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U.S. Department of Health and Human Services

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Enforcement Report for February 8, 2006

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

February 8, 2006
06-06

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

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PRODUCT
Fisher Deluxe Mixed Nuts - No Peanuts, Net Wt. 32 Oz. (2 Lbs.) 907 g; 32 oz. clear plastic jars, 6 jars per case; UPC 70690-69841, Recall # F-060-6
CODE
Best By 110506 S1
RECALLING FIRM/MANUFACTURER
John B. Sanfilippo & Son, Inc., Elk Grove Village, IL, by telephone on January 6, 2006 and by press release on January 9, 2006. Firm initiated recall is ongoing.
REASON
Product labeled as "Deluxe Mixed Nuts -- No Peanuts" actually contained peanuts.
VOLUME OF PRODUCT IN COMMERCE
872 cases
DISTRIBUTION
FL, ME, and CA

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PRODUCT
(top label) Albertson's Pumpkin Pie * Fresh Baked Quality * Net Wt 24 oz (1 LB 8 OZ) 680g. Label as appears on the top of each whole pie which is packed in clear rigid plastic. (bottom label) PECAN PIE * Nutrition Facts xxx * Ingredients: Corn syrup, bleached flour with malted barley, sugar, eggs, pecans, partially hydrogenated soy-bean oil, with soy lecithin, water, margarine (liquid and partially hydrogenated soybean oil, water, salt, vegetable mono-and diglycerides, soy lecithin, preservatives [potassium sorbate, citric acid], artificially flavored, colored with beta carotene, vitamin A palmitate added), contains 2% or less of each of the following: salt, yeast, soy lecithin, artificial flavors, l-cysteine, cornstarch, caramel color, sulfites. Contains Wheat, Eggs, Pecans, Soy *. The product is a whole, ready to eat pumpkin pie packed and sold in a clear rigid plastic container, Recall # F-061-6
CODE
Product number 4009868, MM5259, MM5260, MM5261, MM5262 (Applied by store -- 3 day ambient store display)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Schwan Sales Ent. Inc., Marshall, MN, by telephone on November 3, 2005.
Manufacturer: Mrs. Smith Bakery, Spartanburg, SC. Firm initiated recall is ongoing.
REASON
Undeclared Milk; Although the label on top of the package correctly identifies the product as Pumpkin Pie which contains milk, the label on the bottom of the product states Pecan Pie, which does not list milk as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
24,652 cases (12 pies per case)
DISTRIBUTION
ID

______________________________
PRODUCT
MIN YUE FOODS brand Sweetpotato strip, Net Wt. 16 oz., Serving Size 16 oz. (454 g). The product is packed in a heat-sealed plastic bag. UPC barcode # 6 920824 900390, Recall # F-062-6
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Starway Inc., Brooklyn, NY, by press release and letters dated November 15, 2005.
Manufacturer: Zibo Minyue Food Co., Ltd, Yiyuan, China. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (579 ppm) based on sampling & analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
1,701 -- 16 oz. packages
DISTRIBUTION
NY

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PRODUCT
Smoked Fish Dip Cajun Style. Brand name: "Island Stylin", Recall # F-063-6
CODE
100405, located on a white sticker on the bottom of the container.
RECALLING FIRM/MANUFACTURER
Ultra Foods, Inc., Bradenton, FL, by press release on September 26, 2005. Firm initiated recall is ongoing.
REASON
The product is contaminated with Listeria Monocytogenes based on the Florida Department of Agriculture and Consumer Services' analysis.
VOLUME OF PRODUCT IN COMMERCE
78 cases
DISTRIBUTION
FL

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PRODUCT
a) Spreadables Gourmet Cheese Spread,
Crab Creole, Net wt. 7 oz. and 32 oz.
(packaged in plastic tub with snap-off lid).
Recall # F-065-6;
b) Spreadables Gourmet Cheese Spread,
Lobster Bisque, Net wt. 7 oz. and 32 oz.
(packaged in plastic tub with snap-off lid).
Recall # F-066-6
CODE
All lots on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Family Fresh Pack, LLC, Belleville, WI, by telephone and fax on beginning on July 1, 2005. Firm initiated recall is ongoing.
REASON
The product fails to bear a complete ingredient statement, including ingredients derived from crustacean, fish, egg, soy, and wheat.
VOLUME OF PRODUCT IN COMMERCE
1800 units Crab Creole; 501 units Lobster Bisque
DISTRIBUTION
MA, FL, NJ, WI, IL and MI

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

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PRODUCT
Assi Brand? Korean Cakes, 3 lb., item number 20657D, frozen, packed in plastic bags. The rice cake product is known to the Korean community as "Song Pyeon". Ingredients are listed on the label in dual languages, Recall # F-064-6.
CODE
Item #20657D
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rhee Brothers Incorporated, Columbia, MD, by letter on September 29, 205.
Manufacturer: Ohbok Bakery, Philadelphia, PA. Firm initiated recall is complete.
REASON
Food item contains a certified color additive (FD&C Red 40), which is undeclared on the label.
VOLUME OF PRODUCT IN COMMERCE
240 cases of 12/case
DISTRIBUTION
East of the Mississippi River

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
Mylanta Gelcaps (Calcium Carbonate 550mg) 50 solid gelcaps, OTC, NDC 16837-850-50, Recall # D-146-6
CODE
Lot number JDM166 exp 3/06
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
Microbial Contamination: product intended for destruction due to pseudonomas aeruginosa found in water port was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

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PRODUCT
Children's Tylenol Strawberry Suspension 4 oz. Acetaminophen (APAP) 160 mg per 5 ml suspension, OTC, NDC 50580-493-04, Recall # D-147-6
CODE
Lot number JFM184 exp 6/06
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 was intended for destruction due to a piece of latex glove found on a mesh screen was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

_______________________________
PRODUCT
Simply Sleep (Diphenhydramine HCI-25 mg) Nighttime Sleep Aid, 130 mini-caplets, OTC, NDC 50580-843-13, Recall # D-148-6
CODE
Lot number JJM120 exp 7/06
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 foreign tablets: product intended for destruction due to foreign tablets found in filler was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

_______________________________
PRODUCT
Simply Sleep (Diphenhydramine HCI-25 mg) Nighttime Sleep Aid, 100 mini-caplets, OTC, NDC 50580-843-10, Recall # D-149-6
CODE
Lot number JJM121 exp 7/06
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 foreign tablets: product intended for destruction due to foreign tablets found in filler was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

_______________________________
PRODUCT
Histex I/E Capsules (Carbinoxamine Maleate) 2mg/8mg, 60 count bottles and bulk containers, Each capsule contains: Carbinoxamine Maleate 2mg designed for immediate-release to provide rapid action, Carbinoxamine Maleate 8mg in a specially prepared base to provide extended-release action, Rx Only, NDC 67336-050-60 and NDC 67336-050-99, Recall # D-159-6
CODE
60 count bottles; Lot Numbers: 3327 Exp. Date 04/05, 3328 Exp. Date 04/05, 3329 Exp. Date 04/05, 3430 Exp. Date 05/05, 4348 Exp. Date 04/06; 4441 Exp. Date 05/06; 4459 Exp. Date 05/06; 4664 Exp. Date 08/06; 5066 Exp. Date 12/06; 5211 Exp. Date 02/07; 5494 Exp. Date 05/07; 5693 Exp. 08/07; 5694 Exp. Date 06/07; and 5901 Exp. Date 10/07 AND Bulk capsules: Lot Numbers: 3327 Exp. Date 04/05, 3430 Exp. Date 05/05, 3581 Exp. Date 07/05, 4348 Exp. Date 04/06; 4664 Exp. Date 08/06; 5066 Exp. Date 12/06; 5337 Exp. Date 02/07; 5494 Exp. Date 05/07; and 5747 Exp. Date 09/07
RECALLING FIRM/MANUFACTURER
PharmaFab Lp, Grand Prairie, TX, by letters on January 9 and January 11, 2006. Firm initiated recall is ongoing.
REASON
Product does not meet dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE
11,860,294 total capsules
DISTRIBUTION
TN and MI

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

_______________________________
PRODUCT
Children's Motrin Chewable Grape Flavor (Ibuprofen tablets 50mg) 24 chewable tablets, OTC, NDC 50580-907-24, Recall # D-150-6
CODE
Lot number JPM035 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 an incorrect batch formulation of the active ingredient was possibly diverted to retail stores.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Unknown

______________________________
PRODUCT
Anagrelide HCI Capsules, 0.5 mg, 100 count bottle, Rx Only, NDC 0115-4611-01, Recall # D-160-6
CODE
Lot number 4100831
RECALLING FIRM/MANUFACTURER
Impax Laboratories, Inc., Hayward, CA, by letters dated January 4, 2006. Firm initiated recall is ongoing.
REASON
Exceeded Impurity Specification.
VOLUME OF PRODUCT IN COMMERCE
0.5: 2086 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________________
PRODUCT
Reagent Red Blood Cells A1 and B (Pooled Cells) - Referencells,
Package Size: 2 x 10mL, 4 x 10mL, and 50 x 10mL (unlabeled for export), Recall # B-0429-6
CODE
Lot Numbers 09092 & 09092A
Expiration Date: April 29, 2005
RECALLING FIRM/MANUFACTURER
Immucor, Inc., Norcross, GA, by letter dated April 22, 2005. Firm initiated recall is complete.
REASON
Reagent Red Blood Cells, with varying hematocrits, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8,556 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Source Plasma, Recall # B-0560-6
CODE
Unit numbers: HS0045656, HS0045884, HS0046368
RECALLING FIRM/MANUFACTURER
DCI Biologicals Hot Springs, LLC, Hot Springs, AR, by telephone on September 24, 2003. Firm initiated recall is complete.
REASON
Blood products, which were not properly quarantined after receiving post donation information concerning high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
KY

_______________________________
PRODUCT
Source Plasma, Recall # B-0564-6
CODE
Unit number: 05MOHA6472
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Lima, OH, by facsimile on May 23, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not properly quarantined after receiving post donation information concerning a history of incarceration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0578-6
CODE
Unit number: 0835389
RECALLING FIRM/MANUFACTURER
The Blood Connection, Inc., Greenville, SC, by telephone on April 5, 2005. Firm initiated recall is complete.
REASON
Red Blood Cells, mislabeled as to Rh type, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0582-6
CODE
Unit number: 06LV67954
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by letter dated June 11, 2004 and July 11, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0583-6
CODE
Unit number: 06LW41246
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern California Region, Pomona, CA, by letter dated June 11, 2004 and July 11, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT    
Red Blood Cells, Leukocytes Reduced, Recall # B-0586-6
CODE
Unit number 04LC17193
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by facsimile and letter on October 25, 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
ME

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0587-6
CODE
Unit number 18N97894
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by facsimile and letter on September 13, 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
MI

_______________________________
PRODUCT
a) Platelet Pheresis, Leukocytes Removed,
Recall # B-0588-6;
b) Platelet Pheresis, Leukocytes Removed,
Irradiated, Recall # B-0589-6
CODE
a) Unit numbers: 04KE47255 (part 1), 04KE46390 (part1),
and 04KE44868 (part1);
b) Unit number 04KE46390 (part1)
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by facsimile and letter on October 28, 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
4 units
DISTRIBUTION
ME, MA and NY

_______________________________
PRODUCT
Red Blood Cells Pheresis, Recall # B-0602-6
CODE
Unit numbers: 18GJ85709
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on July 19, 2005. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may compromise the sterility of the product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI

_______________________________
PRODUCT
Red Blood Cells Pheresis, Leukocytes Reduced, Recall # B-0603-6
CODE
Unit number: 04KJ05081 (Part I)
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by telephone and letter dated November 8, 2005. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may compromise the sterility of the product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated, Recall # B-0606-6
CODE
Unit number: 027GX95980
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on August 11, 2005. Firm initiated recall is complete.
REASON
Blood product, for which documentation of irradiation was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0609-6
CODE
Unit number: 113396242
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., El Paso, TX, by telephone on December 8, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
New Mexico

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0581-6
CODE
Unit number: 5161741
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, East Orange, NJ, by telephone on December 16, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a history of hemochromatosis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0590-6
CODE
Unit number: LH24339
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., Dba Rhode Island Blood Center, Providence, RI, by telephone on October 13, 2005. Firm initiated recall is complete.
REASON
Blood product, which may have reached an unacceptable temperature during storage, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0601-6
CODE
Unit number: 20LH04051
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Boise, ID, by telephone on April 28, 2003. Firm initiated recall is complete.
REASON
Blood product, which was stored at an incorrect temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0604-6;
b) Red Blood Cells, Leukocytes Reduced,
Recall # B-0605-6
CODE
a) Unit numbers: 20LC35696, 20LC28822, 20LC31834,
20LC22679;
b) Unit numbers: 20LC47618, 20LC44420, 20LC18525
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Boise, ID, by facsimile on September 12, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of hemochromatosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA, ID, OR, PA, and UT

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

______________________________
PRODUCT
The Flextome Cutting Balloon Device consists of a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Flextome Cutting Balloon Device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. This process, referred to as AtherotomyQ3J, allows dilatation of the target lesion with less pressure. The device is provided in 6 mm, 10 mm, and 15 mm lengths. The working length is the distance between the radiopaque marker bands. The proximal catheter shaft of the Flextome Cutting Balloon Device is a hypotube. This hypotube contains the inflation lumen for the balloon. The distal shaft is made of flexible material and contains two lumens. One lumen is for balloon inflation, and the second lumen is a guidewire lumen. The distal shaft is coated with a hydrophilic coating. The guidewire lumen is colored green for greater visibility. The guidewire exit port is 24 cm from the catheter tip. This port facilitates rapid exchanges. A needle with a luer port is included for flushing the wire lumen prior to the insertion of appropriate coronary guide wires. CLIPIT1M clips are provided to aid in handling of the catheter. Recall # Z-0409-06
CODE
Lot/Batch# EF0341 EF0349 EF0350 EF0354 EF5047 EF5048 EF5093 EF5098 EF51 05 EF5168 EF5169 EF5170 EF5390 EF5396 EF5398 EF5404 EF5574 EE0914E EF5046 EF5068 EF5198 EF5329 EF5562 EE0885E EE0939E EF0411 EF0429 EF5050 EF5051 EF5056 EF5095 EF5194 EF5273 EF5285 EF5341 EF5478 EF5566 EF5566'' EE0916E EF5007 EF5086 EF5391 EE0937E EF0351 EF5096 EF5235 EF5567 EE0915E EF5067 EE0943E EF5230 EF0213 EF5101 EF5172 EF5236 EF5573 EF0342 EF5217 EF5403 EE0924E EF5102 EF5242 EF5296 EF5479 EE0932E EF5286 EE0933E EF5209 EF5392 EFO028E EF5004 EF5091 I EF5229 EF5291 EF5564 EF0339 EF5222 EF5261 EF5397 EE0880E EF0340 EF0343 EF0419 EF5092 EF5097 EF5100 EF51 04 EF5195 EF5243 EF5280 EF5287 EF5315 EF5331 EF5476 EF5485 EF5537 EF5563 EF0348 EF0353 EF5006 EF5171 EF5197 EF5314 EF5389 EF5497 EF5575 EF5368 EF5383 EF5363 EF5402 EF5379 EF5386 EF5387 EF5409 EF5401 EF5384 EF5571 EE0940E EF5008 EF5282 EE0904E EF0370 EF5049 EF5200 EF5272 EF5292 EF0345 EF5099 EF0204 EF5050 EF5267 EF5294 EE0917E EF5293 EE0906E EF5196 EF5388 EF5360 EF5385 EF5361 EF5588 EF5589 EFO057 EFO097 EF5109 EF5311 EF5481 EF5556 EFO033 EFO067 EF0150 EF0167 EF0407 EF5015 EF5020 EF5063 EF5110 EF5149 EF5249 EF5446 EF5461 EF5462 EF5551 EF5561 EF5615 EF0202 EF0315 EF0316 EF0317 EF0426 EF5073 EF5122 EF5441 EF5460 EF5501 EF5550 EF5586 EF5607 EFO041 EFO056 EFO078 EF0147 EF0163 EF0166 EF0193 EF0304 EF0319 EF0320 EF0409 EF5014 EF5016 EF5025 EF5114 EF5123 EF5139 EF5144 EF5145 EF5151 EF5183 EF5299 EF5300 EF5301 EF5302 EF5312 EF0208 EF5021 EF5023 EF5024 EF5027 EF5031 EF5037 EF5058 EF5065 EF5115 EF5132 EF5140 EF5585 EFO059 EFO068 EFOO77 EFO080 EFO095 EF0152 EF0162 EF0165 EF0201 EF0207 EF0305 EF0406 EF5022 EF5041 EF5060 EF5070 EF5085 EF5124 EF5125 EF5126 EF5127 EF5130 EF5147 EF5157 EF5158 EF5178 EF5185 EF5238 EF5248 EFO058 EFO069 EF0107 EF0158 EF0301 EF5083 EF5089 EF5116 EF5131 EF5146 EF5557 EE0881 E EFO074 EF0127 EF0128 EF0129 EF0131 EF0132 EF0155 EF0168 EF5084 EF5090 EF5159 EF5179 EF5221 EF5241 EF5250 EF5558 EFOO08 EF0187 EF0323 EF5044 EF5045 EF5057 EF5121 EF5447 EF5500 EF5502 EF5606 EF01 06 EF0395 EF0424 EF5119 EF5150 EF5448 EF5498 EF5540 EF5580 EF0192 EF0199 EF0303 EF0396 EF0397 EF0398 EF5029 EF5035 EF5052 EF5088 EF5120 EF5141 EF5155 EF5156 EFO079 EF0157 EF0186 EF5079 EF5134 EF5451 EF5499 EF5541 EFOO09 RB43 EF0198 EF0302 EF5013 EF5017 EF5053 EF5059 EF5076 EF5148 EF5152 EF5310 EF5450 EF5503 EFOO07 EF0185 EF0292 EF5237 EF5452 EF5470 EF5548 EF0161 EF0322 EF5039 EF5080 EF5111 EF5440 EF5506 EF5549 EFO081 EF0299 EF5018 EF5465 EF5504 EF5555 EFO075 EFO093 EFO098 EF0115 EF0149 EF0151 EF0205 EF5087 EF5240 EF5251 EFO018 EFO094 EF5077 EF5420 EF5469 EF5519 EFO066 EF0105 EF0368 EF0379 EF5072 EF5078 EF5081 EF5112 EF5463 EF0428 EF5192 EF5262 EE0925E EF5207 EF5263 EE0934E EF0360 EF5094 EF5208 EF527 4 EF5279 EF5477 EF5565 EE0941 E EF5005 EF5193 EF5265 EF5496 EF0352 EF0369 EF5103 EF5106 EF5216 EF5330 EF5486 EF5572 EFO017 EFO032 EF0114 EF0117 EF0321 EF5422 EF5521 EF5527 EFO016 EF0104 EF0116 EF0124 EF0148 EF0189 EF0365 EF0366 EF5107 EF5135 EF5532 EF5553 EFO052 EF0159 EF0296 CBM335015 EF0297 EF5074 EF5082 EF5464 EF5480 EF5505 EF5584 EF0408 EF0410 EF5061 EF5075 EF5475 EF5533 EF5587 EFO030 EF5033 EF5064 EF5108 EF5219 EF5220 EF5254 EF5449 EF5552 EF5599 EFO082 EF0421 EF5239 EF5252 EF5442 EF5518 EFO031 EF0156;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, San Diego, CA, by letter on January 26, 2006.
Manufacturer: Boston Scientific Corporation, Letterkenny, Ireland. Firm initiated recall is ongoing.
REASON
The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.
VOLUME OF PRODUCT IN COMMERCE
36,513 devices
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Baxter Colleague Single Channel Volumetric
Infusion Pumps; product codes 2M8151, 2M8151R,
BRM8151(Brazilian Portugese), DNM8151(French),
HNM8151(German), PNM8151(Spanish), CNM8151
(Swedish), GNM8151(Danish), TRM8151(Turkish),
WNM8151(Dutch) , 2M8161, 2M8161R,
Recall # Z-0444-06;
b) Baxter Colleague Triple Channel Volumetric
Infusion Pumps; product codes 2M8153, 2M8153R,
BRM8153(Brazilian Portugese), DNM8153(French),
HNM8153(German), PNM8153(Spanish), CNM8153
(Swedish), GNM8153(Danish), TRM8153(Turkish),
WNM8153(Dutch) ,2M8163, 2M8163R,
Recall # Z-0445-06
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., RoundLake, IL, by letter on December 13, 2005.
Manufacturer: Baxter Healthcare Corp., Singapore. Firm initiated recall is ongoing.
REASON
Interruption of therapy due to battery undercharging, the generation of air-in-line alarms due to IV administration set tugging, and gearbox wear; and underinfusion due to misalignment of the pump head components.
VOLUME OF PRODUCT IN COMMERCE
344,068 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550, Recall # Z-0159-06
CODE
Serial numbers 12040401AB through 12040420AB, serial number 12050501AB and above, and those pumps that had syringe clamp assembly AAS5001503RP replaced on refurbished or serviced AS50 pumps since 5/14/02.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., RoundLake, IL, by letters dated May 5, 2005.
Manufacturer: Baxter Healthcare Corp., Singapore. Firm initiated recall is ongoing.
REASON
A "Check Flange" alarm may occur even though the syringe has been properly loaded into the AS50 Infusion Pump. The false alarm may occur during the syringe loading process or while an infusion is running. Also, the occlusion detection and alarm may be delayed when the pumps are used with larger volume syringes at low flow rates.
VOLUME OF PRODUCT IN COMMERCE
10,414 pumps
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
The Peripheral Cutting Balloon Device small Monorail Delivery System features a balloon with 3 or 4 atherotomes (microsurgical blades) mounted longitudinally on its outer surface. When the Peripheral Cutting Balloon device is inflated, the atherotomes score the plaque, creating initiation sites for crack propagation. Percutaneous Transluminal Angioplasty(PTA) with the Peripheral Cutting Balloon Device allows dilatation of the target lesion with less pressure. Recall # Z-0410-06
CODE
Lot/Batch# EF0206 EF0300 EF5054 EF5062 EF5066 EF5113 EF5142 EF5187 5140F EF5188 EF5253 EFO017 EF0160 EF5069 EF5421 EF5547 EF5554
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, San Diego, CA, by letter on January 26, 2006.
Manufacturer: Boston Scientific Corporation, Letterkenny, Ireland. Firm initiated recall is ongoing.
REASON
The distal shaft of the catheter may separate during withdrawal of the device from the patient. If the shaft separates, the surgical procedure may be prolonged or require more in-depth surgery to physically remove the broken-off shaft from the blood vessel.
VOLUME OF PRODUCT IN COMMERCE
US: 376, International distribution pending
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I, Recall # Z-0411-06
CODE
Serial numbers 501001HR-501263HR, 502001HR-502156HR, 503001HR-503155HR, 505001HR-505210HR, 507001HR-507054HR, 502001HG-502060HG, 503001HG-503048HG, 505001HG-505276HG, 506001HG-506180HG, 501001HJ-501072HJ, 502001HJ-502072HJ, 503001HJ-503060HJ, 504001HJ-504060HJ, 505001HJ-505060HJ, 501001HW-501020HW, 502001HW-502024HW, 501001HF-501012HF, 502001HF-502024HF
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated November 7, 2005.
Manufacturer: Baxter Healthcare Corp., Singapore. Firm initiated recall is ongoing.
REASON
Possible shorting of some printed circuit boards could result in a possible interruption of therapy or cause the pump to fail the Power-On Self Test.
VOLUME OF PRODUCT IN COMMERCE
3,141 pumps
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Recall # Z-0412-06
CODE
All serial numbers of all product codes.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated November 14, 2005.
Manufacturer: Baxter Healthcare Corp., Singapore. Firm initiated recall is ongoing.
REASON
Failures within the PCA profile as well as incidents resulting in interruptions of therapy in various profiles.
VOLUME OF PRODUCT IN COMMERCE
34,000 pumps
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Omron brand 3-Way Instant Thermometer, Model Numbers MC-600 (USA) and MC-600CAN (Canada); an OTC device used to take an accurate patient temperature measurement in 4-6 seconds typically in the oral, rectal or under arm modes when the ambient temperature is between 50 degrees F and 93.2 degrees F; UPC 73796-43600, Recall # Z-0466-06
CODE
Model Numbers MC-600 (USA) and MC-600CAN (Canada) Lot numbers beginning with 1-32, 1-36, 1-37, 1-38.
RECALLING FIRM/MANUFACTURER
Manufacturer: Omron Healthcare, Inc., Vernon Hills, IL, by letters dated October 21, 2005 and by press release on October 24, 2005.
Manufacturer: Ionics EMS, Inc, Cabuyao, Philippines. Firm initiated recall is ongoing.
REASON
Omron is recalling the Omron 3-Way Instant Thermometers due to possible overheating of the probe tip.
VOLUME OF PRODUCT IN COMMERCE
48,000 units
DISTRIBUTION
Nationwide, Canada, Chile, Venezuela and Singapore

______________________________
PRODUCT
a) BD Perisafe catheter with catheter connector.
The catheter connector has four components:
body (green), cap (white), washer (white),
and gasket (grey). It is used for continuous
administration of anesthesia. It is allocated
to be packaged and sold in kits, trays,
Perisafe and bulk. Reorder Number 400507,
Recall # Z-0467-06;
b) BD Perisafe epidural mini-kit: 18 G x 3 1/2 in.
Weiss needle. The catheter connector has four
components: body (green), cap (white), washer
(white), and gasket (grey). It is used for
continuous administration of anesthesia. It is
allocated to be packaged and sold in kits, trays,
Perisafe and bulk. Reorder Number 400273,
Recall # Z-0468-06
CODE
a) Lot number 5222801;
b) Lot Number 5164796
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on November 17, 2005.
Manufacturer: Becton Dickinson P R, Inc, Juncos, PR. Firm initiated recall is ongoing.
REASON
The catheter connector could not be sufficiently tightened to secure the catheter tubing.
VOLUME OF PRODUCT IN COMMERCE
105,908 caps
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Agfa CronexT 10T Radiographic film. Catalog number LF5D1, Recall # Z-0471-06
CODE
Lot number 79260070
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp, Greenville, SC, by telephone and letter on/about December 21, 2005.
Manufacturer: AGFA Corp., Goose Creek, SC. Firm initiated recall is ongoing.
REASON
Mislabeling; Product labeled CronexT 10T actually contains Afga, Curix Ultra UVL Plus.
VOLUME OF PRODUCT IN COMMERCE
118 boxes
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
Atrisorb FreeFlow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier, Sterile, Recall # Z-0476-06
CODE
Lot 2072A, Exp. 5/2007
RECALLING FIRM/MANUFACTURER
QLT USA, Inc., Fort Collins, CO, by letter on January 26, 2006. Firm initiated recall is ongoing.
REASON
Injectable needles were included in procedure kits instead of sterile blunt cannulas.
VOLUME OF PRODUCT IN COMMERCE
136 pack units
DISTRIBUTION
PA

______________________________
PRODUCT
a) CryoValve, Pulmonary Valve & Conduit,
Recall # Z-0477-06;
b) CryoValve, Aortic Valve & Conduit,
Recall # Z-0478-06;
c) CryoValve, Pulmonary Valve & Conduit - SG,
Recall # Z-0479-06
CODE
a) Donor #40658, Serial #6547591, Model #PV00*
Donor #40914, Serial #6565514, Model #PV00*
Donor #52097, Serial #7082478, Model #PV00*
Donor #52100, Serial #7085341, Model #PV00*
Donor #52647, Serial #7075544, Model #PV00*
Donor #54259, Serial #7284361, Model #PV00;
b) Donor #42409, Serial #6619932, Model #AV00*
Donor #43543, Serial #4299744, Model #AV00*
Donor #47563, Serial #6811631, Model #AV00;
c) Donor #54782, Serial #7176836, Model #SGPV00*
Donor #56853, Serial #7391356, Model #SGPV00*
Donor #57296, Serial #7441881, Model #SGPV00
RECALLING FIRM/MANUFACTURER
Cryolife Inc, Kennesaw, GA, by letter dated May 11, or May 12, 2004. Firm initiated recall is ongoing.
REASON
During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
FL, NC, NE, NV, NY, TN, TX, UT, WA, and Canada

______________________________
PRODUCT
CryoValve, Pulmonary Valve & Conduit, Donor number 78142, Model number PV00, Recall # Z-0480-06
CODE
Serial number 8306247
RECALLING FIRM/MANUFACTURER
Cryolife Inc, Kennesaw, GA, by letters on January 25, 2006. Firm initiated recall is ongoing.
REASON
Additional serological testing performed after distribution indicates the donor has a past Hepatitis B infection.
VOLUME OF PRODUCT IN COMMERCE
1 tissue
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
a) AMPLATZER Duct Occluder, Order No. 9-PDA-003,
Device Size 5/4mm, Length 5 mm. Sterile EO.
Single Use Only. The AMPLATZER Duct Occluder
is a self-expandable device made from a
Nitinol wire mesh. A retention skirt on the
aortic side provides secure positioning in
the ampulla of the ductus. As the occluder
is implanted, it expands outward and the wires
push against the wall of the ductus. Polyester
fabric is sewn into the occluder with polyester
thread. The fabric induces thrombosis that
closes the communication. Recall # Z-0461-06
b) AMPLATZER Duct Occluder, Order No. 9-PDA-004,
Device Size 6/4mm, Length 7 mm. Sterile EO.
Single Use Only. The AMPLATZER Duct Occluder
is a self-expandable device made from a Nitinol
wire mesh. A retention skirt on the aortic side
provides secure positioning in the ampulla of
the ductus. As the occluder is implanted, it
expands outward and the wires push against
the wall of the ductus. Polyester fabric is
sewn into the occluder with polyester thread.
The fabric induces thrombosis that closes the
communication. Recall # Z-0462-06;
c) AMPLATZER Duct Occluder, Order No. 9-PDA-005,
Device Size 8/6mm, Length 7 mm. Sterile EO.
Single Use Only. The AMPLATZER Duct Occluder
is a self-expandable device made from a Nitinol
wire mesh. A retention skirt on the aortic side
provides secure positioning in the ampulla of
the ductus. As the occluder is implanted, it
expands outward and the wires push against the
wall of the ductus. Polyester fabric is sewn
into the occluder with polyester thread. The
fabric induces thrombosis that closes the
communication. Recall Z-0463-06;
d) AMPLATZER Duct Occluder, Order No. 9-PDA-006,
Device Size 10/8mm, Length 8 mm. Sterile EO.
Single Use Only. The AMPLATZER Duct Occluder
is a self-expandable device made from a Nitinol
wire mesh. A retention skirt on the aortic side
provides secure positioning in the ampulla of
the ductus. As the occluder is implanted, it
expands outward and the wires push against the
wall of the ductus. Polyester fabric is sewn
into the occluder with polyester thread. The
fabric induces thrombosis that closes the
communication. Recall # Z-0464-06;
e) AMPLATZER Duct Occluder, Order No. 9-PDA-007,
Device Size 12/10mm, Length 8 mm. Sterile EO.
Single Use Only. The AMPLATZER Duct Occluder
is a self-expandable device made from a Nitinol
wire mesh. A retention skirt on the aortic side
provides secure positioning in the ampulla of
the ductus. As the occluder is implanted, it
expands outward and the wires push against the
wall of the ductus. Polyester fabric is sewn
into the occluder with polyester thread. The
fabric induces thrombosis that closes the
communication. Recall Z-0465-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
AGA Medical Corp., Golden Valley, MN, by email beginning September 6, 2005. Firm initiated recall is ongoing.
REASON
The pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic lining of the sheath. Those shavings could potentially migrate into a patient's bloodstream.
VOLUME OF PRODUCT IN COMMERCE
18,725 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
AngioJet XMI Rapid Exchange+, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use. Sterilized with Ethylene Oxide. Single Use Only. Model number: 105421-002, Recall # Z-0469-06
CODE
Lot number 56594
RECALLING FIRM/MANUFACTURER
Possis Medical, Inc., Minneapolis, MN, by email on December 12, 2005. Firm initiated recall is ongoing.
REASON
The catheter model inside the product tray and box was not an XMI RX Plus, but an XMI over-the-wire model.
VOLUME OF PRODUCT IN COMMERCE
48 units
DISTRIBUTION
Nationwide, Italy, UK and the Netherlands

_______________________________
PRODUCT
Sickle-STAT Test Kit, Catalog # SC901, a qualitative test kit for the determination of the presence of hemoglobin S in human blood --- FOR IN VITRO DIAGNOSTIC USE --- FOR PROFESSIONAL USE ONLY --- Contents: 48 pre-filled Sickle-STAT reaction tubes containing sodium hydrosulfite. 1 bottle phosphate buffer containing surfactant and stabilizer, and 1 Instruction leaflet. Accessories available: SC902: Sickle-STAT 5-place Observation rack, SC903: Sickle-STAT Hemoglobin S Control Set; 4 x 1 vials: 2 A?A negative and 2 A/S positive, SC904: Sickle-STAT Phosphate Buffer, 200 ml. Recall # Z-0470-06
CODE
Lot SC050305, Exp. 31OCT06;
Lot SC062805, Exp. 30NOV06
RECALLING FIRM/MANUFACTURER
Chembio Diagnostic Systems, Inc., Medford, NY, by telephone and letters dated December 15, 2005 and response forms on December 22, 2005. Firm initiated recall is ongoing.
REASON
Internal testing by the firm has shown that the kit lot may result in invalid or false negative interpretations.
VOLUME OF PRODUCT IN COMMERCE
757 test kits
DISTRIBUTION
Nationwide, the Dominican Republic, and West Indies

_______________________________
PRODUCT
Cilli II Cooled Ablation Catheter, Model M00490310, Recall # Z-0473-06
CODE
Batch numbers: 804828 and 8048029
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp, San Jose, CA, by letters on December 30, 2005. Firm initiated recall is ongoing.
REASON
Product is mislabeled with the incorrect catheter curve description.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) OULTER LH 700 Series Hematology
Analyzer, PN 6605632 and 6605632R,
Recall # Z-0474-06;
b) COULTER GEN.S Series Hematology Analyzer,
PN 6605632, 6605632R; GENS: 6605381,
6605381R, 6605360, 6605360R, 6605470,
6605470R Recall # Z-0475-06
CODE
All software versions
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter the week of December 19, 2005. Firm initiated recall is ongoing.
REASON
There is a risk of sample misidentification when processing samples in the Manual aspiration mode.
VOLUME OF PRODUCT IN COMMERCE
2,849 units
DISTRIBUTION
Nationwide and Canada

END OF ENFORCEMENT REPORT FOR FEBRUARY 8, 2006

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