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U.S. Department of Health and Human Services

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Enforcement Report for August 2, 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.

 

August 2, 2006
06-31

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

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PRODUCT
Duncan Hines Family-Style Chewy Fudge Brownies mix in 21 oz. box with UPC code 44209 31131, Recall # F-279-6
CODE
JUN 16 07 GC6 "HH:MM" (HH:MM is a time stamp). Case code 064420931131
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pinnacle Food Corp., Mountain Lakes, NJ, by press release and letter dated April 5, 2006.
Manufacturer: Gilster-Mary Lee Corporation, Centralia, IL. Firm initiated recall is ongoing.
REASON
Duncan Hines Family Style Chewy Fudge Brownies mix package contains Walnut Brownie mix. The label of the Chewy Fudge Brownies mix does not list walnuts as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
Approximately 400 retail cartons
DISTRIBUTION
CA, NV and HI

______________________________
PRODUCT
M & F brand Tuna Salad sandwiches, Net Wt. 4.5 oz, Recall # F-280-6
CODE
06/27/06, 06/29/06, 06/30/06 and 07/03/06
RECALLING FIRM/MANUFACTURER
M & F Distributing Co., Inc., Bedford, IN, by visit on June 27, 2006. Firm initiated recall is complete.
REASON
The product contains undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
74 sandwiches
DISTRIBUTION
IN

______________________________
PRODUCT
a) Fast Bites, Spicy Breaded Chicken sandwiches, Net. Wt. 3.55 oz.,
two sandwiches per package, Recall # F-281-6;
b) Fast Bites, BBQ Chicken sandwiches, Net. Wt. 3.75 oz.,
two sandwiches per package, Recall # F-282-6
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pierre Foods, Inc., Cincinnati, OH, by letter on or about June 21, 2006.
Manufacturer: Pierre Foods, Inc., Claremont, NC. Firm initiated recall is ongoing.
REASON
The bun portion of the sandwich contains undeclared milk ingredients.
VOLUME OF PRODUCT IN COMMERCE
33,523 cases/24 sandwiches per case
DISTRIBUTION
Nationwide

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
a) Thyro-Tab (levothyroxine sodium), 0.50mg, packaged in 150,000-tablet drums
for further packaging, Recall # D-309-6;
b) Levothroid (levothyroxine sodium tablets, USP) 50 mcg., packaged in
100- and 1,000-ct. bottles, RX, NDC 0456-1321-01(100 ct.) and
NDC 0456-1321-00 (1,000 ct). Recall # D-310-6
CODE
a) HB20205, HC20205, and HD20205, all with an exp. date of Aug 06;
b) Lot #080525 (100 ct.) from bulk lot HB20205,
Lot #080526 from bulk lot HC20205 (100 ct.), and
Lot #090510 (1,000-ct.) from bulk lot HD20205,
all with an Aug 06 exp. date
RECALLING FIRM/MANUFACTURER
Lloyd Inc of Iowa, Shenandoah, IA, by telephone and e-mail on June 22, 2006. Firm initiated recall is complete.
REASON
Subpotent: The product failed stability at the 9-month test interval.
VOLUME OF PRODUCT IN COMMERCE
5,831,211 bulk tablets dist. by Lloyd; 38,149/100-ct. btls and 1,824/1,000-ct. btls. dist. by Forest
DISTRIBUTION
OH

______________________________
PRODUCT
a) Fexofenadine Hydrochloride, 60 mg tablets, 30-tablet box,
NDC# 61392-331-30, Recall # D-312-6;
b) Fexofenadine Hydrochloride, 60 mg tablets, 250-tablet bag,
NDC# 61392-331-25. Recall # D-313-6
CODE
a) lot K43240R30, exp. 12-12-06;
b) lot K43240R25, exp. 12-12-06
RECALLING FIRM/MANUFACTURER
Heartland Repack Services LLC, Toledo, OH, by telephone on July 11, 2006 and by letter on July 13, 2006. Firm initiated recall is ongoing.
REASON
Packaging mixup-The outer packaging is labeled as Fexofenadine Hydrochloride 60 mg tablets, but the unit dose blister strips inside the box may contain and be labeled Hydralazine Hydrochloride, 100 mg. tablets.
VOLUME OF PRODUCT IN COMMERCE
1,841/30 count boxes & 18/250 count bags
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Lannett Morphine Sulfate Concentrated Oral Solution, 120 mL bottle, NDC 0527-1425-62, 240mL bottle NDC 0527-1425-63, Recall # D-314-6
CODE
Lot numbers: 801-05066-010, 801-05073-011
RECALLING FIRM/MANUFACTURER
Cody Laboratories, Inc., Cody, WY, by telephone and letter on June 22, 2006. Firm initiated recall is complete.
REASON
Subpotent: Drug failed assay specifications at 12 month stability testing.
VOLUME OF PRODUCT IN COMMERCE
7,044/120mL bottles, 1,980/240mL bottles
DISTRIBUTION
PA

______________________________
PRODUCT
a) Cilostazol, 100 mg tablets, 30 tablet box, NDC # 66993-009-60;
Recall # Z-316-6;
b) Cilostazol, 100 mg tablets, 250 tablet bag, NDC # 66993-009-60 (ARE BOTH RECALLS SUPPOSE TO HAVE THE SAME ND #)
Recall # Z-317-6
CODE
a) Lot K43243R30, exp. 12-13-06;
b) Lot K43242R25, exp. 12/13/06
RECALLING FIRM/MANUFACTURER
Heartland Repack Services LLC, Toledo, OH, by telephone and letter on July 14, 2006. Firm initiated recall is ongoing.
REASON
Packaging mixup; The outer package is labeled as Cilostazol, 100 mg tablets, but the unit dose strips inside the outer packaging may contain and be labeled as Benztropine Mesylate, 0.5 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
743/30 count boxes and 25/250 count bags
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
a) Corn and Callus Remover --- ½ ounce bottle --- OTC ---- Active Ingredient:
Salicylic acid 17% w/w. The product was distributed under the following
labels: 1) Clay-Park Labs label: NDC 45802-239-61, UPC # 0-81642-23961;
2) CVS label: NDC CVS-239-61, UPC # 0-50428-34534-4;
3) equaline label: NDC 41163-239-61, UPC # 0-41163-26755-8;
4) Rite-Aid label: NDC RITE AID-239-61, UPC # 0-11822-31528.---
IMPROVED Corn & Callus Remover --- For External Use Only ---
½ FL OZ (14 mL), Recall # D-307-6;
b) Wart Remover Solution --- ½ ounce bottle --- OTC --- Active Ingredient:
Salicylic acid 17% w/w. The product was distributed under the following labels:
NDC 24385-236-63 --- UPC # 87701-89434, Brite-Life® Wart
Remover Solution --- For the Removal of Common Warts --- ½ FL. OZ.
(14 mL);
2) Clay-Park Labs label: NDC 45802-236-63, NSN-6501-01-121-2337,
UPC # 3-45802-236-63-0, -- Wart Remover Liquid --- Salicylic Acid ---
NET CONT. ½ fl oz (14 mL);
3) CVS label: CVS® pharmacy WART REMOVER --- FAST-ACTING LIQUID ---
SALICYLIC ACID --- ½ FL OZ (14 mL), CVS-236-63, UPC # 0-50428-21032-1;
4) Eckerd label: NDC 19458-6009-1, UPC # 0-34575-50697-1,
NDC 19458-6009-1 --- ECKERD Wart Remover Liquid ---
Salicylic Acid 17% --- ½ FL OZ (14 mL);
5) equaline label: NDC 41163-236-63, equaline wart remover liquid ---
net wt. 0.5 fl oz (14 mL)UPC # 0-41163-26756-5;
6) equate label: equate® wart remover --- FOR SAFE REMOVAL OF
COMMON WARTS --- 0.5 FL OZ (14 mL) NDC EQUATE-499-63,
UPC # 6-81131-76900-6;
7) Longs label: NDC 12333-9430-1 --- Longs MAXIMUM STRENGTH ---
Wart Remover Solution ---NET CONT ½ fl oz (14 mL) --- SALICYLIC ACID 17%
UPC # 3 12333-94301-6;
(8) RITE AID Liquid Wart Remover --- ½ FL OZ (14 mL),
NDC RITEAID-236-63, UPC # 0-11822-31391-9,
Recall # D-308-6
CODE
a) All lots within expiry;
b) All lots within expiry.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Perrigo Company, Allegan, MI, by letters on February 13, 2006.
Manufacturer: Pharma Pac, LLC, De Kalb, MS, Firm initiated recall is ongoing.
REASON
Complaints from the market indicating the product has been drying out thus leaving a crystallized substance.
VOLUME OF PRODUCT IN COMMERCE
1,108,323 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Breckenridge Pharmaceuticals Sulfatol Gel 5%, Sodium Sulfacetamide 10% and Sulfur 5% 1.5 Fl. Oz.. (45 mL) Rx only, NDC 51991-172-45, Recall # D-311-6
CODE
Lot Numbers: 50419E0307 and 50420EO307 Exp. 3/07
RECALLING FIRM/MANUFACTURER
Sheffield Laboratories, Div. of Faria Limited LLC, New London, CT, by letter dated June 29, 2006. Firm initiated recall is complete.
REASON
Superpotent: sulfur levels exceeded the specifications of 4.5-5.5%.
VOLUME OF PRODUCT IN COMMERCE
26,736 units
DISTRIBUTION
CT

______________________________
PRODUCT
Bausch & Lomb * Advanced * Eye ReliefÔ * Opcon-Aâ * Allergy * 6.5 FL oz (15mL) *, Recall D-315-6
CODE
Lot GE 6024
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb, Inc., Rochester, NY, by letter on June 30, 2006.
Manufacturer: Bausch & Lomb, Inc., Greenville, SC. Firm initiated recall is ongoing.
REASON
Labeling: Product with the new trade dress (‘Advanced Eye Relief) was distributed prior to receiving FDA approval.
VOLUME OF PRODUCT IN COMMERCE
48,000 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1277-6
CODE
Unit 003P59114
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by letter dated October 28, 2005. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1288-6
CODE
Unit 12GS37972
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated November 29, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1289-6;
b) Platelets, Leukocytes Reduced, Recall # B-1290-6
CODE
a) and b) Unit 11GL79280
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Missouri-Illinois Region, St. Louis, MO, by telephone on August 18, 2004 and by letter dated August 27, 2004. 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
2 units
DISTRIBUTION
MO and KY

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1294-6;
CODE
Unit 2598508
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by facsimile dated October 1, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

______________________________
PRODUCT
Corneas, Recall # B-1322-6
CODE
Unit 06710501 and 06710502
RECALLING FIRM/MANUFACTURER
Northeast Pennsylvania Lions Eye Bank, Inc., Allentown, PA, by telephone and facsimile on or about December 22, 2005. Firm initiated recall is complete.
REASON
HCT/Ps, which were collected from a donor who tested repeatedly reactive for the antibody to the hepatitis B core antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Saudi Arabia

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1323-6
CODE
Unit FM24078
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on November 1, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

______________________________
PRODUCT
a) Red Blood Cells, B-1437-6;
b) Fresh Frozen Plasma, Recall # B-1438-6;
c) Platelets, Recall # B-1439-6
CODE
a) and c) Units 1006510, 1015600 and 1025208;
b) Unit 1025208
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on February 16, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Lanoxin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
GA

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1442-6
CODE
Unit 03F17704
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone and by letter dated February 18, 2006. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately distributed in a single storage bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1513-6
CODE
Unit 11LE19573
RECALLING FIRM/MANUFACTURER
American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by telephone on November 11, 2004 and follow-up letter dated November 30, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1514-6;
b) Platelets, Recall # B-1515-6
CODE
a) and b) Unit: 11GN22366
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by telephone on May 17, 2004 and follow-up letter on June 25, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA

______________________________
PRODUCT
Source Plasma, Recall # B-1516-6
CODE
Units: 0200349151, 0200348943, 0200347688, 0200347429, 0200346417, 0200346158, 0200345435, 0200344129, 0200344008
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma Inc., Norman, OK, by fax on September 17, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
NC

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1517-6;
CODE
Unit: 9705331
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on May 27, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1518-6
CODE
Unit: 6922130
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on May 24, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1519-6
CODE
Units: 9025985 (Split product)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on June 6, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL and MN

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1520-6
CODE
Unit: 11GL75089
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by telephone on March 13, 2004 and follow-up letter dated March 18, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1557-6
CODE
Unit: 2485597
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 8, 2003. 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
Red Blood Cells Leukocytes Reduced, Recall # B-1558-6
CODE
Unit: 2554978
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on August 17, 2004. 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
Platelet Pheresis Leukoreduced, Recall # B-1559-6
CODE
Unit: 04GR33513
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on April 1, 2006 and follow-up letters on April 4 and May 3, 2006. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with micrococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA

______________________________
PRODUCT
Platelet Pheresis Leukoreduced, Recall # B-1560-6
CODE
Unit: 04GJ20511
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on March 12, 2006 and follow-up letter on March 13, 2006. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with micrococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1561-6
CODE
Unit: 03FK39386
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region, Atlanta, GA, by telephone and letter on May 14, 2004. Firm initiated recall is complete.
REASON
Blood product, possibly contaminated with bacillus species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
a) Platelets Pheresis Leukocytes Reduced, Recall # B-1562-6;
b) Fresh Frozen Plasma Pheresis, Recall # B-1563-6
CODE
a) Units: 7785664- 1, 7785664- 2, 7785850- 1, 7785850- 2,
5111003- 1, 5111003- 2, 7785329, 7785260, 7785414, 7785392- 1,
7785392- 2, 7784468, 7785425;
b) Unit: 7785537
RECALLING FIRM/MANUFACTURER
Life Source, Glenview, IL, by telephone on March 27 and April 18, 2006. Firm initiated recall is complete.
REASON
Blood products, collected in an open system and not given an expiration time of 24 hours, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
IL

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1564-6;
b) Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-1565-6;
c) Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1566-6
CODE
a) Unit: 10046-7501;
b) Units: 10046-0189 (Parts 1 & 2), 10046-0195 (Parts 1 & 2),
10046-5913 (Parts 1 & 2), 10046-6395, 10046-7496, 10046-7511
(Parts 1 & 2), 10046-7519 (Parts 1 & 2), 10046-7524 (Parts 1 & 2),
10046-8222, 10047-0276 (Parts 1 & 2), 10047-0281, 10046-8225,
10046-6376 (Parts 1 & 2), 10046-9988;
c) Unit: 10046-7501 (Part 2)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on January 27, 2004. Firm initiated recall is complete.
REASON
Blood products, which lacked assurance of sterility due to improper use of the Sterile Connecting Device, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
AZ

______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-1567-6
CODE
Unit: 04FP80337
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Dedham, AL, by telephone on April 20, 2006 and by letter dated April 25, 2006. Firm initiated recall is complete.
REASON
Blood product, which was contaminated with a Staphlyococcus coagulase negative organism, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

______________________________
PRODUCT
Cryoprecipitated, AHF, Recall # B-1568-6
CODE
Unit: LY04724
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., Dba Rhode Island Blood Center, Providence, RI, by telephone and letter on April 4, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor with a history of erythrocytosis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA

______________________________
PRODUCT
Platelet Pheresis Leukoreduced Irradiated, Recall # B-1569-6
CODE
Unit: F206787
RECALLING FIRM/MANUFACTURER
Paget Sound Blood Center, Seattle, WA, by telephone on May 9, 2003. Firm initiated recall is complete.
REASON
Blood product, labeled as leukoreduced, but which did not meet the requirements for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

______________________________
PRODUCT
Red Blood Cells, Recall # B-1570-6
CODE
Unit: 9607861
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by fax on October 5, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

______________________________
PRODUCT
Platelets Pheresis Leukocyte Reduced Irradiated, Recall # B-1572-6
CODE
Units: 21LQ13666, 21KP62024
RECALLING FIRM/MANUFACTURER
Legacy Emanuel Hospital and Health Center, Portland, OR, by telephone on August 9, 2004. Firm initiated recall is complete.
REASON
Blood products, labeled with extended expiration dates, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OR

______________________________
PRODUCT
a) Red blood Cells, Recall # B-1578-6;
b) Red Blood Cells Leukocytes Reduced, Recall # B-1579-6;
c) Platelets, Recall # B-1580-6;
d) Platelets Leukoreduced, Recall # B-1581-6;
e) Cryoprecipitated AHF, Recall # B-1582-6;
f) Plasma, Recall # B-1583-6;
g) Fresh Frozen Plasma, Recall # B-1584-6;
h) Plasma Frozen Cryoprecipitated Reduced, Recall # B-1585-6;
i) Recovered Plasma, Recall # B-1586-6
CODE
a) Units: 18S90190, 18FX00898, 18R98468, 18FQ28948,
18R91485, 18R89139, 18E93288, 18E91572, 18FK05922,
18R63592, 18FC51274, 18X63058, 18E54611, 18X53332;
b) Units: 18FV64233, 18FK80793, 18FZ38543, 18FX48755,
18GC03612, 18FZ28245, 18FQ65458, 18FW09271, 18FS36649;
c) Units: 18S90190, 18FX00898, 18R98468, 18FQ28948, 18R89139,
18FK05922;
d) Units: 18GC03612, 18FZ28245, 18FW09271;
e) Units: 18FV64233, 18FZ38543, 18GC03612, 18FQ65458,
18R91485;
f) Unit: 18R91485;
g) Units: 18FX48755, 18FZ28245, 18FW09271, 18R98468,
18R89139, 18E54611;
h) Units: 18FV64233, 18FZ38543, 18GC03612, 18FQ65458;
i) Units: 18FK80793, 18R63592, 18FC51274
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by telephone, fax, e-mail and/or letter beginning on March 30, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose sexual partner tested reactive for hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
51 units
DISTRIBUTION
CA, CT, FL, MD, MI, OH and UT

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1587-6;
b) Cryoprecipitated AHF, Recall # B-1588-6;
c) Recovered Plasma, Recal # B-1589-6
CODE
a), b) and c) Unit: 2016719
RECALLING FIRM/MANUFACTURER
Walter Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on March 13, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA and Germany

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1590-6;
b) Fresh Frozen Plasma, Recall # B-1591-6
CODE
a) and b) Unit: 2443595
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on June 30, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1592-6;
b) Fresh Frozen Plasma, Recall # B-1593-6
CODE
a) and b) Unit: 2545596
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by facsimile on December 14, 2004 and January 3, 2005. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who may be at increased risk 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-1594-6
CODE
Unit: 6707887
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on June 19, 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
KY

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1595-6
CODE
Unit: 9700180
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on June 14, 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
CO

______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-1596-6
CODE
Unit: 9071834
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on June 14, 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
NJ

______________________________
PRODUCT
Red Blood Cells, Recall # B-1597-6
CODE
Unit: 6962628
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on May 31, 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
CO

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1599-6;
b) Platelets, Recall # B-1600-6;
c) Fresh Frozen Plasma, Recall # B-1601-6
CODE
a) Units: 4015161, 2012773;
b) Unit: 4015161;
c) Unit: 2012773
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile dated June 29, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking Topamax, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
GA and SC

______________________________
PRODUCT
Human Tissue for Transplantation, Recall # B-1610-6:
a) CryoVein, CryoPatch Allografts, Pulmonary Hemi-Artery;
b) CryoVein, CryoPatch Allografts, Saphenous Vein
CODE
a) Serial #: 8491819;
b) Serial #s: 8491622, 8491613
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letter dated May 5, 2006. Firm initiated recall is complete.
REASON
Human Tissue, collected from a donor with a history of IV drug use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
3 tissues
DISTRIBUTION
MI and IN

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1651-6
CODE
Unit: 003GF24857
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on December 26, 2005 and by letter dated January 4, 2006. Firm initiated recall is complete.
REASON
Blood product, which lacked assurance of sterility due to improper use of the Sterile Connecting Device, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1652-6;
b) Platelets, Recall # B-1653-6
CODE
a) Units: 3022290, 3115201, 4015438;
b) Unit: 3115201
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on June 21, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malarial, was distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
GA

______________________________
PRODUCT
Red Blood Cells, Recall # B-1662-6
CODE
Unit: 2016727
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on April 28, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated as endemic for malarial, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1441-6
CODE
Units: 003L69383, 003L69365, 003L69368
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on December 9, 2004 and by letter dated January 5, 2005. Firm initiated recall is complete.
REASON
Blood products, collected on a trip scale that was incorrectly calibrated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1571-6
CODE
Units: 7024204, 7024196
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by facsimile on September 9, 2004. Firm initiated recall is complete.
REASON
Blood products, with an unacceptably low red cell recovery rate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AK

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-1573-6
CODE
Units: 21LC19328, 21KL84140, 21KW29232, 21LC19308, 21LJ04897,21KL83906
RECALLING FIRM/MANUFACTURER
Providence Portland Medical Center, Portland, OR, by facsimile on June 11, 2004. Firm initiated recall is complete
REASON
Blood products, labeled with extended expiration dates, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
OR

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-1602-6
CODE
Unit: 027LR48002
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on January 30, 2006 and by letter dated February 7, 2006. Firm initiated recall is complete.
REASON
Red Cells, mislabeled for the Fyb antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

______________________________
PRODUCT
Red Blood Cells, Recall # B-1648-6
CODE
Unit: G153410
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by letter dated January 6, 2004.
Manufacturer: Puget Sound Blood Center, Renton, WA. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a unit of whole blood more than eight hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-1650-6
CODE
Units: GF29645, LE46222
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone and facsimile on October 12, 2004. Firm initiated recall is complete.
REASON
Blood products, which were out of controlled storage for more than 30 minutes during irradiation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-1654-6;
b) Fresh Frozen Plasma, Recall # B-1655-6;
c) Platelets, Recall # B-1656-6
CODE
a), b), and c) Units: 5107239, 5107917, 5109832
RECALLING FIRM/MANUFACTURER
Walter L. Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile on March 20, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested negative for Hepatitis B surface antigen (HBsAg) and for the antibody to Hepatitis B core antigen (anti-HBc), but were collected from a donor who previously tested positive for HBsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
GA and SC

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

______________________________
PRODUCT
Welch Allyn PIC 50 Portable Intensive Care System Multi-Parameter Monitor/Defibrillator; a portable, 12V internal battery powered defibrillator, Part numbers 971081, 971082, 971083 and 971084, Recall # Z-1195-06
CODE
Serial numbers 80104, 80119, 80120, 80204, 80211, 80212, 80429, 80432, 80569, 80627, 80661, 80685, 80880, 80964, 81056, 81134, 81263, 81293/81295, 81303, 81445/ 81448, 81733, 81738, 81739, 81744/81752, 81757, 81761/81781, 81802/81807, 81824, 81825, 81835, 81845, 81846, 81852, 81864, 81865, 81868, 81869, 81884/81886, 81892/81897, 81918/81955, 81957, 81983/81990, 81996/82025, 82027/82033, 82035/82039, 82043, 82044, 82061/82080, 82084, 82097/82111, 82122/82128, 82133, 82136/82143, 82150/82169, 82172/82204, 82245, 82252/82273, 82283/82286, 82307/82330, 82340/82349, 82405/82426, 82430, 82460/82490, 82498/82553, 82555/82565, 82568/82570, 82612/82631, 82654/82673, 82689, 82690, 82773/82813, 82827/82830, 82852, 82856/82859, 82906, 82936, 82937, 82958/82977, 82983/83013, 83060/83071, 83083/83090, 83093, 83142/83147, 83153/83172, 83198/83239, 83255, 83368/83370, 83400/83407, 83414/83418, 83420/83429, 83440/83443, 83499/83517, 83578/83580, 83633, 83644, 83645, 83654, 85001/85005, 85009/85013, 85026/85029, 85032/85052, 85073/85079, 85093, 85094, 85110, 85111, 85143/85157, 85187/85201, 85223, 85224, 85226/85238, 85244/85249, 85329, 85332/85334, 85337/85350, 85364, 85365, 85368/85370, 85381, 85388/85398, 85402/85404, 85410/85414, 85420/85433, 85441, 85505/85515, 85517/85520, 85522/85530, 85534, 85552, 85554/85557, 85587/85589, 85602/85607, 85619/85623, 85630, 85645/85655, 85658/85667, 85686, 85728/85734, 85755/85757, 85761/85766, 85771/85785, 85787/85793, 85810, 85812/85823, 85825/85838, 85856/85872, 85877/85884, 85888/85902, 85931/85933, 85945, 85955, 85964, 85967/85970, 86017, 86018, 86024/86029, 86055/86057, 86103, 86104, 86118, 86141/86147, 86149, 86150, 86222/86228, 86230, 86245, 86256/86258, 86261/86268, 86281/86283, 86289/86293, 86295, 86296, 86299, 86305, 86306, 86314, 86315, 86320/86322, 86324/86328, 86334, 86335, 86358, 86359, 86385, 86387, 86389/86399, 86400, 86411, 86412, 86419, 86420, 86439, 86440
RECALLING FIRM/MANUFACTURER
Recalling Firm: Welch Allyn Inc., Skaneateles Falls, NY, by letters dated June 30, 2006.
Manufacturer: MRL, Inc., A Welch Allyn Company, Buffalo, IL. Firm initiated recall is ongoing.
REASON
The Welch Allyn PIC 50 Defibrillators may display a "Defib Comm" or "Pace Comm" error message on the device display during use which may result in a terminal failure of the device to analyze the patient’s ECG and deliver the appropriate therapy.
VOLUME OF PRODUCT IN COMMERCE
1184 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
a) MD3 X-ray system, Recall # Z-0851-06;
b) MD4 X-ray system, Recall # Z-0852-06
CODE
a) Site numbers 59515, 38929, 76329, 83654, 82673, 35471, 59524,
86146, 38922, 101151, 38714, 38716, 44865, 6847, 103855, 26071,
103856, 40941, 83047, 62502, 38266, 38422, X1198, 50317, 38289,
17669, 6931, X0917, 26019, 26020, 13661, 38418, 59571, 41462,
82721, 101782, 103209;
b) Site numbers 102550 (20279385), 103023, 38783, 102562 (20279430),
83957, 101155, 82628, 38442, 83038, 13721, 85034, 102583, 80306,
41156, 38993, 84930, X1321, 41032, X1077, 100014, 50328, 17656,
83367, 38586, 100954, 76834, 87176, 41426, 104137, 82800, 103651,
10388, 41111, 17622, 13918, 103377, 101038, X0934, 102034, 52471,
76804, 50251, 44898, 13258, 86545, 101863, 38587, 103043 (20283876),
82688, 38635, 47160, 14099, 45042, 38917, 101156 (20278521), 86328,
38501, 13879, 41439, 41069, 76975, X1277, 100637, X1078, 35484,
101759, 84463, 105022, X1751, 76877, 13172, 38944, 41143, 85694,
87140, 59546, 13704, 10458, 45039, 76869, 52455, 84892, 41271,
87302, 6842, 41031, 41000, X0662, 87030, 76808, 6838, 62938, 86218,
85491, 50340, 82687, 38912, 101153, 103210
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on April 6, 2006.
Manufacturer: Philips Medical Systems, Best, Netherlands. Firm initiated recall is ongoing.
REASON
Potential for unexpected table movement.
VOLUME OF PRODUCT IN COMMERCE
137 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent
multifunction electrode products for pediatrics. Catalog number 30-595,
Catalog number 3100-1700, Catalog number 3111-1720,
Catalog number 3112-1730, Catalog number 3114-1740,
Catalog number 3200-1711, Recall # Z-1241-06
b) Kimberly-Clark/Ballard medical R2 triangle shaped non-radiolucent
multifunction electrode products for adults, Catalog number 30-585,
Catalog number 30-590, Catalog number 30-591, Catalog number 30-593,
Catalog number 3100-1702, Catalog number 3100-703,
Catalog number 3111-1721, Catalog number 3112-1731,
Catalog number 3114-1741, Catalog number 3200-1715,
Catalog number 3250-1780, Recall # Z-1242-06
CODE
a) Lot number 288003; Lot numbers 284026 and 299215;
Lot numbers 288963, 288969, 290317, 291534, 293216, 294205,
295161, 296269, 298031, 300851, 301438, 303002, 304752, 305508;
Lot number 282182, 286334, 286341, 290319, 290906, 291536, 293219,
294865, 295602, 296272, 298034, 299217, 301440, 302660, 303005, 305511;
Lot numbers 290321, 297265 and 302661; Lot numbers 282187, 282941,
288973, 290910, 291540, 292666, 293223, 294209, 294869, 295606,
297268, 298037, 299990, 300856, 301443, 302664, 303007, 305514;
b) Lot number 300847; Lot numbers 28802, 297261, 304750;
Lot number 299214; Lot number 288962, 293213, 294860, 302657;
Lot number 297735; Lot number 282936, 293214, 300849, 303000;
Lot numbers 282181, 282938, 286332, 286339, 288964, 288970,
290318, 290905, 291535, 292660, 293217, 294206, 294862, 295600,
296270, 297263, 298032, 299985, 302659, 303003, 304091, 304753,
305509; Lot numbers 282183, 282939, 285955, 286335, 286342, 290320,
290907, 291537, 292662, 293220, 294208, 294866, 295603, 296273,
299218, 299987, 300853, 304093, 305512; Lot numbers 282185, 284030,
290322, 291538, 292664, 295604, 297266, 300854, 304095;
Lot numbers 282188, 282942, 284031, 288004, 288005, 288966,
288967, 288974, 288975, 290911, 291541, 292667, 293224,
294210 294870, 295607, 296276, 297269, 298038, 299221,
299991, 301444, 302665, 303008, 304097, 304757, 305515;
Lot numbers 292086, 297270, 301445, 302666
RECALLING FIRM/MANUFACTURER
Kimberly-Clark Corporation, Roswell, GA, by telephone and letter on May 18, 2006. Firm initiated recall is ongoing.
REASON
The tinfoil in the triangle electrodes has the potential to develop cracks, which may hinder electrical flow and product performance during defibrillation.
VOLUME OF PRODUCT IN COMMERCE
95,639 electrode sets
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
SoftPath ASXII Software Releases 2.3.0 and 4.3.7. The software is used in pathology labs for administrative and clinical documentation and data processing, Recall # Z-1243-06
CODE
Software Releases 2.3.0 and 4.3.7
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Palm Harbor, FL, by letter on October 27, 2004. Firm initiated recall is complete.
REASON
Text from one case is overwriting another. This could cause an incorrect diagnostic report to be sent to a clinician/surgeon.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
a) Hamilton brand RAPHAEL Ventilator (Software Version 2.2x),
Recall # Z-1249-06;
b) Hamilton brand RAPHAEL Silver Ventilator (Software Version 2.2xS),
Recall # Z-1250-06;
c) Hamilton brand RAPHAEL Color Ventilator (Software Version 2.2xC, 2.2xCU),
Recall # Z-1251-06
CODE
a), b) and c) Serial Numbers: 2975 to 5360
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hamilton Medical, Inc., Reno, Nevada, by a Medical Device Field Correction on June 1, 2006.
Manufacturer: Hamilton Medical AG, Bonaduz, Switzerland. Firm initiated recall is ongoing.
REASON
Alarm Failure -- Following an oxygen cell calibration, the user may inadvertently and unknowingly disable the alarm system.
VOLUME OF PRODUCT IN COMMERCE
2,385 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
SoftPath ASCII Software, used in pathology labs to track and report specimens and diagnostic results. Releases 1.2, 2.1, and 2.3, Recall # Z-1252-06
CODE
Software Releases 1.2, 2.1, and 2.3
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Palm Harbor, FL, by letter on January 9, 2001. Firm initiated recall is complete.
REASON
The client had made a decision to use the SoftPath Module in a nonstandard manner. User specific circumstances, incorrect text may appear on a patient report.
VOLUME OF PRODUCT IN COMMERCE
171
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
ExacTrac Robotics, sold alone as Robotic Tilt Module catalog 49720 and in a bundle as catalog 49700, for installation on the Varian Exact Couch, a component of the Novalis Shaped Beam Surgery System; a table tilt device - powered radiation therapy patient support assembly, Recall # Z-1255-06
CODE
Bundle #06-69448-49700, tilt module #3520-05-011-49720; bundle #06-69445-49700, tilt module #3520-05-006-49720; bundle #06-78573-49700, tilt module #3520-05-017-49720; bundle #06-69573-49700, tilt module #3520-05-002-49720; bundle #06-78149-49700, tilt module #3520-05-015-49720; bundle #06-66427-49700, tilt module #3520-05-013-49720; bundle #06-62416-49700, tilt module #3520-05-008-49720; tilt module #3520-05-018-49720; bundle #06-77290-49700, tilt module #3520-05-019-49720; bundle #06-77669-49700, tilt module #3520-05-020-49720; bundle #06-78440-49700, tilt module #3520-05-014-49720; bundle #06-74601-49700, tilt module #3520-05-010-49720; bundle #06-64377-49700, tilt module #7520-05-005-49720
RECALLING FIRM/MANUFACTURER
Brainlab AG, Kirchheim B. Muenchen, Germany, by letters on June 2, 2006 and June 7, 2006. Firm initiated recall is ongoing.
REASON
During ExacTrac Robotics installation on the Varian Exact Couch, the couch height position indication is re-calibrated to read out the correct positions. This re-calibration could cause the eventual failure of the vertical lift mechanism of the couch, which might result in patient injury or death.
VOLUME OF PRODUCT IN COMMERCE
19 devices
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Soft Cosmetic Contact Lenses sold under the brand names: Circle Lens, Europa, Pacifica, Gothika and Water Color, Recall # Z-1257-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hebron International, Inc., Atlanta, GA, by letters on May 22, 2006.
Manufacturer: Mi Gwang Contact Lens Co., Ltd., Kyungsan, Korea. Firm initiated recall is ongoing.
REASON
Contact lenses were distributed and sold to inappropriate retail establishments without professional eye care involvement.
VOLUME OF PRODUCT IN COMMERCE
334,187 lenses
DISTRIBUTION
Nationwide

______________________________
PRODUCT
St. Francis Medical Technologies brand X STOP® Interspinous Process Decompression (IPD) System, 14 mm X STOP implants in peel pouch, Catalog #1-2210; The X STOP consists of a main body, a spacer, and a tissue expander that is secured using a universal wing assembly consisting of a wing and a setscrew, Recall # Z-1258-06
CODE
Lot numbers 051122, 060126, 060213, 060306, 060322, 060405, 060413, 060420, 060504, 060509
RECALLING FIRM/MANUFACTURER
St. Francis Medical Technologies, Inc., Alameda, CA, by letters on May 22, 2006. Firm initiated recall is ongoing.
REASON
Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant.
VOLUME OF PRODUCT IN COMMERCE
440 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Beckman Coulter Cytomics FC 500 Flow Cytometry System, Part Numbers 626553 (TN; FC500 with UPS), 6605627 (TN; 5 CLR, FC500 (100V), 6605628 (TN; 5CLR, FC500 (120V), 6605629 (TN; 5 CLR, FC500 (220V), 6605630 (TN; 5 CLR, FC500 (240V) with CXP Software Versions 2.0 and 2.1, Recall # Z-1259-06
CODE
Software Versions 2.0 and 2.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter on May 22, 2006.
Manufacturer: Applied Cytometry, Sheffield, United Kingdom. Firm initiated recall is ongoing.
REASON
Beckman Coulter has determined that under certain conditions a system error generated during a Pause and rotate routine may result in a sample misidentification with a risk of reporting erroneous results.
VOLUME OF PRODUCT IN COMMERCE
424 devices
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
Waste tubing, Model # 842-326 (pump tube for waste) and Model # 842-327 (pump tube for solution), Waste Tubing used on ABL 7xx and ABL8xx component of the ABL700/800 Blood Gas Analyzers, also included in service kits part no. 905-671, Recall # Z-1260-06
CODE
No lot numbers supplied.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America, Inc., Westlake, OH, by letter dated May 22, 2006.
Manufacturer: Radiometer A/S, Copenhagen, Denmark. Firm initiated recall is ongoing.
REASON
An increased failure rate was observed with the yellow rubber tubing. The tubing was found to be leaking blood and solutions after distribution.
VOLUME OF PRODUCT IN COMMERCE
2,576 units
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
Dri-Tex BG-OX Cartridge, Model # D7120, Catalog # 946-003. Cartridges used in the NPT7 Analyzer, an in vitro diagnostic device, Recall # Z-1261-06
CODE
Lot # R0299, Expiration Date: 02/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America, Inc., Westlake, OH, by letter dated May 1, 2006.
Manufacturer: Radiometer A/S, Copenhagen, Denmark. Firm initiated recall is ongoing.
REASON
Air bubbles may be trapped on or close to the O2 sensor in the pO2 chamber of the cuvettes in cartridges used for blood gas analysis on NPT7 analyzer. This produces too high pO2 readings without a question mark.
VOLUME OF PRODUCT IN COMMERCE
185 units
DISTRIBUTION
Nationwide

________________________________
PRODUCT
Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System, in vitro diagnostic, Model 914-317 Radiance Basic Kit, Recall # Z-1262-06
CODE
Version 2.42 operating software
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America, Inc., Westlake, OH, by letters dated March 2, 2005.
Manufacturer: Radiometer A/S, Copenhagen, Denmark. Firm initiated recall is complete.
REASON
Software anomaly. Data generated by blood gas equipment did not correlate with data shown in the Radiance Data Management System.
VOLUME OF PRODUCT IN COMMERCE
306 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Microcuff Endotracheal Tube; Pediatric Oral/Nasal Magill: ID Size: 3,0mm,
Microcuff Product Reference: I-MPEDC-30; ID Size: 3,5mm, Product
Reference: I-MPEDC-35; ID Size: 4,0mm, Product Reference: I-MPEDC-40;
ID Size: 4.5mm, Product Reference: I-MPEDC-45; ID Size: 5,0mm, Product
Reference: I-MPEDC-50; ID Size: 5,5mm, Product Reference: I-MPEDC-55;
ID Size: 6,0mm, Product Reference: I-MPEDC-60; ID Size: 6,5mm, Product
Reference: I-MPEDC-65 and ID Size: 7,0mm, Product Reference: I-MPEDC-70
* Sterile * Single use only * , Recall # Z-1263-06;
b) Microcuff Pediatric Endotracheal Tubes - Oral Pre-Curved: ID Size: 3,0mm,
Microcuff Product Reference: I-MPEDC-30; ID Size: 3,5mm, Product Reference:
I-MPEOC-35; ID Size: 4,0mm, Product Reference: I-MPEOC-40; ID Size: 4.5mm,
Product Reference: I-MPEOC-45; ID Size: 5,0mm, Product Reference: I-MPEOC-50;
ID Size: 5,5mm, Product Reference: I-MPEOC-55; ID Size: 6,0mm, Product
Reference: I-MPEOC-60; ID Size: 6,5mm, Product Reference: I-MPEOC-65 and ID
Size: 7,0mm, Product Reference: I-MPEOC-70 * Sterile * Single use only *,
Recall # Z-1264-06;
c) Microcuff Adult Endotracheal Tubes - Oral/Nasal Magill with Murphy Eye *
ID Size: 5,0mm, Microcuff Product Reference: I-HMICU-50; ID Size: 5.5mm,
Product Reference: I-HMICU- 55; ID Size: 6.0mm, Product Reference:
I-HMICU- 60; ID Size: 6.5mm, Product Reference: I-HMICU- 65; ID
Size: 7.0mm, Product Reference: I-HMICU- 70; ID Size: 7.5mm, Product
Reference: I-HMICU-75; ID Size: 8.0mm, Product Reference: I-HMICU-80;
ID Size: 8.5mm, Product Reference: I-HMICU-85; ID Size: 9.0mm, Product
Reference: I-HMICU-90; and ID Size: 10.0mm Product Reference: I-HMICU-10 *
Sterile * Single use only *,Recalll # Z-1265-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Microcuff Gmbh, Weinheim, Germany, by telephone in April 2006, and by letter on June 29, 2006.
Manufacturer: Unomedical Industries, Kedah, Malaysia. Firm initiated recall is ongoing.
REASON
Inadequate seals and/or holes in the pouch may compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
1,730 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Terumo Advanced Perfusion System 4 inch diameter Roller Pump;
Model 801040, Recall # Z-1266-06;
b) Terumo Advanced Perfusion System 1 Large Roller Pump; Model 801041,
Recall # Z-1267-06
CODE
a) Serial numbers: 0031 through 1188;
b) Serial numbers: 0033 through 1339
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by firm representative visit, beginning on September 30, 2005. Firm initiated recall is complete.
REASON
The pump may stop during the autodose delivery without completion of the dose delivery to the patient.
VOLUME OF PRODUCT IN COMMERCE
1,898 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Gamma Win software, part number GM11019110, versions up to and
including 1.62, for the GammaMedplus radionuclide applicator system,
for radiation therapy, Recall # Z-1268-06;
b) Gamma Win software, part number GM11019110, versions up to and
including 1.62, for the GammaMedplus 3/24 radionuclide applicator system,
for radiation therapy, Recall # Z-1269-06;
c) Gamma Win software, part number GM11019110, versions up to and
including 1.62, for the Mammo Source radionuclide applicator system,
for radiation therapy, Recall # Z-1270-06
CODE
All lots are recalled. Serial numbers are described: H64Y001 H64A032
H64A052 H64B074 H64C096 H64D120 H64Y002 H64A033 H64A053
H64B075 H64C097 H64D121 H64Y003 H64A034 H64A054 H64B076
H64C098 H64D122 H64Y006 H64A035 H64A055 H64B077 H64C099
H64D123 H64Y007 H64A036 H64A056 H64B078 H64C100 H64D124
H64Y009 H64A037 H64A057 H64B079 H64C101 H64D127 H64Y012
H64A038 H64A058 H64B080 H64C102 H64D128 H64Y013 H64A039
H64A059 H64B081 H64C103 H64D129 H64Z015 H64A040 H64A060
H64B082 H64C104 H64D130 H64Z018 H64A041 H64A061 H64B083
H64C106 H64D131 H64Z019 H64A042 H64A062 H64B084 H64C107
H64D132 H64Z021 H64A043 H64A063 H64B085 H64C108 H64D133
H64Z022 H64A044 H64A064 H64B087 H64C109 H64D134 H64Z024
H64A045 H64A066 H64B088 H64C110 H64D135 H64Z025 H64A046
H64A067 H64B089 H64C112 H64D136 H64Z026 H64A047 H64A068
H64B090 H64C113 H64E137 H64Z027 H64A048 H64B070 H64B091
H64D115 H64E138 H64Z028 H64A049 H64B071 H64C093 H64D116
H64E140 H64Z029 H64A050 H64B072 H64C094 H64D117 H64E141
H64Z030 H64A051 H64B073 H64C095 H64D118 H64E142 H64E143
H64E166 H64F191 H64F211 H640234 H640254 H64E147 H64E167
H64F192 H64F212 H640235 H640255 H64E148 H64E168 H64F193
H64F213 H640236 H640256 H64E149 H64E169 H64F194 H64F216
H640237 H640257 H64E150 H64E170 H64F195 H640217 H640238
H640258 H64E151 H64E171 H64F196 H640218 H640239 H640259
H64E152 H64E172 H64F197 H640219 H640240 H640260 H64E153
H64E173 H64F198 H640220 H640241 H640261 H64E154 H64E175
H64F199 H640221 H640242 H640262 H64E155 H64E176 H64F200
H640222 H640243 H640264 H64E156 H64E177 H64F201 H640224
H640244 H640265 H64E157 H64E178 H64F202 H640225 H640245
H640266 H64E158 H64E179 H64F203 H640226 H640246 H640267
H64E159 H64E180 H64F204 H640227 H640247 H640268 H64E160
H64F181 H64F205 H640228 H640248 H640269 H64E161 H64F182
H64F206 H640229 H640249 H640270 H64E162 H64F183 H64F207
H640230 H640250 H640271 H64E163 H64F184 H64F208 H640231
H640251 H640273 H64E164 H64F185 H64F209 H640232 H640252
H640275 H64E165 H64F189 H64F210 H640233 H640253;
b) All lots are recalled. Serial numbers are described: H64Y001 H64A032
H64A052 H64B074 H64C096 H64D120 H64Y002 H64A033 H64A053
H64B075 H64C097 H64D121 H64Y003 H64A034 H64A054 H64B076
H64C098 H64D122 H64Y006 H64A035 H64A055 H64B077 H64C099
H64D123 H64Y007 H64A036 H64A056 H64B078 H64C100 H64D124
H64Y009 H64A037 H64A057 H64B079 H64C101 H64D127 H64Y012
H64A038 H64A058 H64B080 H64C102 H64D128 H64Y013 H64A039
H64A059 H64B081 H64C103 H64D129 H64Z015 H64A040 H64A060
H64B082 H64C104 H64D130 H64Z018 H64A041 H64A061 H64B083
H64C106 H64D131 H64Z019 H64A042 H64A062 H64B084 H64C107
H64D132 H64Z021 H64A043 H64A063 H64B085 H64C108 H64D133
H64Z022 H64A044 H64A064 H64B087 H64C109 H64D134 H64Z024
H64A045 H64A066 H64B088 H64C110 H64D135 H64Z025 H64A046
H64A067 H64B089 H64C112 H64D136 H64Z026 H64A047 H64A068
H64B090 H64C113 H64E137 H64Z027 H64A048 H64B070 H64B091
H64D115 H64E138 H64Z028 H64A049 H64B071 H64C093 H64D116
H64E140 H64Z029 H64A050 H64B072 H64C094 H64D117 H64E141
H64Z030 H64A051 H64B073 H64C095 H64D118 H64E142 H64E143
H64E166 H64F191 H64F211 H640234 H640254 H64E147 H64E167
H64F192 H64F212 H640235 H640255 H64E148 H64E168 H64F193
H64F213 H640236 H640256 H64E149 H64E169 H64F194 H64F216
H640237 H640257 H64E150 H64E170 H64F195 H640217 H640238
H640258 H64E151 H64E171 H64F196 H640218 H640239 H640259
H64E152 H64E172 H64F197 H640219 H640240 H640260 H64E153
H64E173 H64F198 H640220 H640241 H640261 H64E154 H64E175
H64F199 H640221 H640242 H640262 H64E155 H64E176 H64F200
H640222 H640243 H640264 H64E156 H64E177 H64F201 H640224
H640244 H640265 H64E157 H64E178 H64F202 H640225 H640245
H640266 H64E158 H64E179 H64F203 H640226 H640246 H640267
H64E159 H64E180 H64F204 H640227 H640247 H640268 H64E160
H64F181 H64F205 H640228 H640248 H640269 H64E161 H64F182
H64F206 H640229 H640249 H640270 H64E162 H64F183 H64F207
H640230 H640250 H640271 H64E163 H64F184 H64F208 H640231
H640251 H640273 H64E164 H64F185 H64F209 H640232 H640252
H640275 H64E165 H64F189 H64F210 H640233 H640253;
c) All lots are recalled. Serial numbers are described: H64Y001
H64A032 H64A052 H64B074 H64C096 H64D120 H64Y002 H64A033
H64A053 H64B075 H64C097 H64D121 H64Y003 H64A034 H64A054
H64B076 H64C098 H64D122 H64Y006 H64A035 H64A055 H64B077
H64C099 H64D123 H64Y007 H64A036 H64A056 H64B078 H64C100
H64D124 H64Y009 H64A037 H64A057 H64B079 H64C101 H64D127
H64Y012 H64A038 H64A058 H64B080 H64C102 H64D128 H64Y013
H64A039 H64A059 H64B081 H64C103 H64D129 H64Z015 H64A040
H64A060 H64B082 H64C104 H64D130 H64Z018 H64A041 H64A061
H64B083 H64C106 H64D131 H64Z019 H64A042 H64A062 H64B084
H64C107 H64D132 H64Z021 H64A043 H64A063 H64B085 H64C108
H64D133 H64Z022 H64A044 H64A064 H64B087 H64C109 H64D134
H64Z024 H64A045 H64A066 H64B088 H64C110 H64D135 H64Z025
H64A046 H64A067 H64B089 H64C112 H64D136 H64Z026 H64A047
H64A068 H64B090 H64C113 H64E137 H64Z027 H64A048 H64B070
H64B091 H64D115 H64E138 H64Z028 H64A049 H64B071 H64C093
H64D116 H64E140 H64Z029 H64A050 H64B072 H64C094 H64D117
H64E141 H64Z030 H64A051 H64B073 H64C095 H64D118 H64E142
H64E143 H64E166 H64F191 H64F211 H640234 H640254 H64E147
H64E167 H64F192 H64F212 H640235 H640255 H64E148 H64E168
H64F193 H64F213 H640236 H640256 H64E149 H64E169 H64F194
H64F216 H640237 H640257 H64E150 H64E170 H64F195 H640217
H640238H640258 H64E151 H64E171 H64F196 H640218 H640239
H640259 H64E152 H64E172 H64F197 H640219 H640240 H640260
H64E153 H64E173 H64F198 H640220 H640241 H640261 H64E154
H64E175 H64F199 H640221 H640242 H640262 H64E155 H64E176
H64F200 H640222 H640243 H640264 H64E156 H64E177 H64F201
H640224 H640244 H640265 H64E157 H64E178 H64F202 H640225
H640245 H640266 H64E158 H64E179 H64F203 H640226 H640246
H640267 H64E159 H64E180 H64F204 H640227 H640247 H640268
H64E160 H64F181 H64F205 H640228 H640248 H640269 H64E161
H64F182 H64F206 H640229 H640249 H640270 H64E162 H64F183
H64F207 H640230 H640250 H640271 H64E163 H64F184 H64F208
H640231 H640251 H640273 H64E164 H64F185 H64F209 H640232
H640252 H640275 H64E165 H64F189 H64F210 H640233 H640253
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems, Charlottesville, VA, by letter on May 1, 2006.
Manufacturer: Varian Medical Systems, Haan, Germany. Firm initiated recall is ongoing.
REASON
Medical device software for brachytherapy may cause erroneous data to be recorded and affect patient radiation treatments. Erroneous data may be listed on the treatment history report, and the default step size may lead to a misadministration if treatment data is entered manually.
VOLUME OF PRODUCT IN COMMERCE
254 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
8 mm diameter, 130 mm length non-sterile, catalog no. 4309-08-13
(00-4309-008-13), Recall # Z-1271-06;
b) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
9 mm diameter, 130 mm length non-sterile, catalog no. 4309-09-13
(00-4309-009-13), Recall # Z-1272-06;
c) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
10 mm diameter, 130 mm length non-sterile, catalog no. 4309-10-13
(00-4309-010-13), Recall # Z-1273-06;
d) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
11 mm diameter, 130 mm length non-sterile, catalog no. 4309-11-13
(00-4309-011-13), Recall # Z-1274-06;
e) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
12 mm diameter, 130 mm length non-sterile, catalog no. 4309-12-13
(00-4309-012-13), Recall # Z-1275-06;
f) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
13 mm diameter, 130 mm length non-sterile, catalog no. 4309-13-13
(00-4309-013-13), Recall # Z-1276-06;
g) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
14 mm diameter, 130 mm length non-sterile, catalog no. 4309-14-13
(00-4309-014-13), Recall # Z-1277-06;
h) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
15 mm diameter, 130 mm length non-sterile, catalog no. 4309-15-13
(00-4309-015-13), Recall # Z-1278-06;
i) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
16 mm diameter, 130 mm length non-sterile, catalog no. 4309-16-13
(00-4309-016-13), Recall # Z-1279-06;
j) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
17 mm diameter, 130 mm length non-sterile, catalog no. 4309-17-13
(00-4309-017-13), Recall # Z-1280-06;
k) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
18 mm diameter, 130 mm length non-sterile, catalog no. 4309-18-13
(00-4309-018-13), Recall # Z-1281-06;
l) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
8 mm diameter, 170 mm length non-sterile, catalog no. 4309-08-17
(00-4309-008-17), Recall # Z-1282-06;
m) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
10 mm diameter, 170 mm length non-sterile, catalog no. 4309-10-17
(00-4309-010-17), Recall # Z-1283-06;
n) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
12 mm diameter, 170 mm length non-sterile, catalog no. 4309-12-17
(00-4309-012-17), Recall # Z-1284-06;
o) Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot,
14 mm diameter, 170 mm length non-sterile, catalog no. 4309-14-17
(00-4309-014-17), Recall # Z-1285-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letter dated June 30, 2006. Firm initiated recall is ongoing.
REASON
During provisional trialing, the instrument may become stuck in the humeral canal and require surgical removal.
VOLUME OF PRODUCT IN COMMERCE
324 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Guidant CONTAK RENEWAL 3 (models H170, H175) CONTAK
RENEWAL 3 HE (models H177, H179) Cardiac Resynchronization
Therapy Defibrillator (CRT-D). Cardiac resynchronization therapy
defibrillators (CRT-D) provide ventricular tachyarrhythmia and cardiac
resynchronization therapies. Ventricular tachyarrhythmia therapy is
for the treatment of ventricular tachycardia (VT) and ventricular
fibrillation (VF), rhythms that are associated with sudden cardiac
death (SCD). Cardiac resynchronization therapy is for the treatment
of heart failure (HF) and uses biventricular electrical stimulation to
synchronize ventricular contractions. Cardioversion/defibrillation
therapies include a range of low-and high-energy shocks using either
a biphasic or monophasic waveform, Recall # Z-1288-06;
b) These models are not available in the US. Guidant CONTAK RENEWAL
4 (models H190, H195). Cardiac Resynchronization Therapy Defibrillator
(CRT-D). Cardiac resynchronization therapy defibrillators (CRT-D)
provide ventricular tachyarrhythmia and cardiac resynchronization
therapies. Ventricular tachyarrhythmia therapy is for the treatment of
ventricular tachycardia (VT) and ventricular fibrillation (VF), rhythms
that are associated with sudden cardiac death (SCD). Cardiac
resynchronization therapy is for the treatment of heart failure
(HF) and uses biventricular electrical stimulation to synchronize
ventricular contractions. Cardioversion/defibrillation therapies
include a range of low-and high-energy shocks using either a
biphasic or monophasic waveform, Recall # Z-1289-06;
c) CONTACT RENEWAL 4 AVT HE model numbers M177. Cardiac
Resynchronization Therapy Defibrillator. CONTAK RENEWAK AVT
models provide both atrial and ventricular tachyarrhythmia and cardiac
resynchronization therapies, Recall # Z-1290-06;
d) VITALITY AVT, model A155. Implantable Cardioverter, Defibrillator,
Atrial and Ventricular Therapies, Model A155, Recall # Z-1291-06;
e) Guidant VITALITY 2 (models T165, T175), VITALITY DS (model T125),
VITALITY EL (model T135), Implantable Cardioverter Defibrillators (ICD),
are designed to detect and terminate ventricular tachycardia (VT) and
ventricular fibrillation (VF) and provide bradycardia therapy (atrial and
ventricular pacing). Therapies include both low- and high-energy shocks
using either a biphasic or monophasic waveform. Vitality 2 devices also
offer a wide variety of antitachycardia pacing schemes to terminate slower,
more stable ventricular tachyarrhythmias. Bradycardia pacing, including
adaptive-rate features, is available to detect and treat bradyarrhythmias
and to support the cardiac rhythm after defibrillation therapy. Devices
denoted with DR offer dual-chamber bradycardia features (atrial and/or
ventricular pacing and sensing), and the devices denoted with VR offer
single-chamber bradycardia features (ventricular pacing and sensing),
Recall # Z-1292-06
CODE
a) Model H170, Serial numbers: 509659, 509677, 509678, 509679,
509685, 509694, 509695, 509696, 509762, 509884, 509974, 510012
model H175, serial numbers: 512665, 512666, 512667, 512668, 512708,
512709, 512710, 512711, 512713, 512719, 512721, 512722, 512723,
512759, 512791, 512793, 513062, 513064, 513073, 513085, 513086, 513227
model H177, serial numbers: 506951, 506953, 506954, 506955, 506956,
506957, 506959, 506960, 506967, 506969, 506970, 506973, 506974,
507013, 507014, 507472 model H179, serial numbers: 508312, 508316,
508322, 508325, 508326, 508336, 508342, 508349, 508404;
b) Model H190, Serial numbers: 301196, 301198, 301204, 301206
Model H195, Serial numbers: 306327, 306332, 306333, 306334,
306337, 306339, 306348, 306349, 306351, 306367, 306368, 306378,
306380, 306447;
c) Serial numbers: 100160, 100161, 100162;
d) Serial numbers: 113567, 113568, 113569, 113570, 113572, 113574,
113585, 113586, 113587, 113591, 113612, 113613, 113616, 113617,
113618, 113619, 113620, 113621, 113623, 113624, 113626, 113627,
113628, 113629, 113631, 113633, 113635, 113637, 113639, 113640,
113641, 113654, 113659, 113660, 113672, 113674, 113675, 113676,
113678, 113679, 113680, 113681, 113682, 113684, 113686, 113687,
113690, 113693, 113694, 113695, 113696, 113778, 113779, 113781,
113783, 113784, 113789, 113791, 113792, 113814, 113908, 113910,
113912, 113913, 113914, 114083;
e) Model T165, Serial numbers: 106641, 106643, 106644, 106645,
106646, 106647, 106648, 106649, 106651, 106652, 106676, 106677,
106678, 106679, 106680, 106681, 106683, 106685, 106686, 106687,
106691, 106692, 106693, 106694, 106696, 106697, 106700, 106701,
106702, 106778, 106779, 106780, 106781, 106782, 106788, 106789,
106790, 106792, 106793, 106794, 106795, 106796, 106797, 106798,
106799, 106803, 106804, 106805, 106806, 106807, 106808, 106810,
106813, 106815, 106816, 106817, 106818, 106819, 106820, 106821,
106822, 106823, 106824, 106825, 106826, 106827, 106828, 106829,
106830, 106831, 106832, 106833, 106834, 106835, 106836, 106837,
106838, 106839, 106840, 106841, 106842, 106843, 106844, 106845,
106846, 106847, 106849, 106850, 106851, 106852, 106853, 106854,
106855, 106856, 106857, 106858, 106860, 106861, 106862, 106863,
106864, 106865, 106867, 106868, 106869, 106870, 106871, 106872,
106873, 106874, 106875, 106876, 106877, 106878, 106879, 106880,
106881, 106882, 106883, 106884, 106885, 106886, 106888, 106889,
106890, 106891, 106892, 106894, 106895, 106896, 106898, 106899,
106900, 106901, 106903, 106905, 106906, 106907, 106908, 106909,
106910, 106911, 106914, 106915, 106916, 106917, 106919, 106920,
106922, 106923, 106925, 106926, 106929, 106932, 106935, 106936,
106937, 106939, 106940, 106941, 106942, 106943, 106945, 106946,
106947, 106948, 106949, 106952, 106953, 106954, 106955, 106956,
106957, 106959, 106960, 106962, 106963, 106964, 106965, 106968,
106969, 106970, 106971, 106972, 106973, 106974, 106975, 106976,
106977, 106978, 106979, 106980, 106981, 106982, 106983, 106984,
106985, 106987, 106990, 106991, 106992, 106993, 106996, 106997,
106998, 106999, 107000, 107001, 107002, 107003, 107004, 107007,
107008, 107009, 107010, 107011, 107012, 107013, 107015, 107017,
107018, 107019, 107020, 107021, 107033, 107034, 107035, 107036,
107037, 107039, 107043, 107044, 107045, 107046, 107047, 107057,
107058, 107059, 107060, 107061, 107062, 107064, 107065, 107066,
107067, 107068, 107069, 107070, 107072, 107075, 107077, 107078,
107079, 107082, 107087, 107091, 107092, 107099, 107101, 107102,
107103, 107106, 107110, 107116, 107123, 107124, 107141, 107208,
107210, 107254, 107263, 107264, 107265, 107266, 107267, 107298,
107299, 107300, 107301, 107303, 107304, 107306, 107307, 107308,
107315, 107316, 107317, 107318, 107320, 107321, 107322, 107389,
107718, 108310, 108376, 115934
Model T175, serial numbers: 105118, 105119, 105120, 105122, 105126,
105130, 105131, 105140, 105141, 105156, 105157, 105158, 105161,
105162, 105165, 105166, 105167, 105169 105170, 105172, 105173,
105174, 105176, 105177, 105178, 105179, 105180, 105181, 105182,
105183, 105184, 105186, 105187, 105189, 105191, 105192, 105194,
105196, 105197, 105200, 105207, 105208, 105209, 105210, 105211,
105212, 105213, 105217, 105304, 105305, 105306, 105307, 105308,
105364, 105365, 105366, 105367, 105368, 105369, 105370, 105371,
105372, 105373, 105374, 105375, 105376, 105377, 105378, 105379,
105380, 105381, 105382, 105383, 105384, 105385, 105386, 105387,
105388, 105389, 105390, 105391, 105393, 105395, 105397, 105398,
105399, 105400, 105401, 105402, 105403, 105404, 105405, 105406,
105407, 105409, 105410, 105411, 105412, 105413, 105414, 105415,
105416, 105417, 105418, 105419, 105420, 105421, 105422, 105423,
105424, 105425, 105426, 105427, 105428, 105429, 105431, 105432,
105433, 105434, 105435, 105436, 105437, 105438, 105439, 105440,
105442, 105443, 105444, 105445, 105446, 105447, 105448, 105449,
105450, 105451, 105452, 105453, 105454, 105455, 105456, 105458,
105459, 105460, 105461, 105462, 105463, 105464, 105465, 105466,
105467, 105468, 105469, 105470, 105471, 105472, 105473, 105474,
105476, 105477, 105478, 105479, 105480, 105481, 105482, 105483,
105484, 105485, 105487, 105488, 105573, 105575, 105576, 105577,
105578, 105579, 105580, 105581, 105584, 105586, 105587, 105588,
105589, 105590, 105591, 105592, 105593, 105594, 105595, 105596,
105598, 105599, 105600, 105602, 105603, 105604, 105605, 105606,
105607, 105611, 105613, 105624, 105625, 105627, 105628, 105629,
105630, 105632, 105633, 105634, 105635, 105636, 105638, 105639,
105640, 105642, 105643, 105644, 105645, 105646, 105647, 105648,
105649, 105650, 105651, 105652, 105654, 105655, 105656, 105657,
105658, 105659, 105660, 105661, 105662, 105663, 105664, 105665,
105666, 105667, 105668, 105669, 105670, 105671, 105672, 105673,
105674, 105675, 105676, 105677, 105678, 105679, 105680, 105681,
105682, 105683, 105687, 105688, 105689, 105690, 105691, 105694,
105705, 105706, 105707, 105712, 105713, 105714, 105715, 105716,
105717, 105718, 105720, 105721, 105722, 105723, 105724, 105725,
105726, 105727, 105728, 105739, 105740, 105741, 105743, 105744,
105745, 105746, 105747, 105748, 105749, 105750, 105752, 105753,
105754, 105755, 105756, 105757, 105758, 105759, 105760, 105762,
105763, 105764, 105765, 105766, 105767, 105768, 105785, 105786,
105790, 105792, 105796, 105820, 105857, 105881, 105884, 105885,
105895, 105898, 105914, 105915, 105917, 105919, 105923, 105924,
105925, 105926, 105927, 105928, 105929, 105930, 105931, 105932
105933, 105934, 105935, 105936, 105937, 105940, 105944, 105945,
105946, 105947, 105948, 105949, 105950, 105951, 105952, 105953,
106074, 106155, 106156, 106157, 106171, 106172, 106173, 106174,
106177, 106178, 106186, 106187, 106189, 106191, 106199, 106200,
106201, 106212, 106213, 106235, 106282, 106361, 106503, 107047,
107301, 107593, 108285
Model T125, Serial numbers: 113211, 113221, 113222, 113223, 113224,
113241, 113243, 113244, 113272, 113273, 113274, 113275, 113276,
113277, 113278, 113279, 113282, 113283, 113284, 113285, 113286,
113287, 113288, 113291, 113292, 113294, 113295, 113296, 113297,
113298, 113299, 113300, 113301, 113317, 113318, 113319, 113320,
113322, 113323, 113324, 113325, 113326, 113327, 113328, 113329,
113330, 113331, 113333, 113334, 113335, 113336, 113337, 113339,
113340, 113341, 113342, 113343, 113344, 113345, 113346, 113347,
113348, 113349, 113350, 113351, 113352, 113353, 113355, 113356,
113359, 113360, 113362, 113363, 113364, 113365, 113366, 113367,
113368, 113369, 113370, 113372, 113373, 113374, 113375, 113378,
113379, 113380, 113381, 113383, 113384, 113385, 113386, 113387,
113388, 113389, 113390, 113391, 113393, 113394, 113396, 113397,
113398, 113399, 113400, 113403, 113408, 113414, 113417, 113420,
113422, 113425, 113427, 113428, 113429, 113430, 113431, 113433,
113434, 113435, 113487, 113492, 113495, 113496, 113500, 113557,
113643, 113847, 113850, 114102
Model T135, Serial numbers: 941570, 941572, 941573, 941574, 941578,
941585, 941589, 941590, 941591, 941592, 941593, 941595, 941597,
941601, 941602, 941603, 941604, 941605, 941606, 941607, 941608,
941609, 941610, 941613, 941614, 941615, 941616, 941618, 941619,
941620, 941621, 941622, 941623, 941624, 941625, 941626, 941627,
941628, 941629, 941630, 941632, 941633, 941634, 941652, 941653,
941654, 941680, 941681, 941682, 941683, 941688, 941689, 941690,
941691 941692, 941695, 941696, 941697, 941698, 941699, 941700,
941701, 941702, 941703, 941704, 941709, 941710, 941712, 941715,
941716, 941717, 941718, 941719, 941721, 941722, 941723, 941724,
941725, 941727, 941728, 941732, 941734, 941735, 941736, 941737,
941738, 941739, 941740, 941741, 941742, 941743, 941745, 941747,
941748, 941749, 941750, 941752, 941753, 941754, 941756, 941757,
941759, 941762, 941767, 941775, 941776, 941777, 941778, 941781,
941784, 941786, 941787, 941788, 941789, 941800, 941802, 941803,
941804, 941805, 941807, 941810, 941812, 941813, 941814, 941819,
941829, 941830, 941831, 941845, 941846, 941929, 941930, 941933,
941940, 941948, 941953, 941956, 941962, 941970, 941975, 941978,
941979, 942017
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, Saint Paul, MN, by letter dated May 12, 2006.
Manufacturer: Guidant-Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
REASON
Guidant had identified a pattern of premature battery depletion in devices manufactured with a single lot of capacitors from a single supplier. If function of this low voltage capacitor is compromised, the battery may deplete prematurely.
VOLUME OF PRODUCT IN COMMERCE
996 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Boston Scientific Urovac Bladder Evacuator, sterile, single use only, REF/Catalog no. 730-125 and sold individually as UPN M0067301250 and in packaged of ten as UPN M0067301251, Recall # Z-1300-06
CODE
All lots expiring on or before June 12, 2010
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Spencer, IN, by letter dated June 30, 2006. Firm initiated recall is ongoing.
REASON
Sterility is compromised because the product is labeled as sterile, but the packages may have holes in them.
VOLUME OF PRODUCT IN COMMERCE
446,097 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
Ultra-Filtration (UF) Removal Regulators(Rgltr Assy UF REM Molded Spare); a spare part used with Baxter’s System 1000, Tina, Arena, Altratouch and Aurora Hemodialysis Instruments; item numbers 6001276024 and 6001276028, Recall # Z-1253-06
CODE
Lot numbers 01095126 and 01092479; Lot number 01095127
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letters dated June 21, 2006.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is ongoing.
REASON
The UF Removal Regulators were assembled incorrectly. The mis-assembly results in a failure to successfully calibrate the instrument and begin patient therapy.
VOLUME OF PRODUCT IN COMMERCE
569 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
VIASYS Healthcare Disposable Bar Electrodes. Re-order No. 019-435600. Single Use only, Recall # Z-1254-06
CODE
Lot 604664
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nicolet Biomedical Div. of Viasys Healthcare, Madison, WI, by telephone and letter on April 28, 2006.
Manufacturer: Tyco Healthcare Uni-Patch, Wabasha, MN. Firm initiated recall is ongoing.
REASON
The Bar Electrodes do not meet performance specification for electrode impedance. A manufacturing defect was discovered in disposable bar electrodes, part number 019-435600, lot 604664, that has the potential to reduce the amplitude of a motor or sensory nerve action potential. These possible lower amplitudes will be measured only if the bar electrode is used as a bar.
VOLUME OF PRODUCT IN COMMERCE
53 boxes, 10 electrodes per pouch, 10 pouches per box
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
IMPAX 4.5 Systems, used in the acceptance, transfer, display, storage and digital processing of medical images, Recall # Z-1256-06
CODE
All Impax 4.5 sites running Solaris 9 (Sun OS 5.9) that do not have Sun Patch ID 118305-08 installed.
RECALLING FIRM/MANUFACTURER
AGFA Corp., Greenville, SC, by firm representative visit for software upgrade, on June 30, 2006. Firm initiated recall is ongoing.
REASON
Possible corrupted image appearing after System Start.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY

______________________________
PRODUCT
a) Terumo Advanced Perfusion System 1; 100V -- 120V, 15 A (circuit breaker),
50/60 Hz (20A power source required); Models 801763 and 801763 (Japan unit).
Units using Power Manager software versions 1.10, Recall # Z-1286-06;
b) Terumo Advanced Perfusion System 1; 220V -- 240V, 7 A (circuit breaker),
50/60 Hz (10A power source required); Model 801764. Not distributed within
the United States. Units using Power Manager software versions 1.10,
/Recall # Z-1287-06
CODE
a) Serial numbers 11 through 339;
b) Serial numbers 6 through 156
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular System Corp., Ann Arbor, MI, by letter dated October 19, 2005. Firm initiated recall is complete.
REASON
While on battery power, the system may flash a low battery warning even though the battery is adequately charged.
VOLUME OF PRODUCT IN COMMERCE
442 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS II

______________________________
PRODUCT
Express 10# Starter X200, Medicated, Beef Cattle-Feedlot Supplement, containing 200 g/ton oxytertracycline, packaged in 50- lb, Recal # V-099-6
CODE
49MH286 and 49MY246
RECALLING FIRM/MANUFACTURER
Hubbard Feeds Inc., Beloit, KS, by telephone on June 7, 2006. Firm initiated recall is complete.
REASON
The oxytetracycline used to manufacture the feed was expired.
VOLUME OF PRODUCT IN COMMERCE
279/50-lb. bags
DISTRIBUTION
KS

______________________________
PRODUCT
a) CO-OP 32% Sinking Catfish, Recall # V-100-6;
b) Performance Sheep Pell W/Decox/A/N, medicated,
net wt. 50 lbs, Recall # V-101-6;
c) Pro 40% Swine Conc Meal -- 50 lb, Recall # V-102-6;
d) CO-OP 32% Sinking Catfish Food Medicated,
Recall # V-103-6;
e) "Big Jim’s" BBB Deer Ration, Big Buck Blend,
Recall # V-104-6;
f) CO-OP 40% Hog Supplement Medicated Pelleted,
Tylosin 100 grams/ton, 50 lb. bag, Recall # V-105-6;
g) Pig Starter Pell II, 18% W/MCDX Medicated 282020,
Carbadox -- 0.0055%, Recall # V-106-6;
h) CO-OP STARTER-GROWER CRUMBLES, Complete
Feed for Chickens from Hatch to 20 Weeks, Medicated,
Bacitracin Methylene Disalicylate, 25 and 50 Lbs,
Recall # V-107-6;
i) CO-OP LAYING PELLETS, Complete Feed for Laying
Chickens, Recall # 108-6;
j) CO-OP LAYING CRUMBLES, Recall # V-109-6;
k) CO-OP QUAIL FLIGHT CONDITIONER MEDICATED,
net wt 50 Lbs, Recall # V-110-6;
l) CO-OP QUAIL STARTER MEDICATED, Net Wt. 50 Lbs,
Recall # V-111-6;
m) CO-OP QUAIL GROWER MEDICATED, 50 Lbs,
Recall # V-112-6
CODE
Product manufactured from 02/01/2005 until 06/06/2006
RECALLING FIRM/MANUFACTURER
Alabama Farmers Cooperative, Inc., Decatur, AL, by telephone, fax, email and visit on June 9, 2006. FDA initiated recall is complete.
REASON
Animal and fish feeds which were possibly contaminated with ruminant based protein not labeled as "Do not feed to ruminants".
VOLUME OF PRODUCT IN COMMERCE
125 tons
DISTRIBUTION
AL and FL

______________________________
PRODUCT
Bulk custom dairy feds manufactured from concentrates, Recall # V-113-6
CODE
All dairy feeds produced between 2/1/05 and 6/16/06 and containing H. J. Baker recalled feed products.
RECALLING FIRM/MANUFACTURER
Vita Plus Corp., Gagetown, MI, by visit beginning on June 21, 2006. Firm initiated recall is complete.
REASON
The feed was manufactured from materials that may have been contaminated with mammalian protein.
VOLUME OF PRODUCT IN COMMERCE
27,694,240 lbs
DISTRIBUTION
MI

______________________________
PRODUCT
Bulk custom made dairy feed, Recall # V-114-6
CODE
None
RECALLING FIRM/MANUFACTURER
Burkmann Feeds LLC, Glasgow, KY, by letter on July 14, 2006. Firm initiated recall is ongoing.
REASON
Custom made feeds contain ingredient called Pro-Lak, which may contain ruminant derived meat and bone meal.
VOLUME OF PRODUCT IN COMMERCE
?????
DISTRIBUTION
KY

END OF ENFORCEMENT REPORT FOR AUGUST 2, 2006

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