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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October 6, 2004
04-40

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

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PRODUCT
California/Dyno Mix sold in 4 oz., plastic bags. Recall # F-551-4.
CODE
Catalog numbers CC42447 and CC424471.
RECALLING FIRM/MANUFACTURER
Bucks County Distributors, Trevose, PA, by telephone on June 10, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds that were recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
60 lbs.
DISTRIBUTION
CT, DE, MA, NH, NJ, NY and PA.

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PRODUCT
1) Alfalfa Sprouts labeled as: a) LifeForce 100% natural ALFALFA SPROUTS NET WT 4.0 OZ., in rigid plastic clam shell; b) Sprouters ALFALFA NET WT 5 OZ in rigid plastic square “cup” with lid; c) Sprouters NET WT. 1 LB ALFALFA SPROUTS in clear plastic bag. Product also packaged in 2, 3 and 5 pound living trays of Alfalfa sprouts wrapped in plastic and shipped in boxes identified with “Sprouters Northwest, Inc.” logo and “KEEP REFRIGERATED”. Recall # F-552-4; 2) Alfalfa Onion - 5 ounce rigid plastic cups with lid KEEP REFRIGERATED. Recall # F-553-4; 3) SALAD - 5 oz. rigid plastic cup with lid labeled as Sprouters NORTHWEST, INC. SALAD NET WT 5 oz. KEEP REFRIGERATED. Recall # F-554-3.
CODE
7705XX where “77” represents the product as a green leaf such as alfalfa, “05” represents the month (i.e. 5 for May), and “XX” represents the week of the month and the day of the week. The lot codes are 770546, 770611, and 770613.
RECALLING FIRM/MANUFACTURER
Sprouters Northwest, Inc., Kent, WA, by letters on June 3, and June 21, 2004 and by telephone on June 4, 2004. State (WA and OR) initiated recall is complete.
REASON
These sprouts were manufactured using alfalfa seed lot X3023 that was recalled by Caudill Seed & Warehouse Inc. because of its association with an outbreak of Salmonella Bovismorbificans illness.
VOLUME OF PRODUCT IN COMMERCE
Approx. 13,358 lbs.
DISTRIBUTION
OR, WA, ID, AK, NV and CA.
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PRODUCT
Alfalfa sprouts packaged in 3.5 oz semi-rigid, lidded plastic cups for retail sale. Recall # F-555-4.
CODE
All product on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Northland Soy Products, Inc., Anchorage, AK, by telephone on June 10, 2004, letter on June 11, 2004, and by press release on June 18, 2004. Firm initiated recall is complete.
REASON
These sprouts were manufactured using alfalfa seed lot X3023 that was recalled by Caudill Seed & Warehouse Inc. because of its association with an outbreak of Salmonella Bovismorbificans illness.
VOLUME OF PRODUCT IN COMMERCE
144/3.5 oz. containers and 168/1 lb bags (215 lbs).
DISTRIBUTION
AK

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PRODUCT
a) Alfalfa sprouts in 4 oz clear plastic bags. Recall # F-556-4; b) Alfalfa sprouts in 4 oz clear plastic bags also containing radish sprouts. Recall # F-557-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Down To Earth Sprout Farm, Helena, MT, by letter on June 11, 2004, visit on June 12 and 13, 2004 and by press release on June 17, 2004. Firm initiated recall is complete.
REASON
These sprouts were manufactured using alfalfa seed lot X3023 that was recalled by Caudill Seed & Warehouse Inc. because of its association with an outbreak of Salmonella Bovismorbificans illness.
VOLUME OF PRODUCT IN COMMERCE
1014 - 4 oz and 170 - 1 lb packages.
DISTRIBUTION
MT.

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PRODUCT
a) Sunshine brand Alfalfa Sprouts in 5 oz. rigid plastic clam shell, 1 pound plastic cup and 6 lb. bulk tray. 5 oz. plastic containers. Recall # F-558-4; b) Sunshine brand Spicy Sprout Mix (alfalfa, radish, and clover) in 5 oz. rigid plastic clam shell. Recall # F-559-4.
CODE
All product sold up to and including June 10, 2004.
RECALLING FIRM/MANUFACTURER
Sunshine Sprouts, Medford, OR, by press release and telephone on June 10, 2004. Firm initiated recall is complete.
REASON
These sprouts were manufactured using alfalfa seed lot X3023 that was recalled by Caudill Seed & Warehouse Inc. because of its association with an outbreak of Salmonella Bovismorbificans illness.
VOLUME OF PRODUCT IN COMMERCE
1,674 lb.
DISTRIBUTION
OR and CA.

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PRODUCT
Dried Sesame Seed in 14 oz. clear plastic bags. Recall # F-560-4
CODE
All products sold after March 30, 2004.
RECALLING FIRM/MANUFACTURER
Kam Lee Yuen Trading Co., Inc., San Francisco, CA, by telephone and press release on August 5, 2004. Firm initiated recall is complete.
REASON
Sesame seeds are contaminated with Salmonella based on the California Department of Health Services’ analysis.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2000 bags.
DISTRIBUTION
CA.

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PRODUCT
Lucerne seed (alfalfa seeds) packaged in 25kg woven bags. Recall # F-561-4.
CODE
Lot code: “X3023” stamped on woven bag.
RECALLING FIRM/MANUFACTURER
Caudill Seed and Warehouse, Inc., Louisville, KY, by telephone on June 10, 2004 and by letter on June 18, 2004. Firm initiated recall is ongoing.
REASON
Sprouts manufactured using this lot of seed were linked to an outbreak of Salmonella Bovismorbificans illness.
VOLUME OF PRODUCT IN COMMERCE
800/55 lb. woven bags.
DISTRIBUTION
AK, CA, HI, MT, OR, WA, GU, and Canada.

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PRODUCT
King Chief brand dried dehydrated cole, net wt. 5.3 oz. UPC barcode # 6 907419 922173. Recall # F-562-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Jetgo Wholesale Corp., Brooklyn, NY, by press release on July 16, 2004. Firm initiated recall is complete.
REASON
Undeclared sulfites (582 ppm) based on sampling and analysis by the New York State Department of Agriculture & Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
25 cases (100-5.3 oz. bags per case).
DISTRIBUTION
NY.

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PRODUCT
999 Brand White Sesame Seeds, packaged in 4 oz. or 8 oz. clear plastic bags. Recall # F-563-4.
CODE
All lots produced after March 30, 2004.
RECALLING FIRM/MANUFACTURER
U.S. Trading Company, San Francisco, CA, by telephone, press release and letters on June 23, 2004. Firm initiated recall is complete.
REASON
Sesame seeds are contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,523 - 4 oz. bags and 860 - 8 oz. bags.
DISTRIBUTION
MN, WI, CA, and AK.

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PRODUCT
ROYAL Hollandia(R) Belle Blanche(R) GOAT GOUDA. PRODUCT OF HOLLAND. Product is packaged in approximately 9 lb. (4 Kg) bulk wheels or in retail size packages each weighing approximately 1 oz. Recall # F-564-4.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Milky Way International, Inc., Ramsey, NJ, by telephone and letter on May 26, 2004. Firm initiated recall is ongoing.
REASON
The product contains undeclared egg white lysozyme.
VOLUME OF PRODUCT IN COMMERCE
500 cartons.
DISTRIBUTION
West coast.

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PRODUCT
a) PERFECT SPROUTS brand Alfalfa Sprouts packaged in 5 ounce and 1 LB. clear plastic package and 2 LB. and 3 LB. black plastic trays. Recall # F-565-4;
b) PERFECT SPROUTS brand Green Sprout Mix packaged in 4 ounce clear plastic containers. Recall # F-566-4;
c) PERFECT SPROUTS brand Zesty Sprout Mix packaged in 4 ounce clear plastic containers. Recall # F-567-4;
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Perfect Sprouts, Mulino, OR, by telephone and press release on June 18, 2004. Firm initiated recall is complete.
REASON
These sprouts were manufactured using alfalfa seed lot X3023 that was recalled by Caudill Seed & Warehouse Inc. because of its association with an outbreak of Salmonella Bovismorbificans illness.
VOLUME OF PRODUCT IN COMMERCE
Approx. 1,200 lbs.
DISTRIBUTION
OR, and WA.

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PRODUCT
HP Schmid White sesame seeds in 50 lb bulk bags and 25 lb. bulk bags. Recall # F-568-4.
CODE
Lot codes 29162-01-0454, and 28937-01-3473.
RECALLING FIRM/MANUFACTURER
H P Schmid, Inc., San Francisco, CA, by letters on June 24, 2004. Firm initiated recall is complete.
REASON
Sesame seeds are contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
50475 lbs.
DISTRIBUTION
Distributed to domestic consignees, with many being bakeries that use the product in their baked products, and other wholesale distributors. There are no foreign consignees.

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PRODUCT
Rainbow Garden brand Alfalfa Sprouts in 1 lb. bulk and 4 oz. plastic bags. Recall # F-569-4.
CODE
All product distributed through June 10, 2004.
RECALLING FIRM/MANUFACTURER
Rainbow Garden, Kapa Kauai, HI, by telephone on June 10, 2004, letters on June 22, 2004, and by press release on June 23, 2004. Firm initiated recall is complete.
REASON
These sprouts were manufactured using alfalfa seed lot X3023 that was recalled by Caudill Seed & Warehouse Inc. because of its association with an outbreak of Salmonella Bovismorbificans illness.
VOLUME OF PRODUCT IN COMMERCE 613 lbs.
DISTRIBUTION HI.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

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PRODUCT
Outta Hand brand Ceramics Porcelain Cocktail Plates, each box contains four cocktail plates and has UPC numbers of 17433 98001 or 17433 98003, item numbers: 09-8002A or 09-8003A. Recall # F-544-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Axis Imex, Inc., Livermore, CA, by press release and letters on August 5, 2004. Firm initiated recall is ongoing.
REASON
Ceramic Porcelain Cocktail Plates contain excessive leachable levels of lead and cadmium.
VOLUME OF PRODUCT IN COMMERCE
6,407 sets/set of 4 or 6 plates per carton.
DISTRIBUTION
FL, DE, CA, MI, PA, NY, GA, CO, AL and IA.

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PRODUCT
Marie Callender’s Pecan Pie, Net Wt. 32 oz. (2 lbs) 907 g. The product is frozen. There is 6 pies per case. UPC #6 12781 10210 3. Recall # F-545-4.
CODE
Product has a Julian date prior to August 25, 2004, Julian date code 237 and earlier, including Julian date codes from 2003.
RECALLING FIRM/MANUFACTURER
American Pie, Syosset, NY, by telephone and letters dated September 16, 2004 and September 20, 2004. Firm initiated recall is ongoing.
REASON
Product contains undeclared colors FD&C Yellow #5 and FDC Red #40.
VOLUME OF PRODUCT IN COMMERCE
87,384 pies (14,564 cases).
DISTRIBUTION
Nationwide.

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PRODUCT
Dehydrated Fruit Papaya Spears, No Sugar, No SO2, Product of Thailand, 11 lb. Containers and 21 kg master cartons.Recall # D Dehydrated Fruit Papaya Spear ll lb. Containers and 21 kg master cartons. Recall # F-546-4.
CODE
All Lot Codes.
RECALLING FIRM/MANUFACTURER
Hershey Import, Co., Edison, NJ, by letter dated May 25, 2004. Firm initiated recall is ongoing.
REASON
Product contains undeclared sulfites
VOLUME OF PRODUCT IN COMMERCE
1,764 units.
DISTRIBUTION
Nationwide.

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PRODUCT
American Ginseng Capsules, 5% Ginsenosides, 500 mg.; packaged in 50 capsule and 100 capsule bottles; Manufactured by Now Foods, marketed under the following labels:
a) Now American Ginseng, 50 capsule bottles, catalog 4002, UPC 33739-04002 and 100 capsule bottles, catalog 4004, UPC 33739- 04004 and catalog CN4004, UPC 33739-10411;
b) Nature’s Blessing Baar American Ginseng, 50 capsule bottles, catalog 4002 and 104002;
c) Take Your Vitamins American Ginseng, 50 capsule bottles, catalog 104002;
d) NaturaSalud Formulas Naturales Energy-2-Life, 50 capsule bottles, catalog 104002, UPC 33739-44002;
e) Oasis Vitamins American Ginseng, 50 capsule bottles, catalog104002, UPC 33739-44002;
f) Starfire International Panax qinquefolius American Ginseng, Sacramental-Healing, 50 capsule bottles, catalog 104002;
g) Dr. Lynne M.D. American Ginseng, 50 capsule bottles, catalog 104002, UPC 33739-44002;
h) Harvest Health Nutrition American Ginseng, 50 capsule bottles, catalog 104002, and 100 capsule bottles, catalog 4004 and 104004;
i) Pleasant Stone Farm American Ginseng, 100 capsule bottles, catalog 104004, UPC 33739-44004. Recall # F-547-4.
CODE
50 capsule bottles: catalog 4002, lots 355252, exp. 19-Jul-2004; 383363, exp. 09-Aug-2004; 397025, exp. 13-Oct-2004; 507305, exp. 13-Mar-2005; 517227, exp. 13-May-2005; 521807, exp. 08-Jun-2005; 527573, exp. 19-Jul-2005; 537291, exp. 18-Sep-2005; 541136, exp. 11-Oct-2005; 551235, exp. 04-Dec-2006; 566433, exp. 08-Feb-2007; catalog 104002, lots 378022, exp. 27-Jul-2004; 398432, exp. 19-Oct-2004; 494542, exp. 30-Dec-2004; 542303, exp. 16-Mar-2007; 596386, exp. 20-Jul-2007; 100 capsule bottles; catalog 4004, lot numbers 355113, exp. 18-Jul-2004; 377967, exp. 03-May-2007; 383998, exp. 12-Aug-2004; 399093, exp. 24-Oct-2004; 494381, exp. 23-Dec-2004; 506900, exp. 09-Mar-2005; 513904, exp. 25-Apr-2005; 519181, exp. 25-May-2005; 526333, exp. 14-Jul-2005; 533053, exp. 25-Aug-2005; 538044. exp. 22-Sep-2005; 542303, exp. 30-Apr-2007; 544053, exp. 07-Nov-2005; 556492, exp. 04-Jan-2007; 573579, exp. 05-Mar-2007; 596409, exp. 11-Jun-2007; 603862, exp. 06-Aug-2007; catalog CN4004, lot 555114, exp. 01-Jan-2007 catalog 104004, lots 355161, exp. 29-Jul-2005; 377967, exp. 06-Aug-2005; 560703, exp. 14-Jan-2007; 584802, exp. 20-Apr-2007; 585816, exp. 28-Apr-2007; 587227, exp. 05-May-2007; 604234, exp. 19-Jul-2007.
RECALLING FIRM/MANUFACTURER
NOW Foods, division of The Fruitful Yield, Inc., Bloomingdale, IL, by letters dated August 30, 2004 and by telephone on September 3, 2004. Firm initiated recall is ongoing.
REASON
The ginseng capsules contain quintozene, pentachloroaniline and oxadixyl, fungicides/pesticides that have no tolerances.
VOLUME OF PRODUCT IN COMMERCE
7,197 - 50 capsule bottles and 10,504 - 100 capsule bottles.
DISTRIBUTION
Nationwide and Internationally.

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PRODUCT
a) Cadbury DAIRY MILK TURKISH *** Milk Chocolate with Turkish Delight Filling *** BEST BEFORE 05 2005 *** L 4133 ***. Barcode # 5 034660 507147. Recall # F-548-4;
b) Cadbury DAIRY MILK MINT CRISP *** Mint Flavoured Milk Chocolate with Honeycombed Granules ***MADE IN CADBURY IRELAND *** BEST BEFORE END 02 2005 *** L4043(14) ***. Barcode # 5 034660 507178. Recall # F-549-4;
c) Revels® *** 35 g *** CARAMEL? *** CHOCOLATE? *** ORANGE? *** COFFEE? *** MALTESERS® *** PEANUT***Milk Chocolate with Assorted Centers. Recall # F-550-4.
CODE
All codes on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Posh Nosh Imports, Kearny, NJ, by letters starting on June 11, 2004. Firm initiated recall is ongoing.
REASON
Candy bars may contain non-permitted and uncertified color additives.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

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PRODUCT
Caffeine Free Dr. Pepper in 12 oz. cans and in 12 can cartons. Recall # F-543-4.
CODE
APR0405 LW D.
RECALLING FIRM/MANUFACTURER
Coca Cola Enterprises, Atlanta, GA, by visit beginning on August 8, 2004. Firm initiated recall is complete.
REASON
The product may contain aspartame and does not have the phenylalanine declaration on the label.
VOLUME OF PRODUCT IN COMMERCE
1,740/12 pack cases.
DISTRIBUTION
TX.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
Spironolactone Tablets, 25mg, blister packages of 30 tablets, Rx only, NDC 61392-083-30. Recall # 283-4.
CODE
Lot #U31990B30.
RECALLING FIRM/MANUFACTURER
Heartland Repack Services, Llc, Toledo, OH, by letter on August 30, 2004. Firm initiated recall is ongoing.
REASON
Mispacked; Two unit dose strips of Furosemide 40mg tablets were found in a unit dose box of Spironolactone 25mg tablets.
VOLUME OF PRODUCT IN COMMERCE
1,343/30 count boxes.
DISTRIBUTION
OH, IN, TN, KY, WA, and MD.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
Isopropyl Rubbing Ethyl Alcohol 70%, First Aid Antiseptic, 16 Fl oz, NDC 0395-4201-16. Recall # D-282-4.
CODE
Lot Numbers: 19138, 19168.
RECALLING FIRM/MANUFACTURER
Aaron Industries Inc., Lynwood, CA, by letters on September 1, 2004. Firm initiated recall is ongoing.
REASON
Mislabeling; product label incorrectly identifies the product as “isopropyl Rubbing Ethyl Alcohol 70%” instead of “Rubbing Alcohol Ethyl Alcohol 70%”.
VOLUME OF PRODUCT IN COMMERCE
8,240.
DISTRIBUTION
Nationwide.

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PRODUCT
Diltiazem Hydrochloride Extended Release Capsules, 120 mg, Rx only, 90 capsules, NDC 0093-5112-98. Recall # D-284-4.
CODE
Lot number 0303T01 exp 10/05.
RECALLING FIRM/MANUFACTURER
Teva Neuroscience, Inc., North Wales, PA, by letter dated September 14, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
1,437 bottles.
DISTRIBUTION
Nationwide.

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PRODUCT
OxyContin Tablets (oxycodone hydrochloride controlled release), 20mg, 100 tablets, Rx only, Distributed by: Purdue Pharma, L.P., Norwalk, CT 06850-3590, NDC 59011-103-10. Recall # D-285-4.
CODE
Lot 8R2NI Exp. 10/04.
RECALLING FIRM/MANUFACTURER
The Purdue Frederick Company, Stamford, CT, by letters on September 1, 2004. Firm initiated recall is ongoing.
REASON
Mispackaging: One OxyContin 10mg tablet was found within a previously unopened OxyContin 20mg tablet bottle.
VOLUME OF PRODUCT IN COMMERCE
10,285 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
Platelets Leukocytes Reduced. Recall # B-2055-4.
CODE
Unit number 22KX62899.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on March 9, 2004 and by letter on April 13, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Red Blood Cells that was possibly contaminated with coagulase negative Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PR.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
Alveolus Tracheobronchial Stent Technology System (TB-STS). Recall # Z-1487-04.
CODE
Size 12x40, Part #90129-20, Lot #AC0406; Size 14x40, Part #90129-21, Lot #AC0409; Size 16x40, Part #90129-22, Lot #AA0411; Size 16x60, Part #90129-23, Lot #A0413; Size 12x20, Part #90129-24, Lot #AA0404; Size 14x40, Part #90129-25, Lot 3AA0409; Size 14x40, Part #90129-26, Lot #AC0409; Size 16x60, Part #90129-27, Lot #AA0413.
RECALLING FIRM/MANUFACTURER
Alveolus, Inc., Charlotte, NC, by telephone on April 22, 2004. Firm initiated recall is ongoing.
REASON
The tracheal stent may collapse resulting in blockage of the air passage because the stents were not properly coated with the polyurethane material to the very end of the stent.
VOLUME OF PRODUCT IN COMMERCE
47 units.
DISTRIBUTION
FL, SC, and TX.

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PRODUCT
NT Intera Magnetic Resonance Image System. Recall # Z-1488-04.
CODE
Part #s 9896 030 09981, 9896 030 10251 Site #s 504531, 104343, 59488, 41391, 37996, 37979, 85119, 26269, 59435, X1281, 504409, 102353, 13606, 103166, 37929, 104392, 103149, 84418, 6947, 63046, 86293, 102978, 103904, 105315, 504866, X0038, 103582, 100745, 101946, 103333, 504412, 13056, 100786, 59428, 103818, 105314, 50430, 104808, 85139, 45016, X0716, X0942, X1272, X1086, X0214, 103324, 101420, 103579, 103847, 6808, 104467, 38652, 103347, 14117, 86335, 68196, 104032, 103417, 103243, 103207, 104102, 52408, 6841, 47029, 41346, 45065, X0164, X1082, 104912, X0083, 104054, 83325, 103911, 101477, 250156, 25958, 104193, 102547, 85172, 104897, 104070, 506190, 103946, 504608, 104340, 100462, 505007, 101595, 104095, 13932, 87527, 38966, 87604, 50336, 86085, 103291, 103592, 103098, 38257, 104532, 101162, 504897, 87018, 104336, X1693, 59637, 103143, 102933, 505021, 103631, 103552, 82678, X1635, X0162, 14065, 103530, 505568, 500034, 250498, 103099, 38438, 76359, 104138, 101561, 101560, 47043, 17394, 105271, X1215, 13057, 250475, 102569, 103770, 86313, X1179, X1523, 504632, 504527, X1412, 104942, 38317, 103101, 26119, 103509, 103544, 85433, 103547, 250122, 102896, 85158, 41342, 86012, 103907, 103909, 101408, 38420.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Sales & Service Region No. America, Bothell, WA, by letter on August 20, 2004. Firm initiated recall is ongoing.
REASON
Potential for patient burn.
VOLUME OF PRODUCT IN COMMERCE
156 units.
DISTRIBUTION
Nationwide.

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PRODUCT
Medtronic FLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036. Recall # Z-1489-04.
CODE
Lot numbers 2003080199, 2003090147, 2003100101, 2004010371, and 2004030070.
RECALLING FIRM/MANUFACTURER
Medtronic, Inc., Minneapolis, MN, by letter dated September 23, 2004. Firm initiated recall is ongoing.
REASON
Spiral tip from DLP VAD cannula may be loose and potentially detach during use.
VOLUME OF PRODUCT IN COMMERCE
753 units.
DISTRIBUTION
Nationwide and Internationally.

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PRODUCT
a) Impervious Stockinette, Large, 12” X 48” or 12” X 54”, Ref #9806-54, #9816-54, and #9978-12; X-Large, 16” X 48”, Ref #9978-16. Recal # Z-1490-04; b) Stockinette, Single Ply Econo Weave, 8 X 72", Ref #9999-72. Recall # Z-1491-04; c) Stockinette, Single Ply, Standard Weave, 8 X 72” and 10 X 48”, Ref #9508-72, #9510-48, #9510-48, #9510-60. Recall # Z- 1492-04; d) Stockinette, Double Ply, Standard Weave, 6 X 60", 6 X 72", 8 X 48", 8 X 60", 8 X 72", 10 X 48". Recall # Z-1493-04; e) Stockinette, Double Ply, Econo Weave, 6 X 54", 6 X 60", 6 X 72", 8 X 48", 8 X 72", Ref #9984-54, #9984-54, #9985-60, #9986-72, #9987-48, #9988-60, #9988-72. Recall # Z-1494-04; f) Stockinette, Double Ply, Econo Weave, EZ Roll, 6 X 60”, 8 X 60”, Ref#9991-60, #9993-60. Recall # Z-1495-04.
CODE
a) Lot # 1007298 1007335 1007360 1030228 1030244 1045526 1049113 1081519 1107441 1141972 1161316 1161332 1200979 1225252 1306538 1310369 1315021 1330597 1330600 1342811 1375681 1375808 1375816 1490540 1504008 1504032 1521713 1543630 1571438 1650988 1736028 1759511 1802072 1911543 1911615 2076658 2076738 2137810 2137828 2138062 2187067 2228121 2376204 2701345 765821 765855 804316 805431 805440 825580 825598 825635 825643 850507 900691 932991 933071 933097 933118 933151 950663 950680 950743 974585 974593 974665; b) Lot: 1503929; c) Lots: 1030279 1600315 929506 929514; d) Lot: 1007212 1030172 1030181 1142043 1225324 1225332 1225341 1225359 1306298 1330669 1330677 1341190 1375832 1375841 1375867 1375875 1407072 1431304 1521772 1543672 1543681 1627016 1634152 1678542 1678606 1736079 1736087 1736095 1736108 1736116 1800384 1800608 1876426 1911375 1911421 2055689 2075217 2136454 2136471 2268684 2375877 728683 783421 805360 805378 805482 825555 900762 900797 900800 974681 974729; e) Lots: 9984-54 9985-60 9991-60 9986-72 9987-48 9988-72; f) Lot: 932924 1330482 1407048.
RECALLING FIRM/MANUFACTURER
Deroyal Surgical-Rose Hill, Rose Hill, VA, by letter on September 9, 2004. Firm initiated recall is ongoing.
REASON
Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.
VOLUME OF PRODUCT IN COMMERCE
3,098 cases.
DISTRIBUTION
Nationwide, Ireland, Peru and Israel.

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PRODUCT
Architect Anti-HBs Reagent Kit; list 7C18-20, 4 x 100 tests, list 7C18-25, 100 tests and list 7C18-30, 4 x 500 tests; Recall # Z-1498-04.
CODE
List 7C18-20, lots 10014M200, 08672M200, 07780M300 and 17048M100; list 7C18-25, lots 08672M201, 10014M201, 15692M100 and 17048M101; list 7C18-30, lots 09140M300, 09238M200, 08458M200, 02348M300, 10015M200 and 13251M100. list 7C18-20, lots 10014M200, 08672M200, 07780M300 and 17048M100; list 7C18-25, lots 08672M201, 10014M201, 15692M100 and 17048M101; list 7C18-30, lots 09140M300, 09238M200, 08458M200, 02348M300, 10015M200 and 13251M100.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter on August 27, 2004. Firm initiated recall is ongoing.
REASON
There is a potential for significant differences in quantitative results for certain specimens when using the affected reagent lots.
VOLUME OF PRODUCT IN COMMERCE
6,691 kits.
DISTRIBUTION
Canada, Japan, Australia, New Zealand, Germany and England.

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PRODUCT
Neonatal Total Galactose Test Kits. Reagents for 960 (4800) assays, Item #NG-4000. Recall # Z-1499-04.
CODE
Lot #244468.
RECALLING FIRM/MANUFACTURER
PerkinElmer LAS Inc., Norton, OH, by letter on September 8, 2004. Firm initiated recall is ongoing.
REASON
The test kits are producing lower values than expected which may result in an increased number of false positive results increasing the risk of missing a baby with galactosemia. VOLUME OF PRODUCT IN COMMERCE
49 kits.
DISTRIBUTION
IN, MO, TX, WI, and MN.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

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PRODUCT
Crosseal, fibrin sealant (human), One Applicator, Two Vial cups, Sterile, Disposable, Single Use, Rx Only. Recall # Z-1497-04.
CODE
Lot 0404 exp. Oct. 2008; Lot 0417 exp. Jan. 2009; Lot 0419 exp. Jan. 2009.
RECALLING FIRM/MANUFACTURER
Omrix Biopharmaceuticals, Ltd., Plasma Fract. Inst., Magen David Adom Blood Services Ctr., Ramat Gan, Israel, by letter on July 25, 2004. Firm initiated recall is ongoing.
REASON
5 mL Crosseal fibrin sealant (human) is difficult to expel from the device resulting in product leakage from the vial insertion port.
VOLUME OF PRODUCT IN COMMERCE
4,277 units.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR October 6, 2004

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