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U.S. Department of Health and Human Services

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Enforcement Report for February 22, 2006

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.

February 22, 2006
06-08

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

______________________________
PRODUCT
a) Shampoo caps with conditioner, 1 disposable
shampoo cap per package, 30 packages per case.
The shampoo caps are manufactured under the
following labels: (1) CompleteBath,
(2) ReadyBath, and (3) No Rinse Shampoo Cap,
Recall # F-068-6;
b) No-Rinse Shampoo Cap, Shampoo & Condition
Hair with Absolutely No Water, No Mess,
No Rinsing. Recall # F-069-6
CODE
All inventory manufactured prior to 10/27/05. An example of the code would be A102705 or B102705.
RECALLING FIRM/MANUFACTURER
ICP Medical, Olivette, MO, by letter dated October 26, 2005 and November 2, 2005, and by press release on October 31, 2005. Firm initiated recall is ongoing.
REASON
Shampoo caps may be contaminated with Serratia marcescens.
VOLUME OF PRODUCT IN COMMERCE
Approximately 10,962/30-cap cases
DISTRIBUTION
IL, OH, and MO

______________________________
PRODUCT
Trader Joe's Gourmet Chocolate Fudge Original, Recall # F-070-6
CODE
BB 07/01/06 Lot 008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trader Joe's, Monrovia, CA, by press release on January 4, 2005.
Manufacturer: Alexander's Famous Foods, Los Angeles, CA. Firm initiated recall is ongoing.
REASON
The product may contain walnuts that are not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
1,296 units (8 oz)
DISTRIBUTION
CT, DE, MD, MA, NJ, NY, PA, and VA

______________________________
PRODUCT
a) Refrigerated vending machine sandwiches:
Chicken Salad, net wt. 4.5-oz., packaged
under the Hasty Tasty Sandwiches/Valley
Vending label, and the following private
labels: M & M Vending, and Venture Vending,
Recall # F-071-6;
b) Refrigerated vending machine sandwiches:
Ham Salad, net wt. 4.5-oz., packaged
under the Hasty Tasty Sandwiches/Valley
Vending label, and the following private
labels: M & M Vending, and Venture Vending,
Recall # F-072-6;
c) Refrigerated vending machine sandwiches:
Egg Salad, net wt. 4.5-oz., packaged
under the Hasty Tasty/Valley Vending
Sandwiches label, and the following private
labels: M & M Vending, and Venture Vending,
Recall # F-073-6;
d) Refrigerated vending machine sandwiches:
Tuna Salad, net wt. 4.5-oz., packaged
under the Hasty Tasty/Valley Vending
Sandwiches label, Recall # F-074-6
CODE
a) On or before 1/26/06;
RECALLING FIRM/MANUFACTURER
Hasty Tasty Food Service, Davenport, IA, by telephone on January 26,2006. Firm initiated recall is complete.
REASON
The sandwiches contain undeclared sweet dairy whey and butter.
VOLUME OF PRODUCT IN COMMERCE
1,188 sandwiches
DISTRIBUTION
IA and IL

______________________________
PRODUCT
Yoruk Dried Apricots, 8 oz. sealed plastic bag, Recall # F-075-6
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Ethnic International Holding, Inc., Cranbury, NJ, by press release and letter on November 15, 2005. Firm initiated recall is ongoing.
REASON
Dried Apricots contain undeclared sulfites based on the New York State Department of Agriculture and Markets' analysis.
VOLUME OF PRODUCT IN COMMERCE
59 lbs.
DISTRIBUTION
VA, MD, and NY

______________________________
PRODUCT
Product is labeled as part: Publix Bakery**Cinnamon Raisin Sliced Bagels 4 Bagels net wt. 12 oz (340 g), Recall # F-076-6
CODE
Lot number 30351
RECALLING FIRM/MANUFACTURER
Recalling Firm: Publix Super Markets, Inc., Lakeland, FL, by e-mail on January 2, 2006 and by press release dated January 4, 2006. Firm initiated recall is ongoing.
REASON
Four packs of bagels labeled as cinnamon raisin bagels actually contained egg bagels. The label does not list any ingredient derived from egg.
VOLUME OF PRODUCT IN COMMERCE
327 cases
DISTRIBUTION
FL

______________________________
PRODUCT
Martin's Potatobread Soft Cubed Stuffing 12 oz packages, Recall # F-078-6
CODE
Sell by dates: 2/8/06, 2/15/06, 2/22/06, 3/1/06, 3/8/06 and 3/15/06
RECALLING FIRM/MANUFACTURER
Martin's Famous Pastry Shoppe, Inc., Chambersburg, PA, by telephone, e-mail and/or fax and by press release on November 21, 2005. Firm initiated recall is ongoing.
REASON
Product contained undeclared wheat and dairy.
VOLUME OF PRODUCT IN COMMERCE
129,232 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS III

______________________________
PRODUCT
A & W Sparkling Vanilla Cream Soda Caffeine Free packaged in 20-fl. oz. plastic bottles, 24 bottles per case. Recall # F-077-6
CODE
G5188OT5, G5196OT5, G5197OT5, G5202OT5, G5204OT5, G5209OT5, and G5210OT5
RECALLING FIRM/MANUFACTURER
The American Bottling Co, Ottumwa, IA, by telephone on August 1, 2005. Firm initiated recall is complete.
REASON
The bottles were labeled as caffeine free but the product contained caffeine.
VOLUME OF PRODUCT IN COMMERCE
18,553/24/20-fl. oz. bottles cases
DISTRIBUTION
IA, NE, SD, KS, MO, MN, ND, and WI

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

______________________________
PRODUCT
AMO Endosol, Balanced Salt Solution, Each mL contains: Sodium chloride 0.64%; potassium chloride 0.075%; calcium chloride, dihydrate 0.048%, magnesium chloride, hexahydrate 0.03%; sodium acetate, trihydrate 0.39%; sodium citrate, dihydrate 0.17%, 500mL Glass Bottles and 18mL and 500mL plastice bottles, Rx only, Recall # D-167-6
CODE
500 mL Glass Bottles NDC 23731-8100-5, Lot #s A5l5B A51B A52B A537B A53B C519D D556B F521B F523B F525B F526B F527B G516B G517B G532B G536B G545B H516B H517B H518D H519B H520B H545B H554B K527B M41B M42B M43B M44B M48B ---- 18mL Plastic Bottles NDC 23731-8100-8, Lot #s B526J B527J B535J B536J B552J C529E C530E C537E C538E C539E C544E C545E C546E C547E C56E C57E C58E D510E D51lE D512E D513E D51E D570L D59E E528K E528L E529K E529L E531K E531L E532K E532L F520K F520L F530K F530L F56K F56L H524K H54K H552K J53K ----- 500mL Plastic Bottles, NDC 23731-8100-1, Lot #s A514B A525B A526B B515D B516D B547D C510D C51lD C512D C513B D521B E515B E516B E539B E540B F414B F415B F514B F533B F534B F54B F55B G413B G414B G415B G416B G417B G519B G520B G527B G528D G544B G547B H527B H528D H546B H558D J524B J525B J526B M416B
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advanced Medical Optics, Inc., Santa Ana, CA, by letter on November 18, 2005.
Manufacturer: Cytosol Laboratories, Inc., Braintree, MA. Firm initiated recall is ongoing.
REASON
Failed Pyrogen Test Specifications
VOLUME OF PRODUCT IN COMMERCE
370,338 bottles
DISTRIBUTION
Nationwide, Dominican Republic, and Barbados

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
a) Furosemide Tablets, USP, 40mg, 1000 and
5000 count bottles (packaged in white HDPE
bottles), Rx only, NDC 0603-3740-32 (1000s)
and NDC 0603-3740-34 (5000s), Recall # D-161-6
b) Furosemide Tablets, USP, 80mg, 500 and 1000
count bottles (packaged in white HDPE bottles),
Rx only, NDC 0603-3751-28 (500s) and
NDC 0603-3741-32 (1000s), Recall # D-162-6
CODE
a) Lot Nos.: T012J04A, exp 09/06;
T013J04A, exp 09/06; T013J04B, exp 09/06;
b) Lot Nos.: T009J04A, exp 09/06;
T009J04B, exp 09/06
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC, Huntsville, AL, by letters on December 14 and 15, 2005. Firm initiated recall is ongoing.
REASON
Mold Growth
VOLUME OF PRODUCT IN COMMERCE
5,772 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Metformin Hydrochloride Extended-Release Tablets 500 mg, 100 count bottles, Rx only, NDC 0172-4435-60, Recall # D-164-6
CODE
142691A
RECALLING FIRM/MANUFACTURER
Ivax Pharmaceuticals, Inc., Cidra, PR, by letter, on December 28, 2005. Firm initiated recall is ongoing.
REASON
Subpotent
VOLUME OF PRODUCT IN COMMERCE
8,459 bottles (100-count)
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Nifediac CC (Nifedipine) Extended-Release Tablets, USP 30 mg,100 count bottles, Rx only, NDC 0093-5272-01, Recall # D-168-6
CODE
Lot number's: 000407T12 exp 05/2006, 000410T15 exp 08/2006, 000412T53 exp 01/2006, 000503T03 01/2007 and 000505T25 exp 02/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals, USA Sellersville, PA, by letter dated January 11, 2005.
Manufacturer: Biovail Corporation, Mississauga, Ontario, Canada, Firm initiated recall is ongoing.
REASON
Superpotent
VOLUME OF PRODUCT IN COMMERCE
45,347 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0295-6
CODE
Unit numbers: 0749041, 0749042, 0749044, 0749045, 0749046, 0749047, 0749048, 0749050, 6179068, 6179069, 6179070, 6179072, 6179075, 6179078, 6179079, 6179080, 6179081, 6179086, 6179089, 6179090, 6179092, 6179351, 6179352, 6179358, 6179360, 6179361, 6179362, 6179363, 6179778, 6179781, 6180112, 6180113
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on March 25, 2003. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for antibody to hepatitis B core antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION
CO, NY, FL, MS, and VA

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
Recall # B-0383-6;
b) Platelets Pheresis, Leukocytes Reduced,
Irradiated, Recall # B-0384-6
CODE
a) Unit numbers: GS44538, GS47010, GS49338, GS49894,
GS49909, GS55029, GS55040, GS55096, GS49935, GS44805;
b) Unit numbers: GS44613, GS46583, GS55004, GS55019,
GS55117
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by letter dated July 30, 2004. Firm initiated recall is complete.
REASON
Blood products, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0458-6
CODE
Unit number 7154369
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., Bradenton, FL, by facsimile on February 3, 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
FL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0511-6
CODE
Unit number 113445944
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, El Paso, TX, by telephone on February 7, 2005. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly tested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NM

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0512-6;
b) Recovered Plasma, Recall # B-0513-6
CODE
a) and b) Unit number: D147235
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by facsimile on December 9, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria and WA

_______________________________
PRODUCT
Source Plasma, Recall # B-0514-6
CODE
Unit number: RZ007153
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Hammond, IN, by facsimile on October 20, 2005. Firm initiated recall is complete.
REASON
Blood product, that tested elevated for Alanine Aminotransferase (ALT), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

_______________________________
PRODUCT
Source Plasma, Recall # B-0562-6
CODE
Unit numbers: RM135330, RM135158, RM134910, RM134723, RM124751, RM124573, RM124279, RM127410, RM127219, RM127009, RM126538, RM126207, RM125955, RM125799, RM124067, RM123787, RM123544, RM123242, RM123066, RM122759, RM122567, RM122317, RM122058, RM121829, RM121559, RM121303, RM121129, RM119718, RM119575, RM119271, RM118758, RM118559, RM118275, RM118084, RM117792, RM117582, RM117376, RM117143, RM116868, RM116613, RM116337, RM116046, RM115857, RM115631, RM115428, RM112983, RM111224, RM110950, RM110680, RM110425, RM110067, RM109859, RM109328, RM108863, RM108257
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Hattiesburg, MS, by facsimile transmission dated April 29, 2004. Firm initiated recall is complete.
REASON
Source Plasma, collected from a previously deferred donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
55 units
DISTRIBUTION
NC, CA, and VA

_______________________________
PRODUCT
Human Tissue for Transplantation, Recall # B-0585-6:
a) CryoGraft, Ascending Thoracic Aorta;
b) CryoGraft, Descending Thoracic Aorta;
c) CryoGraft, Peroneus Tendon;
d) CryoGraft, Pulmonary Artery SG;
e) CryoGraft, Quadriceps Tendon;
f) CryoGraft, Tibialis Tendon;
g) CryoPatch, Pericardium;
h) CryoPatch, Pulmonary Hemi-Artery;
i) CryoPatch, Pulmonary Monocusp Hemi-Artery;
j) CryoVein, Femoral Vein;
k) CryoVein, Saphenous Vein
CODE
a) Tissue 6170579;
b) Tissue 8026244;
c) Tissues 8006123, 8006139, 8013723, 8069253,
8033748, 8033824;
d) Tissue 7988025;
e) Tissues 8033835, 4119355;
f) Tissues 8026292, 8026251, 8021192, 8021180, 8025826,
8025816, 7960138, 7960151, 7960120, 7960142;
g) Tissue 80473335;
h) Tissue 8366898;
i) Tissue 8026238;
j) Tissue 7972025;
k) Tissues 8025321, 8042392, 6201504
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letters beginning November 17, 2003. Firm initiated recall is ongoing.
REASON
Human tissues for transplantation, recovered from a donor for whom the companion sample from a different site was positive for microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE
28 tissues
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0626-6
CODE
Unit number: 7614244
RECALLING FIRM/MANUFACTURER
Florida Blood Services Inc., Bradenton, FL, by fax on January 21, 20003. 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

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-0628-6
CODE
Unit numbers: 16KF49520 (split)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH, by telephone on July 28, 2005 and follow-up letter dated July 29, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected in an apheresis collection kit that may have exceeded the acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
Recall # B-0630-6;
b) Platelets Pheresis, Leukocytes Reduced,
Irradiated, Recall # B-0631-6
CODE
a) Unit numbers: 20FR13403, 20FR13416 (2 units),
20FR13420, 20FR13422, 20FR13426, 20FR13427,
20FR13429, 20FR13430, 20FR13433, 20FR13440,
20FR13443, 20FR13446, 20P19865 (2 units),
20P19880 (2 units), 20P19885, 20P19891, 20P19894,
20P19900 (2 units), 20P19905, 20P19913, 20P19927,
20P19943, 20P19952 (2 units), 20P19966,
20P19988 (2 units), 20P20008 (2 units), 20P20091;
b) Unit numbers: 20FR13411, 20FR13451, 20P19885,
20P19905, 20P19977
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Boise, ID, by letter dated December 23, 2003. Firm initiated recall is complete.
REASON
Blood products, collected using automated equipment that was not validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
39 units
DISTRIBUTION
ID, MT, and UT

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0639-6
CODE
Unit numbers: 04KK04254, 04KK04258, 04KK04259, 04KQ48944, 04KQ48945, 04KQ49017, 04KQ49030, 04KQ49034, 04KQ49036, 04KT77257, 04KT77259, 04KT77264, 04KT77266, 04KT77268, 04KT77269, 04KT77272, 04KT77276, 04KT77283, 04KT77284, 04KT77289, 04KT77387, 04KT77393, 04KT77395, 04KT77399, 04KT77406, 04KT77414, 04KK04248
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by telephone on September 1, 2005 and by letter dated September 8, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose arm scrubs may have been incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
CA, MA, ME, NH, NY, and Vermont

_______________________________
PRODUCT
Recovered Plasma, Recall # B-0643-6
CODE
Unit numbers: R170537, R165863, and R158308
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by facsimile on October 7, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT
Human Tissue for Transplantation, Recall # B-0390-6:
a) Achilles Tendon;
b) Lordotic ASR Cortical-Cancellous Block;
c) Cancellous Chips (4-10 mm) 30 cc
CODE
a) allograft numbers: 2886064, 2886065;
b) allograft numbers: 2857241, 2857242, 2857243,
2857244, 2857245, 2857246, 2857247, 2857248,
2857249, 2857250, 2857251, 2857252, 2857253,
2857254, 2857255, 2857256;
c) allograft numbers: 2857257, 2857258, 2857259,
857260, 2857261
RECALLING FIRM/MANUFACTURER
Southeast Tissue Alliance, Inc., Gainesville, FL, by letter dated July 22, 2005 or August 25, 2005, firm initiated recall is complete.
REASON
Human tissue, recovered from a donor in which infectious disease testing was performed with an invalid testing specimen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
23 allografts
DISTRIBUTION
FL, TN, and Korea

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0591-6
CODE
Unit numbers: GQ47665, GW56060, GN37778, GN39004, GX84436, GQ47675, GN35664, GN35656, Y90950, GN36857, GQ47527, GN29994, GN35901, GN36789, GN35895, GX84218, GN36347
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by letter dated October 22, 2004. Firm initiated recall is complete.
REASON
Blood products, which were exposed to unacceptable temperatures during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0592-6
CODE
Unit number: 182J10355
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by in-person visit on September 23, 2005. Firm initiated recall is complete.
REASON
Blood product, which was shipped at an unacceptable temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0612-6
CODE
Unit numbers: 11347-1394 (splits 1, 2, 3), 11347-1395 (splits 1,2,3), 11347-4202 (split 1,2,3), 11347-4206 (split 1,2,3)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, El Paso, TX, by telephone on June 10, 2005. Firm initiated recall is complete.
REASON
Platelets, not manufactured according to manufacturer's specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
CO, NM, and TX

_______________________________
PRODUCT
Source Plasma, Recall # B-0614-6
CODE
Unit number SP151077
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, San Diego, CA, by facsimile on August 28, 2003. 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
Austria

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0627-6
CODE
Unit numbers: 4836761, 4836762, 4836764, 4836765, 4836766, 4836767, 4836769, 4836770, 4836771, 4836773, 4836774, 4836775
RECALLING FIRM/MANUFACTURER
Northwest Florida Blood Center, Inc., Pensacola, FL, by fax on June 22, 2004.
REASON
Blood products, collected from donors whose temperatures had been taken using an unapproved method, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
FL

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0635-6
CODE
Unit number 6867900
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by telephone on November 10, 2003. Firm initiated recall is complete.
REASON
Platelets, which were irradiated twice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
a) Proteus XR/a Radiographic X-ray System,
models 2259973-1, 2259973-2, 2259973-3,
2259973-4. The system consists of a
radiographic table, a overhead tube
suspension, high frequency generator and
power distribution unit, wall stand, dual
focal spot x-ray tube and operator's
console, Recall # Z-0219-05;
b) Precision 500D Radiographic/Fluoroscopic
X-ray System, model numbers 2225849, 005853.
The Precision 500D system consists of an X-ray
generator; angulating table with X-ray Tube,
collimator and image intensifier; wall stand;
overhead tube suspension; operator console
and digital archive system, Recall # Z-0220-05
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
General Electric Med Systems LLC, Waukesha, WI, by letter on December 30, 2004 and site visit thereafter. Firm initiated recall is complete.
REASON
Units had a defect in accordance with 21 CFR 1003.2 because an incorrect exposure can occur.
VOLUME OF PRODUCT IN COMMERCE
Approximately 3,638 units
DISTRIBUTION
Nationwide and Internationally

 ______________________________
PRODUCT
Architect Stat Troponin-I Reagent Kit, list 2K41-20; each 400 test kit contains 4 bottles each of microparticles, conjugate and assay diluent, Recall # Z-0513-06
CODE
Lot 95567G005, Exp. 6-30-2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letters dated December 20, 2005.
Manufacturer: Fisher Diagnostic, a Company of Fisher Scientific LLC, Middletown, VA. Firm initiated recall is ongoing.
REASON
There has been an increase in customer complaints observed for failure to calibrate or inability to generate patient result errors.
VOLUME OF PRODUCT IN COMMERCE
181 kits
DISTRIBUTION
Nationwide, Canada, Australia, Germany and Taiwan

_______________________________
PRODUCT
Microlab AT, part numbers 135001, 135001OOC, 135002, 135003, 135005, 135006, 135006R, 135007, 135008, 135016, 135028, 135029, 936400, 936400BLU. Microlab AT+ and Microlab AT+2, part numbers 142000, 142001, 142001R, 142002, 142003, 142005, 142006, 142006R, 142007, 142008, 142009, 142015, 142017, 142035, 142036, Recall # Z-0514-06
CODE
All codes included
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hamilton Co., Reno, NV, by letters on December 15, 2005.
Manufacturer: Hamilton Bonaduz, Bonaduz, Switzerland. Firm initiated recall is ongoing.
REASON
Heat sinking on power boards may not operate as intended and the board may cease to operate.
VOLUME OF PRODUCT IN COMMERCE
1,071 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Babylog 8000 plus with software version 5.n. Neonatal Respirator-Continuous Ventilator. Catalog numbers 8418300, 8411162, 8418002, and 8418000, Recall # Z-0515-06
CODE
Software version 5.n
RECALLING FIRM/MANUFACTURER
Recalling Firm: Draeger Medical, Inc., Telford, PA, by letter on January 3, 2006.
Manufacturer: Draeger Medical AG & Co., Lubeck, Germany. Firm initiated recall is ongoing.
REASON
Failure to generate an alarm when an unintended disconnection occurs.
VOLUME OF PRODUCT IN COMMERCE
2,261 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Clinical Chemistry Multiconstituent Calibrator, List number: lE65-02, Recall # Z-0516-06
CODE
Lot number(s): 19906M200 (expiration date 02/28/2006), 20879MIOO (expiration date 02/28/2006), & 26674MIOO (expiration date 07/31/2006)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories Diagnostic Div, South Pasadena, CA, by letter on December 27, 2005.
Manufacturer: Medical Analysis Systems Inc., Camarillo, CA, Firm initiated recall is ongoing.
REASON
The two Multiconstituent Calibrator (MCC) lot numbers 19906M200 and 20879M100 failed to meet product performance expectations throughout the labeled expiration period, as a result of the shortened expiration dating, two lots are now expired. The expiration date for Lot number 26674M100 will be revised from 2006-07-31 to 2006-01-31.
VOLUME OF PRODUCT IN COMMERCE
13,961 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Ultraview SL Capnography Module, Model 91517 A mainstream and sidestream gas analyzer designed to measure the concentration of carbon dioxide in a gas mixture, to aid in determining the patient's ventilatory, circulatory, and metabolic status. Recall # Z-0517-06
CODE
Lot number BMP007559
RECALLING FIRM/MANUFACTURER
Spacelabs Medical Incorporated, Issaquah, WA, by telephone on July 20, 2005. Firm initiated recall is ongoing.
REASON
The transducer used to compensate for pressure changes was mounted backwards on the printed circuit board assembly. The module will not compensate for pressure changes and CO2 readings will be inaccurate at higher altitudes.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
WY, France and Belgium

______________________________
PRODUCT
Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair, Recall # Z-0518-06
CODE
Serial numbers: 1GMo1B5500522 1GL02B7500022, 1GL02B7500019, 1GM01B6500422, 1GL02B9400338
RECALLING FIRM/MANUFACTURER
Sunrise Medical, Fresno, CA, by telephone and letter on November 9, 2005. Firm initiated recall is complete.
REASON
While operating the powered wheelchair beyond a specified angle of recline, the wheelchair can travel at an unsafe speed when in this position.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA, MA, NC, and OH

______________________________
PRODUCT
The GISH Vision Hollow Fiber Oxygenator with GBS coating (a non-leaching heparin coating) is a sterile, non-pyrogenic, single use, disposable, extracorporeal device designed to be used in an extracorporeal blood circuit to control exchange of gases. It is intended for the supply of oxygen to, and the removal of carbon dioxide from, the blood of humans. An integral heat exchanger is included which is intended to control the temperature of the blood. Recall # Z-0519-06
CODE
313417, 324404, 241506, 192513, 206510, 241506, 255514, 283507, 40501, 88508, 199547, 208500, 213508, 213508A, 231517, 290542, 007515, 328426, 074507, 122554, 174519, 262552, 323419, 007515, 338420, 035504, 047500, 047501, 047502, 067549, 088507, 122555, 151543, 151542, 215501, 231519, 129535, 250502, 255515, 323419, 336410, 005504, 031514, 087515, 143509, 157511, 199513, 234518, 262511, 313451, 334412, 334412A, 038500, 045550, 053513, 102500, 129525, 160500, 193500, 216501, 252500, 276506, 283512, 241509, 255514, 122554, 047502, 328426, 074507, 125515, 157527, 290519, 199512, 133500, 130500, 241500, 314410, 328426, 213508, 313420, 024509, 004507, 067516, 348414, 101518, 047502, 314409, 323419, 007515, 045557, 059500, 109507, 154510, 046502, 143507, 067518, 101520, 038522, 348418, 038522, 080511, 129527, 206515
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gish Biomedical Inc, Rancho Santa Margarita, CA, by letter on November 14, 2005.
Manufacturer: Sunrise Medical Inc, Fresno, CA. Firm initiated recall is ongoing.
REASON
Gish received four reports of potential leakage. All reports were associated with GBS coating. There was no patient injury reported.
VOLUME OF PRODUCT IN COMMERCE
2,306 units
DISTRIBUTION
Nationwide, Canada, and Mexico

______________________________
PRODUCT
RotoProne powered patient rotation bed, part #209500, Recall # Z-0520-06
CODE
Serial numbers: RRFK00036 -- RRFK00128
RECALLING FIRM/MANUFACTURER
Kinetic Concepts, Inc., San Antonio, TX, by letter on January 24, 2005. Firm initiated recall is complete.
REASON
To correct software issues in software versions 1.3 and 1.5 and to upgrade hatch latch handles to a more ergonomic design.
VOLUME OF PRODUCT IN COMMERCE
91 beds
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) The product is a mobile 3-wheeled electric scooter,
model HMV 220. The product contains either a red
or blue base. The red base is identified with
SKU #9153641905. The blue base is identified
with SKU #9153641906. Recall # Z-0521-06;
b) The product is a mobile 3-wheeled electric scooter,
model HMV 250. The product contains either a red
or blue base. The red base is identified with
SKU #915363224. The blue base is identified with
SKU #915363225. Recall # Z-0522-06
CODE
All serial numbers 04H86001 to 05A468246
RECALLING FIRM/MANUFACTURER
Tung Keng Enterprise Co., Ltd., Tai-Tzu Hsiang, Taiwan, Republic of China, by letters on November 1, 2005. Firm initiated recall is ongoing.
REASON
The throttle spring, located in the hand throttle assembly, can fracture, resulting in the scooter not stopping when the user releases the throttle.
VOLUME OF PRODUCT IN COMMERCE
8,213 devices
DISTRIBUTION
CA, IN, OH, and TX

______________________________
PRODUCT
Guardian? Distal Femur Axial Pin, Recall # Z-0523-06
CODE
Lot Nos. 75258083 and 7521663501
RECALLING FIRM/MANUFACTURER
Wright Medical Technology Inc., Arlington, TN, by letter dated January 10, 2005. Firm initiated recall is ongoing.
REASON
The product was not fully assembled prior to packaging.
VOLUME OF PRODUCT IN COMMERCE
10 devices
DISTRIBUTION
Nationwide and PR

______________________________
PRODUCT
IMMULITE 2000 Total Testosterone Kit, Catalog Numbers: L2KTW and L2KTW, Recall # Z-0528-06
CODE
2 Lot 126 (200-test kit), 6 Lot 126 (600-test kit)
RECALLING FIRM/MANUFACTURER
Diagnostic Products Corp, Los Angeles, CA, by telephone starting on January 5, 2005, and by e-mail or Fax starting on January 3, 2005. Firm initiated recall is ongoing.
REASON
The reagent for this kit lot (L2KTW 2,6 126) was manufactured with a raw material that can carryover and interfere with DPC Kit IMMULITE 2000 Estradiol (L2KE2) causing a false elevation in the observed estradiol concentration.
VOLUME OF PRODUCT IN COMMERCE
710 kits
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Lumenis brand Lumenis One System with Multi-Spot Nd: YAG, LightSheer and Universal IPL, Recall # Z-0529-06
CODE
Software versions lower than 2.02. All serial numbers; All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lumenis, Inc., Santa Clara, CA, by letters on April 8, 2005.
Manufacturer: Lumenis, Ltd., Yokneam, Israel. Firm initiated recall is complete.
REASON
Software anomaly recorded incorrect filter in patient database and this may lead to patient skin burns.
VOLUME OF PRODUCT IN COMMERCE
142 units
DISTRIBUTION
Nationwide and New Zealand

______________________________
PRODUCT
a) Depuy brand Acclaim Elbow linked ulnar bearing,
sterile; catalog # 1722-60-000, Recall # Z-0530-06;
b) Depuy brand Acclaim Elbow linked ulnar bearing,
assembly (ulnar bearing and locking screw),
sterile; catalog # 1722-63-000, Recall # Z-0531-06
CODE
All units
RECALLING FIRM/MANUFACTURER
Depuy Orthopedics, Inc. Warsaw, IN, by letter dated November 10, 2005. Firm initiated recall is ongoing.
REASON
The ulnar bearing may damage the implant's polyethylene sleeve such that revision surgery is necessary.
VOLUME OF PRODUCT IN COMMERCE
808 units
DISTRIBUTION
Nationwide, Argentina, Ireland, New Zealand and Spain

______________________________
PRODUCT
a) Sigma implantable pulse generators (IPGs)
dual Chamber Pacemaker, models SD203, SD303,
Recall # Z-0534-06;
b) Sigma implantable pulse generators (IPGs)
Dual Chamber Rate Responsive Pacemaker,
models SDR203, SDR303, SDR306,
Recall # Z-0535-06;
c) Sigma implantable pulse generators (IPGs)
Dual Chamber Atrial Sensing, Ventricular
Sensing and Pacing Pacemaker. Atrial
Bipolar sensing connector, ventricular
Bipolar connector, model SVDD303,
Recall # Z-0536-06;
d) Sigma implantable pulse generators (IPGs)
Single Chamber Pacemaker, models SS103,
SS106, SS203, SS303, Recall # Z-0537-06;
e) Sigma implantable pulse generators (IPGs)
Single Chamber Rate Responsive Pacemaker,
models SSR203, SSR303, SSR306,
Recall # Z-0538-06;
f) Sigma implantable pulse generators (IPGs)
Single Chamber Pacemaker model SVVI103,
for ventricular use only, Recall # Z-0539-06
CODE
a) Serial no. PJD182918H - PJD191025H,
PJD432660H - PJD449026H, PJD674196S -
PJD690881S, PJD731443S - PJD743447S;
Serial no. PJD183969H - PJD186285H,
PJD187584H - PJD187735H, PJD190274H,
PJD190305H, PJD190308H, PJD195395H,
PJD195444H, PJD441326 - PJD448026H,
PJD674200S - PJD681640S, PJD691135S,
PJD691231S, PJD729895S - PJD742209S;
b) Serial no. PJD183978h - PJD184012h,
PJD186200H - PJD186279H, PJD187571H --
PJD187669H, PJD193734H, PJD195394H --
PJD195470H, PJD442170H, PJD445718H --
PJD452929H, PJD674175S - PJD680868S,
PJD685590S, PJD689228S, PJD691226S,
PJD731742S - PJD739835S.
Serial no. PJD182452H - PJD199059H,
PJD205280H, PJD440288H - PJD451956H,
PJD674216S - PJD691410S, PJD730124S --
PJD746998S.
Serial no. JE120662H - PJE120706H,
PJE620733S - PJE621387S;
c) Serial no. PJD183400H - PJD183447H,
PJD186130H - PJD186199H, PJD188418H --
PJD188519H, PJD430299H - PJD430332H,
PJD441378H - PJD441396H, PJD442436H --
PJD442448H, PJD445371H - PJD448139H,
PJD675113S - PJD675193S, PJD675694S --
PJD676809S, PJD677182S - PJD677945S,
PJD678157S - PJD686906S, PJD730001S --
PJD744349S;
d) Serial no. PJG160592H - PJG161247H,
PJG162149H - PJG162607H, PJG163245H --
PJG163805H, PJG165759H - PJG168541H,
PJG170637H - PJG170921H, PJG428851H --
PJG431485H, PJG677154S - PJG748119S,
PJG748671S - PJG748710S, PJG748732S --
PJG750863S, PJG751336S - PJG751944S,
PJG752070S - PJG754744S, PJG231054M --
PJG233721M, PJG748407C - PJG748670C,
PJG748711C - PJG748722C.
Serial no. PJH117098H - PJH118839H,
PJH624138S - PJH624610S, PJH626910S --
PJH626967S.
Serial no. PJG165866H, PJG170641H --
PJG170782H, PJG428850H - PJG431464H,
PJG676637S - PJG681858S, PJG682490S,
PJG683196S, PJG684296S - PJG689861S,
PJG695412S, PJG747908S - PJG754745S,
PJG231551M - PJG234346M.
Serial no. PJG162131H - PJG16371H,
PJG427797H - PJG431510H, PJG676969S --
PJG691865, PJG740396S - PJG757886S;
e) Serial no. PJG159204H - PJG178395H,
PJG462302H - PJG434280H, PJG740166S --
PJG766757S, PJG675988S - PJG694391S.
Serial no. PJG159103H, - PJG178395H,
PJG426302H - PJG434280H, PJG740166S --
PJG766757S, PJG675988S - PJG694391S.
Serial no. PJH116644H - PJH118708H,
PJH624113S - PJH627050S;
f) Serial no.PJG159902H - PJG176701H,
PJG432779H - PJG432895H, PJG230582M --
PJG236398M, PJG677442S - PJG696014S,
PJG748310S - PJG755468S, PJG747654C --
PJG755171C
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic, Inc., Fridley, MN, by press release and letters on November 29, 2005.
Manufacturer: Madtronic Med Rel Inc, Humacao, PR, Firm initiated recall is ongoing.
REASON
An issue exists with a specific subset of Sigma series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or not output. There have been no reported patient injuries or deaths due to this issue.
VOLUME OF PRODUCT IN COMMERCE
40,595 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

_______________________________
PRODUCT
a) AmTech Group, Inc. GentaPoult (Gentamicin Sulfate
Injection), Sterile Injection Veterinary,
Anti-Infective for Day-Old Chickens and 1 to
3 Day-Old Turkeys, packaged in 100-ml.
multi-dose vials (12 vials per carton,
6 cartons per shipper), each ml contains
Gentamicin sulfate veterinary equivalent to
100 mg gentamicin base, ANADA 200-147,
NDC 59130-742-01. Recall # V-058-6;
b) AgriLabs Oxytocin Injection, For uterine-
contracting and milk-releasing action,
packaged in 100-ml. multi-dose vials
(12 vials per carton, 6 cartons per shipper),
each ml contains Oxytocic activity equivalent
to 20 USP posterior pituitary units with
sodium hydroxide/acetic acid for pH adjustment,
RX, NADA 99-169. Recall # V-059-6;
c) Gentamicin Sulfate Solution, 100 mg/ml,
For use in horses only, packaged in 100-ml.
sterile multiple dose vials (12 vials per carton,
6 cartons per shipper), each ml contains
gentamicin sulfate equivalent to 100 mg gentamicin
base, RX, ANADA 200-137. The product is manufactured
under the following:
Phoenix GentaMax 100, NDC 57319-286-05; Butler
Gentamicin Sulfate Solution, NDC 11695-3536-1;
VEDCO GentaVed 100, NDC 50989-193-12;
VetTek Gentamicin Sulfate Solution, NDC 60270-584-10;
AgriLabs Legacy Gentamicin Sulfate Solution;
and RXV Gentamicin Sulfate Solution, Recall # V-060-6;
d) Phenylbutazone 20% Injection (Phenylbutazone),
For Horses Only, packaged in 100-ml. multi-dose
vials (12 per carton, 6 cartons per shipper),
each ml contains Phenylbutazone 200 mg.,
RX, ANADA 200-126. The product is manufactured
under the following brand names and labels:
Phenylbute Injection 20%, NDC 57319-339-05;
and VEDCO Equi-Phar Phenylbutazone Injection,
NDC 50989-262-12, Recall # V-061-6
CODE
a) Lot 5081097, Exp. 08/07;
b) Lot #5081099, Exp. 08/07;
c) Lot #5081052, Exp. 08/08;
d) Lot #5081046, Exp. 08/08
RECALLING FIRM/MANUFACTURER
IVX Animal Health Inc., Saint Joseph, MO, by telephone and letter on December 27, 2005. Firm initiated recall is ongoing.
REASON
The products were manufactured on a processing line that had a sterility failure due to defective equipment.
VOLUME OF PRODUCT IN COMMERCE
74,205 vials
DISTRIBUTION
MO, OH, TX, and GA

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS III

_______________________________
PRODUCT
a) Medicated bulk feed containing Lasalocid labeled as:
Pohl -- Eckel Bros 18% Hfr Pel. Recall # V-051-6;
b) Medicated bulk feed containing Lasalocid labeled as:
Pohls -- Vaill M. 18% Calf Pel 9/28/04, Recall # V-052-6;
c) Medicated bulk feed containing Lasalocid labeled as:
Pohl's Finndale 18% Calf Pel 11/18/05, Recall # V-053-6;
d) Medicated bulk feed containing Lasalocid labeled as:
Guzik W. & J. 23% Heifer ML, Recall # V-054-6;
e) Medicated bulk feed containing Lasalocid labeled as:
LFC-Drexler 18% Heifer Pel 3/25/05, Recall # V-055-6;
f) Medicated bulk feed containing Lasalocid labeled as:
Cook M. RC 18% Calf Pel W/Bov, Recall # V-056-6;
g) Medicated bulk feed containing Lasalocid labeled as:
Hewitt -- 35% Pre-Mix Pel W/Bovatec, Recall # V-057-6
CODE
Uncoded
RECALLING FIRM/MANUFACTURER
I.L. Richer Co, Inc., Sangerfield, NY, by letters on/about January 24, 2006. Firm initiated recall is complete.
REASON
Medicated bulk feed was distributed with labeling that lacked directions for use.
VOLUME OF PRODUCT IN COMMERCE
32 tons
DISTRIBUTION
NY

 

END OF ENFORCEMENT REPORT FOR FEBRUARY 22, 2006

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