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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June 22, 2005
05-25

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III

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PRODUCT
Hi-C, Strawberry Kiwi Kraze * 6.75 fl.oz. (200 mL) * Strawberry Kiwi Flavored Drink With Other Natural Ingredients * Product is packed in aseptic drink boxes, packaged 10 to a multi-pack with a card insert. Four multi-packs are packaged together for the trade in a shrink-wrapped tray as a case. UPC# 250000906. Recall # F-432-5.
CODE
Expiration Code: DEC2205 WT 3 or WT 4
RECALLING FIRM/MANUFACTURER
Recalling Firm: Coca Cola Enterprises, Atlanta, GA, by telephone and letters on April 18, 2005.
Manufacturer: Coca Cola, North America, Waco, TX. Firm initiated recall is ongoing.
REASON
The product is spoiled due to yeast contamination.
VOLUME OF PRODUCT IN COMMERCE
2618 cases
DISTRIBUTION
AR, CO, FL, KY, LA, MS, TX and PR

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
MAGNESIUM SULFATE 40 g (80 ml of 50% Injection) added to 1000 ml Lactated Ringers” Injection USP C.O.M.P.A.S.S. is a Compounding Service of NDC Code: 61553-408-04. Recall # D-254-5.
CODE
Lot #: 04011428 Expiration date: 2/28/04
RECALLING FIRM/MANUFACTURER
PharMedium Services, Llc, Houston, TX, by telephone on February 10, 2005. Firm initiated recall is complete.
REASON
Presence of particulate matter
VOLUME OF PRODUCT IN COMMERCE
120 bags
DISTRIBUTION
Nationwide
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PRODUCT
MAGNESIUM SULFATE 1 g (2 ml of 50% Injection) added to 50 ml 5% Dextrose Injection USP C.O.M.P.A.S.S. is a Compounding Service of PharMedium Services. NDC Code: 61553-410-41. Recall # D-255-5.
CODE
Lot #: 04013008 Expiration date: 3/15/04
RECALLING FIRM/MANUFACTURER
PharMedium Services, Llc, Houston, TX, by telephone on February 17, 2005. Firm initiated recall is complete.
REASON
Mislabeling
VOLUME OF PRODUCT IN COMMERCE
240 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced. Recall # B-1084-5.
CODE
Unit: 246320206 (split unit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, by telephone on January 8, 2004.
Manufacturing Firm: Blood Systems Inc., Rapid City, SD. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
SD and MS
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PRODUCT
Human Tissue for Transplantation, Corneas. Recall # B-1311-5.
CODE
Tissue numbers NY-05-04-017-R1 and NY-05-04-017-L1
RECALLING FIRM/MANUFACTURER
Sight Society of Northeastern New York, Albany, NY, by telephone on April 22, 2005. Firm initiated recall is complete.
REASON
Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
PA and SD
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PRODUCT
Source Plasma. Recall # B-1321-5.
CODE
Unit numbers 65931R and 01347T
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., Lakeland, FL, by facsimile on February 14, 1998. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to a recent tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
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PRODUCT
a) Red Blood Cells. Recall # B-1322-5;
b) Fresh Frozen Plasma. Recall # B-1323-5.
CODE
a) and b) Unit number B169359
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on August 7, 2002.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to a recent tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
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PRODUCT
Red Blood Cells. Recall # B-1326-5.
CODE
Unit number FG02482.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aurora Blood Bank, Heartland Blood Centers, Aurora, IL, by letter dated April 4, 2005.
Manufacturer: Heartland Blood Centers, Elgin Donor Center, Elgin, IL. 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
IL.
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PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
Recall # B-1327-5;
b) Platelets Pheresis, Leukocytes Reduced Irradiated.
Recall # B-1328-5.
CODE
a) and b) Unit number 40P03881.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of America Region, Peoria, IL, by telephone on February 21, 2005, and by letter on March 3, 2005. Firm initiated recall is complete.
REASON
Blood products, collected in an apheresis collection kit that had exceeded the acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
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PRODUCT
Platelets. Recall # B-1363-5.
CODE
Unit number 238849.
RECALLING FIRM/MANUFACTURER
Aultman Hospital Blood Bank, Canton, OH, by telephone on November 2, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred for a history of intravenous (IV) drug use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT
Source Plasma. Recall # B-1263-5.
CODE
Unit number 04844303
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Inc., Jackson, TN, by facsimile on October 8, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
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PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1317-5.
CODE
Unit number 26173-6759
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on September 5, 2002. Firm initiated recall is complete.
REASON
Blood product, that was labeled as leukoreduced but failed
quality control testing due to an elevated white blood cell
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR
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PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1362-5.
CODE
Unit number 6705757
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc, Anchorage, AK, by telephone on September 2, 2003. Firm initiated recall is complete.
REASON
Blood product, which was not leukoreduced within the appropriate time period after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AK

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

****CORRECTION****
The Enforcement Report 05-20 dated May 18, 2005, Recall # Z-0805-05, the recall product is the CM 100-Headstart Adapter Cable, Cat. No. 920650 (not Laerdal Medical Corp, CM 100-HeadStart® Automatic External Defibrillator Adapter Cables). The recalled Adapter Cables are for use with the Laerdal Heartstart 4000 and various Philips models listed. The Laerdal Heartstart 3000 is not involved or affected by this recall. It should not be included. The subject Adapter Cable cannot be attached to a Heartstart 3000.
Customers are instructed to discontinue use of the Adapter Cables, and to order alternative cabled electrodes that do not require adapters (not alternative cables) from Philips Medical Systems. The recalling firm is Laerdal Medical, not Volex Inc., and Laerdal’s firm initiated recall is ongoing.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
a) Clinical Technologies, Inc., 25 G Spinal Painpak,
Reorder No.: 4043. Recall # Z-0885-05;
b) 22G Nerve Block PainPak, Reorder No.: 3269.
Recall # Z-0886-05.
CODE
a) Lot number 1004328;
b) Lot numbers: 0804370, 0904191,
0904014, and 0904207;
Lot number: 0904239;
Lot numbers 1104306, 0305143,
and 0105001
RECALLING FIRM/MANUFACTURER
Recalling Firm: Spinal Specialties, Inc., San Antonio, TX, by letter on April 15, 2005.
Manufacturer: Becton Dickinson & Co, Franklin Lakes, NJ. Firm initiated recall is ongoing.
REASON
Becton Dickinson recalled the needles due to reports of leakage associated with an undersized Luer taper in the spinal needle hub.
VOLUME OF PRODUCT IN COMMERCE
642 kits
DISTRIBUTION
VA, OH, TX, CA, IL, and FL
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PRODUCT
LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Recall # Z-0887-05.
CODE
OneTouch Ultra Test Strip Lot: 1022859; [A second lot (# 1022865) was also mislabeled with the incorrect Control Solution range. This lot was distributed outside of the US, exclusively in Italy.]
RECALLING FIRM
LifeScan, Inc., Milpitas, CA, by letters on November 17, 2003. Firm initiated recall is complete.
REASON
A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL.
VOLUME OF PRODUCT IN COMMERCE
8,718 boxes (containing 435,900 test strips)
DISTRIBUTION
Nationwide and Italy
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PRODUCT
a) Hitachi Altaire Magnetic Resonance Imaging Device.
Recall # Z-0888-05;
b) Hitachi AIRIS II Magnetic Resonance Imaging Device.
Recall # Z-0889-05;
c) Hitachi AIRIS Elite Magnetic Resonance Imaging Device.
Recall # Z-0890-05.
CODE
a) L001 thru L182;
b) C002 thru C795, C907, and C910;
c) H003 thru H059
RECALLING FIRM/MANUFACTURER
Hitachi Medical Systems America Inc., Twinsburg, OH, by letters on April 21, 2005. Firm initiated recall is ongoing.
REASON
Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
VOLUME OF PRODUCT IN COMMERCE
983 devices
DISTRIBUTION
Nationwide, Wales and London
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PRODUCT
a) Peri-Strips Dry with Veritas Collagen Matrix Staple
Line Reinforcement (PSD-V), 4506 ETS-V. PSD-V is an
implantable surgical mesh comprised of non-crosslinked
bovine pericardium in a dehydrated form. Do not reuse.
Consult Instructions for Use. Sterilized. Product
treated with sodium hydroxide. Produt derived from
USDA-inspected cattle. Made in the U.S.A. Rx Only.
Recall # Z-0891-05;
b) Peri-Strips Dry with Veritas Collagen Matrix Staple Line
Reinforcement (PSD-V), 4506 E-V. PSD-V is an implantable
surgical mesh comprised of non-crosslinked bovine
pericardium in a dehydrated form. Do not reuse.
Consult Instructions for Use. Sterilized. Product
treated with sodium hydroxide. Product derived from
USDA-inspected cattle. Made in the U.S.A. Rx Only.
Recall # Z-0892-05.
CODE
a) Lot Number: 5707464-166925, 5707598-118352,
5708605-151644, 5708622-152524, 5708624-152526,
5709355-167627, 5709825-173142, 5709826-173143 and
5709827-173144;
b) Lot number: 5707471-116932, 5707579-118319 and
5709356-167628
RECALLING FIRM
Synovis Surgical Innovations A Division of Synovis Life Technologies, Inc., St. Paul, MN, by telephone and recall notice, dated May 31, 2005. Firm initiated recall is ongoing.
REASON
Device is contained in 2 pouches. The outer pouch’s seal may be compromised; this may render the exterior of the interior pouch non-sterile.
VOLUME OF PRODUCT IN COMMERCE
376 boxes
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR JUNE 22, 2005

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