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 4, 2006
06-01

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I

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PRODUCT
Trypan Blue 0.06% Ophthalmic Solution, packaged one cc syringes, Rx only, Recall # D-075-6
CODE
Lot numbers: 08182005:43@17; 08012005:63@24; 06282005:91@27; 05252005:36@13 and 05042005:86@17
RECALLING FIRM/MANUFACTURER
Custom-Rx Compounding Pharmacy, Richfield, MN, by telephone on August 25, 2005, and by letter and press release on August 26, 2005. Firm initiated recall is ongoing.
REASON
Microbial contamination (Pseudomonas aeruginosa).
VOLUME OF PRODUCT IN COMMERCE
219
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
Red Blood Cells, Recall # B-0373-6
CODE
Unit numbers: 6863817, 6863820
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by letter dated September 16, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested initially reactive for an infectious disease were repeat tested in duplicate on an invalidated test run, and were not retested on a subsequent run, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ

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PRODUCT
Source Plasma, Recall # B-0374-6
CODE
Unit numbers: 01630992, 01628135, 01616422, 01613384, 01608991, 01606386, 01620975
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Service, LP, Van Nuys, CA, by facsimile transmission dated September 24, 2004.
Manufacturer: ZLB Plasma Services, Columbia, SC. Firm initiated recall is complete.
REASON
Blood products that tested negative for antibodies to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor that subsequently tested positive for anti-HIV-1/2, were not properly quarantined, and were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA

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PRODUCT
Source Plasma, Recall # B-0391-6
CODE
Unit number: 7030260750
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., San Antonio, TX, by facsimile and telephone on September 29, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who was deferred due to risk factors associated with variant Creutzfeldt-Jakob disease (vCJD) travel, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

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PRODUCT
Source Plasma, Recall # B-0393-6
CODE
Unit numbers: 0150012788 and 0150013147
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Kalamazoo, MI, by facsimile on or about January 6, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor who had been permanently deferred due to exchanging sex for money, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Spain

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PRODUCT
a) Red Blood Cells, Recall # B-0420-6;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-0421-6;
c) Red Blood Cells, Leukocytes Reduced,
Irradiated, Recall # B-0422-6;
d) Platelets, Recall # B-0423-6;
e) Platelets, Leukocytes Reduced,
Recall # B-0424-6;
f) Fresh Frozen Plasma, Recall # B-0425-6
CODE
a) Unit number: 17KK08653;
b) Unit numbers: 17KM49180, 17FR15101, 17GM42739,
17KQ43514, 17KQ38249;
c) Unit number: 17KM42040;
d) Unit numbers: 17KK08653, 17KP52866;
e) Unit numbers: 17GM42739, 17KM42040, 17KQ43514,
17KQ38249, 17Q31127, 17KM49180;
f) Unit numbers: 17KM49180, 17KQ38249
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, Saint Paul, MN, by letters dated June 10, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus, but were collected from a donor who previously tested reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
MN, MA, SD, IA, and MO

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PRODUCT
Platelets, Recall # B-0428-6
CODE
Unit number: 2109787
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by telephone on June 10, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced
Recall # B-0456-6;
b) Recovered Plasma, Recall # B-0457-6
CODE
a) Unit number: 06FR39967;
b) Unit numbers: 06FR37676, 06FR39967
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, California, by telephone on June 2, 2002, and by letter dated, June 20, 2002, and by facsimile transmission dated June 19, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at increased risk of variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA and Switzerland

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PRODUCT
a) Red Blood Cells, Recall # B-0459-6;
b) Platelets, Recall # B-0460-6
CODE
a) and b) Unit numbers: 6723768
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by facsimile on August 29, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

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PRODUCT
Red Blood Cells, Recall # B-0461-6
CODE
Unit number: 0120622
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by facsimile on September 8, 2005. 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
OH

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PRODUCT
a) Red Blood Cells, Recall # B-0462-6;
c) Platelets, Recall # B-0463-6
CODE
a) and b) Unit numbers: 0603349
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter dated May 26, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0464-6
CODE
Unit number: 007GE24478
RECALLING FIRM/MANUFACTURER
American National Red Cross, Arizona Region, Tucson, AZ, by telephone on July 13, 2005, and by letter dated July 19, 2005. Firm initiated recall is complete.
REASON
Red Cells, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ

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PRODUCT
Red Blood Cells (Apheresis), Recall # B-0470-6
CODE
Unit number: FL20909
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile transmission dated September 13, 2005. Firm initiated recall is complete.
REASON
Red Cells, lacking appropriate quality control documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

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PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0474-6
CODE
Unit numbers: 157407254 -- split unit
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock Center, Lubbock, TX, by telephone on April 3, 2005. Firm initiated recall is complete.
REASON
Platelets, possible contaminated with microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0495-6
CODE
Unit number: 216646
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated March 23, 2005. Firm initiated recall is complete.
REASON
Red Cells, possibly contaminated with microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0399-6
CODE
Unit number: 0649979
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, on December 23, 1999. Firm initiated recall is complete.
REASON
Blood product, for which there was no documentation of weld acceptability for the sterile docking of the filter, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0411-6
CODE
Unit numbers: 0653551, 0659554
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, on January 24, 2000. Firm initiated recall is complete.
REASON
Blood products, for which there was no documentation of weld acceptability for the sterile docking of the filter, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0412-6
CODE
Unit numbers: 0650067, 0657598, 0650086, 0659625, 0654485
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, on January 3, 2000. Firm initiated recall is complete.
REASON
Blood products, for which there was no documentation of weld acceptability for the sterile docking of the filter, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CO

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PRODUCT
a) Red Blood Cells For Further
Manufacture, Recall # B-0426-6;
b) Recovered Plasma, Recall # B-0427-6
CODE
a) Unit number: 17KP52866;
b) Unit numbers: 17FR15101, 17KM42040,
17KQ43514, 17KK08653, 17Q31127, 17GM42739,
17KP52866
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, Saint Paul, MN, by letters dated June 10, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus, but were collected from a donor who previously tested reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CA, and France

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0465-6
CODE
Unit numbers: 07GJ13519, 07GJ13526, 07FH33976, 07FN47847
RECALLING FIRM/MANUFACTURER
American National Red Cross, Arizona Region, Tucson, AZ, by telephone on June 24, 2005. Firm initiated recall is complete.
REASON
Red Cells, collected from ineligible donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AZ and CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
a) Insulin Pump, Model R1000,
Recall # Z-0306-06;
b) Insulin Pump, Model IR1000,
Recall # Z-0307-06;
c) Insulin Pump, Model IR1200,
Recall # Z-0308-06;
d) Insulin Pump, Model IR1250,
Recall # Z-0309-06
CODE
a) Serial numbers: 07856-10, 22-09127-10;
b) Serial numbers: 06003-10, 31-04891-11;
c) Serial numbers: 08472-10, 88-06100-10;
d) Serial numbers: 26-07356-10, 90-14159-01
RECALLING FIRM/MANUFACTURER
Animas Corporation, West Chester, PA, by telephone on October 31, 2005. Firm initiated recall is complete.
REASON
Pumps were refurbished more than one time for the same failure mode in violation of the company's procedure.
VOLUME OF PRODUCT IN COMMERCE
32 pumps
DISTRIBUTION
Nationwide

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PRODUCT
a) EnVision+, an ImmunoHistoChemistry
reagent. This in-vitro diagnostic
(reagent) is marketed both as a component
in various finished assay kits and as a
standalone product. Model Number K4000,
Recall # Z-0310-06;
b) EnVision+, an ImmunoHistoChemistry
reagent. This in-vitro diagnostic
(reagent) is marketed both as a
component in various finished assay
kits and as a standalone product.
Model Number K4001, Recall # Z-0311-06;
c) EnVision+, an ImmunoHistoChemistry
reagent. This in-vitro diagnostic
(reagent) is marketed both as a
component in various finished assay
kits and as a standalone product.
Model Number K4002, Recall # Z-0312-06;
d) EnVision+, an ImmunoHistoChemistry
reagent. This in-vitro diagnostic
(reagent) is marketed both as a
component in various finished assay
kits and as a standalone product.
Model Number K4003, Recall # Z-0313-06;
e) EnVision+, an ImmunoHistoChemistry
reagent. This in-vitro diagnostic
(reagent) is marketed both as a
component in various finished assay
kits and as a standalone product.
Model Number K4005, Recall # Z-0314-06;
f) EnVision+, an ImmunoHistoChemistry
reagent. This in-vitro diagnostic
(reagent) is marketed both as a
component in various finished assay
kits and as a standalone product.
Model Number K4006, Recall # Z-0315-06;
g) EnVision+, an ImmunoHistoChemistry
reagent. This in-vitro diagnostic
(reagent) is marketed both as a
component in various finished assay
kits and as a standalone product.
Model Number K4007, Recall # Z-0316-06;
h) EnVision+, an ImmunoHistoChemistry
reagent. This in-vitro diagnostic
(reagent) is marketed both as a
component in various finished assay
kits and as a standalone product.
Model Number K4008, Recall # Z-0317-06;
i) EnVision+, an ImmunoHistoChemistry
reagent. This in-vitro diagnostic
(reagent) is marketed both as a
component in various finished assay
kits and as a standalone product.
Model Number K4009, Recall # Z-0318-06;
j) EnVision+, an ImmunoHistoChemistry
reagent. This in-vitro diagnostic
(reagent) is marketed both as a
component in various finished assay
kits and as a standalone product.
Model Number K4010, Recall # Z-0319-06;
k) EnVision+, an ImmunoHistoChemistry
reagent. This in-vitro diagnostic
(reagent) is marketed both as a
component in various finished assay
kits and as a standalone product.
Model Number K4011, Recall # Z-0320-06
CODE
a) Lot numbers: 065021 and 085031;
b) Lot numbers: 045036, 065022,
and 085032;
c) Lot numbers: 045037 and 065139;
d) Lot numbers: 045038 and 065140;
e) Lot numbers: 035194, 055030,
and 065142;
f) Lot numbers: 045172 and 075112;
g) Lot numbers: 045173 and 075113;
h) Lot numbers: 085146 & 065143;
i) Lot numbers: 045175, 065144 and
085147;
j) Lot numbers: 035293, 055031 and
075114;
k) Lot numbers: 035196, 055032,
and 075115
RECALLING FIRM/MANUFACTURER
Dakocytomation California, Inc., Carpinteria, CA, by letter dated October 14, 2005. Firm initiated recall is ongoing.
REASON
This recall has been initiated due to a formulation error in the EnVision+ visualization reagent.
VOLUME OF PRODUCT IN COMMERCE
5,270 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
0.10% BreathScan Alcohol Detector. Product sold in bulk and individually packaged. Bulk product (500-1000 units) distributed in unlabeled clear plastic bags. Individually packaged product packaged and sealed in clear plastic bags with labeling and sold in boxes containing 100 units/box, Recall # Z-0323-06
CODE
D121898
RECALLING FIRM/MANUFACTURER
Recalling Firm: WNCK, Inc, The Woodlands, TX, by letter on November 29, 2005.
Manufacturer: James Alexander Corporation, Blairstown, NJ. Firm initiated recall is ongoing.
REASON
Device marketed without 510(k) as required; 0.10% BreathScan Alcohol Detector turning positive with breath alcohol samples 50% below the test cutoff.
VOLUME OF PRODUCT IN COMMERCE
126,552 units
DISTRIBUTION
Nationwide, Canada and Israel

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PRODUCT
a) Digital Radiography System
Model DFP8000D, Recall # Z-0324-06;
b) Digital Radiography System,
Model DFP-8000D/FPD,
Recall # Z-0325-06
CODE
a) Serial Numbers: A3622068 A4512074
A3582042 A3542012 A4512073 A3552017
A4552098 A3622065 A3622066 A4542090
A3592048 B4602125 B4612134 B5512155
B4582116 W1B0542168 A3572018 A4562102
A35B2041 B4612132 A3542011 A3582037
A3622069 B4622149 B4602129 A3542006
B4612133 A3572032 A3522002 B4622146
A3542008 A3602050 A4512076 A4522079
A4522081 B4622150 B5522162 A3592046
A3532005 A3612057 A4572109 A3517002
B4622148 A4562099 A3612061 A4562101
B4612137 A3602055 A4542092 B5512154
A4542088 A3572030 A3582035 A3522004
A3562022 A3582036 B4622151 A3582013
A3582013 A45721 07 B4612141 A3517003
A4522080 A3522001 W180542173;
b) Serial Numbers: B5522165 B4592121
B4602124 B4602126 W1B0542172
W1B0542174 B4582115 B4622147 B4572111
B5522161 B5512160 A4562105 B4582113
RECALLING FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Sys, Inc., Tustin, CA, by letter on November 10, 2005.
Manufacturer: Toshiba Medical Systems Company, Tochigi-Ken, Japan. Firm initiated recall is ongoing.
REASON
To correct a software problem that caused the LV images, which were acquired for 15 seconds at the end of the examination, to be lost.
VOLUME OF PRODUCT IN COMMERCE
85 units
DISTRIBUTION
Nationwide

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PRODUCT
Disposable Tips 1000 µl with filter Conductive disposable tips for Tecan Genesis Series * Order Number 612513.1, Part Number 10612523, Blister 1 x 96 pcs. Recall # Z-0326-06
CODE
Lot No. U122098L-1325,
Lot No. U122098L-3225 and
Lot No. U122098L-2325.
The sub-lot numbers (i.e. 1325, 3225 and 2325) are printed on each blister and stamped in blue color on the shipping container in the upper right corner of the box.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tecan US, Inc, Research Triangle Park, NC, by letter on/about November 8, 2005.
Manufacturer: Eppendorf Ag, Hamburg, Germany. Firm initiated recall is ongoing.
REASON
Double filtering of 1000 µl tips. The defect could result in cross contamination of other samples due to possible dripping of sample while moving over other samples.
VOLUME OF PRODUCT IN COMMERCE
3,000 Tips
DISTRIBUTION
IL and Europe

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

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PRODUCT
HeartStart Pads Pediatric Plus, Pediatric Plus Multifunction Defibrillation Electrode Pads, Model M3717A, Recall # Z-0321-06
CODE
Lot number: Y042005-1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems, Andover, MA, by letter on November 30, 2005.
Manufacturer: Katecho Inc., Des Moines, IA. Firm initiated recall is ongoing.
REASON
The Apex/Anterior and the Sternum/Posterior pad labels are located in reverse position to the wire and connector.
VOLUME OF PRODUCT IN COMMERCE
253 cases (5/cs)
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
OLA 2500 Olympus Lab Automation Systems to include the following models (all serial numbers): S2 Full Size, S3 Full Size, Standard Full Size and High Speed Full Size (Aliquoter), Recall # Z-0322-06
CODE
Serial Numbers: 93, 96, 112, 114, 1014 and 1054. Serial numbers correspond to units currently in distribution.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Olympus America, Inc, Irving, TX, by letter on November 18, 2005.
Manufacturer: Olympus Diagnostica Lab-Automation Gmbh, Freiburg, Germany. Firm initiated recall is ongoing.
REASON
Lab Automation System may dilute samples with water.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR JANUARY 4, 2006

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