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U.S. Department of Health and Human Services

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Enforcement Report for March 12, 2008

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 12, 2008
08-11

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT
SANFORD LIMITED SUSTAINABLE SEAFOOD, Mussel Meat, Perna Canaliculus, Net Wt. 10.00 Kg x 22.05 Lb., Packaged in a Bag, Harvest Date 16 Nov 2007, Production Date 19 Nov 2007, Sell by 18 Nov 2009, Lot No L177703590, Serial No 2684952, Bar Code 21177002684952, Recall # F-221-8
CODE
Products with a production date of May 23rd thru June 18th are being recalled.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mark Foods Inc., New York, NY, by telephone on November 19, 2007 and by letter on December 18, 2007.
Manufacturer: Sanford Limited Auckland, Freeman's Bay, Auckland, New Zealand. Firm initiated recall is ongoing.
REASON
The product is contaminated with Listeria monocytogenes based on information provided to the importer by the foreign manufacturer.
VOLUME OF PRODUCT IN COMMERCE
2,243 cases
DISTRIBUTION
CA, NY MD, PA, RI, NJ

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT
Quality Farms Apple Juice in 2 qt bottles labeled 'QUALITY FARMS ALL NATURAL APPLE JUICE 2 QUARTS, Recall # F-217-8
CODE
ENJOY BY 12/17/07 ENJOY BY 12/29/07
RECALLING FIRM/MANUFACTURER
Fruitland Juice Company, Fruitland, ID, by e-mail, telephone and letter dated December 14, 2007. FDA initiated recall is complete.
REASON
Product contains elevated levels of patulin.
VOLUME OF PRODUCT IN COMMERCE
Code 12-17-07: 315 2qt. cases; Code 12-29-07: 108 2qt. cases
DISTRIBUTION
ID, UT, MT, and OR

___________________________________
PRODUCT
Tarritos Liquid Chili Snack, 3.3oz. (100gm); Imported; packaged in a mug-shaped jar with plastic seal lid and green label, Recall # F-218-8
CODE
All products distributed between 11/2006 and 12/3/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm Name: Villa Mex Imports, Inc., San Antonio, TX, by telephone and faxed letter on beginning on December 4, 2007.
Manufacturer: Productos Avila Sa De Cv, Guadalajara, Mexico. Firm initiated recall is ongoing.
REASON
Imported Mexican candy contains lead in excess of the 0.1 ppm maximum level recommended by FDA.
VOLUME OF PRODUCT IN COMMERCE
73 cases (14 displays per case / 6 mugs per display)
DISTRIBUTION
TX
___________________________________
PRODUCT
Diamond A Baby Whole Pickled Beets, Net Wt. 15 oz (425 g). Ingredients: Beets, Water, High Fructose Corn Syrup, Vinegar, Salt, Natural Flavor, Recall # F-219-8
CODE
Top Line Code: H7CG041J Bottom Line Code: 4TS7C time stamp: 10:24 - 10:44
RECALLING FIRM/MANUFACTURER
Seneca Foods, Inc., Janesville, WI, by telephone on November 21, 2007 and by letter on January 15, 2007. Firm initiated recall is complete.
REASON
Cans labeled as Baby Whole Pickled Beets actually contain pizza sauce with cheese (milk). No milk ingredients were listed on the beet label.
VOLUME OF PRODUCT IN COMMERCE
2698 cans
DISTRIBUTION
AK and WA

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III

___________________________________
PRODUCT
Marine Harvest of Scotland, Scottish Atlantic Fresh Salmon Gutted Head On, Various Weights, Recall # F-220-8
CODE
Lots between the dates shipped on or about February 7 to February 12, 2008.
Lot numbers: 89379 89380 89382 89383 89385 89386 89397 89398 89399 89400 89430 89431 89432 89433
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lewis Mills & Co. LLC, Gloucester, MA, by fax on February 22, 2008.
Manufacturer: Marine Harvest (Scotland) Ltd, Ratho Station, Newbridge, UK. Firm initiated recall is complete.
REASON
Product is contaminated with petroleum resulting in off odor and off taste.
VOLUME OF PRODUCT IN COMMERCE
97, 587 lbs
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT
a) Major Infants' Gas Relief Drops, (Active ingredient in each 0.6 mL) Simethicone, 40mg, 1 Fl. Oz. (30mL) bottles with Plastic Dropper Enclosed, NDC - Major 094-5067-30; Also labeled as: b) Tri-Med Gas Relief Drops, (Active ingredient in each 0.6 mL) Simethicone 40 mg, 1 fl. oz (30 mL) with Plastic Dropper Enclosed, NDC Tri-Med: 55654-009-01. Suitable for Infant Use, Recall # D-168-2008
CODE
Lot E617 Expiration Date: 4/09
RECALLING FIRM/MANUFACTURER
Tri-Med Laboratories Inc., Somerset, NJ, by letter on February 11, 2008. Firm initiated recall is ongoing.
REASON
Microbial Contamination of Non Sterile Product; Yeast.
VOLUME OF PRODUCT IN COMMERCE
a) 1440 bottles; b) 10,800 bottles
DISTRIBUTION
MI, OH, FL, IL, NJ and IN
___________________________________
PRODUCT
a) Duragesic® 25 mcg/h (Fentanyl Transdermal System), Each transdermal system contains; 2.5mg fentanyl and 0.1mL alcohol USP, supplied in boxes of 5 systems, Rx only, Recall # D-169-2008
b) Fentanyl Transdermal System 25 mcg/h, Each transdemal system contains: 2.5mg fentanyl and 0.1 mL alcohol USP, supplied in boxes of 5, Rx only, Recall # D-170-2008
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
GPSG - Unit of ALZA Corp., Vacaville, CA, by press release, e-mail and letter. Firm initiated recall is ongoing.
REASON
Defective Delivery System; drug reservoir containing API concentrated gel is leaking due to improper cutting of patch delivery system.
VOLUME OF PRODUCT IN COMMERCE
3,577,458 cartons
DISTRIBUTION
Nationwide and Canada

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT
Megestrol Acetate Oral Suspension USP 40 mg/ml, sold in a 240 ml bottle (8 fl. oz.), Rx only. NDC number is 0093-9634-87, Recall # D-167-2008
CODE
Lot number 26784 exp 2/2009
RECALLING FIRM/MANUFACTURER
TEVA Pharmaceuticals USA, Inc., Sellersville, PA, by letter on February 7, 2008. Firm initiated recall is ongoing.
REASON
Subpotent; megestrol
VOLUME OF PRODUCT IN COMMERCE
3,624 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS II

___________________________________
PRODUCT
Red Blood Cells (Apheresis), Recall # B-0572-08
CODE
Units: 12KY21430, 12LQ24674
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone on July 12, 2006 and by letter dated August 3, 2006. Firm initiated recall is complete.
REASON
Blood products, with an unacceptable total hemoglobin level, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0744-08
CODE
Unit: 2131008
RECALLING FIRM/MANUFACTURER
Central Jersey Blood Center, Shrewsbury, NJ, by telephone on April 10, 2007. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Propionibacterium acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0785-08
CODE
Unit: 04H71598
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by the logic system and facsimile on August 3, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT
Source Plasma, Recall # B-0793-08
CODE
Units 386022324, 386020192, 386020056, 386019792, 386019627, 386019290, 386018979, 386017604, 386018464, 386017426, 386017166, 386016869, 386016545, 386016355, 386016039, 386009877
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Waukegan, IL, by facsimile on September 25, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was deferred due to risk factors associated with variant Creutzfeldt-Jakob disease (vCJD) travel, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0865-08
CODE
Unit: 71X162682
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL, by facsimile on January 13, 2005. Firm initiated recall is complete.
REASON
Blood product, for which the documentation of irradiation was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0904-08
CODE
Unit: 163934931
RECALLING FIRM/MANUFACTURER
Blood Systems Inc/dba United Blood Services, Meridian, MS, by telephone on September 11, 2007. Firm initiated recall is complete.
REASON
Blood product, which was possibly contaminated with Propionibacterium species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0942-08
CODE
Unit: 71V108080
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by telephone on March 16, 2007. Firm initiated recall is complete.
REASON
Blood product, associated with a Fresh Frozen Plasma unit that contained a clot, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0943-08
CODE
Unit: 71C544881
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL by facsimile on June 11, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0944-08
CODE
Unit: 72C215027
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Brooksville, FL by facsimile on June 14, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0945-08
CODE
Unit: 72C244662
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL by facsimile on August 13, 2007. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0947-08
CODE
Unit: 72E039393
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc.,Dunwoody, GA, by telephone on October 24, 2007.
Manufacturer: LifeSouth Community Blood Centers, Inc., Inverness, FL Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells (Apheresis), Recall # B-0949-08
CODE
Unit: 72C022229
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL by facsimile on July 16, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not meet the minimum requirement for Red Blood Cell volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
a) Platelets, Recall # B-0956-08;
b) Fresh Frozen Plasma, Recall # B-0957-08;
c) Red Blood Cells Leukocytes Reduced, Recall # B-0958-08
CODE
a), b), and c) Unit: 2305939
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on June 9, 2005 or June 10, 2005. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined after receiving post donation information concerning high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL, SC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0959-08
CODE
Unit: 4250074
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on April 13, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0960-08
CODE
Unit: 72C14050X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on July 9, 2007. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0961-08
CODE
Unit: 9940038 (Part C)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on March 29, 2005. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0977-08
CODE
Units: 7093003 (split unit); and 7093060 (split unit)
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on June 7, 2005. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AR and TX
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # 0980-08;
b) Recovered Plasma (Liquid), Recall # B-0981-08;
c) Cryoprecipitated AHF, Pooled, Recall # B-0982-08
CODE
a) and b) Unit: 2687783;
c) Unit: 6002251
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on April 12, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0983-08
CODE
Unit: 2625829
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on March 18, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0984-08
CODE
Units: 1678435 (part 1); 1678435 (part 2); and 1678435 (part 3)
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, East Orange, NJ, by telephone on June 13, 2007 and by letter dated November 15, 2007. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Fresh Frozen Plasma (Apheresis), Recall # B-0985-08
CODE
Units: 3006006 and 3005285
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on December 21, 2005. 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
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0988-08
CODE
Unit: 2729997
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on January 23, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

___________________________________
PRODUCT
Source Plasma, Recall # B-0994-08
CODE
Units: 0500115443 and 0500115022
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Arlington, TX, by facsimile on May 30, 2007 and by electronic mail on December 17, 2007. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a body piercing within 12 months of the donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Barcelona, Spain
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0995-08
CODE
Unit: V85292
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA, by telephone on November 14, 2007. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS - CLASS III

___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0267-08
CODE
Units: 71X505277 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on November 27, 2006. Firm initiated recall is complete.
REASON
Platelets, associated with a platelet unit that was returned due to the absence of swirling, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0786-08
CODE
Unit: 04H71598
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by the logic system and facsimile on August 3, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA and MA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0788-08
CODE
Units: 49GW22415, 49KG10236, 49KG10238, and 49KQ10742
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by telephone on June 24, 2005. Firm initiated recall is complete.
REASON
Blood products, which were not leukoreduced within the appropriate time period after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
OK and TX
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-0946-08
CODE
Unit: 9971595
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone and facsimile on May 11, 2005. Firm initiated recall is complete.
REASON
Blood product, for which the quality control testing was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pooled Leukocytes Reduced, Recall # B-0948-08
CODE
Platelet Pool 72Z543766 (containing units 72C493691, 72C00775X, 72C121219, 72C121220),
Platelet Pool 72Z543778 (containing units 72C007816, 72C145647, 72C493709, 72C121244)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on July 5, 2007. Firm initiated recall is complete.
REASON
Platelets, which were pooled using expired blood bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0979-08
CODE
Unit: 2691645
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on April 15, 2005. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0986-08
CODE
Unit: 2753503 (double unit)
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by fax on October 28, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had undergone corneal transplant surgery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0989-08
CODE
Unit: 6733888
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on February 11, 2005. Firm initiated recall is complete.  
REASON
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
a) Fresh Frozen Plasma, Recall # B-0990-08;
b) Red Blood Cells Leukocytes Reduced, Recall # B-0991-08
CODE
a) and b) Units: 71R694243
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Birmingham Region, Birmingham, AL, by facsimile on March 16, 2006. Firm initiated recall is complete.
REASON
Blood products, which were untested for the human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the Nucleic Acid Test (NAT), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0992-08
CODE
Unit: 29GS67268
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic, Norfolk, VA, by telephone on May 15, 2006 and by letter dated May 23, 2006. Firm initiated recall is complete.
REASON
Blood product, which tested positive for the Jk(a) red cell antigen, but was labeled as Jk(a-), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0993-08
CODE
Units: 29GP89121, 29GV66758, 29GZ35669,29GZ35671, 29GZ35675, 29GZ35683, 29GV66765, 29GV66773, 29GZ35667, 29GZ35668, 29GZ35677
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic, Norfolk, VA, by telephone on June 14, 2006 and by letter dated June 23, 2006. Firm initiated recall is complete.
REASON
Blood products, which may have been shipped under unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
VA and NC

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II

__________________________________
PRODUCT
BD Biosciences MultiSET Flow Cytometry Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems, Recall # Z-0570-2008
CODE
Software Versions 2.1, 2.1.1, and 2.2 with OS X operating systems
RECALLING FIRM/MANUFACTURER
BD Biosciences, San Jose, CA, by letter on September 14, 2007. Firm initiated recall is ongoing.
REASON
Inaccurate results: Software error results in inaccurate display result statistics. If the user adjusts the lymph gate or attractors in the Lab Report view without using the Manual Gate function (as described in the system manual), the statistic results will not be updated to match the adjusted gate.
VOLUME OF PRODUCT IN COMMERCE
1,136 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical
    Suction Tip, Recall # Z-0573-2008;
b) Stryker Disposable StrykeProbe 32cm Spatula Tip, Ref: 250-070-551, Electrosurgical
    Suction Tip, Recall # Z-0574-2008
CODE
a) Lot Number: 07297FE2;
b) Lot Number: 07298FE2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Endoscopy, San Jose, CA, by telephone and letter dated November 19, 2007.
Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR. Firm initiated recall is ongoing.
REASON
Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable.
VOLUME OF PRODUCT IN COMMERCE
a) 59 boxes of 6 (354 units),
b) 8 boxes of 6 (48 units)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Roche COBAS 6000 Clinical Chemistry analyzer; Catalog Number: 04745914001, Recall # Z-0576-2008
CODE
All cce and cc system configurations with core unit software version 02-03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by telephone and follow-up letter dated December 4, 2007.
Manufacturer: Division, Hitachi Ltd., Hitachinaka-Ibaraki, Japan. Firm initiated recall is ongoing.
REASON
Incorrect results: CRP assays may be calculated using incorrect calibration parameters which could result in falsely high or falsely low patient results being reported.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NE
___________________________________
PRODUCT
Siemans- ACUSON Aspen Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, Model Number: 8247887, Recall # Z-0719-2008
CODE
Serial Numbers: 32118 30032 33270 31789 30264 32770 33492 34115 22353203 40039-1 33468 33732 33808 33867 33906 33972 34080 34085 34104 34161 34168 34174 40009 40024 40046 40062 40093 40094 40101 40102 40132 40148 40163 40178 40187 40189 40197 40257 32603 33548 32611 30509 30991 31397 31770 31824 32018 32090 32551 32738 32927 31214 31518 30803 30828 31805 31875 33209 32053 32319 32497 32531 32830 33505 33421 32140 33515 33347 31997 30640 32141 32208 32209 32251 32450 32582 32625 32646 32796 32819 32886 32965 33020 33197 33206 33239 33269 33338 33454 33470 33494 32321 32117 32784 32831 32926 32581 31218 32992 33514 31117 33358 32674 31975 32539 32686 33712 31995 32718 31270 31804 33650 33433 32700 30167 33227 33757 33910 33796 33390 33098 33781 33995 33882 33516 33974 33709 33973 33992 31124 31619 33193 30033 31520 31876 30555 31335 30176 30472 33742 32741 32884 32887 30382 31599 32701 33432 32934 32761 32932 32540 32762 32827 32736 33041 32554 32583 33024 32978 32365 32496 32338 32449 32473 32917 32918 32514 32510 32222 32856 33059 32891 32877 33044 33049 33276 30412 30575 33300 31471 30993 31131 31363 33416 33261 33244 33230 33131 31810 31856 32042 33431 33195 33089 33162 33285 33060 33196 33101 33544 33070 31746 33283 33229 32143 33452 33517 33105 31367 33310 33724 33403 30834 33559 33587 33624 33652 30715 30315 33797 33774 33399 32772 32168 33032 31055 30695 33561 33672 32955 31976 31241 Material Number 8247888-- with Serial Numbers: 31116 32673 32783 33143 31359 31775 32848 32968 Material Number 8253683-- with Serial Numbers: 40290 40311
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by Urgent Medical Device Notification on September 18, 2007. Firm Initiated recall is ongoing.
REASON
Software error: Error affects all Aspen customer systems using the PAL video standard configuration and has a Perspective PC installed. This can lead to a measurement error under this specific condition: On secondary capture images/clips stored from within any Perspective advanced display option (specifically: 3D Surface Rendering, 3D MultiPlanar Reconstruction, Color Doppler 3D MultiPlanar Reconstruction or FreeStyle extended imaging, FreeStyle compounding, or FreeStyle dynamic CDI technology).
VOLUME OF PRODUCT IN COMMERCE
242 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Pulavac, Plus Wound Debridement System, Component Kit, Catalog # 00-5150-
    420-00, 10 kits/package, Recall # Z-0856-2008;
b) Pulsavac Plus AC Component Kit, Catalog #00-5150-426-01, 1 kit/package,
    Recall # Z-0857-2008;
c) Pulsavac Plus Wound Debridement System, Fan Spray Kit , Catalog #00-5150-475-
    00, 10 kits/package, Recall # Z-0858-2008;
d) Pulsavac Fan Spray Kit ,Catalog #00-5150-475-01; 1kit/package, Recall # Z-0859-
    2008;
e) Pulsavac Plus AC Fan Spray Kit, Catalog #00-5150-476-01, 1 kit/package,
    Recall # Z-0860-2008;
f) Pulsavac Plus Wound Debridement System, Hip Kit, Catalog #00-5150-482-00, 10
    kits/package, Recall # Z-0861-2008;
g) Pulsavac Hip Kit ,Catalog #00-5150-482-01, 1kit/package, Recall # Z-0862-2008;
h) Pulsavac Plus AC Hip Kit, Catalog #00-5150-486-01, 1 kit/package,
    Recall # Z-0863-2008;
i) Pulsavac Plus Wound Debridement System, Shower Spray Kit, Catalog #00-5150-
    495-00, 10kits/package, Recall # Z-0864-2008;
j) Pulsavac Plus Low Pressure Fan Spray Kit, Catalog #00-5150-975-00, 10 kits/
    package, Recall # Z-0865-2008
CODE
a) Lot Numbers: 60613025, 60617428, 60622532, 60626631, 60629996, 60633951,
    60640534, 60650384, 60652419, 60656841, 60661592, 60661594, 60666491,
    60666492, 60671448, 60671449, 60676102, 60693310, 60693311, 60693314,
    60693315, 60693326, 60693327, 60694265, 60694266, 60698941, 60703269,
    60709912, 60715481, 60723866, 60725488, 60733552, 60733553, 60737816,
    60737817, 60739957, 60739958, 60744533, 60744534, 60750514, 60750515, and
    60758733;
b) Lot Numbers: 60622533, 60642558, 60654878, 60656842, 60693312, and 60725489;
c) Lot Numbers: 60607940, 60612145, 60612148, 60613026, 60613027, 60613028,
    60613029, 60613030, 60617429, 60617430, 60617431, 60617432, 60617433,
    60622534, 60622535, 60622536, 60622537, 60626632, 60626633, 60626634,
    60626635, 60626636, 60629997, 60629998, 60629999, 60630001, 60630002,
    60633952, 60633953, 60633954, 60633955, 60640536, 60640537, 60640538,
    60640539, 60640540, 60642559, 60642560, 60642561, 60642562, 60642563,
    60650385, 60650386, 60650387, 60650388, 60652362, 60652363, 60652364,
    60652365, 60652367, 60652368, 60652369, 60652421, 60652422, 60652424,
    60652425, 60652426, 60652427, 60652429, 60661596, 60661598, 60661601,
    60661604, 60661609, 60661616, 60666494, 60666495, 60693316, 60693317,
    60693318, 60693319, 60693328, 60693329, 60693331, 60693332, 60693333,
    60693334, 60694267, 60694268, 60694269, 60694270, 60694271, 60694272,
    60698942, 60698943, 60698944, 60698945, 60698946, 60698947, 60703274,
    60703276, 60703289, 60703301, 60703303, 60708431, 60708432, 60708433,
    60708435, 60708437, 60709913, 60709914, 60709915, 60709916, 60709918,
    60709988, 60715482, 60715484, 60715485, 60715487, 60715488, 60715490,
    60723867, 60723868, 60723869, 60723870, 60723873, 60723874, 60723875,
    60725490, 60725491, 60725493, 60725494, 60725496, 60733554, 60733555,
    60733556, 60733557, 60733558, 60737818, 60737819, 60737820, 60737821,
    60739959, 60739960, 60739961, 60739962, 60739963, 60744536, 60744537,
    60744538, 60744539, 60750517, 60750520, 60750523, 60750526, 60758734,
    60758735, 60758736, 60758737, 60758738, 60758739, 60758740, 60768263,
    60768268, 60768269 60768270, 60768271, 60768272, 60769241, 60769242,
    60769243, 60769244, 60769245, 60778396, 60778397, 60778398, 60778399,
    60782132, 60782133, 60782134, 60782135, 60782136, 60784396, 60784397,
    60784398, 60784401, 60784403, 60788880, 60788881, 60788882, 60788883,
    60788884, 60795133, 60795140, 60795141, 60795142, 60802487, 60802488,
    60802489, 60802490, 60802491, 60802492, 60804280, 60804281, and 60804282;
d) Lot Numbers: 60626637, 60652433, 60671457, 60693320, 60698948, 60708439,
    60715492, and 60725499;
e) Lot Numbers: 60650389, 60693321, 60708442, 60778376, 60788853, and 60809433;
f) Lot Numbers: 60612157, 60612160, 60613031, 60613032, 60617434, 60617435,
    60622538, 60626638, 60630003, 60630004, 60633956, 60633957, 60633958,
    60640541, 60640542, 60642564, 60642565, 60642566, 60650390, 60650391,
    60652435, 60656852, 60656853, 60656854, 60661621, 60661622, 60661623,
    60666504, 60666506, 60693313, 60693322, 60693323, 60693336, 60693338,
    60693340, 60694275, 60694276, 60694278, 60698949, 60703306, 60708444,
    60709920, 60715493, 60723876, 60725500, 60733559, 60733560, 60737822,
    60737823, 60739964, 60739965, 60744540, 60744542, 60750527, 60750528,
    60758741, 60758742, 60768273, 60768274, 60769247, 60769248, 60778401,
    60778402, 60782137, 60782138, 60784405 60784407, 60788885, 60788886, and
    60795145;
g) Lot Numbers: 60613033, 60630005, 60650392, 60656855, 60666509, 60693324,
    60694281, and 60703308;
h) Lot #'s 60680331, 60708447, 60715494, 60733561, 60778403, 60795147, 60835632;
i) Lot Numbers: 60612164, 60613034, 60617436, 60622539, 60622540, 60626639,
    60630007, 60633959, 60642567, 60650393, 60652438, 60652439, 60661624,
    60693325, 60693342, 60694283, 60694285, 60698950, 60698951, 60703310,
    60703312, 60708448, 60708449, 60708450, 60709922, 60723880, 60725501,
    60733562, 60737824, 60739968, 60744543, and 60750529;
j) Lot Numbers: 60626640, 60666511, 60709924, 60734619, and 60778405
RECALLING FIRM/MANUFACTURER
Zimmer Orthopaedic Surgical Products, Dover, OH, by letter dated January 8, 2008. Firm initiated recall is ongoing.
REASON
Sterility (package integrity) compromised: The effect of a silicone stain produced during assembly operations on the sterility barrier properties of the Tyvek lids has not been validated by the firm.
VOLUME OF PRODUCT IN COMMERCE
84,644 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers:
    5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, and T5C4441R, Made in U.S.A,
    Recall # Z-0946-2008
b) HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers;
    5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R, Recall # Z-
    0947-2008
CODE
a) All serial numbers released prior to 09/21/07;
b) All serial numbers released prior to 08/23/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letters dated November 20, 2007.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is ongoing.
REASON
Unrecorded Infusion: If the system is powered down or a power failure occurs during a fill cycle, the HomeChoice system may not record the last 1-4 pump strokes infused into the patient when the power is restored. This situation may create a potential unrecorded delivery of approximately 15-60 mL of fluid being infused into the patient.
VOLUME OF PRODUCT IN COMMERCE
103,490 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Recall # Z-1182-2008
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Custom Ultrasonics, Inc., Ivyland, PA, by letter dated February 11, 2008. Firm initiated recall is ongoing.
REASON
Inadvertent selection of the “wash” cycle.
VOLUME OF PRODUCT IN COMMERCE
3,190 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Icy Hot Heat Therapy, Air Activated Heat Patch, Back and Large Areas, UPC Code
    0-41167-08330-7, Product Code 08330, 4.1" x 8.4" (10.5 cm x 2.1 cm) each, 1 and 3
    count patches, Recall # Z-1196-2008;
b) Icy Hot Heat Therapy, Air Activated Heat Patch, Arm, Neck and Leg and Small
    Areas, UPC Code 0-41167-08335-2, Product Code 08335, 3.9" x 5.3" (10cm x 13.5
    cm) each, 1 and 4 count patches, Recall # Z-1197-2008;
c) Aspercreme, Pain Relieveing Creme with Aloe, Maximum Strength Formula, Net Wt
    3 oz (85g) with Bonus Icy Hot Heat Therapy Air Activated Heat Patch, 1 individually
    wrapped patch, 3.9" x 5.3" (10cm x 13.5cm), Recall # Z-1198-2008
CODE
a) and b) All Lots;
c) Only those Aspercreme units that have the "bonus packs" containing any lot of the
    Icy Hot Heat Therapy patches
RECALLING FIRM/MANUFACTURER
Recalling Firm: Chattem Inc., Chattanooga, TN, by press release on February 8, 2008 and by letter on February 12, 2008.
Manufacturer: Mycoal Products Corp., Tochigi-City, Japan. Firm initiated recall is ongoing.
REASON
Skin irritation and burns with product usage.
VOLUME OF PRODUCT IN COMMERCE
2,164,800 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR MARCH 12, 2008

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