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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January 25, 2006
06-04

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

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PRODUCT
Baroody Dried Apricots, 14 oz plastic containers. Recall # F-057-6
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baroody Imports, Inc., Clifton, NJ, by letter on October 10, 2005.
Manufacturer: Mahmut Yarim Ltd, Antakya, Turkey. Firm initiated recall is ongoing.
REASON
Baroody Dried Apricots contained undeclared sulfites based on the New York State Department of Agriculture and Markets' analysis.
VOLUME OF PRODUCT IN COMMERCE
400 units each 14 oz. containers
DISTRIBUTION
NY and NJ

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PRODUCT
Canterbury Naturals all natural Cinnamon Raisin quick bread mix, Net wt 18oz (510g) in a box, Recall # F-058-6
CODE
6174 1, 6196 1, 6277 1, 7104 1 located on a label on the bottom of each box.
RECALLING FIRM/MANUFACTURER
Conifer Specialties, Medina, WA, by press release on November 22, 2005 and by letter on November 23, 2005. Firm initiated recall is ongoing.
REASON
One of the ingredients, golden raisins, contained undeclared sulfur dioxide.
VOLUME OF PRODUCT IN COMMERCE
8,016 units
DISTRIBUTION
Nationwide

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PRODUCT
Scandinavian Smoke House brand Cold Smoked Norwegian Salmon pieces (trimmings) in clear plastic vacuum packages. Recall # F-059-6
CODE
"AUG 23.05"
RECALLING FIRM/MANUFACTURER
Scandinavian Smoke House Inc., San Francisco, CA, by telephone on September 26, 2005 and by letter on September 27, 2005. Firm initiated recall is ongoing.
REASON
The product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
75 lbs.
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
Adrenalin Chloride Solution, Epinephrine Nasal Solution, USP, l mg per mL, 30mL, Vasoconstrictor, For Topical Application 1:1000, Rx only, NDC 61570-300-31, Recall # D-118-6
CODE
Lot numbers: 01184M, exp 01/06; 009N4M, exp 03/06; 02325M, exp 08/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN, by letter on December 29, 2005.
Manufacturer: Parkedale Pharmaceuticals, Inc., Rochester, MI. Firm initiated recall is ongoing.
REASON
Split cap thread defects which may lead to a lack of sterility assurance.
VOLUME OF PRODUCT IN COMMERCE
34,389 units
DISTRIBUTION
Nationwide

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PRODUCT
Children's Motrin Dye Free 4 oz bottles Berry Flavor, Recall # D-126-6
CODE
Lot number FPM009 exp 11/05
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Product intended for destruction due to foreign organic material/black speck was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

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PRODUCT
Citrucel FiberShake Chocolate .38 oz Packets which are distributed individually as well as in a 5 count starter kits. Methylcellulose (a non-allergenic fiber) 2g...Bulk-forming laxative, Uses***, Warnings***, Directions***, Inactive ingredients***, Recall # D-127-6
CODE
All lots: Case lots with have an A or N() after the lot number: Lot -- Exp. Date: 05A075 -- MAR-07; 05A076 -- MAR-07; 05B212 -- APR-07; 05F002 -- JUL-07; 05B210 -- APR-07; 05B211 -- APR-07; 05D056 -- MAY-07; 05A049 -- MAR-07; 05F001 -- JUL-07; 05A045 -- FEB-07; 05A046 -- MAR-07; 05A048 -- MAR-07; 05C162 -- MAY-07; 05C164 -- MAY-07; 05F003 -- JUL-07; 05C160 -- APR-07; 05C161 -- APR-07; 05C163 -- MAY-07; 05D057 -- MAY-07
RECALLING FIRM/MANUFACTURER
Recalling Firm: GlaxoSmithKline, Parsippany, NJ, by letter on December 8, 2005.
Manufacturer: JB Laboratories, Inc., Holland, MI. Firm initiated recall is ongoing.
REASON
During stability testing of non-commercial/undistributed lots, packets were found to exceed "Total Coliforms" specification of NMT 10 cfu/g at the 12 month station. All commercial lots are being recalled.
VOLUME OF PRODUCT IN COMMERCE
4,429,192 packets
DISTRIBUTION
Nationwide and PR

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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PRODUCT
Infant's Tylenol Concentrated Drops Cherry Flavor 1/2 oz Acetaminophen 80 mg/0.8 ml, OTC, Recall # D-099-6
CODE
Lot number JMM075 exp 10/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Presence of particulate matter: Product intended for destruction due lint free cloth found in mixer was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

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PRODUCT
a) Children's Tylenol Plus Cold Nighttime
Suspension 4 oz. Grape Flavor,
Recall # D-119-6;
b) Children's Tylenol Plus Cold Daytime
Suspension 4 oz Fruit Flavor,
Recall # D-120-6;
c) Children's Tylenol Plus Cough and Cold
Suspension 4 oz Cherry Flavor,
Recall # D-121-6;
d) Children's Tylenol Plus Flu Suspension
4 oz Bubblegum Flavor, Recall # D-122-6
CODE
a) Lot numbers JLM267 exp 9/06, JLM130 exp 9/06,
and JLM266 exp 9/06;
b) Lot numbers JLM270 exp 9/06 and
JMM177 exp 10/06;
c) Lot numbers JLM200 exp 9/06 and
JLM201 exp 9/06;
d) Lot number JLM248 exp 10/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Product intended for destruction due to tamper evident issue was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

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PRODUCT
Members' Mark brand Arthritis Pain Relief acetaminophen extended-release tablets 650 mg. pain reliever in bottles of 200, OTC; NDC 68196-544-82, Recall # D-123-6
CODE
Lot 5LE0031; exp. 08/07
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan, MI, by letter dated January 11, 2006. Firm initiated recall is ongoing.
REASON
Defective Container: The tamper-evident seal on the mouth of the bottle may not be intact.
VOLUME OF PRODUCT IN COMMERCE
5,472 bottles
DISTRIBUTION
Nationwide

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PRODUCT
Equaline first aid antibiotic ointment --- polymyxin B sulfate --- bacitracin zinc --- first aid antibiotic ointment --- NET WT 1 OZ (28.4 g) --- compare to Polysporin active ingredients --- Active Ingredient (each gram contains) --- Bacitracin zinc 400 units ... Polymyxin B Sulfate 5,000 units, Recall # D-124-6
CODE
Lots 5F053 (exp. 6/08), 5F055 (exp. 6/08), 5J050 (exp. 10/08)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Taro Pharmaceuticals U.S.A., Inc, Hawthorne, NY, by telephone on December 14, 2005 and by letter dated December 20, 2005.
Manufacturer: Taro Pharmaceuticals, Inc, Brampton, Canada. Firm initiated recall is ongoing.
REASON
Labeling: label error on declared strength of active ingredients bacitracin zinc and polymyxin B sulfate.
VOLUME OF PRODUCT IN COMMERCE
20,916 units
DISTRIBUTION
Nationwide

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PRODUCT
Maximum Strength Tylenol Cold Nighttime Complete Formula 24 Caplets per blister card, Recall # D-125-6
CODE
Lot number HJM064 exp 4/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Mispackaging: Product intended for destruction due to blister cards from HHM227 (same product) were found in the on line rework bin during startup of batch HJM064 was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

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PRODUCT
Altace, Ramipril Capsules, 2.5 mg, 100 capsule bags, Recall # D-128-6
CODE
Lot 052557B, 052230B, 053676A, 053676B, 055948A, 055023, 055948B, 053803, 052230A, 052557A. All lot codes have an expiration date of 10/31/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Columbus, OH, by letters on January 5, 2006.
Manufacturer: Aventis Pharmaceuticals, Inc., Kansas City, MO. Firm initiated recall is ongoing.
REASON
Labeling: The individual blister cards may contain missing or not clearly printed characters in the expiration dates.
VOLUME OF PRODUCT IN COMMERCE
38 units of 100 capsules each
DISTRIBUTION
Nationwide

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PRODUCT
a) DDF Doctor's Dermatologic Formula, Organic
Sun Protection SPF 30 --- for Sensitive
Skin --- Super Antioxidant Complex, Oil &
Fragrance-Free --- Meets EU Standards for
UVA --- net wt. 4 oz. 113.4 g --- Active
ingredients: Titanium Dioxide 2.5% ---
Zinc Oxide 4%, UPC 0 60748 00040 3,
Recall # D-129-6;
b) DDF Doctor's Dermatologic Formula, Moisturizing
Photo-Age Protection SPF 30, Delays Skin Aging,
Restores Moisture --- Super Antioxidant Complex,
Meets EU Standards For UVA, net. wt. 4 oz. 113.4 g,
Active ingredients: Avobenzone 1%, Octinoxate 7.5%,
Octisalate 5%, Octocryene 6%, UPC 0 60748 00039 7,
Recall # D-130-6;
c) DDF Doctor's Dermatologic Formula, Matte Finish,
Photo-Age, Protection SPF 30 --- Minimizes Shine,
Super Antioxidant Complex, Oil and Fragance-Free,
Meets EU Standards for UVA, net wt. 4 oz. 113.4 g,
Active ingredients: --- Avobenzone 1% --- Octinoxate
7.5% --- Octisalate 5% --- Octocrylene 6%,
UPC 0 60748 00038 0, Recall # D-131-6;
d) DDF Doctor's Dermatologic Formula, Protective Eye
Cream SPF 15 --- 0.5 fl. oz. 15 ml --- Active
ingredient: Octinoxate 5% --- Octisalate 1% ---
Zinc Oxide 2%, Recall # D-132-6;
e) DDF Doctor's Dermatologic Formula, Fade Gel 4 ---
Hydroquinone 2% --- Proven Lightener, Evens Skin
Tone --- Fades Age Spots --- 0.5 fl. oz. 15 ml ---
Active Ingredient: Hydroquinone 2%, UPC bar code
0 60748 00032 8, Recall # D-133-6;
f) DDF Doctor's Dermatologic Formula, Fade Cream,
SPF 30 --- Hydroquinone 2%, Minimizes Age Spots,
Prevents Recurrence, Enriched Moisturizer,
net wt. 1.7 oz. 48 g -- Active Ingredients:
Avobenzone 1% --- Hydroquinone 2% --- Octinoxate
7.5% --- Octisalate 4% --- Octocrylene 5% ---
Oxybenzone 1.5%, UPC 0 60748 00030 4,
Recall # D-134-6;
g) DDF Doctor's Dermatologic Formula, Glossy Lip
Therapy, SPF 15 --- Plumps --- Protects ---
Moisturizes, net wt. 0.25 oz. 7 g --- Active
Ingredients: Octinoxate 5% --- Octisalate 3% ---
titanium Dioxide 1%, UPC bar code 0 60748 00041 0,
Recall # D-135-6
CODE
All lots & sizes on the market
RECALLING FIRM/MANUFACTURER
Recalling Firm: HDS Cosmetics, Inc., Yonkers, NY, by telephone on November 11, 2005 and by letters on November 30, 2005.
Manufacturer: HDS Cosmetics, Inc., Harrison, NY. Firm initiated recall is ongoing.
REASON
Firm does not have adequate stability data to support 2 year expiry period for the OTC products.
VOLUME OF PRODUCT IN COMMERCE
Approx. 218,189 units
DISTRIBUTION
Nationwide

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PRODUCT
Tylenol Sinus Severe Congestion 24 Caplets per blister card, (Acetaminophen 325 mg), OTC, NDC 50580-442-24, Recall # D-136-6
CODE
Lot number JLM095, exp. 8/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
CGMP Deviations: Product intended for destruction due to there was a power failure causing an air handling system failure in coating vector pan/exceeded 50 degrees with erratic spray rate was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

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PRODUCT
Children's Motrin Cough Grape Suspension 4 oz , (ibuprofen 100mg & pseudoephedrine HCl 15mg), OTC, NDC 50580-903-04, Recall # D-137-6
CODE
Lot number JPM182, exp. 10/06
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
CGMP Deviations: Product intended for destruction due to documentation error was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

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PRODUCT
Extra Strength Tylenol Caplets 2 count pouches, (Acetaminophen 500mg), OTC, Recall # D-138-6
CODE
Lot number LAM083, exp. 10/08
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil, Fort Washington, PA, by letter dated September 19, 2005. Firm initiated recall is ongoing.
REASON
Mispackaging: Product intended for destruction due to out of specification result because 3 caplets were released into packaging instead of 2 caplets which was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-0389-6
CODE
Unit number: 9341120
RECALLING FIRM/MANUFACTURER
New York Blood Center Inc., New York, NY, by telephone on June 11, 2004 and follow-up letter on July 7, 2004. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY

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PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-0454-6
CODE
Unit numbers: 04FP76149 Part 1, 04FP76149 Part 2
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on June 18, 2005 and follow-up letter on June 20, 2005. Firm initiated recall is complete.
REASON
Blood products, possible contaminated with Bordetella holmseii, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MA

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0498-6
CODE
Unit number: 71X176072 (Part 3)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by facsimile on April 6, 2005. Firm initiated recall is complete.
REASON
Blood product, which yielded a platelet count that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0499-6
CODE
Unit number: 6462085
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by facsimile on February 13, 2004. Firm initiated recall is complete.
REASON
Blood product, which yielded a platelet count that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-500-6
CODE
Unit numbers: 3928969 (Parts B & C)
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on November 9, 2004. Firm initiated recall is complete.
REASON
Blood products, which yielded a platelet count that was below the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL

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PRODUCT
Source Plasma, Recall # B-0502-6
CODE
Unit numbers: LF262809, LF262583, LF254714, LF253848, LF246294, LF245766
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Lakeland, FL, by facsimile on May 17, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided post donation information regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
NC

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PRODUCT
Platelets, Leukocytes Reduced, Recall # B-0503-6
CODE
Unit number: 17FG33974
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by telephone on June 11, 2003. Firm initiated recall is complete.
REASON
Blood product, associated with an air-contaminated red cell unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN

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PRODUCT
Red Blood Cells, Recall # B-0504-6
CODE
Unit number: GN24831
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern California Region, Oakland, CA, by letter dated August 15, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a history of rheumatoid arthritis and use of the medications Methotrexate and Plaquenil, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

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PRODUCT
Red Blood Cells, Recall # B-0507-6
CODE
Unit number: B311422
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by letter dated February 13, 2004.
Manufacturer: Puget Sound Blood Center, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

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PRODUCT
Red Blood Cells, Recall # B-0508-6
CODE
Unit number: E168494
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by letter dated October 31, 2003.
Manufacturer: Puget Sound Blood Center, Seattle, WA. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0518-6
CODE
Unit number: 2141795
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by telephone on November 18, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malaria endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0519-6
CODE
Unit number: 03E39789
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region, Atlanta, GA, by telephone on August 28, 2003. 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
GA

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PRODUCT
Red Blood Cells Leukocytes, Recall # B-0521-6
CODE
Unit numbers: 6960593, 6957583
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on February 14, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN and MS

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PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0522-6
CODE
Unit number: 6919182
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on February 14, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

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PRODUCT
Red Blood Cells, Recall # B-0523-6
CODE
Unit number: 280987
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on March 11, 1997. 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
CO

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0528-6
CODE
Unit number: 574766
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by fax on February 11, 1998. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had a tattoo applied within twelve months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

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PRODUCT
a) Red Blood Cells Leukocyte Reduced,
Recall # B-0530-6;
b) Recovered Plasma, Recall # B-0531-6
CODE
a) and b) unit number: 12GN74153
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC, by letter dated December 19, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA and NC

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0538-6
CODE
Unit numbers: 785862 and 838711
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by letter dated January 25, 1999. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to hepatitis B core antigen (anti-HBc) but were collected from a donor who tested repeatedly reactive for anti-HBc on two separate occasions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced, Recall # B-0539-6
CODE
Unit number: R36391
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, Inc., South Bend, IN, by letter dated October 4, 2005. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0540-6;
b) Cryoprecipitated AHF, Recall # B-0541-6;
c) Plasma, Cryoprecipitate Reduced,
Recall # B-0542-6;
d) Platelets, Recall # B-0543-6;
e) Fresh Frozen Plasma, Recall # B-0544-6
CODE
a) d) and e) Unit number: FS50178
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on September 6, 2005. Firm initiated recall is ongoing.
REASON
Blood products, collected from a donor who provided post donation information regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
OH and PA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0545-6
CODE
Unit number: 04G72553
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by telephone on September 12, 2005. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as having been irradiated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0546-6
CODE
Unit number: 30659-2677
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 4, 2004.
Manufacturer: Blood Systems, Inc., Fargo, ND. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
ND

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0547-6
CODE
Unit number: Y83281
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by letter dated November 5, 2003. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may compromise the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0549-6
CODE
Unit number: 23148-7953
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on June 14, 2004.
Manufacturer: Blood Systems, Inc., Billings, MT. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WY

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0552-6
CODE
Unit number: 4426304
RECALLING FIRM/MANUFACTURER
Florida's Blood Center, Inc., St. Petersburg, FL, by facsimile on July 8, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who may have been at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT
a) Red blood Cells Leukocytes Reduced,
Recall # B-0516-6;
b) Cryoprecipitated AHF, Pooled,
Recall # B-0517-6
CODE
a) and b) Unit number: 16GR13839
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH, by telephone on April 13, and April 19, 2003 and by follow-up letters dated April 14 and April 20, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH and MD

_______________________________
PRODUCT
Platelet Pheresis Leukocyte Reduced Irradiated, Recall # B-0524-6;
CODE
Unit number: 16KF49020
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH, by telephone on June 19, 2005 and by follow-up letter dated June 24, 2005. Firm initiated recall is complete.
REASON
Blood product, labeled as leukoreduced but not tested for white blood cell (WBC) count as required, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

_______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0532-6
CODE
Unit number: 16KQ00310
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH, by telephone on May 8, 2005. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably low red cell recovery rate, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0548-6
CODE
Unit number: 084FT43562
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern California Region, Oakland, CA, by letter dated December 19, 2001. Firm initiated recall is complete.
REASON
Blood product, which may have been manufactured from a unit of whole blood more than eight hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Recovered Plasma, Recall # B-0550-6
CODE
Unit number: 23148-7953
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by electronic notification on July 8, 2004.
Manufacturer: Blood Systems, Inc., Billings, MT. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland

_______________________________
PRODUCT
Whole Blood, Recall # B-0551-6
CODE
Unit number: 84K22028
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Northern California Region, Oakland, CA, by letter dated November 1, 2001.
Manufacturer: The American National Red Cross, San Jose, CA. Firm initiated recall is complete
REASON
Blood product, collected in an expired collection bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

_______________________________
PRODUCT
VapothermT Respiratory Gas Humidifier, Model 2000i, Recall # Z-0360-06
CODE
All S/Ns of the VapothermT Model 2000i are affected
RECALLING FIRM/MANUFACTURER
Vapotherm, Inc, Stevensville, MD, by letters on October 13, 2005, October 31, 2005, November 4, 2005, December 20, 2005 and December 22, 2005. Firm initiated recall is ongoing.
REASON
Vapotherm changed the labeling of its respiratory gas humidifier by revising the protocol for higher level disinfectants to be used by healthcare practitioners.
VOLUME OF PRODUCT IN COMMERCE
5,092 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

CORRECTION

In the November 16, 2005 Enforcement Report, 05-46, the VITROS ECi /EciQ System Recall # Z-0137-06 -- CODE The recall applies to systems with software below Version 3.1 and not software version 3.1 or lower.

______________________________
PRODUCT
Medtronic Activa Deep Brain Stimulation (DBS) system including the following system components: Model 7424 Itrel II Neurostimulator (DBS applications only); Model 7426 Soletra Neurostimulator; Model 7428 Kinetra Neurostimulator; Models 3387, 3389 DBS Leads; and Models 7482,7495 DBS Extensions. Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. The Medtronic Activa System is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain. The Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via Extension and Lead. These components comprise the implantable portion of the Activa System, Recall # Z-0370-06
CODE
All serial numbers and lot codes are affected
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc, Neurological & Spinal Division, Columbia Heights, MN, by letters on November 30, 2005 and December 5, 2005.
Manufacturer: Medtronic Puerto Rico Inc., Villalba, PR. Firm initiated recall is ongoing.
REASON
A safety concern exists regarding the Medtronic Activa Deep Brain Stimulation system instructions for performing MRI (magnetic resonance imaging). Medtronic's instructions have until now recommended a use of a displayed MRI head specific absorption rate (SAR) of not more than 0.4 W/kg. To maintain the intended tissue heating safety margin, the recommended maximum displayed head SAR is now 0.1 W/kg.
VOLUME OF PRODUCT IN COMMERCE
149,656 units
DISTRIBUTION
Nationwide and Internationally
__________________________
PRODUCT
Smith & Nephew Drill, 2.7mm for BioRaptor Suture Anchor (non-sterile) Reference number: 7210430, Recall # Z-0371-06
CODE
Lot number: 50102446
RECALLING FIRM/MANUFACTURER
Smith & Nephew Inc., Endoscopy Division, Mansfield, MA, by letter on July 1, 2005. Firm initiated recall is ongoing.
REASON
Drill does not contain laser etched depth marks to assure proper depth of inserted device.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC and PR

_______________________________
PRODUCT
BD Vacutainer Push Button Blood Collection Set with Pre-Attached holder, Recall # Z-0372-06
CODE
Catalog # -- Lot #: 367352 -- 5188576; 367352 -- 5208448; 367352 -- 5217290; 368656 -- 5164491; 368656 -- 5164526; 368656 -- 5187894; 368656 -- 5192496; 368656 -- 5220204; 368656 -- 5238936
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letter on December 5, 2005.
Manufacturer: Becton Dickinson Preanalytical Solutions, Sumter, SC. Firm initiated recall is ongoing.
REASON
Cracked finger grip luer adapter components on the Push Button Blood Collection Set.
VOLUME OF PRODUCT IN COMMERCE
118,200 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Kimberly-Clark/Ballard TRACH CARE* -
72 Closed Suction products for Adults, Rx Only,
Sterile * Diameter 14 Fr (4.6 mm), 54 cm
(21.3 in) * Single Use * Made in Mexico,
Catalog number 227, Recall # Z-0373-06;
b) Kimberly-Clark/Ballard TRACH CARE* - 72 Wet
Pak* for Adults * Closed Suction System
with Saline Vials * Diameter 14 Fr (4.6 mm),
Length 30.5 cm (12 in) * Rx Only * Single Use,
Catalog number 8308, Recall # Z-0374-06;
c) Kimberly-Clark/Ballard TRACH CARE Wet Pack *
Y Adapter * Closed Suction System for Neonates
* Rx Only * 8 Fr (2.66 mm) * 30.5 cm (12 in) *
Single Use, Recall # Z-0375-06
CODE
a) Lot number: 317128 and 317129;
b) Lot number: 318065;
c) Lot number: 309962
RECALLING FIRM/MANUFACTURER
Kimberly-Clark Corporation, Roswell, GA, by letter on November 30, 2005. Firm initiated recall is ongoing.
REASON
The integrity of the sterile unit package may become compromised.
VOLUME OF PRODUCT IN COMMERCE
869 cases (20 units per case)
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Boston Scientific brand Microbiology Specimen
Brush, single use, sterile, 220 cm, package
of 10 brushes; Catalog No. 1640, Order No.
M00516401. Recall # Z-0376-06;
b) Boston Scientific brand Microbiology
Specimen Brush, single use, sterile, 90 cm,
package of 10 brushes; Catalog No. 1650,
Order No M00516501, Recall # Z-0377-06;
CODE
a) Lot numbers: 7669915, 7731928, 7809849 and
7580900;
b) Lots 7579586, 7605110, 7606870, 7606871,
7630518, 7630517, 7628255, 7650452, 7646613,
7664540, 7664221, 7661326, 7668106, 7713491,
7697308, 7701032, 7697695, 7731922, 7730456,
7713492, 7731923, 7750676, 7750675, 7750674,
7766684, 7766527, 7790329, 7769605, 7798015,
7799940, 7807535, 7809850, 7825637, 7825638,
7828001, 7854861, 7853825, 7856736, 7860774,
7874570, 7880712, 7899057, 7898228, 7886786,
7933144, 7929889, 7923394, 7924985 and 7949015
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp, Spencer, IN, by letter dated December 8, 2005. Firm initiated recall is ongoing.
REASON
The patient sample may become contaminated because the wax plug, intended to protect the sample from contamination during collection, may be missing.
VOLUME OF PRODUCT IN COMMERCE
12,930
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
GEM PREMIER 3000, Point-of-care blood analyzer. Recall # Z-0378-06
CODE
Serial numbers starting with 18412
RECALLING FIRM/MANUFACTURER
Instrumentation Laboratory Co., Lexington, MA, by letter dated December 16, 2005. Firm initiated recall is ongoing.
REASON
Software error may report higher results for glucose and lactate.
VOLUME OF PRODUCT IN COMMERCE
2,021 units
DISTRIBUTION
Nationwide and Canada

_______________________________
PRODUCT
Cytomics FC500 Cytometer with CXP Software, Part Numbers 629636 629637, Recall # Z-0380-06
CODE
CXP Cytometer Software Version 2.0 (acquisition software only).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc, Brea, CA, by letter on November 28, 2005.
Manufacturer: Applied Cytometry Systems, Dinnington, United Kingdom. Firm initiated recall is ongoing.
REASON
Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0.
VOLUME OF PRODUCT IN COMMERCE
179
DISTRIBUTION
Nationwide and Canada

_______________________________
PRODUCT
a) GE LOGIQ 5 system models 2331752, 2331753,
2332750, 2353313 and 2355477,
Recall # Z-0386-06;
b) GE LOCIQ Book System models: 2399921,
2399923, 2349933, 2349934 and 2349935,
Recall # Z-0387-06
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Med Systems LLC, Waukesha, WI, by letter and Field Modification Instructions FMI 74024 and FMI 71016A beginning on September 2, 2004.
Manufacturer: General Electric Med Systems China Co., Ltd., Wuxi, Jiangsu, China. Firm initiated recall is ongoing.
REASON
The Estimated Fetal Weight (EFW) result will be incorrect if the operator fails to perform the 'end exam' or new patient registration step before starting an EFW measurement procedure on the next patient.
VOLUME OF PRODUCT IN COMMERCE
3,091 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Elation, Class I Medical Device Prosthetic product, Component, External, Limb, Ankle/Foot Parts Numbers: ELP0023L/R-ELP0026L/R, ELP0023RBR, ELP0024RBR &, ELP0028RBR, Recall # Z-0388-06
CODE
Serial Numbers: 5927, 5930, 5935, 5936, 5937, 5938, 5939, 5940, 5941, 5942, 5943, 5944, 5945, 5947, 5948, 5949, 5950, 5951, 5954, 5955, 5956, 5959, 5960, 5961, 5962, 5964, 5965, 5970, 5971, 5972, 5973, 5974, 5975, 5977, 5978, 5979, 5980, 6015, 6016, 6020, 6027, 6028, 6031, 6032
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ossur, Reykjavik, Ireland, by telephone and letters on October 21, 2005.
Manufacturer: Ossur North America Inc., Aliso Viejo, CA. Firm initiated recall is ongoing.
REASON
After one year devices assembled with a new type of O-rings could exhibit enough wear to allow a gradual oil leak which would increase play in the ankle sub-assembly of the foot.
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Hospira brand Plum A+I.V. Infusion Pump, List No. 11971-04; Hospira brand Plum A+I.V. Infusion Pump, List No. 12391-04; Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12618-04; Hospira brand Plum A+3 I.V. Infusion Pump, List No. 12348-04; Infusion pump is a multi-function fluid delivery infusion system, consisting of pumping module and assortment of IV sets, Recall # Z-0389-06
CODE
List No. 11971-04 Plum A+ I.V. Infusion Pump; List No. 12391-04 Plum A+ I.V. Infusion Pump; List No. 12618-04 Plum A+3 I.V. Infusion Pump; List No. 12348-04 Plum A+3 I.V. Infusion Pump. List Numbers: 12618-04; List Numbers: 11971-36; (shipped 12391-04; (shipped 11971-04; domestically) 11971-04; internationally) 12391-04; 12348-04; 12348-04; 12391-13; 12391-1312391-1 12618-04. All serial numbers of the above list numbered product are included in this correction.
RECALLING FIRM/MANUFACTURER
Hospira Inc, Morgan Hill, CA, by letters on May 18, 2005. Firm initiated recall is ongoing.
REASON
The pump may shut-off prematurely during battery operation without providing adequate response time when 'E320' service warning message appears.
VOLUME OF PRODUCT IN COMMERCE
64,404 units
DISTRIBUTION
Nationwide and Internationally
__________________________
PRODUCT
a) Cook brand Zilver 635 Biliary Stent --
Expanding Stent, delivery system length
80 cm, stent diameter 7.0 mm, stent length
40 mm, minimum guiding catheter 8.0 French,
minimum sheath 6.0 French, recommended wire
guide size .035 inch dia., sterile; Catalog
# ZIB6-80-7.0-40. Recall # Z-0390-06;
b) Cook brand Zilver 635 Biliary Stent --
Expanding Stent, delivery system length
80 cm, stent diameter 6.0 mm, stent length
60 mm, minimum guiding catheter 8.0 French,
minimum sheath 6.0 French, recommended wire
guide size .035 inch dia., sterile; Catalog
# ZIB6-80-6.0-60, Recal # Z-0391-06
CODE
a) Lot number: 1546123;
b) Lot number: 1544171
RECALLING FIRM/MANUFACTURER
Cook Inc, Bloomington, IN, by telephone October 24, 2005 and January 6, 2006. Firm initiated recall is ongoing.
REASON
The side of the box gives the size of the stent as 8 x 60 instead of the actual size of 6 x 60. The label front is correct.
VOLUME OF PRODUCT IN COMMERCE
15
DISTRIBUTION
CT, MI, MN, MT, NV, PA, UT, WI and Canada

_______________________________
PRODUCT
Varian brand Radiation Therapy Linear Accelerator VARiS; VARiS Vision v6.5 up to and including v7.3.10 SP2 (used with BrainLab M3 MultiLeaf Collimator (MLC); Eclipse (used with BrainLab M3 MLC); Acuity (used with BrainLab M3 MLC); Product Number 83 (used with Product Number 53); Product Number 48 (used with Product Number 53); Product Number 77 (used with Product Number 53); Recall # Z-0393-06
CODE
H530338, H531026, H532001, H532024, H541335, H532011, H531018, H530104, H532027, H530309, H530321, H530323, H531034, H531995, H530204, H541198, H531038, H530427, H532036, H530313, H530250, H532025, H530064, H530009, H530093, H530311, H530042, H530231, H530316, H530084, H530065, H530022, H530029, H530340, H530302, H532023, H530059, H531037, H530396, H530080, H532038, H530333, H530408, H531024, H530032, H530025, H530414, H530051, H530052, H530310, H533006, H530324, H530419, H530056, H531040, H531043, H531033, H530086, H532028, H532010, H530433, H532035, H531044, H532020, H531039, H535018, H531017, H530078, H532002, H530406, H532019, H530334, H531002, H530019, H532031, H530107, H530066, H530075, H530417, H532015, H533001, H530001, H530018, H530033, H531036, H530402, H534223, H530017, H530011, H530434, H533020, H530074, H530428, H530339, H530425, H530031, H532026, H531031, H531001, H533035, H530050, H530024, H530439, H531470, H531487, H532032, H534015, H530039, H531838, H532022, H533018, H530437, H530030, H532006, H533008, H535009, H533015, H534021, H534022, H534032, H530061, H532037, H530028, H531010, H531028, H535012, H532039, H530013, H530073, H530330, H533030, H534004, H534040, H530085, H533027, H534036, H532005, H530430, H530435, H531029, H530023, H530035, H530036, H530037, H530038, H530045, H530049, H530063, H530126, H530401, H530409, H530410, H530429, H530441, H531020, H531021, H532042, H533036, H535001, H535008, H531035, H531041, H532014, H533004, H535003, H535004, H530014, H533014, H530012, H530021, H530337, H531023, H533037, H530004, H530008, H530027, H530047, H530055, H530068M, H530068R1, H530072, H531008, H532013, H533032, H530087, H533028, H533029, H534026, H535002, H535013, H531025, H532021, H534020, H530081, H532007, H530057, H530076, H533043, H530043, H530405, H531042, H531345, H532004, H532016, H530052, H530104, H530402, H530427, H531044, H530034, H530218, H535015, H530048, H530423, H530005, H530046, H532029, H530319, H535005
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Palo Alto, CA, by letters on November 23, 2005. Firm initiated recall is ongoing.
REASON
The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment. If the treatment plan called for multiple MLC leaf positions then a mistreatment could occur, since the MLC leaves would not change as expected.
VOLUME OF PRODUCT IN COMMERCE
219 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Bivona brand Mid-Range Aire-Cuf Adjustable
Neck Flange Hyperflex Tracheostomy Tube,
I.D. 6.0 mm O.D. 8.7 mm length 110 mm;
REF 75HA60, Recall # Z-0394-06;
b) Bivona brand Mid-Range Aire-Cuf Extra
Length Fixed Hyperflex Adult Tracheostomy
Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm;
REF 75FHXL80, Recall # Z-0395-06;
c) Bivona brand TTS Adjustable Neck Flange
Hyperflex Tracheostomy Tube, I.D. 8.0 mm O.D.
11.0mm length 130 mm; REF 67HA80,
Recall # Z-0396-06
CODE
a) Lot number: G706181;
b) Lot numbers: G711870 and G711871;
c) Lot number: G711880
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Gary, IN, by letters on December 16, 2005. Firm initiated recall is ongoing.
REASON
Sterility is compromised by incomplete package seal.
VOLUME OF PRODUCT IN COMMERCE
178 units
DISTRIBUTION
Nationwide and Canada

_______________________________
PRODUCT
"iSite" PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3, Recall # Z-0399-06
CODE
All models, version 3.3
RECALLING FIRM/MANUFACTURER
Stentor, Inc., Brisban, CA, by letters on December 20, 2005. Firm initiated recall is ongoing.
REASON
When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the patient/exam selected and shown may be different on the radiologist console and diagnostic display screens.
VOLUME OF PRODUCT IN COMMERCE
110 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Milex 60cc Handy-Vak Locking Syringe Ref: MX500, Recall # Z-0401-06
CODE
Lot number: 39608, Exp. Date April 08
RECALLING FIRM/MANUFACTURER
CooperSurgical, Inc., Trumbull, CT, by telephone and letter dated November 3, 2005. Firm initiated recall is ongoing.
REASON
Potential for the plunger to separate from the piston.
VOLUME OF PRODUCT IN COMMERCE
496 units
DISTRIBUTION
CA, CO, HI, IL, MA, NH, PA, VA, WA and Canada

_______________________________
PRODUCT
a) BD 1 mL BD Safety Glide tuberculin syringe
with 27 G x 1/2 in. BD needle, Reference Number
305945: 1mL 27G Blister, Recall # Z-0402-06;
b) D 1 mL BD Safety Glide Tuberculin syringe
with 26 G x 3/8 in. BD needle, Reference Number
305946: Product Description: 1ml 26G Blister,
Recall # Z-0403-06;
c) BD 1 mL Allergist tray with 27 G x 1/2 in.
BD Safety Glide. Reference Number 305950:
Product Description: 1 mL 27G Allergist Tray,
Recall # Z-0404-06;
d) BD 1 mL Allergist tray with 26G x 3/8 in.
BD Safety Glide, Reference Number 305951:
Product Description: 1 mL 26G Allergist tray,
Recall # Z-0405-06
CODE
a)Lot #: 5201851; 5201855; 5201853; 5175734;
5175732; 5175731; 5175730; 5146694; 5146689; 5146686; 5146691; 5146688; 5115764; 5111314; 5111313; 5082345; 5082341; 5082350; 5082344; 5052275; 5052276; 4344969; 4344970; 4344930; 4344978; 4344934; 4323196; 4323195; 4323194; 4296986;
b) Lot #: 5201856; 5175735; 5146697; 5143522;
5111315; 5082352; 5052279; 5020322; 4344951;
4323197;
c) Lot Number: 5167180; 5167183; 5111316; 5111317;
5082354; 5082355; 5052282; 5020329; 5020326;
4344954; 4344973; 4323198; 4323202;
d) Lot #: 5111318; 5082356; 5052286; 4344974; 4323204
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on October 25, 2005.
Manufacturer: Becton Dickinson Medical - Diabetes Care, Holdrege, NB. Firm initiated recall is ongoing.
REASON
Safety mechanisms on the syringes are rotating too freely. This can result in the safety mechanism not holding its rotational position and increasing risk of an accidental needle-stick.
VOLUME OF PRODUCT IN COMMERCE
7,274,800 syringes
DISTRIBUTION
Nationwide and Canada

_______________________________
PRODUCT
BBLT GasPakT Pouch System and BBLT GasPakT CampyPouchT System, Catalog numbers 260651 and 260656, packed in boxes of 25, Recall # Z-0406-06
CODE
BBLT GasPakT Pouch System Batch Expiration Date 5214643 08/31/06 5214642 08/31/06 5214640 08/31/06 5194865 08/31/06 5194863 08/31/06 5189360 07/31/06 5189359 07/31/06 5189358 07/31/06 5189357 07/31/05 5189356 07/31/06 5189355 07/31/06 5189353 07/31/06 5182704 07/31/06 5182703 07/31/06 5182702 07/31/06 5182701 07/31/06 5165500 06/30/06 5165499 06/30/06 5165496 06/30/06 5165494 06/30/06 5165491 06/30/06 5158860 06/30/06 5154612 06/30/06 5154610 06/30/06 5152966 06/30/06 5152958 06/30/06 5146724 06/30/06 5126942 05/31/06 5119623 05/31/06 5119622 05/31/06 5119621 05/31/06 5119620 05/31/06 5119619 05/31/06 4345515 12/31/06 5097847 04/30/06 5097845 04/30/06 5097841 04/30/06 5097838 04/30/06 5097837 04/30/06 5074202 03/31/06 5074200 03/31/06 5074198 03/31/06 5069662 03/31/06 5069660 03/31/06 5069659 03/31/06 5061870 03/31/06 5061866 03/31/06 5056474 03/31/06 5056472 03/31/06 5056471 03/31/06 5052074 01/31/06 5052071 01/31/06 5052070 01/31/06 5048914 01/31/06 5040337 01/31/06 5040336 01/31/06 5035915 01/31/06 5035914 01/31/06 5032185 01/31/06 5032184 01/31/06 5031047 01/31/06 5031045 01/31/06 5028254 01/31/06 5021661 01/31/06 5019413 01/31/06 5019411 01/31/06 5013255 01/31/06 5013253 01/31/06 5010278 01/31/06 5010276 01/31/06 5010274 01/31/06 4365412 01/31/06 4355778 12/31/05 4355774 12/31/05 4355771 12/31/05 4352493 12/31/05 4345533 12/31/05 4345531 12/31/05 4345521 12/31/05 4345518 12/31/05 4345515 12/31/05 4343926 12/31/05 4343923 12/31/05 4343922 12/31/05 4341958 11/30/05 4338027 11/30/05 4338025 11/30/05 4338023 11/30/05 4324272 11/30/05 4324271 11/30/05 4324269 11/30/05 4324267 11/30/05 4316041 11/30/05 4316036 11/30/05 4316035 11/30/05 4316033 11/30/05 4316030 11/30/05 4316029 11/30/05 4315197 11/30/05 4315194 11/30/05 4315192 11/30/05 4303939 11/30/05 4303937 11/30/05 4303933 11/30/05 4303932 11/30/05 ***********************************************************BBLT GasPakT CampyPouchT System Batch Expiration Date 5164299 8/31/2006 5158868 6/30/2006 5158867 6/30/2006 5158866 6/30/2006 5129239 5/31/2006 5126951 5/31/2006 5126949 5/31/2006 5126947 5/31/2006 5104863 4/30/2006 5104862 4/30/2006 5104859 4/30/2006 5063685 3/31/2006 5063687 3/31/2006 5063684 3/31/2006 5055069 3/31/2006 5048900 2/28/2006 5046481 2/28/2006 5046480 2/28/2006 5042726 2/28/2006 5042721 2/28/2006 5024692 1/31/2006 5024129 1/31/2006 5024120 1/31/2006 5024692 1/31/2006 4335944 12/31/2005 4335943 12/31/2005 4335938 12/31/2005 4335940 12/31/2005 4335932 12/31/2005 4335935 12/31/2005 4303906 11/30/2005 4303857 11/30/2005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co., Sparks, MD, by letter on November 23, 2005.
Manufacturer: Becton Dickinson Caribe LTD, Cayey, PR. Firm initiated recall is ongoing.
REASON
Microbiological based test system may be contaminated with bacteria and cause false clinical test results in patient samples.
VOLUME OF PRODUCT IN COMMERCE
61,647 boxes of 25 /box
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

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PRODUCT
a) 6 cm Catheter Reservoir with 10 cm extension,
Recall # Z-0365-06;
b) 7 cm Catheter Reservoir with 10 cm extension,
Recall # Z-0366-06;
c) 10 cm Scopable Catheter Reservoir,
Recall # Z-0367-06
CODE
a) M1475/PR06X/12-2009 and N0112/PR06X/03-2010;
b) M1330/PR07X/11-2009 and M1476/PR07X/12-2009;
c) N0297/SRS10/03-2009
RECALLING FIRM/MANUFACTURER
Vygon Neuro, Norristown, PA, by letter on March 24, 2005 . Firm initiated recall is complete.
REASON
Stylet in package is shorter than that claimed on the label.
VOLUME OF PRODUCT IN COMMERCE
70 units
DISTRIBUTION
CA and Germany

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PRODUCT
Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038" (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with .038" end hole; Reorder # MWCE-38-20-20. Recall # Z-0368-06
CODE
Lots F512190X, F612598, F712671, F782158, F1015070, F1246233, F1296872, F1306174, F1324630, F1333380, F1345472, F1395273 and F1479165
RECALLING FIRM/MANUFACTURER
Cook, Inc., Bloomington, IN, by telephone and letter dated September 26, 2005. Firm initiated recall is complete.
REASON
The coil is 20 centimeters in length, but the label states the length is 20 millimeters.
VOLUME OF PRODUCT IN COMMERCE
242 units
DISTRIBUTION
DE, NY and PA

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PRODUCT
Alsius CoolGard Temperature Regulation System, Recall # Z-0369-06
CODE
Serial # 30000011 30000012 30000013 30000014 30000016 30000017 30000018 30000019 30000020 30000022 30000023 30000024 30000025 30000026 30000027 30000029 30000030 30000031 30000032 30000033 30000034 30000035 30000036 30000037 30000038 30000039 30000040 30000041 30000042 30000043 30000044 30000045 30000046 30000047 30000048 30000049 30000050 30000051 30000052 30000053 30000054 30000055 30000056 30000057 30000058 30000059 30000060 30000061 30000062 30000063 30000064 30000065 30000066 30000068 30000069 30000070 30000071 30000072 30000073 30000074 30000075 30000076 30000077 30000078 30000079 30000081 30000082 30000083 30000084 30000085 30000086 30000087 30000088 30000089 30000090 30000091 30000092 30000093 30000094 30000095 30000096 30000097 30000098 30000100 30000101 30000102 30000103 30000104 30000105 30000106 30000107 30000108 30000109 30000110 30000111 30000112 30000113 30000114 30000115 30000116 30000117 30000118 30000119 30000120 30000121 30000122 30000123 30000124 30000125 30000126 30000127 30000128 30000129 30000130 30000131 30000132 30000133 30000134 30000136 30000138 30000139 30000140 30000141 30000142 30000143 30000144 30000145 30000146 30000147 30000148 30000149 30000150 30000151 30000152 30000154 30000155 30000156 30000157 30000158 30000159 30000160 30000162 30000163 30000164 30000165 30000166 30000167 30000168 30000169 30000170 30000171 30000172 30000173 30000174 30000175 30000176 30000177 30000178 30000179 30000180 30000181 30000182 30000183 30000184 30000185 30000186 30000187 30000188 30000189 30000190 30000191 30000192 30000193 30000194 30000195 30000196 30000197 30000198 30000199 30000200 30000201 30000202 30000203 30000204 30000205 30000206 30000207 30000208 30000209 30000210 30000211 30000212 30000213 30000214 30000215 30000216 30000217 30000218 30000219 30000220 30000221 30000222 30000223 30000224 30000225 30000226 30000227 30000228 30000229 30000230 30000232 30000233 30000234 30000235 30000236 30000237 30000238 30000239 30000240 30000241 30000242 30000243 30000244 30000245 30000246 30000247 30000248 30000249
RECALLING FIRM/MANUFACTURER
Alsius Corporation, Irvine, CA, by letter on November 9, 2005. Firm initiated recall is ongoing.
REASON
Alsius has found that fluid spills or ingress may result in an alarm condition. The potential health risk involved in this state can be the discontinuance of therapy.
VOLUME OF PRODUCT IN COMMERCE
239 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
V.A.C. ATS Canister with Gel (500 mL), Part # M6275063/10.S, Recall # Z-0379-06
CODE
Lot number: 081505806M
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kinetic Concepts, Inc., San Antonio, TX, by telephone and letter on September 16, 2005.
Manufacturer: Pacific Device De Mexico S A De C V, Tijuana, Mexico. Firm initiated recall is complete.
REASON
Possible mislabeling of shipping cartons.
VOLUME OF PRODUCT IN COMMERCE
64 cartons, each containing 10 canisters
DISTRIBUTION
Nationwide
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PRODUCT
a) Roche Elecsys total PSA, catalog
number 11731262322, Recall # Z-0381-06;
b) Roche Elecsys total PSA CalSet, catalog
number 11731696322, Recall # Z-0382-06
CODE
a) Lot number: 171640;
b) Lot number: 171735
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by reagent bulletin dated December 7, 2005.
Manufacturer: Roche Diagnostics GmbH, Penzberg, Germany. Firm initiated recall is ongoing.
REASON
There is a possibility of high results with sera expected to have non-detectable levels of tPSA if these reagent lots are used in combination on the Modular Analytics E170 analyzer.
VOLUME OF PRODUCT IN COMMERCE
50,000 kits
DISTRIBUTION
Nationwide

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PRODUCT
a) Clinical Chemistry Apolipoprotein A1,
List Number 9D92-20, Recall # Z-0383-06;
b) Clinical Chemistry Immunoglobulin M,
List Number 1E01-20, Recall # Z-0384-06;
c) Clinical Chemistry Prealbumin,
List Number 1E02-20, Recall # Z-0385-06;
CODE
a) Lot numbers: 30029HW00, 28002HW00,
26027HW00 and 23006HW00;
b) Lot numbers: 30067HW00, 27057HW00 and
23026HW00;
c) Lot numbers: 32063HW00, 27019HW00 and
23044HW00
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Diagnostic Div., South Pasadena, CA, by letter on November 10, 2005. Firm initiated recall is ongoing.
REASON
These specific protein assays are not meeting the 57-day on board stability claim.
VOLUME OF PRODUCT IN COMMERCE
2,626 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Medtronic Slimline Single-Use Internal Reference pH Catheter for Gastroesophageal pH measurements. Models 9012P3101, 9012P3111, 9012P3121, 9012P3131 and 9012P3141. Recall # Z-0392-06
CODE
Lot numbers: 571, 606, 695, 754, 952, 945, 1024, 1066
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Gastroenterology/Urology, Shoreview, MN, by letters on December 14, 2005.
Manufacturer: Catheter and Disposables Technology, Inc., Plymouth, MN. Firm initiated recall is ongoing.
REASON
Certain lots have a manufacturing defect that allows the water pushed through the catheter to travel back into the connector of the Digitrapper pH recorder. Medtronic has determined that patient safety is not compromised, but catheter function may be affected and damage may result to the Digitrapper pH recorder.
VOLUME OF PRODUCT IN COMMERCE
140 catheters
DISTRIBUTION
CA, CO, FL, MA, OH, PA, Finland, Italy and Portugal

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PRODUCT
VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument), Recall # Z-0397-06
CODE
PI.79; PI.79/I; PI.79/IIII; PI.80; PI.80/III; PI.80/IIII; PI.80/IIIII
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plus Orthopedics USA, San Diego, CA, by e-mail on December 2, 2005.
Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing.
REASON
The adjustment knob tower on one device was found to have broken off from the body of the instrument. This did not happened during a surgery and is believed to have been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.
VOLUME OF PRODUCT IN COMMERCE
14 devices
DISTRIBUTION
AZ, CA, CO, ID, NY, OK, TX, UT and WI

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PRODUCT
ARCHITECT c8000 System Software, Version 2.11, Product List/Model #5F48-12, Recall # Z-0398-06
CODE
All lots/serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Inc, Irving, TX, by letter dated December 8, 2005.
Manufacturer: Toshiba Medical Systems Company, Tochigi-Ken, Japan. Firm initiated recall is ongoing.
REASON
System software assigns a calibrator default volume of 2.OuL when field is left empty by operator at time assay parameters set. Patient results could be affected if the volume required is not 2.0 uL.
VOLUME OF PRODUCT IN COMMERCE
1,206 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Architect Stat Myoglobin Calibrators; List 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL, Recall # Z-0400-06
CODE
Lot number: V96128
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, by telephone on October 17, 2005.
Manufacturer: Fisher Diagnostic, A Company of Fisher Scientific LLC, Middletown, VA. Firm initiated recall is ongoing.
REASON
Some of the kits were shipped at the incorrect shipping temperature. They were shipped ambient, but should have been shipped frozen.
VOLUME OF PRODUCT IN COMMERCE
11 kits
DISTRIBUTION
TX, WA, MT, PA, KY and Korea

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PRODUCT
SonoSite L25 Needle Guide Kit, 21 GAUGE, Part Number P04053-01. Each kit is packaged in a hermetically sealed clear plastic pouch with white backing. Product is labeled as Sterile. 24 pouches are packaged in a white cardboard box and labeled as SonoSite L25 Needle Guide Kit, 21 GAUGE REF# P04053-01, Quantity: 24, CONTENTS STERILE IF PACKAGE IS INTACT. Recall # Z-0407-06
CODE
Box Lot Code: M778940; M779110; M785430; M790190; M791960; M793010; M793020; M793530; M799610; M799620; M803570; M803580; M806400; M806410; M806420; M809020; M810990; M823040; M830430. Pouch Lot Code: M761640; M778400; M781250; M783140; M785270; M791720; M797960; M801010; M802700; M804630; M807010; M811660; M831060; M832790
RECALLING FIRM/MANUFACTURER
Recalling Firm: SonoSite, Inc., Bothell, WA, by telephone between December 12-19, 2005 and by letter on December 14, 2005.
Manufacturer: Contour Plastics, Inc., Baldwin, WI. Firm initiated recall is ongoing.
REASON
22 gauge needle guides were intermixed with 21 gauge guides and labeled as 21 gauge needle guides.
VOLUME OF PRODUCT IN COMMERCE
355 boxes/8,520 pouches
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
STA Liatest Free Protein S, cat. 00516. These kits are intended for use with analyzers of the STA brand name for the quantitative determination of free protein S in plasma by the immuno-turbidimetric method. Recall # Z-0408-06
CODE
Lot number 0422671, Exp. March 2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diagnostica Stago, Inc., Parsippany, NJ, by letters on October 26, 2005 and November 10, 2005.
Manufacturer: Diagnostica Stago, Franconville, France. Firm initiated recall is ongoing.
REASON
The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range.
VOLUME OF PRODUCT IN COMMERCE
150 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR JANUARY 25, 2006

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