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U.S. Department of Health and Human Services

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Enforcement Report for March 28, 2007

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.

March 28, 2007
07-13

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

___________________________________
PRODUCT
Knorr Caldo con sabor de Pollo Chicken Flavor Bouillon Peso Neto/Net Wt. 2.5oz (72 grams) Unilever UPC 4800171162 on carton Note: Cases are marked Knorr FIsh Flavor Bouillon, UPC 4800171167 and may contain properly labeled carton of Knorrs Fish flavor Bouillon, Recall # F-125-7
CODE
Best if Used BY Date of Mar 17 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Unilever United States, Inc., Englewood, NJ., by letters on January 31, 2007.
Manufacturer: Unilever de P.R. (Arecibo Plant), Arecibo, PR. Firm initiated recall is complete.
REASON
Containers labeled as chicken bouillon actually contain fish bouillon with cod powder as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
Approximately 400 cartons
DISTRIBUTION
MD, NY, NJ, FL, ME, RI and MA

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

___________________________________
PRODUCT
Diet Coke, 2 liter plastic bottles packed 12 per case, UPC Bar Code: 0 496630 6, Recall # F-127-7
CODE
MAR0507NH C 2300-0039
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coca Cola Enterprises Inc, Atlanta, GA, by letter on December 28, 2006.
Manufacturer: Coca Cola New England Division, Needham, MA. Firm initiated recall is ongoing.
REASON
Product may contain undeclared sugar.
VOLUME OF PRODUCT IN COMMERCE
2,000 cases
DISTRIBUTION
CT and MA

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PRODUCT
a) Donuts - Betsy Ross Family Bakeries brand, 6 Chocolate Donuts in box
with clear plastic window, Net Wt 12 OZ, UPC 72220 022081, Recall # F-134-7;
b) Donuts - Betsy Ross Family Bakeries brand, 6 Old Fashioned in box
with clear plastic window, Net Wt 12 OZ, UPC 72220 22080, Recall # F-135-7
CODE
a) and b) Sell by dates of JAN 30 FS through FEB 7 FS;
RECALLING FIRM/MANUFACTURER
Franz Seattle – Weller (formerly Gai), Seattle, WA, by press release, telephone and email on January 30, 2007. Firm initiated recall is complete.
REASON
Label claims whey as an ingredient, however fails to declare that milk was the source of the whey.
VOLUME OF PRODUCT IN COMMERCE
Chocolate – 351 boxes, Old Fashioned – 657 boxes
DISTRIBUTION
WA, OR, ID and WY

___________________________________
PRODUCT
Avian-Rx™ tablets, Hi-Tech Pharmaceuticals * Dietary Supplement * Bullet Proof Your Immune System * 45 tablets 500mg, Hi-Tech Pharmaceuticals, Inc., 5015 B Unity Drive, Norcross, GA 30871, sold over-the-counter, labeled to contain a combination of herbal ingredients for use as an immune support booster. The primary ingredients (per tablet) listed on the product's labeling include the following: star anise extract, shikimic acid, and hypericum perforatum. The product's labeling recommends a dosage of 3 tablets for 10 days, followed by 1 tablet daily; manufactured January 2006. UPC of: 8 57084 00079 8, Recall # F-158-7
CODE
Lot # 06202044, expiration January 2009
RECALLING FIRM/MANUFACTURER
Hi Tech Pharmaceuticals, Norcross, GA, by letter on/about May 16, 2006. Firm initiated recall is ongoing.
REASON
Dietary Supplement makes unapproved drug claim that it can prevent Bird Flu and also fails to label one of its ingredients, star anise, properly.
VOLUME OF PRODUCT IN COMMERCE
2,331 bottles containing 45 tablets per bottle
DISTRIBUTION
CA, MD, SD and TX

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

___________________________________
PRODUCT
Ultra Brite Advanced Whitening All in One Clean Mint Toothpaste in a 6.0 oz tube, over-the-counter, Distributed by Colgate-Palmolive Company, New York, NY NDC # 065954-064-60; SKU 0156685, UPC 3500056685, Recall # D-468-2007
CODE
Lots 6293, 6294, 6295, 6296, 6297, 6301, 6302, 6303, 6304 and 6305. All lots expire between 10/08 and 01/09.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Colgate Palmolive Company, Jeffersonville, IN, by letter on January 12, 2007.
Manufacturer: Colgate Palmolive Company, Mission Hills, Mexico. Firm initiated recall is ongoing.
REASON
Misbranded; The label ingredient statement is incorrect. The product contains the following ingredients which are not declared: sodium fluoride, PEG-12 and cocamidopropyl betaine and does not contain the following ingredients which are declared: sodium monophosphate, alumina and glycerin.
VOLUME OF PRODUCT IN COMMERCE
1,441,200 tubes
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Breckenridge Pharmacuetical Sulfatol Cleanser, Sodium Sulfacetamide 10%, Sulfur 5% in Urea vehicle, Rx Only, Net Wt. 355 mL tubes, Recall # D-480-2007
CODE
Lot Numbers: 50718E02/07; 50712E06/07; 50329E02/07; 60615E05/08
RECALLING FIRM/MANUFACTURER
Sheffield Laboratories, Div. of Faria Limited LLC, New London, CT, by letter dated February 7, 2007. Firm initiated recall is ongoing.
REASON
Product is subpotent
VOLUME OF PRODUCT IN COMMERCE
71,848 tubes
DISTRIBUTION
FL

___________________________________
PRODUCT
Hydrocortisone Lotion, USP 2.5% (each mL contains 25mg of hydrocortisone in a vehicle consisting of carbomer 940, cetyl alcohol, cholesterol, isopropanol myristate, polysorbate 40, propylene glycol, propylene glycol monostearate, purified water, simethicone, sorbic acid, sorbitan palmitate, and trolamine), 2 fl oz., Rx only, NDC # 0603-7785-52, ANDA: 40-417, Recall # D-483-2007
CODE
Lot No. L025K06A, EXP 10/08
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC, Huntsville, AL, by letters on February 23, 2007 and February 26, 3007. Firm initiated recall is ongoing.
REASON
Superpotent at 3 months for Hydrocortisone
VOLUME OF PRODUCT IN COMMERCE
3935 bottles
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0215-07;
b) Platelets, Pooled, Recall # B-0216-07
CODE
a) Units: KZ59913 (double collection), KZ58041, KZ55657, KZ52830;
b) Unit: KZ58041
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile dated June 16, 2006. Firm initiated recall is complete.
REASON,
Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
WI

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0794-07;
b) Platelets, Recall # B-0795-07
CODE
a) and b) Unit: K67198
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by fax and letter on February 16, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with polycythemia, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA and TN

___________________________________
PRODUCT
Platelets, Recall # B-0797-07
CODE
Unit: L56640
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by fax on February 1, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose eligibility to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0913-07
CODE
Unit: FW51925
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on November 6, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

___________________________________
PRODUCT
Recovered Plasma, Recall # B-0914-07
CODE
Unit: LP50215
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on July 14, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

___________________________________
PRODUCT
Human Cornea for Transplantation, Recall # B-0918-07
CODE
Tissue: 07-0009-200
RECALLING FIRM/MANUFACTURER
East Tennessee Lions Eye Bank, Knoxville, TN, by telephone on January 17, 2007. Firm initiated recall is complete.
REASON
Human tissue for transplantation, which tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
NC

___________________________________
PRODUCT
Human Cornea for Transplantation, Recall # B-0919-07
CODE
Tissues: 07-0022-100, 07-0022-200
RECALLING FIRM/MANUFACTURER
East Tennessee Lions Eye Bank, Knoxville, TN, by telephone on January 31, 2007. Firm initiated recall is complete.
REASON
Human tissues for transplantation, which tested negative for hepatitis prior to distribution, but were subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
NC

___________________________________
PRODUCT
Human Immunodeficiency Virus Type 1 (HIV-1), Vironostika® HIV-1, Microelisa System, Recall # B-0920-07
CODE
Lot number: 160354, expiration date: 4/10/2007
RECALLING FIRM/MANUFACTURER
bioMerieux, Inc., Durham, NC, by letter dated December 18, 2006. Firm initiated recall is complete.
REASON
HIV-1 test kits, with a potential to cause false negative test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
200 test kits
DISTRIBUTION
Nationwide and Canada

___________________________________
PRODUCT
a) Plasma, Cryoprecipitate Reduced, Recall # B-0921-07;
b) Cryoprecipitated AHF, Recall # B-0922-07;
c) Platelets, Recall # B-0923-07;
d) Fresh Frozen Plasma, Recall # B-0924-07
CODE
a) Unit: GV85431;
b) Units: GV85431, KT11679;
c) and d) Unit: LR89955
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on November 29, 2006. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
PA

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0925-07;
b) Red Blood Cells, Recall # B-0926-07;
c) Platelets, Recall # B-0927-07;
d) Cryoprecipitated AHF, Recall # B-0928-07;
e) Recovered Plasma, Recall # B-0929-07
CODE
a) Units: 2246252, 2221931, 2146330, 9222431, 9212327;
b) and c) Unit: 2012839;
d) Unit: 2146330;
e) Units: 2246252, 2221931, 2146330, 9222431, 9212327
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE, by facsimile on November 28, 2006 or by telephone on November 29, 2006, and by follow-up letter dated December 27, 2006.
REASON
Blood products, which tested negative for hepatitis, but were collected from a donor who was previously deferred for positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
DE, MD and NJ

___________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0930-07;
b) Whole Blood, Leukocytes Reduced, Recall # B-0931-07
CODE
a) Unit: FW49080;
b) Unit: FW43972
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on June 6, 2003 or June 19, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI

___________________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0936-07
CODE
Units: FW62404, LR89237
RECALLING FIRM/MANUFACTURER
Blood Center of Wisconsin, Inc., Milwaukee, WI, by facsimile on June 23, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI

___________________________________
PRODUCT
Source Plasma, Recall # B-0937-07
CODE
Unit: 364014398
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, dba Talecris Plasma Resources, Inc., Fort Worth, TX, by facsimile on July 27, 2006. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for new variant Creutzfeldt - Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

___________________________________
PRODUCT
Source Plasma, Recall # B-0840-07
CODE
Units: 363013686, 363005822, 363005839, 363005984, and 363006291
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Fort Worth, TX, by facsimile dated June 30, 2006. Firm initiated recall is complete.
REASON
Source Plasma, collected from donors whose eligibility to donate was not accurately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NC

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0869-07
CODE
Unit: 32GP27476
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Madison, WI, by letter dated October 22, 2003. Firm initiated recall is complete.
REASON
Blood product, which was not stored at appropriate storage conditions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

___________________________________
PRODUCT
a) One Touch Ultra Blood Glucose Test Strips,
b) One Touch Ultra Basic/Profile Test Strips,
Recall # Z-0477-2007
CODE
a) Lot #’s: 2691191, 2691261;
b) Lot #’s 272894A, 2619932, 2606340, 2651211
RECALLING FIRM/MANUFACTURER
Matrix Distributors, Inc., E Brunswick, NJ, by telephone from October 9 to October 13, 2006. A follow-up letter (January 19, 2007) was issued to the pharmacies extending the recall to the user level. Firm initiated recall is ongoing.
REASON
Counterfeit Test Strips (manufacturer unknown)
VOLUME OF PRODUCT IN COMMERCE
800 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
a) HoMedics Thera P Standard size Dry Heating Pad; Model No. HP-100,
UPC 031262003621, Recall # Z-0622-2007;
b) Thera-P Standard size Moist/Dry Heating Pad, Model No. HP-150 (UPC 031262003638)
and sold as Walgreens by HoMedics model number 802857 (UPC 04922149892),
Recall # Z-0623-2007;
c) HoMedics Thera P Standard size Moist/Dry Heating Pad with Auto Shut-off,
Model No. HP-200 (UPC 031262007926), Recall # Z-0624-2007;
d) HoMedics Thera P King size Moist/Dry Heating Pad; Model No. HP-300
(UPC 031262003645), Recall # Z-0625-2007;
e) HoMedics Thera P Model King size Moist/Dry Heating Pad with Auto Shut-off;
Model No. HP-500 (UPC 031262003652), Recall # Z-0626-2007
CODE
All units with a four digit date code ending in '01' (this code is located on the hand control and on the bottom panel of the heating pad box).
RECALLING FIRM/MANUFACTURER
Recalling Firm: HoMedics, Inc., Commerce Township, MI, by press release and letter on February 9, 2007.
Manufacturer: Teamedics, Shenzhen, China. Firm initiated recall is ongoing.
REASON
Heating pads may have a loose electrical connection, which could result in excessive heat being generated that poses a risk of patient burns, fire, and property damage.
VOLUME OF PRODUCT IN COMMERCE
292,108 devices
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

CLASS II MEDICAL DEVICE RECALL EXTENSION
Originally listed in the December 27, 2006 Enforcement Report:

___________________________________
PRODUCT
KaVo QUATTROcare Spray, 500 ml aerosol can; a maintenance spray for lubrication of KaVo turbines, air motors, straight and contra-angle dental handpieces. For use with the KaVo QUATTROcare maintenance unit only; Made in Germany The spray was produced under the following labels: a) KaVo QUATTROcare Spray AMERICA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany, single can: item #04117630, type 2106, 6-pack: item #04117640, type 2106A b) KaVo QUATTROcare Spray CANADA, Kaltenbach & Voigt GmbH, Biberach/Riss Germany; Distributed by SciCan, 1440 Don Mills Rd, Toronto, Ontario, Canada M3B 3P9, single can: item #04117680, type 2107, 6-pack: item #04117690, type 2107A c) KaVo QUATTROcare Spray, Kaltenbach & Voigt GmbH, Postfach 1454, D-88396 Biberach/Riss Germany, single can: item #04117590, type 2108, 6-pack: item #04117720, type 2108A, Recall # Z-0289-2007
CODE
All cans manufactured prior to 11/18/06 Replacement product will have a new date/lot code on the bottom of the can which will end in R3X.
******* On 2/26/07 the firm expanded the recall to include the replacement product which has a lot code on the bottom of the can that ends in R3X.
RECALLING FIRM/MANUFACTURER
Recalling Firm: KaVo America Corp, Lake Zurich IL, by letter, telephone and email on November 22, 2006.
******* KaVo expanded the recall to include the replacement cans with lot numbers ending in R3X via letters dated 2/26/07. The instructions and recall strategy remain the same as in the 11/22/06 letter, but requesting the dealers to notify their customers by 2/28/07. The QUATTROcare Spray will be replaced with Kavo Spray until the problem with the QUATTROcare Spray is resolved.
Manufacturer: Kaltenbach & Voigt Gmbh & Co. KG, Biberach, Germany. Firm initiated recall is ongoing.
REASON
The QUATTROcare Spray cans may allow the gas (propane) to escape from the can under certain circumstances. In rare cases, when an ignition source is nearby, this escape of gas may lead to the emission of smoke and possibly flames from the can which could lead to property damage or personnel injury.
VOLUME OF PRODUCT IN COMMERCE
619,434 cans plus 23,088 replacement cans
DISTRIBUTION
Nationwide and Canada

___________________________________
PRODUCT
Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75, Recall # Z-0497-2007
CODE
Lot ''06AA003'', expiration date 06/08 Lot ''06AA001'', expiration date 06/08 Lot ''06AA002'', expiration date 06/08 Lot ''06AA004'', expiration date 07/08 Lot ''06AA005'', expiration date 07/08 Lot ''06AA006'', expiration date 10/08 Lot ''06AA007'', expiration date 10/08
RECALLING FIRM/MANUFACTURER
Gebauer Company, Cleveland, OH, by letters dated January 23, 2007, February 13, 15, 22, 2007 and by press release on March 1, 2007. Firm initiated recall is ongoing.
REASON
Microbial Contamination. Certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing.
VOLUME OF PRODUCT IN COMMERCE
34545 cans
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) OEC 9800 Fluoroscopic X-ray System, Model Number A349855,
GE Healthcare, Surgery, Recall # Z-0556-2007;
b) OEC FluoroTrak Plus 9800 Fluoroscopic X-ray System, Recall # Z-0557-2007;
c) OEC 9800 Plus Fluoroscopic X-ray System, Recall # Z-0558-2007;
d) OEC 9800MD Motorized C-arm System, Fluoroscopic X-ray System, Recall # Z-0559-2007
CODE
Serial numbers: 82-7092-MH, 89-0247-RC, 89-0599, 89-0972, 89-1001, 89-1685, 89-2383, 89-2877, 89-2907, 89-2987, 89-3330
RECALLING FIRM/MANUFACTURER
GE OEC Medical Systems, Inc, Salt Lake City, UT, by telephone on February 9, 3007 and site visit on February 12, 2007. Firm initiated recall is complete.
REASON
During routine service, a cover may have been installed without the required proper lead shielding.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
a) Baxter Flo-Gard 6201 Volumetric Infusion Pump, catalog #2M8063, 2M8063R
(refurbished), Recall # Z-0632-2007;
b) Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump, catalog #2M8064,
2M8064R (refurbished), Recall # Z-0633-2007;
c) Baxter Flo-Gard 6200 Volumetric Infusion Pump, catalog #2M8043, 2M8043R
(refurbished), Recall # Z-0634-2007;
d) Baxter Flo-Gard 6300 Dual Channel Volumetric Infusion Pump, catalog #2M8048,
2M8048R (refurbished), Recall # Z-0635-2007
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp, Round Lake, IL, by letters on November 27, 2006.
Manufacturer: Baxter Healthcare Corp, Singapore. Firm initiated recall is ongoing.
REASON
There is the potential for non-detection of, and no alarm for, upstream occlusion for Flo-Gard Volumetric Infusion Pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, Buretrol or blood filter.
VOLUME OF PRODUCT IN COMMERCE
219,566 pumps
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
Brilliance CT System, Big Bore Configuration, Model #728243. (version 2.2.1), Recall # Z-0636-2007
CODE
Serial numbers: 7009, 7056, 7060, 7066, 7069, 7072, 7079, 7088, 7111, 7112, 7113, 7114, 7117, 7118, 7119, 7121, 7125
RECALLING FIRM/MANUFACTURER
Phillips Medical Systems (Cleveland) Inc, Cleveland, OH, by letter on October 4, 2006 and October 25, 2006. Firm initiated recall is ongoing.
REASON
Two conditions have been identified with the Philips Medical System Brilliance Bore ,version 2.2.1 Tumor Localization, that may lead the user to misinterpret the displayed data.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
VIASYS VELA Ventilator, Viasys Respiratory Care, Inc., Recall # Z-0638-2007
CODE
Lot numbers: AGT03640 thru AGT06049
RECALLING FIRM/MANUFACTURER
Viasys Respiratory Care, Inc.dba Bird Products, Palm Springs, CA, by letter on January 31, 2007. Firm initiated recall is ongoing.
REASON
The graphical user interface may become slow in its response and in some cases non-responsive. Under some circumstances this situation may cause the ventilator to delay the annunciation of alarms.
VOLUME OF PRODUCT IN COMMERCE
878 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
CELL-DYN 4000 Diluent/Sheath Reagent, List Number 01H73-01, Recall # Z-0640-2007
CODE
Lot Numbers: 1091612, 1091712, 1091812, 1091912, 1092012, 1092112
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letters on February 24, 2004. Firm initiated recall is complete.
REASON
Incorrect Test Results. Product may show a higher than expected platelet background count when used on the CELL-DYN 4000 System and report patient results that are unacceptable (out-of-range).
VOLUME OF PRODUCT IN COMMERCE
9,800 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
BacT/ALERT® FA Culture Bottles, 30 ml, for in vitro diagnostic use, Recall # Z-0643-2007
CODE
Lot 1014768
RECALLING FIRM/MANUFACTURER
bioMerieux, Inc., Durham, NC, by letter on January 12, 2007. Firm initiated recall is ongoing.
REASON
Bacillus sp. contamination was detected in inoculated and uninoculated bottles of BacT/ALERT FA Culture bottles.
VOLUME OF PRODUCT IN COMMERCE
2136 cases (100 bottles per case)
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
BacT/VIEW C.30a Software update (P/N 514515-1) diagnostic data management system, Recall # Z-0644-2007
CODE
All BacT/ALERT 3D instruments (version C.30a only, not the C.30 version of software).
RECALLING FIRM/MANUFACTURER
bioMerieux, Inc., Durham, NC, by letter on December 20, 2007. Firm initiated recall is ongoing.
REASON
Bottle data is not sent to BacT/ALERT 3D instrument.
VOLUME OF PRODUCT IN COMMERCE
1233 disks
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
ADVIA Centaur CP System, Catalog/Part Number 086-A001. Automated Immunoassay Analyzer, Recall # Z-0645-2007
CODE
All serial numbers of the ADVIA Centaur CP System.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer Healthcare, LLC (Diagnostics Division), Tarrytown, NY, by email on November 9, 2006.
Manufacturer: Stratec Biomedical Systems AG, Birkenfeld, Germany. Firm initiated recall is ongoing.
REASON
Firm received complaints for signal 2 & 4 errors, and shifts in Relative Light Units (RLU). Investigations showed that the On-Board Stability (OBS) of the acid & base reagents may be compromised after 4 days after installation onto the Centaur CP system due to evaporation.
VOLUME OF PRODUCT IN COMMERCE
306 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

___________________________________
PRODUCT
Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic agents (i.e. heparin, saline, thrombolytic agents, etc.) in the peripheral vasculature. The wire allows for the delivery of agents in either a "pulse-spray" or "slow weep" technique. Order No. REF: 46-193 (M001461930), Recall # Z-0642-2007
CODE
Lot/Batch #: 9052739
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific, Maple Grove, MN, by letter dated December 12, 2006.
Manufacturer: Boston Scientific Corporation, Miami, FL. Firm initiated recall is ongoing.
REASON
Boston Scientific is voluntarily recalling one lot/batch of Katzen Infusion Wires because they have identified that the label on the carton may indicate a different length device than what is actually in the carton. The affected batch was manufactured using the Katzen Core Assembly of 146 cm, instead of a 177cm assembly.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
Thyrotest TSH POC Rapid membrane test. In vitro diagnostic, Product Code 1020, Recall # Z-0646-2007
CODE
Lot numbers 21086-02 expiration 06/08 and Lot number 02106-06 expiration 04/08.
RECALLING FIRM/MANUFACTURER
Thyro Tec Inc., Honey Brook, PA, by letters on January 24, 2007 and February 5, 2007. Firm initiated recall is ongoing.
REASON
Positive control showed little or no positive line.
VOLUME OF PRODUCT IN COMMERCE
284 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR MARCH 28, 2007

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