006;
4KM005 -- AUGUST 2006;
4LM024 -- AUGUST 2006;
4LM025 -- AUGUST 2006;
4LM048 -- AUGUST 2006;
4MM101 -- SEPTEMBER 2006;
4MM109 -- SEPTEMBER 2006;
4MM110 -- OCTOBER 2006;
5AM165 -- OCTOBER 2006;
5AM166 -- OCTOBER 2006;
5CM286 -- JANUARY 2007;
5CM294 -- JANUARY 2007;
5CM295 -- JANUARY 2007;
5DM359 -- FEBRUARY 2007;
5EM416 -- MARCH 2007;
5GM426 -- FEBRUARY 2007;
5GM443 -- FEBRUARY 2007;
5GM477 -- APRIL 2007;
5JM547 -- MAY 2007;
5KM623 -- MAY 2007;
5LM657 -- MAY 2007;
5LM658 -- SEPTEMBER 2007
RECALLING FIRM/MANUFACTURER
OMJ Pharmaceuticals, Inc., Manati, PR, by letters on February 9, 2006. Firm initiated recall is ongoing.
REASON
Subpotent: The active Norgestimate component of TriNessa tablets fails stability assay.
VOLUME OF PRODUCT IN COMMERCE
1,383,709/6 packs
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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PRODUCT
Wyeth brand FiberCon calcium polycarbophil, 626 mg., bulk-forming laxative, 36 caplets in blister packs, OTC. Recall # D-171-6
CODE
Lots 6AI0162, 5LE0563, 5KE1121, 5KE1122 and 5KE1123
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan, MI, by telephone on or about February 9, 2006. Firm initiated recall is ongoing.
REASON
Stability data does not support expiration date.
VOLUME OF PRODUCT IN COMMERCE
21,972 packs
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0385-6
CODE
Unit: 11339-4665
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., El Paso, TX, by letter dated March 29, 2004. Firm initiated recall is complete.
REASON
Blood product, manufactured from a unit of Whole Blood that was designated as a low volume collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NM

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0645-6
CODE
Unit: 113469013
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., El Paso, TX, by telephone on May 23, 2005. Firm initiated recall is complete.
REASON
Blood product, manufactured from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

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PRODUCT
Red Blood Cells, Apheresis, Leukocyte Reduced, Recall # B-0646-6
CODE
Unit: 11347347 (Bags 1 & 2)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., El Paso, TX, by telephone on May 25, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NM

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PRODUCT
Platelets, Leukocytes Reduced, Recall # B-0656-6
CODE
Unit: 49GV26362
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK, by telephone on April 19, 2005 and by facsimile on April 20, 2005. Firm initiated recall is complete.
REASON
Blood product associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0661-6
CODE
Unit: 4204008
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Tallahassee, FL, by letter dated February 20, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0670-6
CODE
Unit: 11342-1675
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., El Paso, TX, by letter dated February 24, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NM

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PRODUCT
Red Blood Cells, Apheresis, Recall # B-0671-6
CODE
Unit: GV76365
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by telephone and fax on October 26, 2005. Firm initiated recall is complete.
REASON
Blood product, with a hemoglobin below the acceptable range, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0672-6
CODE
Unit: 06FS82042
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern California Region, Pomona, CA, by letters dated April 9, 2004, and May 10, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0675-6
CODE
Unit: 04LQ35545
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by fax and follow-up letter on November 16, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

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PRODUCT
a) Red Blood Cells, Recall # B-0677-6;
b) Cryoprecipitated AHF, Recall # B-0678-6;
c) Fresh Frozen Plasma, Recall # B-0679-6
CODE
a), b), and c) Unit: 53C03234
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD, by letter dated April 16, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had been deferred after receiving a blood transfusion, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MD and D.C.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

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PRODUCT
Source Plasma, Recall # B-0647-6
CODE
Unit: WSG009430
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on October 21, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Spain

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0658-6
CODE
Units: 21FP24437, 21FP24438, 21KT00990, 21KT00993
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK, by telephone on April 26, 2005. Firm initiated recall is complete.
REASON
Platelets, which were not stored under continuous agitation and controlled temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX

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PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-0669-6
CODE
Unit: S56514
RECALLING FIRM/MANUFACTURER
HCSC-Blood Center, Bethlehem, PA, by telephone on June 29, 2005. Firm initiated recall is complete.
REASON
Blood product, quality control tested with expired reagent, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

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PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0673-6
CODE
Unit: D145521
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by letter dated April 28, 2005. Firm initiated recall is complete.
REASON
Blood product, out of controlled storage for 90 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

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PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0674-6
CODE
Units: 38GP23754 (2 units),
38GP23774, 38GP23775 (2 units),
38GP23786 (2 units),
38P98742 (2 units),
38P98744 (2 units),
38P98750 (2 units),
38P98753 (2 units),
38P98770 (2 units),
38P98784 (2 units),
38P98792 (2 units),
38P98801 (2 units),
38P98811 (2 units),
38P98812 (2 units),
38P98820 (2 units),
38P98846 (2 units),
38P98870 (2 units),
38P98872, 38P98878 (2 units),
38P98880 (2 units),
38P98896 (2 units)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on May 26, 2005. Firm initiated recall is complete.
REASON
Blood products, with un-verified platelet counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION
IN and OH

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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PRODUCT
Ultimax System MDX-8000A equipped with the EPS-Plus/ADR-1000A/E2D Digital Spot Film device for diagnostic fluoroscopic imaging, Recall # Z-0533-06
CODE
Serial numbers D4622390, D4622394, D4623349, D4612382, D5512402.
RECALLING FIRM/MANUFACTURER
Toshiba America Medical Systems, Inc., Tustin, CA, by software installation beginning on February 22, 2006. Firm initiated recall is on going.
REASON
Systems are defective under 21 CFR 1003.2 in that they may deliver radiation unintended to their use.
VOLUME OF PRODUCT IN COMMERCE
5 systems
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) BD Logic - Blood Glucose Monitor,
Catalog numbers: 322051(48), 322029,
322068, 322069, Recall # Z-0560-06;
b) BD Latitude (DMS) - Blood Glucose Monitor,
Catalog numbers: 322050, 322000,
322015, 322067, Recall # Z-0561-06;
c) Paradigm Link - Blood Glucose Monitor,
Catalog numbers: 322200; 322201; 322202;
322203; 322204; 322205; 322206; 322207,
Recall # Z-0562-06;
CODE
All lots under the above Catalog numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters beginning on January 5, 2006 and January 9, 2006.
Manufacturer: Nova Biomedical Corp., Waltham, MA, firm initiated recall is ongoing.
REASON
BD Blood Glucose Monitors may inadvertently switch the Unit of Measure from mg/dL to mmol/L or vice versa during battery insertion or when a meter is dropped.
VOLUME OF PRODUCT IN COMMERCE
1,129,764 units
DISTRIBUTION
Nationwide, Canada and Germany

_______________________________
PRODUCT
AUDICOR 200 D Inovise Part Number 30047 (console part number 20158), Recall # Z-0565-06
CODE
Serial Numbers: 411005, 411007, 411008, 411010, 411011, 411013, 411014, 411015, 411016, 411017, 411018, 411019, 411020, 411023, 411024, 411025, 411026, 411030, 411031, 411032, 411033, 411047, 411048, 411049, 411051, 411052, 411053, 411054
RECALLING FIRM/MANUFACTURER
Inovise Medical, Inc., Portland, OR, by telephone on January 12, 2006, and by visit on January 16-17-2006. Firm initiated recall is ongoing.
REASON
Use of the AUDICOR 200 D in-line with a defibrillator/monitor resulted in interruption of pacing therapy to a patient when the AUDICOR 200 D stopped working due to low battery power.
VOLUME OF PRODUCT IN COMMERCE
28 units
DISTRIBUTION
FL and WA

_______________________________
PRODUCT
a) Accu-Chek Comfort Curve blood glucose
test strips; Reference numbers
12030420001, 12030373001, 12030381001,
12030365001, 04388208001, 04388186001
and 03000141001. (Sold in the United
States), Recall # Z-0566-06;
b) Accu-Chek Advantage blood glucose test
strips; Reference numbers 03144917001,
03144704001, 03145263001, (sold within
the United States) and 12030551001,
12030578001 and 12030586001 (sold
outside of the United States),
Recall # Z-0567-06;
c) Accu-Chek Advantage II blood glucose test
strips; Reference numbers 12030659001,
12030667001, 03137872001, 03137899001,
03000281001, 12030535001, 12030543001,
03033449001, 03033465001 and 12030543047
(All sold outside of the United States),
Recall # Z-0568-06;
d) Accu-Chek Advantage Plus blood glucose
test strips; Reference number 04735102001
(All sold outside of the United States),
Recall # Z-0569-06;
e) Accu-Chek Advantage Pro blood glucose
test strips; Reference number 04534972001
(All sold outside of the United States),
Recall # Z-0570-06;
f) Accu-Chek Sensor Comfort blood glucose
test strips; Reference numbers 03261956170,
03261964170, 03146154192, 03146146192,
03374700023, 03374718023, 11895133192,
11895141192, 03522091016, 03051161003,
03051170003, 03322033122, 03322041122
and 03587304122 (All sold outside of
the United States), Recall # Z-0571-06;
g) Accu-Chek Sensor Comfort Pro blood
glucose test strips; Reference numbers
0375877001, 03360652080, 03051188003,
03620115003 and 04535235003 (All sold
outside of the United States),
Recall # Z-0572-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letters dated February 10, 2006. Firm initiated recall is ongoing.
REASON
There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.
VOLUME OF PRODUCT IN COMMERCE
33 million vials nationwide and 47 million vials internationally
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Roche brand CEDIA Tobramycin II Reagent Catalog # 1815385, Material # 11815385216, Recall # Z-0574-06
CODE
Lot 56292625, exp. 05/31/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by telephone and letter on or about February 10, 2006.
Manufacturer: Microgenics Corp., Fremont, CA, Firm initiated recall is ongoing.
REASON
Product may have tobramycin over-recovery at the trough level.
VOLUME OF PRODUCT IN COMMERCE
1,806 kits
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
The GISH Vision Blood Cardioplegia System with GBS coating (a non-leaching heparin coating) (product desgination VBCXGBS) consists of an extracorporeal heat exhanger and fluid administration set. The heat exchanger consists of a one piece, stainless steel bellows-configured heat exchanger as the primary element to effect heat exchange. This element is encased by a polycarbonate housing, which directs the blood through the convolutions, and therefore improves heat exchange, minimizes priming volume, and reduces shunting. All materials of the heat exchanger are biocompatible. The device allows for the monitoring of pressure and allows for trapping and removal of air. Additionally, the device includes an integral bubble trap, gross filter and pressure relief device designed to open in the event of excessive fluid pressure during use. Solutions are delivered to the patient through a roller pump through the table line extension and appropriate cannula, Recall # Z-0575-06
CODE
315402, 307412, 336406, 010506, 067511, 080507, 171510, 220523, 336410, 005504, 031514, 087515, 143509, 157511, 199513, 234518, 262511, 0535818, 180501, 348420, 053515, 249512, 125515, 157527, 178525, 130500, 241500, 133500, 320408, 234515, 285417, 313418, 334408, 024507, 053510, 117501, 122508, 151509, 210510, 220526, 224519, 328415, 053511, 067515, 157509, 178520, 199510, 266509, 067518, 101520, 220530, 270503, 348400
RECALLING FIRM/MANUFACTURER
Gish Biomedical Inc., Rancho Santa Margarita, CA, by letter on November 14, 2005. Firm initiated recall is ongoing.
REASON
The coated Gish Vision Blood Cardioplegia Systems are associated with an increased incidence of heat exchanger leaks.
VOLUME OF PRODUCT IN COMMERCE
1,216 systems
DISTRIBUTION
CA, FL, IN, MA, MI, NJ, NY

______________________________
PRODUCT
a) Praxair Grab'n Go Vantage unit,
model PRX-9495, Recall # Z-0579-06;
b) Praxair Grab'n Go Vantage unit,
model PRX-9496, Recall # Z-580-06
CODE
All codes (Product manufactured from March, 2005 to the present)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Praxair Distribution, Inc., Middleburg Heights, OH, by letter, dated December 21, 2005.
Manufacturer: Western -- Scott Fetzer Company, Westlake, OH, firm initiated recall is ongoing.
REASON
The units may experience a delay in oxygen flow upon initial actuation.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2,486 units
DISTRIBUTION
OH, MA, IL, CA, UT, PA, MD, IN and Canada

______________________________
PRODUCT
a) Allura Xper FD10/10 x-ray system,
Recall # Z-0581-06;
b) Allura Xper FD10 x-ray system,
Recall # Z-0582-06
CODE
a) Site numbers 533762, 534634, 535667,
534678, 532799, 532800, 539107,
537630, 534638, 533278, 533282,
533283, 538514, 540016, 538744,
538485, 538486, 535415, 538028,
532614, 533476, 538409, 536789,
538516, 532611, 538157, 538368,
536715, 534731, 540841, 537804,
522138, 538903, 538476, 536899,
536028, 540237, 530666, 530667,
533619, 537698, 539628, 541276,
537745, 531942, 542113, 542117,
536138, 533289, 536031, 536034,
536035, 536037, 536042, 540234;
b) site numbers provided with the
Allura Xper FD10/10
RECALLING FIRM/MANUFACTURER
Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on February 6, 2006. Firm initiated recall is ongoing.
REASON
Potential lock-up of system requiring reboot of system.
VOLUME OF PRODUCT IN COMMERCE
55 devices
DISTRIBUTION
Nationwide

______________________________
PRODUCT
UniCel Dxl 800 Access Immunoassay System, Recall # Z-0583-06
CODE
Software Versions 2.2.1 and earlier
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter the week of February 6, 2006.
Manufacturer: Beckman Coulter, Inc., Chaska, MN, firm initiated recall is ongoing.
REASON
The UniCel Dxl 800 Access Immunoassay may aspirate a sample from an incorrect rack and generate a result, which is not flagged (under a specific set of circumstances)
VOLUME OF PRODUCT IN COMMERCE
280 units
DISTRIBUTION
Nationwide and Canada

_______________________________
PRODUCT
B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector, 4000ml size, Catalog Number SH4000, Recall # Z-0586-06
CODE
Lot Numbers: 05A14474, 05A18561, & 05A19926
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical Inc, Irvine, CA, by letter between December 1, 2005 and January 11, 2006.
Manufacturer: Stedim, S.A., Aubagne Cedex, France, firm initiated recall is ongoing.
REASON
A small percentage of the lots leak from the set port when the set port is opened. The leak was identified by Stedim to be due to the incorrect placement of a septum in the set port. The set closure is intact and the leak remains internal until the set port is opened.
VOLUME OF PRODUCT IN COMMERCE
13,480 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

_______________________________
PRODUCT
Centrifuge Model CF-6 with lid lock. (Block Model number OCT-VI), Recall # Z-0563-06
CODE
Serial Numbers: For MTF - 034135 through 034144;
For Cascade - 034119 through 034128
RECALLING FIRM/MANUFACTURER
Cygnus LLC, Paterson, NJ, by letter on February 14, 2005. Firm initiated recall is complete.
REASON
The units were exhibiting tolerance stacking in the electronic circuit timer that controls the electric motor that spins the centrifuge and applies the centrifuge brake.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
NY

______________________________
PRODUCT
Centrifuge Model CF-6 with lid lock. (Block Model Number OCT-VI). Units are distributed to Bloch Scientific, Holbrook, NY for Bloch's customers MFT and Cascade, Recall # Z-0564-06
CODE
Serial Numbers: Labeled for MFT -- 033824; 033825; 033827 through 033840; 033842 through 033844; 033852 through 033855; 033857 through 033863; 034411 through 034415; 034417 through 034445; 08296594 through 08296608.
Labeled for Cascade -- 033690; 033989; 034109; 033942 through 033956; 033958 through 033960; 034119 through 034128
RECALLING FIRM/MANUFACTURER
Cygnus LLC, Paterson, NJ, by letter on September 8, 2005. Firm initiated recall is ongoing.
REASON
When device was packaged, too much expanding foam was added causing the lid to deform and causing the lid locking mechanism to be out of alignment.
VOLUME OF PRODUCT IN COMMERCE
110 units
DISTRIBUTION
NY

______________________________
PRODUCT
a) Star Profile Critical Care (CCX)
Analyzer Catalog Number: 35942,
Recall # Z-0576-06;
b) Star Profile Critical Care PLUS (CCX)
Analyzer Catalog Number: 37413,
Recall # Z-0577-06;
c) CCX Operating Software, Version 4.08,
Recall # Z-0578-06
CODE
a) and b) All serial numbers;
c) Version 4.08
RECALLING FIRM/MANUFACTURER
Nova Biomedical Corporation, Waltham, MA, by letter on January 27, 2006, firm initiated recall is ongoing.
REASON
Analyzers may fail to perform scheduled automatic two-point calibrations and Quality Control runs.
VOLUME OF PRODUCT IN COMMERCE
906 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95, Model Numbers: 3002N95-M, Recall # Z-0587-06
CODE
Lot number 051130-161
RECALLING FIRM/MANUFACTURER
Inovel LLC, Culver City, CA, by letter on February 22, 2006, firm initiated recall is ongoing.
REASON
Mislabeling-A customer reported mislabeled product display boxes. Review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect model/size number.
VOLUME OF PRODUCT IN COMMERCE
40 cases (6,400 respirators)
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR MARCH 8, 2006

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