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U.S. Department of Health and Human Services

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Enforcement Report for August 4, 2004

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.

August 4, 2004
04-31

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
a) Warner's Raw Whole Almonds, Net Wt. 2.25 oz. (63.78 g),
24 bags per case; Recall # F-304-4;
b) Tropical Mix; the product was packaged in Net Wt. 16 oz.
E-Z Open/Close plastic bags, 18 bags per case, and 25 lb.
stenciled bulk cases, item #34006, and in 5 oz. plastic
bags, 24 bags per case. Recall # F-305-4;
c) Energy Mix packaged in 16 oz. plastic bags. Recall # F-306-4;
d) Figi's Inc. California Fruit Mix, packaged in 25 lb. bulk
boxes, product code 012-0126-9-01. Recall # F-307-4;
e) Dot's Tropical Mix, packaged in 5 oz. plastic bags. Recall # F-308-4.
CODE
a) Lot number 021104;
b) 25 lb. bulk - lot number 41404,
16 oz. bags , lot number 033104,
5 oz. bags , lot numbers 021204 and 021104;
c) Lot number 4092, EXP. 10-01-04;
d) Lot number 032304;
e) Lot number 120103.
RECALLING FIRM/MANUFACTURER
Superior Nut & Candy Dist. CO, Chicago, IL, by press release on May 28, 2004. Firm initiated recall is complete.
REASON
The products were 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
9,964.5 pounds.
DISTRIBUTION
IL, IN, MN, MO and WI.

_______________________________
PRODUCT
Red Flower, Natural Almond, Product of the U.S.A., Net Wt. 12 oz. Recall # F-309-4.
CODE
The product was not coded. The firm recalled shipments from September 19, 2003 to February 28, 2004.
RECALLING FIRM/MANUFACTURER
Red Flower Ltd, Linden, NJ, by letters dated May 28, 2004 and press release on June 3, 2004. FDA 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
668/12 oz. bags.
DISTRIBUTION
FL, MA, MD, MO, NC, NJ, NY, PA, TX, AND VA.

_______________________________
PRODUCT
a) Awrey brand Marquise Tropical Chocolate Cake,
2 1/2 pounds, Product Code 7240. Recall # F-310-4;
b) Awrey brand Marquise Variety Assortment #1
(includes a Marquise tropical chocolate cake);
Product Code 7290. Recall # F-311-4;
c) Sysco Bakersource brand Variety Assortment #1
(includes a tropical chocolate cake), Product Codes
7288 and 9523622.
CODE
a) Lot 111103;
b) Lots: 016703, 020204, 108003, 111103 and 111203;
c) Lots: 003304, 014404, 016204, 016703, 020204,
026204, 107003, 111103, 111203, 114003 and 123103.
RECALLING FIRM/MANUFACTURER
Awrey Bakeries, Inc., Livonia, MI, by press release, fax and email on May 26, 2004 and telephone on May 27 and May 28, 2004. Firm initiated recall is complete.
REASON
The products were 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
13,000 cakes.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Raw whole almonds in 5 lb. Clear plastic bag, heat sealed. Bags are not labeled. Recall # F-313-4.
CODE
The product was not coded. The affected product was distributed from August 21, 2003 to April 5, 2004.
RECALLING FIRM/MANUFACTURER
Pacific Food Importers Inc., Seattle, WA, by telephone on May 25, 2004 and by letter on May 28, 2004. Firm initiated recall is complete.
REASON
The products were 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
119/5 lb. Bags.
DISTRIBUTION
WA.

_______________________________
PRODUCT
a) Harvest Health Foods brand Almonds, whole raw
in random size packages. Recall # F-314-4;
b) Harvest Health Foods brand Harvest Mix, raw
in random size packages. Recall # F-315-4
CODE
All packages purchased on or before May 28, 2004.
RECALLING FIRM/MANUFACTURER
Harvest Health, Inc., Grand Rapids, MI, by press release on May 28, 2004. Firm initiated recall is complete.
REASON
The products were 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
5,310 pounds.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Archer Farms Breaded Cod Fillets, approximately 8 fillets, Net Wt, 24 oz. (1 lb 8 oz) 680g carton, frozen. Recall # F-316-4.
CODE
Date codes having the following first 4 digits located on flap to the left of principal display panel: 2106, 2130, 2175, 2189, 2198, 2296, 3015, 3069, 3092, 3098, 3112, 3189, 3204, 3273, 3322, 3352, 4027, 4041, 4057, 4119.
RECALLING FIRM/MANUFACTURER
High Liner Foods, Inc., Portsmouth, NH, by telephone and email on June 23, 2004. Firm initiated recall is ongoing.
REASON
The product contains undeclared egg whites.
VOLUME OF PRODUCT IN COMMERCE
24,000 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Oasis brand almond garlic spread in 8 oz., plastic tub. Recall # F-317-4.
CODE
If Frozen Use By: 05/04/04.
RECALLING FIRM/MANUFACTURER
Kastoria, Inc., Seattle, WA, by telephone on May 29, 2004 and by press release on June 2, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
12 cases/12/8 oz containers.
DISTRIBUTION
AK, OR, and WA.

_______________________________
PRODUCT
a) Bear Foods brand RAW-Supreme Almonds packed in
clear plastic bags ranging in weight from 8 oz.
to 6 lbs. Recall # F-318-4;
b) Bear Foods brand Bear's Delight Trail Mix packed
in clear plastic bags ranging in weight from 8 oz.
to 6 lbs. Recall # F-319-4;
c) Bear Foods brand Diabetic Snack Mix packed
in clear plastic bags ranging in weight from 8 oz.
to 6 lbs. Recall # F-320-4;
d) Bear Foods brand Stehekin Trail Blazer packed
in clear plastic bags ranging in weight from 8 oz.
to 6 lbs. Recall # F-321-4;
CODE
"Packed on May 22, 04" or before.
RECALLING FIRM/MANUFACTURER
Bears Foods Market, Chelan, WA, by press release on May 26, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
184 case/12/8 oz. packages; 111 cs/12/2.5 oz. packages.
DISTRIBUTION
WA.

_______________________________
PRODUCT
Almonds sold as R. Hirt Jr., Company brand Whole Raw Almonds in 1-lb. bags and Non-Pareil Almonds, #5024 in 5-lb. bags. Recall # F-322-4.
CODE
All lots numbers ending in a 3 or a 4.
RECALLING FIRM/MANUFACTURER
R. Hirt Jr., CO., Detroit, MI, by telephone on May 26, 2004 and press release on May 27, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
4,850 pounds.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Sin Fill brand Green Pistachio Pudding artificially flavored dessert mix in 36 pound bags; Product code 3246R. Recall # F-323-4.
CODE
The product is coded "Mfg Date: Dec. 23, 2003-01, Use By: Dec. 2004" and "Mfg Date: Jan. 05, 2004-01, Use By: Jan. 2005".
RECALLING FIRM/MANUFACTURER
Michigan Dessert Corporation, Oak Park, MI, by telephone and letter on May 26, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
199 bags.
DISTRIBUTION
OR.

_______________________________
PRODUCT
Stone Mill Foods brand SM Pistachio Cr?me Dessert Salad (pudding blend) in 6 lb. Containers. Recall # F-324-4.
CODE
The product is coded 20040522, 20040618, 20040620, 20040702, 20040706, 20040709, 20040722.
RECALLING FIRM/MANUFACTURER
Reser's Fine Foods, Inc., Beaverton, OR, by telephone and fax on May 27, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
815 cases of 2/6 lb. Containers.
DISTRIBUTION
WA, OR, and CA.

_______________________________
PRODUCT
Gold Shield brand raw whole almonds in 2.5 oz. and 8 oz. plastic bags. 12 packages/case. Recall # F-325-4.
CODE
The product is coded "Best When Used By" 4049 FEB 05, 4120 APR 05, 4139 MAY 05 (2.5 OZ.) AND 3294 OCT 04, 3321 NOV 04 (8 oz.).
RECALLING FIRM/MANUFACTURER
Pacific Seasonings, Inc., Kent, WA, by telephone and fax on May 27, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
184 cs/12 pkgs/8 oz. bags; 111 cs/12 pkg/2.5 oz bags.
DISTRIBUTION
WA and CA.

_______________________________
PRODUCT
a) A.L. Verna "Fresh V" almond bits in 2.25 oz.
(63 g) plastic package. Packed in 12 bags to 1 unit.
Recall # F-326-4;
b) A.L. Verna "Fresh V" whole almonds in 2.25 oz. (63g)
plastic package. Packed in 12 bags to 1 unit.
Recall # F-327-4.
CODE
a) Sell by date 11/01/2004;
b) Sell by 01/01/2005.
RECALLING FIRM/MANUFACTURER
A. L. Verna Co., Inc., Vineland, NJ, by telephone and press release on June 3, 2004. Firm initiated recall is ongoing.
REASON
The product was manufactured using almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
24,885/2.25 oz packages.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Herold's Salads brand Tuna Salad, Packaged in 5-lb. plastic containers. Recall # F-328-4.
CODE
Best Before 5-17.
RECALLING FIRM/MANUFACTURER
Herolds Salads, Inc., Cleveland, OH, by telephone on May 20, 2004. Firm initiated recall is complete.
REASON
The product is contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
18-5 lb. Containers.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Chamdel brand Yeast Barley Hard Tack, aka and labeled as Korean Cookies, in 6.34 oz. plastic package. Product of Korea. Recall # F-332-4.
CODE
09762K.
RECALLING FIRM/MANUFACTURER
Rhee Brothers, Inc., Columbia, MD, by press release on April 10, 2003 and by site visit on April 12, 2003. Firm initiated recall is complete.
REASON
Cookies contain undeclared ingredients including milk.
VOLUME OF PRODUCT IN COMMERCE
7,500 packages (375 cases).
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Kellogg's Corn Flakes Cereal, Net Wt 18 oz. (1 lb 2 oz) (510g). Recall # F-333-4.
CODE
Better if used before Mar 31 2005/KLB 009.
RECALLING FIRM/MANUFACTURER
Kellogg Co., Battle Creek, MI, by press release and letter on May 24, 2004. Firm initiated recall is complete.
REASON
Cartons of cereal labeled as "Corn Flakes" actually contain "Special K" cereal, which contains milk , and wheat-derived ingredients (dried whey, wheat gluten, and wheat germ). The label of the "Corn Flakes" cereal does not list any milk , or wheat-derived ingredients.
VOLUME OF PRODUCT IN COMMERCE
6,300 cartons.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Raspberry Cocktail Mix in 2-liter containers.
Recall # F-334-4;
Product is a liquid concentrated beverage mix packed
into a 2 liter plastic container with the following label:
RES # 108548 Sunsational STRAWBERRY PERFECT FROZEN COCKTAIL.
PRODUCT OF CANADA.
b) Sub Beverage brand Peach Cocktail Mix in 2-liter containers.
Recall # F-335-4;
c) Sunsational brand Blue Hawaii Delight in 2-liter containers.
Recall # F-336-4;
d) No Ka Oi brand Blue Hawaii Delight in 12-liter plastic
containers. Recall #F-337-4.
CODE
a) Lot # D250309SA;
b) K120209SA, L130209SA, K180209SA, H260309SA and I120309SA;
c) A070309SA, C180309SA, D290309SA, G040309SA, J220309SA, K120309SA;
d) L200209SA, A150309SA, G110309SA and I230309SA.
RECALLING FIRM/MANUFACTURER
Vitality Foodservices, Inc., Tampa, FL, by letter on January 26, 2004 and February 4, 2004. Firm initiated recall is complete.
REASON
Product contains the undeclared allergen whey protein.
VOLUME OF PRODUCT IN COMMERCE
289-12 liter and 930-2 liters.
DISTRIBUTION
Hawaii, WA, FL, and CA.

_______________________________
PRODUCT
a) Repackaged raw whole almonds. Packaged in 5 lbs.,
10 lbs., and 25 lbs. bags in boxes and labeled as
"SHELLED ALMONDS". The firm may also package
product in other sizes if specifically requested
from a customer. Recall # F-338-4;
b) Repackaged raw diced almonds. Packaged in 5 lbs.,
10 lbs., and 25 lbs. bags in boxes and labeled as
"SHELLED ALMONDS". The firm may also package
product in other sizes if specifically requested
from a customer. Recall # F-339-4.
CODE
Viginia & Spanish Peanut Company, Inc. does not utilize any product coding systems including date of manufacture. Repackaged raw almonds are typically packaged in 5 lbs., 10 lbs., and 25 lbs. bags in boxes and labeled as shelled almonds. The firm may also package product in other sizes if specifically requested from a customer.
RECALLING FIRM/MANUFACTURER
Virginia-Spanish Peanut Co., Providence, RI, by letter on June 4, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
3,000 pounds (est).
DISTRIBUTION
RI, MA, CT, NH, VT, and ME.

_______________________________
PRODUCT
California Mix packaged in 11 oz. bags under the Evon's brand name and in 1 lb. 5 oz. packages unbranded, 12 packages per case. Recall # F-340-4.
CODE
11 oz. , Best By 3-30-05-05S1; 1 lb. 5 oz. , Best By 01-30-05-05S2.
RECALLING FIRM/MANUFACTURER
John B. Sanfilippo & Son, Inc., Elk Grove Village, IL, by press release on June 29, 2004. Firm initiated recall is ongoing.
REASON
The product was manufactured using almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
605 lbs.
DISTRIBUTION
IL, WI, IN, MI, MN, and NV.

_______________________________
PRODUCT
Koeze's Nut House and Loeze's Nuts brands Raw Almonds. Recall # F-341-4.
CODE
Code dates of April 9, through May 25.
RECALLING FIRM/MANUFACTURER
Koeze Company, Wyoming, MI, by press release on May 27, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
20 pounds.
DISTRIBUTION
MI.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
a) Duck Sauce packed in 1/2 oz plastic packages.
NO MSG. 500 packages per case. Recall # F-298-4;
b) Hot Sauce packed in 1/2 oz plastic packages.
There are 500 packages per case. Rcall # F-299-4.
CODE
All products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Yi Pin Food Products Inc., Brooklyn, NY, by telephone and letters on July 6, 2004. Firm initiated recall is ongoing.
REASON
The duck sauce contains undeclared colors - FD&C Yellow No. 6 and FD&C Red No. 40. while the hot sauce contains undeclared color , FD&C Yellow No. 6.
VOLUME OF PRODUCT IN COMMERCE
Duck Sauce: 6718 cases (500 packets per case);
Hot Sauce: 1860 cases (500 packets per case).
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Bernard's Pasteurized Crabmeat, 16 oz. cup. Recall # F-329-4.
CODE
Lot 1302, 16 oz cup, exp 01/18/2007.
RECALLING FIRM/MANUFACTURER
Bernard's Seafood Co., Ltd., Marrero, LA, by letter on July 15, 2004. Firm initiated recall is ongoing.
REASON
The product is contaminated with chloramphenicol based on FDA's analysis.
VOLUME OF PRODUCT IN COMMERCE
306 cases of 12 units.
DISTRIBUTION
LA and MS.

_______________________________
PRODUCT
Bernard's Brand Pasteurized Crabmeat Pateurized-Hand Selected, Net Wt. 1 lb (454g). Product of China. Recall # F-330-4.
CODE
Lot Code: 1302; Sell by date handwritten in black ink on case label: 01/18/2007.
RECALLING FIRM/MANUFACTURER
Albertson's Distribution Center, Fort Worth, TX, by letter on May 18, 2004. Firm initiated recall is complete.
REASON
The product is contaminated with chloramphenicol based on FDA's analysis.
VOLUME OF PRODUCT IN COMMERCE
927 tubs.
DISTRIBUTION
TX, LA, and OK.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
Publix Bakery brand Glazed Raspberry Swirl One Half Cr?me Cake 20 oz. Recall # F-331-4.
CODE
Coded 7 26 04 on the frozen cases and the store puts on a Sell By date when displayed that would vary.
RECALLING FIRM/MANUFACTURER
Publix Super Markets, Inc, Lakeland, FL, by letter and press release on April 22, 2004. Firm initiated recall is complete.
REASON
Packages labeled as Glazed Raspberry Swirl One Half Cr?me Cake actually contain a different product, Glazed Almond One Half Cream Cake. Although the ingredient statement on the package does not list almonds as an ingredient, the product is packaged in a clear container and the almonds are plainly visible on top of the cake.
VOLUME OF PRODUCT IN COMMERCE
416 cases of 8.
DISTRIBUTION
Nationwide.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I

_______________________________
PRODUCT
Twice-a-Day 12 HOUR NASAL SPRAY (oxymetazoline hydrocholoride 0.05%), sold in 1/2 FL. OZ (14.8mL) and 1 FL. OZ. (30mL) bottles, MAJOR brand, Regular, NASAL DECONGESTANT, NDC 0904-5217-35, Also sold under other name brand as: DU brand Nasal Spray Atomizador, Maximum Strength, Nasal Decongestant Spray. Recall # D-227-2.
CODE
Lots sold under MAJOR brand: K4496, A4588, L4535, E4410, F4433, H4464, L4529, M4536, A4558 and B459. Lot sold under DU brand: J4492.
RECALLING FIRM/MANUFACTURER
Propharma, Inc., Miami, FL, by press releases were issued on March 18, 2004 and May 14, 2004. Firm initiated recall is ongoing.
REASON
Microbial contamination; Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
416,677 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Children's Motrin Tablets (ibuprofen) 50 mg, 24 count bottles, Grape-Flavored Chewable Tablets, Pain Reliever/Fever Reducer, NDC 50580-907-24. Recall # D-228-4.
CODE
JAM108, Expiration Date 01/2006.
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil-PPC, Inc., Fort Washington, PA, by letters on April 12, 2004. Firm initiated recall is ongoing.
REASON
Mislabeled; bottles labeled as Children's Motrin Chewable Tablets actually contain Tylenol 8 Hour Geltabs.
VOLUME OF PRODUCT IN COMMERCE
73,248 bottles with 24 tablets.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
5% Lidocaine HCI and 7.5% Dextrose Injection, USP, 2mL ampul , 5 single ampuls, Single-dose Container, NDC 0074-4712-01. Recall # D-232-4.
CODE
Lot 09-568-DK, Expiration Date: Sept. 1, 2006.
RECALLING FIRM/MANUFACTURER
Hospira Inc., Rocky Mount, NC, by letter on June 24, 2004. Firm initiated recall is ongoing.
REASON
Some ampuls were found to contain particulates.
VOLUME OF PRODUCT IN COMMERCE
139,600 units.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Trispec-PE Pediatric Drops, Each teaspoonful (5 ml) contains: Dextromethorphan HBr 10 mg, Pseudoephedrine HCI 30 mg, and Guaifenesin 25 mg, 1 Fl oz. bottles, Grape Flavor, Sugar Free, Dye Free,--- NDC 58238-210-01. Recall # D-226-4.
CODE
Lot # 2K143, Exp. Date 10/04.
RECALLING FIRM/MANUFACTURER
Deliz Pharmaceutical Corp., Carolina, PR, by visit on July 7, 2004. Firm initiated recall is ongoing.
REASON
Superpotent; (18 month stability).
VOLUME OF PRODUCT IN COMMERCE
11,450.
DISTRIBUTION
Puerto Rico.

_______________________________
PRODUCT
Nu-Iron? V, Polysaccharide-Iron Complex, Each Maroon Film-Coated Tablet contains: Iron (Elemental) 60mg (as a Polysaccharide-Iron Complex); Folic Acid 1mg; Ascorbic Acid 50mg (as sodium ascorbate); Cyanocobalamin (Vitamin B12) 3mcg; Vitamin A 4,000 I.U.; Vitamin D2 400 I.U.; Thiamine Mononitrate 3mg; Riboflavin 3mg; Pyridoxine Hydrochloride 2mg Niacinamide 10mg; Calcium Carbonate 312mg), 10 x 10 count blister packs (PVC/Foil), Rx only, NDC 0259-0331-01. Recall # D-229-4.
CODE
Lot R0401, Expiration Date 06-05.
RECALLING FIRM/MANUFACTURER
Merz Pharmaceuticals, Greensboro, NC, by letter on July 13, 2004. Firm initiated recall is ongoing.
REASON
Sub-potent (Calcium Carbonate).
VOLUME OF PRODUCT IN COMMERCE
1,187 boxes.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Calcitriol Injection, 1 mcg/mL, 1 mL Single Dose Ampul, 10 ampuls per tray, 5 trays per carton, Rx only, Sterile, For IV Use, NDC 63323-731-01. Recall # D-230-4.
CODE
Lot 2G1492, exp. 11/2004.
RECALLING FIRM/MANUFACTURER
American Pharmaceutical Partners, Inc., Melrose Park, IL, by letters dated July 12, 2004. Firm initiated recall is ongoing.
REASON
Discoloration; Failed Visual and Instrumental Color Specification.
VOLUME OF PRODUCT IN COMMERCE
39,800 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Premarin (conjugated estrogens tablets, USP), 0.625 mg, 100 and 1000 count bottles, Rx only, NDC 0046-0867-81. Recall # D-231-4.
CODE
100 count, Lot 04597, Exp 09/04;
1000 count, Lot 04606, Exp 09/04.
RECALLING FIRM/MANUFACTURER
Rx PAK, Memphis, TN, by email on May 5, 2004. Firm initiated recall is complete.
REASON
Product failed to meet dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE
40,679 bottles of 100 and 1775 bottles of 1000.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1407-4.
CODE
Unit 7793392.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone on March 31, 2004. Firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedure, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1546-4;
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-1547-4;
c) Platelets, Volume Reduced. Recall # B-1548-4.
CODE
a) Units 1791373, 6433182, 1934883, 5359607 -splits
1, 2, 3, 4, and 5;
b) Units 5349598, 1934865, 1934879;
c) Unit 1934860.
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by facsimile on October 21, 2003. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for anti-CMV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
FL and GA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1562-4.
CODE
Units 0520286502, 0520286226, 0520285837, 0520284089, 0520283796, 0520283125, 0520283082, 0520282495, 0520282283, 0520281111, 0520281014, 0520280434, 0520280021, 0520278424, 0520278130, 0520275974, 0520275757, 0520274405, 0520273181, 0520266995, 0520266057, 0520264250, 0520264141, 0520261632, 0520261315, 0520260850, 0520260376, 0520259948, 0520259322, 0520258857, 0520258453, 0520257961, 0520257694, 0520257318, 0520256805, 0520255961, 0520255565, 0520254274, 0520253454, 0520253309, 0520252644, 0520252092, 0520251838, 0520251035, 0520250864, 0520250161, 0520250053, 0520249222, 0520249169, 0520248410, 0520248300, 0520247629, 0520247556, 0520246774, 0520246510, 0520245974, 0520245598, 0520244609, 0520244394, 0520243900.
RECALLING FIRM/MANUFACTURER
Recalling Firm:            ZLB Bioplasma Services, Boca Raton, FL, by facsimile on March 31, 2003.
Manufacturing Firm:   ZLB Bioplasma Inc., Memphis, TN. Firm initiated recall is complete.
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
60 units.
DISTRIBUTION
United Kingdom.

_______________________________
PRODUCT
Granulocytes Pheresis. Recall # B-1569-4.
CODE
Units 49P58582, 49P58579, 49P58596.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK, by telephone on February 27, 2002 and by letter dated March 12, 2002. Firm initiated recall is complete.
REASON
Granulocytes, which were incorrectly labeled, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OK.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1643-4;
b) Recovered Plasma. Recall # B-1644-4.
CODE
a) and b) Unit number: FS95653.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Annandale, VA, by facsimile and letters, dated February 9 and 13, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase the risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA and NJ.

_______________________________
PRODUCT
Source Plasma. Recall # B-1656-4.
CODE
Units 94271096, 94267730, 94260601, 94253122, 94247589, 94238143, 94234138, 94230932, 94227475, 94223422, 94220186, 94110968, 94097917, 94065541, 94045413, 94005189, 68292027, 68264468, 68263249, 68253189, 68246419, 68245191, 68238957, 68237042, 52047862, 52041136, 52039645, 52035500, 52031687.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Saginaw, MI, by facsimile on March 4, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-1661-4.
CODE
Unit DTG014920.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Dallas, TX, by facsimile on April 15, 2003. Firm initiated recall is complete.
REASON
Blood product, with an elevated ALT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1662-4;
b) Recovered Plasma. Recall # B-1663-4.
CODE
a) and b) Unit 49LW12979.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK, by letter on April 24, 2003 or by facsimiles dated April 23, 2003, April 29, 2003, and May 23, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who engaged in high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OK, and Switzerland.

_______________________________
PRODUCT
a) Platelets, Pheresis, Leukocytes Reduced. Recall # B-1665-4;
b) Platelets, Pheresis, Leukocytes Reduced. Recall # B-1666-4.
CODE
a) Unit 3722462;
b) Unit 9612118.
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on March 19, 2004. Firm initiated recall is complete.
REASON
Platelets, with a low volume, or decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1669-4.
CODE
Units 33GT54260, 33GT54270, 33GT54272.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Connecticut Region, Farmington, CT, by telephone and by letter on April 8, 2004. Firm initiated recall is complete.
REASON
Blood products, corresponding to units of Platelets that were pooled and were contaminated with gram positive cocci, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
Ct.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1671-4.
CODE
Unit numbers LE66749, FK86739, FG83771, FK86742, FM84825, and FK85679.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI, by telephone on November 14, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to units of Cryoprecipitated AHF that were pooled and possibly contaminated with Staphylococcus sp. bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 Units.
DISTRIBUTION
RI.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1672-4.
CODE
Unit number 18KT00544.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on April 19, 2004. Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced but was collected on an apheresis device undergoing validation and was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1673-4.
CODE
Unit number 49GP11621.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by telephone on April 4, 2003. Firm initiated recall is complete.
REASON
Blood product was collected in a manner that may compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OK.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1674-4.
CODE
Unit 17KT66393.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, North Central Region, St. Paul, MN, by letter dated December 5, 2002. 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
MA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1676-4;
b) Platelets, Leukocytes Reduced. Recall # B-1677-4;
c) Fresh Frozen Plasma. Recall # B-1678-4.
CODE
a) b) and c) Unit 32KR18197.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Badger-Hawkeye Region, Madison, WI, by letter dated October 20, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to behavior associated with an increased risk of infection with hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL and OH.

_______________________________
PRODUCT
Source Plasma. Recall # B-1680-4.
CODE
Units BJKWLN, BJNCFY, BJNBQB, BJMWJN, BJKTZM, BJKSXQ, BJKRQC, BJKQJJ, BJKNYW, BJKMZN, BJLZMB, BJLYGC, BJLWXH, BJLVVM, BJLTSV, BJLSPH, BJKLHK, BJKKPR, BJKGZQ, BJKGHX, BJKDPJ, BJKDCD, BJFZNX, BJFYWD, BJFXBG, BJFWPM, BJDHGB, BJDGVS, 7GY923, 7GY759, BJDDQJ, BJDDJQ.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc. Oklahoma City, OK, by letter on December 13, 2001. Firm initiated recall is complete.
REASON
Source Plasma, collected from an unreliable donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
32 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1681-4.
CODE
Unit number 032FT10444.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Badger-Hawkeye Region, Madison, WI, by facsimile and letter on October 24, 2002. Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1682-4.
CODE
Unit number 4378835.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on June 16, 2003. 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
TX.

_______________________________
PRODUCT
a) Platelets. Recall # B-1683-4;
b) Fresh Frozen Plasma. Recall # B-1684-4.
CODE
a) and b) Unit number 4535686.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone on July 16, 2003. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1685-4;
b) Recovered Plasma. Recall # B-1686-4.
CODE
a) and b) Unit number 4300635.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on July 30, 2003, and by telephone on August 1, and 4, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who should have been deferred due to use of the medication Arthrotec, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and NJ.

_______________________________
PRODUCT
Source Plasma. Recall # B-1687-4.
CODE
unit numbers BJCVWG and BJCVFK.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc. Oklahoma City, OK, by facsimile on December 10, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1688-4.
CODE
Unit numbers GBLSCP, GBLRFT, GBLKVW, GBLKLS, GBDDNK, and GBDCBR.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Oklahoma City, OK, by facsimile on February 21, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for variant Creutzfeldt-Jacob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1691-4;
b) Recovered Plasma. Recall # B-1692-4.
CODE
a) and b) Unit FC45919.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by letter or facsimile on May 14, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1696-4;
b) Platelets, Leukocytes Reduced. Recall # B-1697-4;
c) Fresh Frozen Plasma. Recall # B-1698-4.
CODE
a), b) and c). Unit number 32KN12811.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Badger-Hawkeye Region, Madison, WI, by telephone on August 29, 2002, and by letter on September 11, 2002. Firm initiated recall is complete.
REASON
Blood products, that were not properly quarantined after the donor of the products reported a post donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL and WI.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1699-4.
CODE
Unit number 6692709.
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Sarasota, FL, by telephone on February 23, 2004. 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
FL.

_______________________________
PRODUCT
Source Plasma. Recall # B-1700-4.
CODE
Unit numbers 9QV330O, 9QV528O, 9QW086O, 9QW364O, 9QW713O, 9QX251O, 9UO191O, 9UO423O, 9YS807O, 94S645O, 94S939O, 94T210O, 94T751O, 98O623O, 98T447O, 98T674O, CHCQYVO, CHCRZWO, CHCSKTO, CHCVYNO, BSCXBVO, and BSCXNFO.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., St. Paul, MN, by facsimile on May 29, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
IL, IN, and Germany.

_______________________________
PRODUCT
Source Plasma. Recall # B-1701-4.
CODE
Unit numbers 91V718O, 91V944O, 91W180O, 91W475O, 91W700O, 91X330O, 97S410O, 97S781O, BSCJHVO, BSCJRWO, BSCKJBO, BSCKVPO, BSCNPCO, BNSCPDLO, BSCPVKO, BSCQFRO, BSCQQCO, BSCQYMO, BSFNWFO, BSFPGZO, BSFPXGO, BSFQGBO, BSFQVRO, BSFRGGO, BSFRRNO, BSFSCHO, BSFSLYO, BSFSWBO, BSFTMSO, BSFTSLO, BSFVKFO, BSFVPWO, BSDDMSO, BSDDWTO, BSDFJSO, BSFFDNO, BSFGGDO, BSFGPRO, BSFHFVO, BSFHWWO, BSFJBZO, BSFJPXO, BSFKGDO, BSFKMDO, BSFLCLO, BSFLKXO, BSFMCNO, BSFMKKO, BSFNBPO, BSFNKMO, 0MV008O, 0LD207O, 0LD752O, 0LEI85O, 0LF084O, 0LL771O, 0LI944O, 0LJ452O, 0LL008O, 0LN764O, 9VF459O, 9VF581O, 9VF810O, 9VG088O, 9VG418O, 9VG865O, 91V291O, 91V573O, BSCRLZO, BSCRVHO, BSCSGWO, BSCSQLO, BSCTDQO, BSCTPXO, BSCVLBO, BSCVXGO, BSCWPJO, BSCWWQO, BSCXNPO, BSCYBYO, BSCZJKO, BSCZRLO, BSDBGPO, BSDBTRO, BSDCBWO, and BSDCQGO.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., St. Paul, MN, by facsimile on November 20, 2001. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
86 units.
DISTRIBUTION
IL, CA, Germany and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1704-4;
b) Platelets. Recall # B-1705-4.
CODE
a) and b) Unit number 4486787.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on July 29, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured in a manner that may have compromised the sterility of the unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1707-4;
b) Fresh Frozen Plasma. Recall # B-1708-4.
CODE
a) and b) Unit number 40LX02816
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of America Region, Peoria, IL, by telephone on May 20, 2004, and by letter on May 28, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis B surface antigen (HBsAg), but were collected from an ineligible due to previous reactive testing for HBsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated. Recall # B-1712-4.
CODE
Unit FQ44874.
RECALLING FIRM/MANUFACTURER
Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI, by telephone on October 25, 2002, Firm initiated recall is complete.
REASON
Blood product, which was contaminated with Staphylococcus species, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WI

_______________________________
PRODUCT
a) Plasma, Frozen. Recall # B-1717-4;
b) Cryoprecipitated AHF, Pooled. Recall # B-1718-4.
CODE
a) Unit 17FL18178;
b) Units 17FV10922, 17FZ62787, 17FZ62788, 17FZ62793.
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by telephone on October 31, 2002 and by letter dated November 21, 2002. Firm initiated recall is complete.
REASON
Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MN.

_______________________________
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced. Recall # B-1762-4;
b) Platelets Pheresis, Leukocytes Reduced, Irradiated. Recall # B-1763-4.
CODE
a) Units 01LZ37540, 01LZ36858, 01LZ36052;
b) Units 01LZ37540, 01LZ37375 (split unit), 01LZ36858, 01LZ36052, 01LZ35333 (split unit).
RECALLING FIRM/MANUFACTURER
Recalling Firm:            American Red Cross Blood Services, West Henrietta, NY, by letter dated June 27, 2004.
Manufacturing Firm: American Red Cross Blood Services, Buffalo, NY. 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
10 units.
DISTRIBUTION
MD and NY.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Source Plasma. Recall # B-1297-4.
CODE
G-16040-040, G-15422-040, G-15050-040, G-14638-040, G-14241-040,
G-13854-040, G-13496-040, G-13100-040, G-12781-040, G-12453-040,
G-12098-040, G-11687-040, G-11311-040, G-10965-040, G-10658-040,
G-10213-040, G-09800-040, G-09392-040, G-09038-040, G-08257-040,
N-97003-040, N-96980-040
RECALLING FIRM/MANUFACTURER
Recalling Firm: Grifols Biologicals Inc., Los Angeles, CA, by facsimile dated August 13, 2001.
Manufacturer: Alpha Therapeutic Corporation, Killeen, TX. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor with a recent history of surgery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
NC and Germany.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1664-4.
CODE
Units 49Y85934, 49S97757, 49GG09128, 49GF68820, 49GF71727.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southwest Region, Tulsa, OK, by letter dated April 22, 2003. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of whole blood more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
OK, and TX.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1670-4.
CODE
Unit 33GY71547.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Connecticut Region, Farmington, CT, by telephone on March 9, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose response to a health history question regarding the use of clotting factors was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets. Recall # B-1679-4.
CODE
Unit 4561677.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by telephone and facsimile on July 1, 2003. Firm initiated recall is complete.
REASON
Blood product, which was produced from a whole blood unit lacking phlebotomy documentation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells, Deglycerolized. Recall # B-1693-4.
CODE
Units 8880787, 9318270, 9321471, 9313932, 9300615, 9351786, 8912001, 9233572, GJ063699, GJ063700, 8902250, 9297306, 8882860, 8893898, 9374135, 9390103, 9295700, 8684108, 9313811, 9303741, 8977416.
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on October 18, 2002, and by letters dated October 30, 2002, November 4, 2002 and November 20, 2002. Firm initiated recall is complete.
REASON
Blood products, frozen after the six-day limit following collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
LA and MS.

_______________________________
PRODUCT
Source Plasma. Recall # B-1706-4.
CODE
Unit number GBLVNH.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Oklahoma City, OK, by letter on March 21, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer all the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
a) COBAS TaqMan Analyzer. Recall # Z-1119-04;
b) COBAS TaqMan 48 Analyzers. Recall # Z-1120-04.
CODE
a) Serial Numbers: 381046; 381053; 391159; 391166; 391181;
371036; 391130; 391095; 381052; 391191; 391096; 381044;
391131; 381050; 381054; 391180; 381045; 391177; 391189;
381047; 381051; 381055; 391182; 391157; 391148; 391135;
391143; 391141; 391138; 391175; 391144; 391161; 391150;
391156.
b) Serial Numbers: 1184; 1077; 1084; 1131; 1135; 1139; 1141;
1143; 1144; 1180; 1185; 1236; 1284; 1453; 1454; 391174;
391171; 1343; 1186; 1052; 1241; 1340; 1045; 1240; 1367;
1402; 1342; 1237; 1244; 1401; 1112; 1175; 1058; 1142;
1039; 1439; 1245; 1111; 1341; 1348; 1057; 1179; 1397;
1246; 1299; 1366; 1339; 1177; 1347; 1113; 1137; 1238;
1242; 1346; 1368; 1298; 1440; 1132; 1147; 1114; 1182;
1398; 1145; 1089; 1183; 1140; 1047; 1133; 1138; 1247;
1396; 1369; 1118; 1181; 1243.
RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc., Belleville, NJ, by letter on May 24, 2004. Firm initiated recall is complete.
REASON
Improper seating of a fiber optic cable which may cause pixel cross-talk leading to falsely elevated test results or cases of misalignment to sample-to-result mismatch.
VOLUME OF PRODUCT IN COMMERCE
110 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Express 2 Monorail Coronary Stent Systems (bare metal stents) , balloon expandable Express 316L stainless steel Stent premounted on a MONORAIL catheter with a Dynaleap balloon. Recall # Z-1121-04.
CODE
2.25 mm - Lot #'s/Expiration date: 5071224 Oct-05 5071225 Oct-05 5071227 Oct-05 5083308 Oct-05 5083309 Oct-05 5083310 Oct-05 5094036 Oct-05 5094037 Oct-05 5094578 Oct-05 5094739 Oct-05 5094740 Oct-05 5206975 Nov-05 5206976 Dec-05 5224840 Dec-05 5224841 Dec-05 5224842 Dec-05 5232145 Dec-05 5232146 Dec-05 5233685 Dec-05 5233686 Dec-05 5233687 Dec-05 5233688 Dec-05 5248813 Dec-05 5248814 Dec-05 5273630 Jan-06 5273631 Jan-06 5273632 Jan-06 5290704 Jan-06 5290705 Jan-06 5323833 Jan-06 5323834 Jan-06 5323835 Jan-06 5323836 Jan-06 5342323 Feb-06 5349091 Feb-06 5349093 Feb-06 5353383 Feb-06 5482581 Apr-06 5482582 Apr-06 5482583 Apr-06 5482584 Apr-06 5505224 Apr-06 5505226 Apr-06 5506773 Apr-06 5506775 Apr-06 4940250 Jul-05 4940251 Jul-05 4940253 Jul-05 4974516 Aug-05 4993447 Aug-05 4993448 Aug-05 4995086 Aug-05 4995092 Aug-05 4995097 Aug-05 4995162 Aug-05 5072605 Oct-05 5072606 Oct-05 5072607 Oct-05 5072608 Oct-05 5080609 Oct-05 5088531 Oct-05 5088532 Oct-05 5088533 Oct-05 5133859 Oct-05 5133860 Oct-05 5133861 Oct-05 5157323 Nov-05 5164085 Nov-05 5177542 Nov-05 5177543 Nov-05 5203023 Nov-05 5203024 Nov-05 5203025 Nov-05 5212889 Dec-05 5212890 Dec-05 5232572 Dec-05 5232573 Dec-05 5232575 Dec-05 5253781 Dec-05 5253782 Dec-05 5253784 Dec-05 5261078 Jan-06 5270798 Jan-06 5285486 Jan-06 5285487 Jan-06 5300227 Jan-06 5300228 Jan-06 5307118 Jan-06 5307279 Jan-06 5307280 Jan-06 5307281 Jan-06 5313467 Jan-06 5313468 Jan-06 5313469 Jan-06 5313993 Jan-06 5313994 Jan-06 5353384 Feb-06 5353386 Feb-06 5369839 Feb-06 5369840 Feb-06 5369841 Feb-06 5369842 Feb-06 5482586 Apr-06 5482587 Apr-06 5482588 Apr-06 5482589 Apr-06 5495762 Apr-06 5495763 Apr-06 5495764 Apr-06 5529365 Apr-06 5544323 Apr-06 5553128 May-06 4942132 Jul-05 4942134 Jul-05 4942651 Jul-05 4942652 Jul-05 4942653 Jul-05 4974517 Aug-05 5074113 Oct-05 5074114 Oct-05 5074115 Oct-05 5080173 Oct-05 5080174 Oct-05 5080311 Oct-05 5080313 Oct-05 5080314 Oct-05 5091685 Oct-05 5094316 Oct-05 5094559 Oct-05 5145184 Nov-05 5206353 Nov-05 5206355 Dec-05 5206356 Dec-05 5234308 Dec-05 5249425 Dec-05 5261260 Jan-06 5261261 Jan-05 5263980 Jan-06 5274685 Jan-06 5274686 Jan-06 5307105 Jan-06 5307106 Jan-06 5311321 Jan-06 5311323 Jan-06 5311324 Jan-06 5311325 Jan-06 5311326 Jan-06 5359881 Feb-06 5359882 Feb-06 5374066 Feb-06 5374068 Mar-06 5377706 Feb-06 5377707 Feb-06 5505233 Apr-06 5505235 Apr-06 5553257 May-06 5553259 May-06 4975683 Aug-05 4975684 Aug-05 4992962 Aug-05 4992963 Aug-05 4992964 Aug-05 5076793 Oct-05 5076794 Oct-05 5076795 Oct-05 5079906 Oct-05 5079907 Oct-05 5079909 Oct-05 5094560 Oct-05 5142567 Nov-05 5142571 Nov-05 5232150 Dec-05 5232151 Dec-05 5234310 Dec-05 5274679 Jan-06 5274680 Jan-06 5290285 Jan-06 5307111 Jan-06 5307113 Jan-06 5313460 Jan-06 5313461 Jan-06 5313462 Jan-06 5378938 Feb-06 5378959 Feb-06 5390260 Mar-06 5417516 Mar-06 5428026 Mar-06 5512020 Apr-06 5512021 Apr-06 5513352 Apr-06 5074352 Oct-05 5074353 Oct-05 5080610 Oct-05 5092673 Oct-05 5092674 Oct-05 5232153 Dec-05 5232155 Dec-05 5243055 Dec-05 5243056 Dec-05 5243057 Dec-05 5276671 Jan-06 5349095 Feb-06 5349096 Feb-06 5349097 Feb-06 5492279 Apr-06 5492280 Apr-06 5516411 Apr-06 5516413 Apr-06 5559840 May-06 5572785 May-06
2.5 mm - Lot #'s/Expiration date: 4939152 Jul-05 4939153 Jul-05 4939346 Jul-05 4939347 Jul-05 4939348 Jul-05 4953456 Aug-05 4953654 Aug-05 4965474 Aug-05 4965476 Aug-05 4991036 Aug-05 4991037 Aug-05 4996362 Aug-05 4996363 Aug-05 4996364 Aug-05 5088634 Oct-05 5088636 Oct-05 5088637 Oct-05 5106079 Oct-05 5106082 Oct-05 5106083 Oct-05 5120538 Oct-05 5120619 Oct-05 5120620 Oct-05 5120622 Oct-05 5120623 Oct-05 5127943 Oct-05 5129699 Oct-05 5129700 Oct-05 5129944 Oct-05 5129947 Oct-05 5129949 Oct-05 5143133 Nov-05 5143134 Nov-05 5155696 Nov-05 5155697 Nov-05 5155976 Nov-05 5155977 Nov-05 5155978 Nov-05 5164060 Nov-05 5175160 Nov-05 5175168 Nov-05 5188377 Nov-05 5188378 Nov-05 5190824 Nov-05 5196287 Nov-05 5202619 Nov-05 5202621 Nov-05 5202623 Nov-05 5202624 Nov-05 5202625 Nov-05 5202626 Nov-05 5212883 Dec-05 5212884 Dec-05 5236053 Dec-05 5236055 Dec-05 5236056 Dec-05 5236057 Dec-05 5236058 Dec-05 5239114 Dec-05 5239116 Dec-05 5239893 Dec-05 5246427 Dec-05 5246428 Dec-05 5246429 Dec-05 5248805 Dec-05 5248806 Dec-05 5248807 Dec-05 5258683 Dec-05 5258684 Dec-05 5263587 Jan-06 5272946 Jan-06 5272947 Jan-06 5273067 Jan-06 5273070 Jan-06 5299712 Jan-06 5299713 Jan-06 5299716 Jan-06 5299717 Jan-06 5299859 Jan-06 5310682 Jan-06 5310683 Jan-06 5310684 Jan-06 5310693 Jan-06 5310694 Jan-06 5316829 Jan-06 5316830 Jan-06 5316832 Jan-06 5316833 Feb-06 5316834 Jan-06 5316835 Jan-06 5324809 Jan-06 5324810 Jan-06 5324812 Feb-06 5324814 Jan-06 5325330 Jan-06 5342760 Feb-06 5342762 Feb-06 5342763 Feb-06 5370538 Feb-06 5370559 Feb-06 5370560 Feb-06 5370561 Feb-06 5370562 Feb-06 5370563 Feb-06 5370564 Feb-06 5376210 Feb-06 5376211 Feb-06 5376212 Feb-06 5376213 Feb-06 5376214 Feb-06 5376663 Feb-06 5376664 Feb-06 5427752 Mar-06 5427753 Mar-06 5427754 Mar-06 5427755 Mar-06 5427756 Mar-06 5488186 Apr-06 5488187 Apr-06 5488188 Apr-06 5488189 Apr-06 5488190 Apr-06 5505227 Apr-06 5505228 Apr-06 5511619 Apr-06 5511620 Apr-06 5511621 Apr-06 5511622 Apr-06 5511623 Apr-06 5514228 Apr-06 5514229 Apr-06 5514232 Apr-06 5514233 Apr-06 5553385 May-06 5553387 May-06 5565440 May-06 4942984 Jul-05 4942985 Jul-05 4942986 Jul-05 4948300 Jul-05 4948301 Aug-05 4949072 Jul-05 4949073 Aug-05 4949074 Jul-05 4950289 Jul-05 4950292 Aug-05 4950511 Aug-05 4950880 Aug-05 4967056 Aug-05 4967057 Aug-05 4967316 Aug-05 4996963 Aug-05 4996964 Aug-05 5072609 Oct-05 5072610 Oct-05 5074347 Oct-05 5074348 Oct-05 5074349 Oct-05 5074350 Oct-05 5074351 Oct-05 5086280 Oct-05 5086281 Oct-05 5086282 Oct-05 5086450 Oct-05 5086451 Oct-05 5108925 Oct-05 5108926 Oct-05 5108929 Oct-05 5108931 Oct-05 5109182 Oct-05 5109185 Oct-05 5109187 Oct-05 5109190 Oct-05 5120768 Oct-05 5120769 Oct-05 5121030 Oct-05 5121036 Oct-05 5130784 Oct-05 5130785 Oct-05 5137218 Oct-05 5137282 Oct-05 5137284 Oct-05 5137286 Nov-05 5140999 Nov-05 5150976 Nov-05 5160634 Nov-05 5160636 Nov-05 5160729 Nov-05 5160730 Nov-05 5160865 Nov-05 5160882 Nov-05 5174628 Nov-05 5174629 Nov-05 5174634 Nov-05 5174638 Nov-05 5175061 Nov-05 5175065 Nov-05 5175069 Nov-05 5182387 Nov-05 5182389 Nov-05 5182390 Nov-05 5193335 Nov-05 5193336 Nov-05 5193337 Nov-05 5196100 Nov-05 5196101 Nov-05 5207389 Nov-05 5207390 Nov-05 5207391 Nov-05 5207392 Dec-05 5207393 Nov-05 5207396 Nov-05 5210124 Dec-05 5210125 Dec-05 5210126 Dec-05 5210127 Dec-05 5229724 Dec-05 5229725 Dec-05 5229726 Dec-05 5233689 Dec-05 5233690 Dec-05 5233691 Dec-05 5233692 Dec-05 5233842 Dec-05 5233843 Dec-05 5233844 Dec-05 5233885 Dec-05 5233886 Dec-05 5252430 Dec-05 5252431 Dec-05 5252432 Dec-05 5252434 Dec-05 5252620 Dec-05 5252626 Dec-05 5253152 Dec-05 5253153 Dec-05 5258510 Dec-05 5258511 Dec-05 5261259 Dec-05 5263593 Dec-05 5263594 Jan-06 5263595 Jan-06 5263596 Jan-06 5267547 Jan-06 5270306 Jan-06 5270410 Jan-06 5270411 Jan-06 5270412 Jan-06 5270413 Jan-06 5286841 Jan-06 5286842 Jan-06 5300232 Jan-06 5300233 Jan-06 5300451 Jan-06 5308535 Jan-06 5308536 Jan-06 5308537 Jan-06 5308538 Jan-06 5309962 Jan-06 5309963 Jan-06 5309964 Jan-06 5309965 Jan-06 5314825 Jan-06 5314826 Jan-06 5314827 Jan-06 5314828 Jan-06 5314829 Jan-06 5314831 Jan-06 5324323 Feb-06 5324324 Jan-06 5324325 Jan-06 5324326 Feb-06 5324327 Jan-06 5326715 Jan-06 5326716 Feb-06 5326717 Jan-06 5326739 Feb-06 5327742 Jan-06 5327743 Jan-06 5335273 Feb-06 5335274 Feb-06 5349461 Feb-06 5349462 Feb-06 5349463 Feb-06 5372589 Feb-06 5372590 Feb-06 5372591 Feb-06 5372598 Feb-06 5372739 Feb-06 5372741 Feb-06 5372742 Feb-06 5372743 Feb-06 5376676 Feb-06 5376677 Feb-06 5376678 Feb-06 5379351 Feb-06 5379353 Feb-06 5379355 Feb-06 5379358 Feb-06 5414239 Mar-06 5414240 Mar-06 5414241 Mar-06 5414242 Mar-06 5414243 Mar-06 5417187 Mar-06 5417188 Mar-06 5417189 Mar-06 5495547 Apr-06 5495548 Apr-06 5495549 Apr-06 5495550 Apr-06 5495820 Apr-06 5495824 Apr-06 5495825 Apr-06 5495826 Apr-06 5513837 Apr-06 5513838 Apr-06 5548220 May-06 5548701 May-06 5548702 May-06 5548703 May-06 4940039 Jul-05 4940040 Jul-05 4940041 Jul-05 4940042 Jul-05 4940043 Jul-05 4953283 Aug-05 4953284 Aug-05 4953441 Aug-05 4953444 Aug-05 4969043 Aug-05 4969044 Aug-05 4970424 Aug-05 4976344 Aug-05 4986130 Aug-05 4986131 Aug-05 4986132 Aug-05 4986461 Aug-05 4986466 Aug-05 5106867 Oct-05 5106869 Oct-05 5108095 Oct-05 5122073 Oct-05 5122074 Oct-05 5122139 Oct-05 5137382 Oct-05 5137383 Nov-05 5137384 Oct-05 5137385 Oct-05 5140232 Nov-05 5140236 Nov-05 5140523 Nov-05 5155326 Nov-05 5155327 Nov-05 5155328 Nov-05 5158456 Nov-05 5158600 Nov-05 5158617 Nov-05 5171741 Nov-05 5171742 Nov-05 5175169 Nov-05 5175170 Nov-05 5175171 Nov-05 5175172 Nov-05 5177397 Nov-05 5177398 Nov-05 5180042 Nov-05 5180046 Nov-05 5180047 Nov-05 5188481 Nov-05 5188482 Nov-05 5188483 Nov-05 5203026 Nov-05 5203028 Nov-05 5203029 Nov-05 5229925 Dec-05 5229927 Dec-05 5229929 Dec-05 5229933 Dec-05 5229934 Dec-05 5229935 Dec-05 5229936 Dec-05 5237371 Dec-05 5237372 Dec-05 5237373 Dec-05 5237374 Dec-05 5237375 Dec-05 5237376 Dec-05 5245223 Dec-05 5245224 Dec-05 5245225 Dec-05 5258685 Dec-05 5271822 Jan-06 5271823 Jan-06 5271825 Jan-06 5271826 Jan-06 5294882 Jan-06 5294883 Jan-06 5294884 Jan-06 5304168 Jan-06 5304169 Jan-06 5305735 Jan-06 5305736 Jan-06 5305737 Jan-06 5305928 Jan-06 5305929 Jan-06 5305931 Jan-06 5306015 Jan-06 5306016 Jan-06 5307114 Jan-06 5313998 Jan-06 5321746 Jan-06 5321750 Jan-06 5321751 Jan-06 5322428 Jan-06 5322429 Jan-06 5324030 Jan-06 5324031 Jan-06 5332512 Feb-06 5332513 Feb-06 5332514 Feb-06 5332515 Feb-06 5332516 Feb-06 5332517 Feb-06 5373927 Feb-06 5373928 Feb-06 5373929 Feb-06 5373930 Feb-06 5378265 Feb-06 5378266 Feb-06 5378267 Feb-06 5382236 Feb-06 5382237 Feb-06 5382238 Feb-06 5382439 Feb-06 5412993 Mar-06 5412994 Mar-06 5412995 Mar-06 5412996 Mar-06 5412997 Mar-06 5412998 Mar-06 5427021 Mar-06 5505427 Apr-06 5505428 Apr-06 5505429 May-06 5505430 Apr-06 5505432 Apr-06 5529366 Apr-06 5529368 Apr-06 5529370 Apr-06 5529464 Apr-06 4965595 Aug-05 4965598 Aug-05 4974109 Aug-05 4974110 Aug-05 4983170 Aug-05 4983171 Aug-05 4983172 Aug-05 4983478 Aug-05 4983599 Aug-05 4984476 Aug-05 4984477 Aug-05 5074263 Oct-05 5074264 Oct-05 5074265 Oct-05 5078028 Oct-05 5078029 Oct-05 5078031 Oct-05 5078169 Oct-05 5078171 Oct-05 5132346 Oct-05 5132348 Oct-05 5132349 Oct-05 5157886 Nov-05 5157887 Nov-05 5175624 Nov-05 5175629 Nov-05 5185130 Nov-05 5185131 Nov-05 5185133 Nov-05 5185134 Nov-05 5206344 Nov-05 5206346 Dec-05 5206348 Dec-05 5209753 Dec-05 5211263 Dec-05 5211264 Dec-05 5239517 Dec-05 5239599 Dec-05 5239601 Dec-05 5248170 Dec-05 5248172 Dec-05 5254335 Dec-05 5254337 Dec-05 5254499 Dec-05 5254985 Dec-05 5263216 Jan-06 5263217 Jan-06 5272948 Jan-06 5307542 Jan-06 5307543 Jan-06 5307544 Jan-06 5307612 Jan-06 5307613 Jan-06 5307614 Jan-06 5307615 Jan-06 5334336 Feb-06 5334337 Feb-06 5334338 Feb-06 5339542 Feb-06 5339551 Feb-06 5342111 Feb-06 5359896 Feb-06 5359897 Feb-06 5370213 Feb-06 5373797 Feb-06 5373920 Feb-06 5376269 Feb-06 5376270 Feb-06 5376271 Feb-06 5382513 Feb-06 5428310 Mar-06 5493945 Apr-06 5493947 Apr-06 5495828 Apr-06 5495829 Apr-06 5495832 Apr-06 5513332 Apr-06 5513333 Apr-06 5556467 May-06 5556469 May-06 5556471 May-06 5556474 May-06 4976225 Aug-05 4976226 Aug-05 4980100 Aug-05 4980101 Aug-05 4980102 Aug-05 4980103 Aug-05 5002035 Aug-05 5002036 Aug-05 5002980 Aug-05 5081081 Oct-05 5108077 Oct-05 5127707 Oct-05 5127709 Oct-05 5131433 Nov-05 5131564 Oct-05 5157093 Nov-05 5177786 Nov-05 5177788 Nov-05 5178997 Nov-05 5185438 Nov-05 5185679 Nov-05 5185759 Nov-05 5210475 Dec-05 5210476 Nov-05 5210477 Dec-05 5210478 Dec-05 5240521 Dec-05 5240522 Dec-05 5240523 Dec-05 5251120 Dec-05 5251121 Dec-05 5273627 Jan-06 5273628 Jan-06 5290069 Jan-06 5309816 Jan-06 5309817 Jan-06 5309818 Jan-06 5324479 Jan-06 5324480 Jan-06 5324484 Jan-06 5324486 Jan-06 5324487 Feb-06 5324488 Jan-06 5341836 Feb-06 5341838 Feb-06 5341859 Feb-06 5376665 Feb-06 5376666 Feb-06 5428649 Mar-06 5428650 Mar-06 5493402 Apr-06 5493404 Apr-06 5513533 Apr-06 5513534 Apr-06 5513824 Apr-06 5513825 Apr-06 5537871 Apr-06 5537872 Apr-06 5544322 Apr-06
2.75 mm - Lot #'s/Expiration date: 4939503 Jul-05 4939504 Jul-05 4939688 Jul-05 4939689 Jul-05 4939690 Jul-05 4953112 Aug-05 4953207 Aug-05 4976346 Aug-05 4990853 Aug-05 5001884 Aug-05 5102792 Oct-05 5102793 Oct-05 5102794 Oct-05 5102795 Oct-05 5120765 Oct-05 5120766 Oct-05 5121229 Oct-05 5129190 Oct-05 5129191 Oct-05 5131576 Oct-05 5139358 Nov-05 5139439 Nov-05 5139761 Nov-05 5163910 Nov-05 5181013 Nov-05 5181014 Nov-05 5182385 Nov-05 5182386 Nov-05 5183894 Nov-05 5183895 Nov-05 5183897 Nov-05 5183898 Nov-05 5212885 Dec-05 5212886 Dec-05 5232565 Dec-05 5232566 Dec-05 5232567 Dec-05 5232568 Dec-05 5240759 Dec-05 5240760 Dec-05 5254515 Dec-05 5258897 Dec-05 5258898 Dec-05 5258979 Dec-05 5258980 Dec-05 5261077 Dec-05 5300223 Jan-06 5300224 Jan-06 5300225 Jan-06 5300226 Jan-06 5308661 Jan-06 5308662 Jan-06 5320074 Jan-06 5320075 Jan-06 5320076 Jan-06 5320834 Jan-06 5320835 Jan-06 5323860 Jan-06 5359446 Feb-06 5359447 Feb-06 5359451 Feb-06 5366464 Feb-06 5367844 Feb-06 5367846 Feb-06 5367848 Feb-06 5367849 Feb-06 5367850 Feb-06 5374061 Feb-06 5374062 Feb-06 5374063 Feb-06 5374064 Feb-06 5376629 Feb-06 5376630 Feb-06 5376631 Feb-06 5418090 Mar-06 5418222 Mar-06 5418223 Mar-06 5418224 Mar-06 5553129 May-06 5553130 May-06 4971477 Aug-05 4971478 Aug-05 4981103 Aug-05 4981107 Aug-05 4981109 Aug-05 4981111 Aug-05 4981113 Aug-05 5001888 Aug-05 5001889 Aug-05 5070678 Oct-05 5070779 Oct-05 5070780 Oct-05 5070781 Oct-05 5070782 Oct-05 5087946 Oct-05 5087947 Oct-05 5087948 Oct-05 5087949 Oct-05 5087950 Oct-05 5108970 Oct-05 5126924 Oct-05 5126928 Oct-05 5126933 Oct-05 5131682 Oct-05 5137983 Nov-05 5137988 Nov-05 5137991 Nov-05 5137992 Oct-05 5161662 Nov-05 5161663 Nov-05 5161664 Nov-05 5176774 Nov-05 5176777 Nov-05 5176778 Nov-05 5176899 Nov-05 5178414 Nov-05 5178415 Nov-05 5178535 Nov-05 5178536 Nov-05 5188485 Nov-05 5188487 Nov-05 5189045 Nov-05 5201870 Nov-05 5201872 Nov-05 5201873 Nov-05 5201874 Nov-05 5201875 Nov-05 5201876 Nov-05 5212621 Dec-05 5212622 Dec-05 5212623 Dec-05 5239762 Dec-05 5239763 Dec-05 5239764 Dec-05 5239765 Dec-05 5239766 Dec-05 5253636 Dec-05 5253637 Dec-05 5253638 Dec-05 5255655 Dec-05 5255656 Dec-05 5272764 Jan-06 5272765 Jan-06 5272869 Jan-06 5272870 Jan-06 5291655 Jan-06 5291656 Jan-06 5291946 Jan-06 5307891 Jan-06 5307894 Jan-06 5307895 Jan-06 5307896 Jan-06 5308672 Jan-06 5308674 Jan-06 5308675 Jan-06 5308676 Jan-06 5317840 Jan-06 5317841 Jan-06 5317842 Jan-06 5317843 Jan-06 5317844 Jan-06 5317960 Jan-06 5324388 Jan-06 5324389 Jan-06 5324390 Jan-06 5324391 Jan-06 5324392 Jan-06 5353113 Feb-06 5366461 Feb-06 5366462 Feb-06 5367159 Feb-06 5367161 Feb-06 5367166 Feb-06 5373933 Feb-06 5373934 Feb-06 5373935 Feb-06 5377357 Feb-06 5377420 Feb-06 5379602 Feb-06 5379605 Feb-06 5379606 Feb-06 5379607 Feb-06 5420426 Mar-06 5420427 Mar-06 5420428 Mar-06 5420429 Mar-06 5420430 Mar-06 5493214 Apr-06 5493215 Apr-06 5493216 Apr-06 5493217 Apr-06 5493259 Apr-06 5496282 Apr-06 5496285 Apr-06 5496289 Apr-06 5496290 Apr-06 5496291 Apr-06 5496292 Apr-06 5548705 May-06 5548706 May-06 5548707 Apr-06 4940776 Jul-05 4940777 Jul-05 4940778 Jul-05 4941059 Jul-05 4941060 Jul-05 4951349 Aug-05 4951350 Aug-05 4951849 Aug-05 4951850 Aug-05 4972208 Aug-05 4972209 Sep-05 4979452 Aug-05 4979453 Aug-05 5070608 Oct-05 5070609 Oct-05 5071108 Oct-05 5071109 Oct-05 5071110 Oct-05 5076913 Oct-05 5076915 Oct-05 5076916 Oct-05 5079309 Oct-05 5079648 Oct-05 5079650 Oct-05 5093751 Oct-05 5093752 Oct-05 5093753 Oct-05 5093755 Oct-05 5093756 Oct-05 5093757 Oct-05 5163906 Nov-05 5163907 Nov-05 5172456 Nov-05 5174398 Nov-05 5174619 Nov-05 5180166 Nov-05 5180173 Nov-05 5180174 Nov-05 5190397 Nov-05 5190398 Nov-05 5190480 Nov-05 5195949 Nov-05 5195950 Nov-05 5196438 Nov-05 5196619 Nov-05 5196620 Nov-05 5196621 Nov-05 5232147 Dec-05 5232148 Dec-05 5232149 Dec-05 5237378 Dec-05 5237406 Dec-05 5249123 Dec-05 5249125 Dec-05 5249126 Dec-05 5259285 Dec-05 5272311 Jan-06 5272312 Jan-06 5272313 Jan-06 5272314 Jan-06 5272315 Jan-06 5272316 Jan-06 5272714 Jan-06 5318979 Jan-06 5318980 Jan-06 5318981 Jan-06 5318982 Jan-06 5321744 Jan-06 5324264 Jan-06 5324265 Jan-06 5324266 Jan-06 5324410 Jan-06 5324411 Jan-06 5324412 Jan-06 5337060 Feb-06 5337062 Feb-06 5337065 Feb-06 5369940 Feb-06 5369941 Feb-06 5421388 Mar-06 5421389 Mar-06 5421390 Mar-06 5421393 Mar-06 5424306 Mar-06 5424307 Mar-06 5424309 Mar-06 5428027 Mar-06 5428028 Mar-06 5431265 Mar-06 5431266 Mar-06 5431267 Mar-06 5431268 Mar-06 5483594 Apr-06 5483595 Apr-06 5483596 Apr-06 5483597 Apr-06 5483598 Apr-06 5493880 Apr-06 5499504 Apr-06 5499505 Apr-06 5499506 Apr-06 5499507 Apr-06 5500184 Apr-06 5500185 Apr-06 5500186 Apr-06 5513334 Apr-06 5513335 Apr-06 5513336 Apr-06 5513337 Apr-06 5553391 May-06 5554222 May-06 5554227 May-06 5554228 May-06 4973565 Aug-05 4973567 Aug-05 4973568 Aug-05 4987150 Aug-05 4987151 Aug-05 4987153 Aug-05 4987154 Aug-05 5072137 Oct-05 5072138 Oct-05 5072479 Oct-05 5072480 Oct-05 5076398 Oct-05 5076560 Oct-05 5076570 Oct-05 5076571 Oct-05 5076791 Oct-05 5077512 Oct-05 5077515 Oct-05 5077516 Oct-05 5163908 Nov-05 5163909 Nov-05 5184634 Nov-05 5184637 Nov-05 5184703 Nov-05 5184706 Nov-05 5209583 Nov-05 5209584 Nov-05 5209585 Nov-05 5239615 Dec-05 5239616 Dec-05 5239617 Dec-05 5239618 Dec-05 5242448 Dec-05 5254983 Dec-05 5254984 Dec-05 5256309 Dec-05 5256311 Dec-05 5256313 Dec-05 5307285 Jan-06 5317429 Jan-06 5317430 Jan-06 5326741 Jan-06 5326742 Jan-06 5334519 Feb-06 5334520 Feb-06 5340323 Feb-06 5340325 Feb-06 5340326 Feb-06 5340328 Feb-06 5340330 Feb-06 5374600 Feb-06 5376272 Feb-06 5376273 Feb-06 5376274 Feb-06 5424991 Mar-06 5424993 Mar-06 5424994 Mar-06 5492290 Apr-06 5492291 Apr-06 5495765 Apr-06 5495766 Apr-06 5495767 Apr-06 4974336 Aug-05 4974337 Aug-05 4995808 Aug-05 4995809 Aug-05 4995810 Aug-05 4995811 Aug-05 5080963 Oct-05 5103826 Oct-05 5103827 Oct-05 5122061 Oct-05 5122062 Oct-05 5131435 Oct-05 5131683 Oct-05 5138964 Nov-05 5138965 Nov-05 5157322 Nov-05 5163912 Nov-05 5209741 Nov-05 5209743 Nov-05 5209744 Nov-05 5251810 Dec-05 5251812 Jan-06 5263981 Jan-06 5310960 Jan-06 5310961 Jan-06 5314530 Jan-06 5314531 Jan-06 5324145 Jan-06 5324149 Jan-06 5354878 Feb-06 5354979 Feb-06 5374146 Feb-06 5378684 Feb-06 5378685 Feb-06 5428025 Mar-06 5495190 Apr-06 5535409 Apr-06 5071214 Oct-05 5071216 Oct-05 5080847 Oct-05 5156156 Nov-05 5164086 Nov-05 5178050 Nov-05 5178054 Nov-05 5236139 Dec-05 5241643 Dec-05 5241644 Dec-05 5256369 Jan-06 5256370 Dec-05 5256371 Dec-05 5317431 Jan-06 5317432 Jan-06 5317433 Jan-06 5373794 Feb-06 5382901 Feb-06 5482770 Apr-06 5495191 Apr-06 5525678 Apr-06 5103828 Oct-05 5103829 Oct-05 5139353 Nov-05 5139354 Nov-05 5173964 Nov-05 5196288 Nov-05 5209849 Dec-05 5230795 Dec-05 5230797 Dec-05 5230798 Dec-05 5267768 Jan-06 5324259 Jan-06 5324260 Jan-06 5341791 Feb-06 5341983 Feb-06 5341985 Feb-06 5428030 Mar-06 5492077 Apr-06 5492078 Apr-06 5529867 Apr-06
3.0 mm - Lot #'s/Expiration date: 4942067 Jul-05 4942068 Jul-05 4942069 Jul-05 4942071 Jul-05 4942072 Jul-05 4950882 Jul-05 4950960 Aug-05 4950961 Aug-05 4950972 Aug-05 4975177 Aug-05 4975178 Aug-05 4981376 Aug-05 4981378 Aug-05 4981500 Aug-05 4981501 Aug-05 5123399 Oct-05 5123400 Oct-05 5123401 Oct-05 5123415 Oct-05 5123416 Oct-05 5133707 Oct-05 5133708 Oct-05 5133709 Oct-05 5133717 Oct-05 5133718 Oct-05 5139440 Nov-05 5139441 Nov-05 5224844 Dec-05 5233074 Dec-05 5233075 Dec-05 5233077 Dec-05 5233219 Dec-05 5233220 Dec-05 5233222 Dec-05 5249432 Dec-05 5249433 Dec-05 5249434 Dec-05 5250149 Dec-05 5250150 Dec-05 5250151 Dec-05 5250152 Dec-05 5351797 Feb-06 5351798 Feb-06 5359891 Feb-06 5359892 Feb-06 5359893 Feb-06 5363482 Feb-06 5363484 Feb-06 5370211 Feb-06 5370943 Feb-06 5370944 Feb-06 5370945 Feb-06 5370946 Feb-06 5372040 Feb-06 5372042 Feb-06 5372043 Feb-06 5372044 Feb-06 5382232 Feb-06 5382233 Feb-06 5382457 Feb-06 5382579 Feb-06 5382580 Mar-06 5389476 Feb-06 5389477 Feb-06 5389880 Feb-06 5389883 Feb-06 5390063 Feb-06 5390064 Feb-06 5390065 Feb-06 5390066 Feb-06 5424872 Mar-06 5424873 Mar-06 5424874 Mar-06 5424876 Mar-06 5489486 Apr-06 5501654 Apr-06 5501657 Apr-06 5501658 Apr-06 5501859 Apr-06 5510829 Apr-06 5510830 Apr-06 5510832 Apr-06 5510833 Apr-06 5536854 Apr-06 5556058 May-06 4938993 Jul-05 4938996 Jul-05 4938997 Jul-05 4939147 Jul-05 4945725 Jul-05 4945726 Jul-05 4945727 Jul-05 4945731 Jul-05 4945996 Jul-05 4945998 Jul-05 4946039 Jul-05 4946040 Jul-05 4946041 Jul-05 4975364 Aug-05 4975365 Aug-05 4990236 Aug-05 4990237 Aug-05 4990238 Aug-05 4991269 Aug-05 4991270 Aug-05 4991274 Aug-05 4993677 Aug-05 4993721 Aug-05 4993844 Aug-05 4994048 Aug-05 4994049 Aug-05 4994190 Aug-05 5124971 Oct-05 5124972 Oct-05 5124973 Oct-05 5124974 Oct-05 5125138 Oct-05 5130535 Oct-05 5130536 Oct-05 5130683 Oct-05 5130684 Oct-05 5130692 Oct-05 5167365 Nov-05 5167377 Nov-05 5167719 Nov-05 5167905 Nov-05 5167910 Nov-05 5167913 Nov-05 5167914 Nov-05 5168027 Nov-05 5168031 Nov-05 5181052 Nov-05 5181053 Nov-05 5181055 Nov-05 5181056 Nov-05 5215025 Dec-05 5215026 Dec-05 5224826 Dec-05 5224828 Dec-05 5228057 Dec-05 5228058 Dec-05 5228479 Dec-05 5228480 Dec-05 5228481 Dec-05 5228482 Dec-05 5251389 Jan-06 5251390 Dec-05 5251391 Dec-05 5251392 Dec-05 5251393 Dec-05 5251394 Dec-05 5251395 Dec-05 5251396 Jan-06 5251805 Dec-05 5251806 Dec-05 5255859 Jan-06 5255860 Jan-06 5280844 Jan-06 5390879 Feb-06 5390880 Feb-06 5390881 Feb-06 5539660 Apr-06 4938491 Jul-05 4938492 Jul-05 4938493 Jul-05 4938690 Jul-05 4947202 Jul-05 4947203 Jul-05 4947420 Jul-05 4947421 Jul-05 4947839 Jul-05 4947840 Aug-05 4947912 Aug-05 4947914 Jul-05 4947915 Jul-05 4971233 Aug-05 4971235 Aug-05 4971237 Aug-05 4985499 Aug-05 4985500 Aug-05 4985501 Aug-05 4985579 Aug-05 4985580 Aug-05 4985581 Aug-05 5000190 Aug-05 5002462 Aug-05 5002463 Aug-05 5002481 Aug-05 5002725 Aug-05 5002738 Aug-05 5002987 Aug-05 5002988 Sep-05 5124337 Oct-05 5124338 Oct-05 5124411 Oct-05 5124412 Oct-05 5124413 Oct-05 5124440 Oct-05 5128919 Oct-05 5128920 Oct-05 5128921 Oct-05 5131437 Oct-05 5137156 Nov-05 5170691 Nov-05 5170692 Nov-05 5170813 Nov-05 5170814 Nov-05 5170930 Nov-05 5170931 Nov-05 5172457 Nov-05 5172458 Nov-05 5173951 Nov-05 5173960 Nov-05 5175756 Nov-05 5175757 Nov-05 5175758 Nov-05 5177395 Nov-05 5177396 Nov-05 5223688 Dec-05 5225342 Dec-05 5229024 Dec-05 5229025 Dec-05 5229026 Dec-05 5229027 Dec-05 5229161 Dec-05 5229162 Dec-05 5229163 Dec-05 5229624 Dec-05 5229625 Dec-05 5229626 Dec-05 5249426 Dec-05 5249427 Dec-05 5250896 Dec-05 5250898 Dec-05 5251019 Dec-05 5251020 Dec-05 5251021 Dec-05 5251022 Dec-05 5251023 Dec-05 5258508 Dec-05 5258509 Dec-05 5261262 Dec-05 5263579 Jan-06 5263580 Jan-06 5269873 Jan-06 5273205 Jan-06 5390615 Feb-06 5390617 Feb-06 5390618 Feb-06 4952035 Aug-05 4952423 Aug-05 4952426 Aug-05 4973761 Aug-05 4973762 Aug-05 4973777 Aug-05 4974101 Aug-05 4974104 Aug-05 4974106 Aug-05 4977061 Aug-05 4981708 Aug-05 4981710 Aug-05 4982118 Aug-05 4982339 Aug-05 4982859 Aug-05 4982860 Aug-05 4992415 Aug-05 4992416 Aug-05 4992418 Aug-05 4992499 Aug-05 5142559 Nov-05 5142560 Nov-05 5163914 Nov-05 5163915 Nov-05 5163916 Nov-05 5163917 Nov-05 5184881 Nov-05 5184883 Nov-05 5184894 Nov-05 5186836 Nov-05 5186837 Nov-05 5186838 Nov-05 5186839 Nov-05 5190827 Nov-05 5190828 Nov-05 5190829 Nov-05 5225820 Dec-05 5225821 Dec-05 5231903 Dec-05 5231904 Dec-05 5231905 Dec-05 5231907 Dec-05 5236974 Dec-05 5236975 Dec-05 5252033 Dec-05 5252034 Dec-05 5252932 Dec-05 5252933 Dec-05 5252934 Dec-05 5253145 Dec-05 5253146 Dec-05 5253147 Dec-05 5256825 Dec-05 5256826 Dec-05 5256827 Dec-05 5263987 Jan-06 5263988 Jan-06 5350779 Feb-06 5350780 Feb-06 5359664 Feb-06 5359665 Feb-06 5359666 Feb-06 5359667 Feb-06 5365298 Feb-06 5365403 Feb-06 5365406 Feb-06 5365407 Feb-06 5372750 Feb-06 5372751 Feb-06 5372752 Feb-06 5374150 Feb-06 5374151 Feb-06 5374153 Feb-06 5424146 Mar-06 5424147 Mar-06 5424150 Mar-06 5425261 Mar-06 5425262 Mar-06 5425266 Mar-06 5425267 Mar-06 5425268 Mar-06 5425483 Mar-06 5433210 Apr-06 5433216 Mar-06 5485856 Apr-06 5485857 Apr-06 5485858 Apr-06 5485999 Apr-06 5486000 Apr-06 5486303 Apr-06 5492962 Apr-06 5492963 Apr-06 5492964 Apr-06 5495551 Apr-06 5495552 Apr-06 5513879 Apr-06 5513880 Apr-06 5513881 Apr-06 5513882 Apr-06 5513883 Apr-06 5527260 Apr-06 5527261 Apr-06 5532164 Apr-06 5532165 Apr-06 5532167 Apr-06 5543893 Apr-06 5556419 May-06 4972703 Aug-05 4973187 Aug-05 4973188 Aug-05 4984473 Aug-05 4984474 Aug-05 4984475 Aug-05 4985225 Aug-05 4985226 Aug-05 4985227 Aug-05 4985228 Aug-05 5126407 Oct-05 5126409 Oct-05 5126518 Oct-05 5126579 Oct-05 5126580 Oct-05 5145180 Nov-05 5145181 Nov-05 5161998 Nov-05 5162239 Nov-05 5162240 Nov-05 5168927 Nov-05 5168928 Nov-05 5183184 Nov-05 5183185 Nov-05 5183186 Nov-05 5183187 Nov-05 5195875 Nov-05 5195876 Nov-05 5195877 Nov-05 5196283 Nov-05 5209338 Dec-05 5209579 Nov-05 5209580 Nov-05 5236045 Dec-05 5236050 Dec-05 5236253 Dec-05 5239118 Dec-05 5239180 Dec-05 5245221 Dec-05 5245222 Dec-05 5252929 Dec-05 5252930 Dec-05 5252931 Dec-05 5253148 Dec-05 5253149 Dec-05 5254501 Dec-05 5254502 Dec-05 5359884 Feb-06 5369243 Feb-06 5369244 Feb-06 5369245 Feb-06 5369247 Feb-06 5369249 Feb-06 5377710 Feb-06 5377712 Feb-06 5377713 Feb-06 5378268 Feb-06 5383211 Feb-06 5383212 Feb-06 5413487 Mar-06 5413489 Mar-06 5413492 Mar-06 5485853 Apr-06 5485854 Apr-06 5485855 Apr-06 5492969 Apr-06 5493706 Apr-06 5493707 Apr-06 5493711 Apr-06 5535406 Apr-06 5542006 May-06 5542007 May-06 5556420 May-06 4953640 Aug-05 4953641 Aug-05 4966627 Sep-05 4966628 Aug-05 4966630 Aug-05 4991373 Aug-05 4991374 Aug-05 4991564 Aug-05 4991566 Aug-05 5000764 Aug-05 5000765 Aug-05 5000766 Aug-05 5001078 Aug-05 5001320 Aug-05 5001883 Aug-05 5195951 Nov-05 5195952 Nov-05 5209754 Nov-05 5210120 Dec-05 5245036 Dec-05 5245219 Dec-05 5245220 Dec-05 5252426 Dec-05 5252427 Dec-05 5252428 Jan-06 5252429 Dec-05 5252627 Dec-05 5252628 Dec-05 5252629 Dec-05 5252630 Dec-05 5254514 Dec-05 5270003 Jan-06 5270004 Jan-06 5270005 Jan-06 5340810 Feb-06 5340811 Feb-06 5351923 Feb-06 5513550 Apr-06 5525760 Apr-06 5559656 May-06 5559657 May-06 5572515 May-06 5572516 May-06 4975378 Aug-05 4975679 Aug-05 4992060 Aug-05 4992061 Aug-05 4992062 Aug-05 4992063 Aug-05 4992064 Aug-05 5210121 Dec-05 5230791 Dec-05 5230792 Dec-05 5230793 Dec-05 5230794 Dec-05 5234312 Dec-05 5234315 Dec-05 5243202 Dec-05 5243203 Dec-05 5243204 Dec-05 5259112 Dec-05 5270811 Jan-06 5323877 Jan-06 5323878 Jan-06 5324263 Jan-06 5338216 Feb-06 5338218 Feb-06 5338359 Feb-06 5340067 Feb-06 5340071 Feb-06 5340072 Feb-06 5493212 Apr-06 5503165 Apr-06 5503166 Apr-06 5526964 Apr-06 5526965 Apr-06 5542008 Apr-06 5542009 Apr-06
3.5 mm - Lot #'s/Expiration date: 4937807 Jul-05 4937808 Jul-05 4937809 Jul-05 4937810 Jul-05 4940248 Jul-05 4947918 Aug-05 4948020 Aug-05 4948459 Aug-05 4948460 Jul-05 4988546 Aug-05 4988547 Aug-05 4988548 Aug-05 5001882 Aug-05 5078645 Oct-05 5078646 Oct-05 5093324 Oct-05 5093325 Oct-05 5108755 Oct-05 5116331 Oct-05 5116332 Oct-05 5125277 Oct-05 5125278 Oct-05 5125859 Oct-05 5125860 Oct-05 5125861 Oct-05 5125862 Oct-05 5130990 Oct-05 5130991 Oct-05 5130992 Oct-05 5136970 Nov-05 5136971 Nov-05 5138976 Nov-05 5138978 Nov-05 5139770 Oct-05 5139771 Oct-05 5159074 Nov-05 5159075 Nov-05 5159076 Nov-05 5159077 Nov-05 5172248 Nov-05 5172249 Nov-05 5178055 Nov-05 5181010 Nov-05 5181011 Nov-05 5359887 Feb-06 5359888 Feb-06 5359889 Feb-06 5359890 Feb-06 5363485 Feb-06 5363486 Feb-06 5366155 Feb-06 5366156 Feb-06 5370212 Feb-06 5370565 Feb-06 5370566 Feb-06 5370567 Feb-06 5370568 Feb-06 5370569 Feb-06 5370570 Feb-06 5370571 Feb-06 5376870 Feb-06 5376904 Feb-06 5376905 Feb-06 5376909 Feb-06 5379406 Feb-06 5379410 Feb-06 5411910 Mar-06 5411911 Mar-06 5488950 Apr-06 5488951 Apr-06 5488952 Apr-06 5488953 Apr-06 5502828 Apr-06 5502829 Apr-06 5502830 Apr-06 5513439 Apr-06 5513829 Apr-06 5529687 Apr-06 5529688 Apr-06 5535325 Apr-06 5535326 Apr-06 5537864 Apr-06 5537866 Apr-06 5537867 Apr-06 5556059 May-06 5556060 May-06 4936710 Jul-05 4936711 Jul-05 4936712 Jul-05 4945917 Jul-05 4946059 Jul-05 4946060 Jul-05 4946061 Jul-05 4948905 Jul-05 4948906 Jul-05 4950157 Aug-05 4950158 Aug-05 4971205 Aug-05 4971206 Aug-05 4977376 Aug-05 4977377 Aug-05 4977378 Aug-05 4977399 Aug-05 4993455 Aug-05 4993862 Aug-05 5081090 Oct-05 5081092 Oct-05 5088614 Oct-05 5088615 Oct-05 5088616 Oct-05 5088617 Oct-05 5088659 Oct-05 5088661 Oct-05 5088662 Oct-05 5094743 Oct-05 5107019 Oct-05 5107022 Oct-05 5107032 Oct-05 5107034 Oct-05 5108622 Oct-05 5108623 Oct-05 5108632 Oct-05 5112778 Oct-05 5116854 Oct-05 5122143 Oct-05 5122144 Oct-05 5122145 Oct-05 5122147 Oct-05 5122150 Oct-05 5124960 Oct-05 5129405 Nov-05 5129407 Nov-05 5129408 Oct-05 5129833 Oct-05 5129834 Oct-05 5137152 Oct-05 5137153 Oct-05 5139767 Nov-05 5139768 Nov-05 5142249 Nov-05 5142250 Nov-05 5160504 Nov-05 5160505 Nov-05 5160622 Nov-05 5160625 Nov-05 5168263 Nov-05 5168264 Nov-05 5168276 Nov-05 5168278 Nov-05 5168419 Nov-05 5168420 Nov-05 5175350 Nov-05 5175351 Nov-05 5175352 Nov-05 5178424 Nov-05 5195703 Nov-05 5195704 Nov-05 5195705 Nov-05 5229527 Dec-05 5229528 Dec-05 5229529 Dec-05 5229530 Dec-05 5236422 Dec-05 5236423 Dec-05 5236424 Dec-05 5236425 Dec-05 5390754 Mar-06 5390756 Feb-06 5390757 Feb-06 4936555 Jul-05 4936557 Jul-05 4936698 Jul-05 4936699 Jul-05 4936701 Jul-05 4942856 Jul-05 4942857 Jul-05 4942858 Jul-05 4949700 Jul-05 4949701 Jul-05 4949703 Aug-05 4949704 Jul-05 4950148 Aug-05 4950149 Aug-05 4971207 Aug-05 4971208 Aug-05 4973574 Aug-05 4976770 Aug-05 4976772 Aug-05 4976945 Aug-05 4976946 Aug-05 4976949 Aug-05 5002025 Aug-05 5002027 Aug-05 5106081 Oct-05 5106084 Oct-05 5106085 Oct-05 5106086 Oct-05 5107114 Oct-05 5107115 Oct-05 5107117 Oct-05 5107219 Oct-05 5116940 Oct-05 5116942 Oct-05 5121466 Oct-05 5121467 Oct-05 5125489 Oct-05 5125490 Oct-05 5125491 Oct-05 5128895 Nov-05 5128896 Oct-05 5128897 Nov-05 5131270 Nov-05 5137157 Nov-05 5137158 Nov-05 5138966 Oct-05 5138967 Nov-05 5138968 Nov-05 5138969 Nov-05 5156528 Nov-05 5156535 Nov-05 5156643 Nov-05 5161703 Nov-05 5167187 Nov-05 5167193 Nov-05 5167237 Nov-05 5167320 Nov-05 5183325 Nov-05 5183326 Nov-05 5183327 Nov-05 5185128 Nov-05 5185129 Nov-05 5185427 Nov-05 5202765 Nov-05 5202766 Nov-05 5202768 Nov-05 5202769 Nov-05 5209843 Nov-05 5209845 Nov-05 5209846 Nov-05 5209847 Dec-05 5236614 Dec-05 5236615 Dec-05 5236618 Dec-05 5236641 Dec-05 5236642 Dec-05 5236643 Dec-05 5236645 Dec-05 5264539 Jan-06 5264547 Jan-06 5264548 Jan-06 5269555 Jan-06 5273207 Jan-06 5390745 Feb-06 5390749 Feb-06 5390750 Feb-06 5448558 Mar-06 4948617 Aug-05 4948618 Aug-05 4948739 Aug-05 4948740 Aug-05 4971218 Aug-05 4971419 Sep-05 4979302 Aug-05 4979303 Aug-05 4979450 Aug-05 4979608 Aug-05 4979641 Aug-05 4979644 Aug-05 4979799 Aug-05 4979811 Aug-05 4985603 Aug-05 5002493 Aug-05 5002626 Aug-05 5074192 Oct-05 5074193 Oct-05 5074194 Oct-05 5074196 Oct-05 5076264 Oct-05 5076267 Oct-05 5076291 Oct-05 5081767 Oct-05 5081768 Oct-05 5081769 Oct-05 5081776 Oct-05 5160116 Nov-05 5160117 Nov-05 5160278 Nov-05 5172251 Nov-05 5172252 Nov-05 5174206 Nov-05 5174207 Nov-05 5174209 Nov-05 5174395 Nov-05 5181297 Nov-05 5181298 Nov-05 5181379 Nov-05 5181380 Nov-05 5181381 Nov-05 5195953 Nov-05 5195955 Nov-05 5236977 Dec-05 5236999 Dec-05 5237000 Dec-05 5351920 Feb-06 5351921 Feb-06 5351922 Feb-06 5359661 Feb-06 5359662 Feb-06 5359663 Feb-06 5366465 Feb-06 5366656 Feb-06 5366657 Feb-06 5368628 Feb-06 5368632 Feb-06 5368635 Feb-06 5368659 Feb-06 5427353 Mar-06 5427354 Mar-06 5427355 Mar-06 5427356 Mar-06 5427357 Mar-06 5427358 Mar-06 5427379 Mar-06 5427380 Mar-06 5427381 Mar-06 5427382 Mar-06 5501098 Apr-06 5501159 Apr-06 5501160 Apr-06 5501163 Apr-06 5501167 Apr-06 5532170 Apr-06 5532171 Apr-06 5532173 Apr-06 5543898 Apr-06 4970425 Aug-05 4970426 Aug-05 4970427 Aug-05 4977410 Aug-05 4977411 Aug-05 4977412 Aug-05 4977413 Aug-05 4988553 Aug-05 4988555 Aug-05 4988556 Aug-05 5076918 Oct-05 5077219 Oct-05 5077220 Oct-05 5080213 Oct-05 5080214 Oct-05 5155652 Nov-05 5155653 Nov-05 5155654 Nov-05 5171746 Nov-05 5172154 Nov-05 5172155 Nov-05 5172679 Nov-05 5173024 Nov-05 5173025 Nov-05 5173026 Nov-05 5173027 Nov-05 5231909 Dec-05 5231968 Dec-05 5251034 Dec-05 5251035 Dec-05 5251036 Dec-05 5255240 Dec-05 5255241 Dec-05 5255242 Dec-05 5255503 Jan-06 5255504 Dec-05 5256828 Dec-05 5256829 Dec-05 5359659 Feb-06 5378420 Feb-06 5378422 Feb-06 5378424 Feb-06 5378426 Feb-06 5378428 Feb-06 5493178 Apr-06 5493200 Apr-06 5495234 Apr-06 5497225 Apr-06 5497227 Apr-06 5513827 Apr-06 5513828 Apr-06 5529691 Apr-06 5529694 Apr-06 5529695 Apr-06 5556461 May-06 4940044 Jul-05 4940045 Jul-05 4950373 Aug-05 4950375 Aug-05 4971420 Aug-05 4971421 Aug-05 4977607 Aug-05 4977608 Aug-05 4989032 Aug-05 5002689 Sep-05 5077223 Oct-05 5080209 Oct-05 5233238 Dec-05 5233399 Dec-05 5233400 Dec-05 5254516 Dec-05 5255651 Dec-05 5267773 Jan-06 5270714 Jan-06 5280856 Jan-06 5280857 Jan-06 5290853 Jan-06 5342441 Feb-06 5342442 Feb-06 5342444 Feb-06 5342445 Feb-06 5342446 Feb-06 5353109 Feb-06 5353110 Feb-06 5353111 Feb-06 5505765 Apr-06 5505766 Apr-06 5525901 Apr-06 4950807 Aug-05 4950808 Aug-05 4950965 Aug-05 4973181 Aug-05 4973184 Aug-05 4982874 Aug-05 4982875 Aug-05 4982939 Aug-05 4982943 Aug-05 5272761 Jan-06 5308664 Jan-06 5308665 Jan-06 5320077 Jan-06 5320159 Jan-06 5321237 Jan-06 5321238 Jan-06 5338373 Feb-06 5338375 Feb-06 5352001 Feb-06 5352002 Feb-06 5353148 Feb-06 5353206 Feb-06 5353208 Feb-06
4.0 mm , Lot #'s/Expiration date: 4938926 Jul-05 4938928 Jul-05 4938991 Jul-05 4939141 Jul-05 4939142 Jul-05 4948940 Aug-05 4948941 Aug-05 4948942 Aug-05 4951682 Aug-05 4951683 Aug-05 4972512 Aug-05 4979814 Aug-05 5080216 Oct-05 5108753 Oct-05 5108754 Oct-05 5125570 Oct-05 5125572 Oct-05 5125573 Oct-05 5131866 Oct-05 5131867 Nov-05 5131868 Oct-05 5131971 Oct-05 5157097 Nov-05 5164059 Nov-05 5164087 Nov-05 5190826 Nov-05 5195455 Nov-05 5195456 Nov-05 5195457 Nov-05 5195458 Nov-05 5215028 Dec-05 5224845 Dec-05 5234306 Dec-05 5249239 Dec-05 5249240 Dec-05 5250525 Dec-05 5272942 Jan-06 5277162 Jan-06 5285407 Jan-06 5285408 Jan-06 5290724 Jan-06 5301463 Jan-06 5301464 Jan-06 5301465 Jan-06 5321365 Jan-06 5321367 Jan-06 5321368 Jan-06 5324663 Jan-06 5324664 Jan-06 5324665 Jan-06 5372747 Feb-06 5372748 Feb-06 5372749 Feb-06 5376215 Feb-06 5376216 Feb-06 5376217 Feb-06 5420918 Mar-06 5427019 Mar-06 5427020 Mar-06 5432945 Mar-06 5489054 Apr-06 5489055 Apr-06 5489056 Apr-06 5506859 Apr-06 5506861 Apr-06 5506862 Apr-06 5537354 Apr-06 5544325 Apr-06 4936970 Jul-05 4936971 Jul-05 4936972 Jul-05 4945899 Aug-05 4945900 Aug-05 4945901 Aug-05 4945902 Aug-05 4972513 Aug-05 4977401 Aug-05 4977402 Aug-05 4989031 Aug-05 4990555 Aug-05 4990556 Aug-05 5078738 Oct-05 5078840 Oct-05 5078858 Oct-05 5126844 Oct-05 5126846 Oct-05 5126847 Nov-05 5126848 Oct-05 5126849 Oct-05 5128888 Oct-05 5128889 Oct-05 5128890 Nov-05 5128891 Oct-05 5131575 Oct-05 5158211 Nov-05 5158212 Nov-05 5164088 Nov-05 5169153 Nov-05 5188270 Nov-05 5188275 Nov-05 5188363 Nov-05 5188366 Nov-05 5203725 Nov-05 5206977 Nov-05 5208041 Nov-05 5208042 Dec-05 5212625 Dec-05 5212629 Dec-05 5212632 Dec-05 5223428 Dec-05 5223429 Dec-05 5223430 Dec-05 5225169 Dec-05 5225172 Dec-05 5226017 Dec-05 5233846 Dec-05 5233849 Dec-05 5233851 Dec-05 5255658 Dec-05 5267548 Jan-06 5274214 Jan-06 5274322 Jan-06 5274325 Jan-06 5274327 Jan-06 5274328 Jan-06 5274330 Jan-06 5301243 Jan-06 5301244 Jan-06 5301245 Jan-06 5301246 Jan-06 5307884 Jan-06 5307885 Jan-06 5307886 Jan-06 5307887 Jan-06 5313274 Jan-06 5313275 Jan-06 5313276 Jan-06 5323759 Jan-06 5323760 Jan-06 5323761 Jan-06 5324381 Jan-06 5336247 Feb-06 5336248 Feb-06 5336249 Feb-06 5336250 Feb-06 5336253 Feb-06 5372585 Feb-06 5372586 Feb-06 5372587 Feb-06 5372592 Feb-06 5372593 Feb-06 5390077 Feb-06 5390220 Mar-06 5390221 Feb-06 5390222 Mar-06 5390228 Mar-06 5419743 Mar-06 5419744 Mar-06 5419745 Mar-06 5419746 Mar-06 5419748 Mar-06 5495188 Apr-06 5495189 Apr-06 5506769 Apr-06 5506770 Apr-06 5506771 Apr-06 5529698 Apr-06 5529779 Apr-06 5529783 Apr-06 5529784 Apr-06 5529785 Apr-06 5529786 Apr-06 5529787 Apr-06 5529792 Apr-06 5543620 Apr-06 5543622 Apr-06 5543626 May-06 5543768 Apr-06 5543770 Apr-06 5543772 Apr-06 4939148 Jul-05 4939157 Jul-05 4939158 Jul-05 4939352 Jul-05 4939353 Jul-05 4947115 Jul-05 4947116 Jul-05 4947369 Jul-05 4947370 Aug-05 4965393 Aug-05 5079104 Oct-05 5079105 Oct-05 5079118 Oct-05 5079300 Oct-05 5079308 Oct-05 5085925 Oct-05 5085927 Oct-05 5085928 Oct-05 5085929 Oct-05 5085930 Oct-05 5156154 Nov-05 5157329 Nov-05 5157330 Nov-05 5157331 Nov-05 5164089 Nov-05 5171747 Nov-05 5171748 Nov-05 5172150 Nov-05 5172151 Nov-05 5173350 Nov-05 5173354 Nov-05 5184714 Nov-05 5184716 Nov-05 5184799 Nov-05 5184814 Nov-05 5184815 Nov-05 5193338 Nov-05 5193619 Nov-05 5193620 Nov-05 5239512 Dec-05 5239513 Dec-05 5242447 Dec-05 5248808 Dec-05 5248809 Dec-05 5248810 Dec-05 5248811 Dec-05 5248812 Dec-05 5253156 Dec-05 5253157 Dec-05 5253379 Dec-05 5253382 Dec-05 5257327 Dec-05 5300234 Jan-06 5300235 Jan-06 5300236 Jan-06 5305180 Jan-06 5305181 Jan-06 5305183 Jan-06 5305187 Jan-06 5305190 Jan-06 5308667 Jan-06 5308669 Jan-06 5322684 Jan-06 5322685 Jan-06 5327745 Feb-06 5327747 Jan-06 5341832 Feb-06 5341833 Feb-06 5341834 Feb-06 5341835 Feb-06 5362765 Feb-06 5373788 Feb-06 5382902 Mar-06 5382903 Feb-06 5382905 Feb-06 5382906 Mar-06 5382910 Mar-06 5382911 Feb-06 5411637 Mar-06 5411740 Mar-06 5427022 Mar-06 5427023 Mar-06 5495222 Apr-06 5495223 Apr-06 5495224 Apr-06 5495225 Apr-06 5506942 Apr-06 5529979 Apr-06 5529980 Apr-06 5529981 Apr-06 5542004 May-06 5542005 Apr-06 5556056 May-06 5556057 May-06 4939756 Jul-05 4939757 Jul-05 4939758 Jul-05 4951129 Aug-05 4951130 Aug-05 4963299 Aug-05 4963300 Aug-05 4980126 Aug-05 4980127 Aug-05 4980128 Aug-05 4980130 Aug-05 4991127 Aug-05 4991128 Aug-05 4991187 Aug-05 5086452 Oct-05 5086453 Oct-05 5167327 Nov-05 5167331 Nov-05 5178226 Nov-05 5178362 Nov-05 5209589 Dec-05 5209590 Dec-05 5209591 Dec-05 5209592 Dec-05 5240571 Dec-05 5240572 Dec-05 5240573 Dec-05 5275842 Jan-06 5275844 Jan-06 5276062 Jan-06 5308519 Jan-06 5308520 Jan-06 5308521 Jan-06 5308522 Jan-06 5308523 Jan-06 5318850 Jan-06 5318852 Jan-06 5318853 Feb-06 5326751 Jan-06 5326754 Feb-06 5341862 Feb-06 5341863 Feb-06 5341864 Feb-06 5370214 Feb-06 5417507 Mar-06 5417509 Mar-06 5417512 Mar-06 5513543 Apr-06 5513547 Apr-06 5529869 Apr-06 5543891 Apr-06 4939502 Jul-05 4939748 Jul-05 4951351 Aug-05 4971518 Aug-05 4971819 Sep-05 4977414 Aug-05 4977415 Aug-05 5080203 Oct-05 5080204 Oct-05 5116334 Oct-05 5129409 Nov-05 5130980 Oct-05 5158446 Nov-05 5162275 Nov-05 5162276 Nov-05 5177547 Nov-05 5177548 Nov-05 5236142 Dec-05 5243209 Dec-05 5250699 Dec-05 5250700 Dec-05 5268961 Jan-06 5272911 Jan-06 5290064 Jan-06 5290065 Jan-06 5290066 Jan-06 5290850 Jan-06 5324157 Feb-06 5324158 Jan-06 5374603 Mar-06 5374604 Mar-06 5376659 Feb-06 5432028 Mar-06 5492976 Apr-06 5495235 Apr-06 5513353 Apr-06 5544120 May-06 4939743 Jul-05 4939745 Jul-05 4972517 Aug-05 4977612 Sep-05 4977613 Aug-05 4977615 Aug-05 4989033 Aug-05 4989034 Aug-05 5234304 Dec-05 5234305 Dec-05 5268962 Jan-06 5272762 Jan-06 5273208 Jan-06 5340517 Feb-06 5340560 Feb-06 5340562 Feb-06 5340566 Feb-06 5340567 Feb-06 5492437 Apr-06 5492438 Apr-06 5505767 Apr-06 5529689 Apr-06 5529690 Apr-06 5533694 Apr-06 5069679 Oct-05 5069802 Oct-05 5069803 Oct-05 5069807 Oct-05 5069808 Oct-05 5081249 Oct-05 5081250 Oct-05 5243205 Dec-05 5243207 Dec-05 5268960 Jan-06 5324261 Jan-06 5324262 Jan-06 5347958 Feb-06 5348000 Feb-06 5348002 Feb-06 5492491 Apr-06 5503167 Apr-06 5529868 Apr-06 5544324 May-06
4.5 mm , Lot #'s/Expiration date: 5067633 Oct-05 5067952 Oct-05 5067953 Oct-05 5067954 Oct-05 5071207 Oct-05 5071209 Oct-05 5095061 Oct-05 5095063 Oct-05 5095064 Oct-05 5095066 Oct-05 5095068 Oct-05 5095069 Oct-05 5095070 Oct-05 5285734 Jan-06 5285735 Jan-06 5310959 Jan-06 5315924 Jan-06 5321529 Jan-06 5321530 Jan-06 5321532 Jan-06 5420902 Mar-06 5420904 Mar-06 5420906 Mar-06 5482737 Apr-06 5511878 Apr-06 5544985 May-06 5067917 Oct-05 5067918 Oct-05 5068259 Oct-05 5068260 Oct-05 5070730 Oct-05 5097887 Oct-05 5097889 Oct-05 5097890 Oct-05 5097891 Oct-05 5141243 Nov-05 5141246 Nov-05 5142572 Nov-05 5285411 Jan-06 5285414 Jan-06 5290068 Jan-06 5321235 Jan-06 5321236 Jan-06 5359879 Feb-06 5359880 Feb-06 5362761 Feb-06 5376635 Mar-06 5376636 Feb-06 5411161 Mar-06 5417191 Mar-06 5495232 Apr-06 5529697 Apr-06 5534501 Apr-06 5534502 Apr-06 5534503 May-06 5068782 Oct-05 5068783 Oct-05 5068784 Oct-05 5068786 Oct-05 5094563 Oct-05 5094564 Oct-05 5094567 Oct-05 5094568 Oct-05 5131978 Oct-05 5132200 Nov-05 5132203 Oct-05 5263215 Jan-06 5373937 Feb-06 5376637 Feb-06 5482769 Apr-06 5492489 Apr-06 5529745 Apr-06 5529746 Apr-06 5077221 Oct-05 5077222 Oct-05 5095321 Oct-05 5095333 Oct-05 5142573 Nov-05 5269556 Jan-06 5269557 Jan-06 5290851 Jan-06 5320837 Jan-06 5359883 Feb-06 5374601 Feb-06 5529744 Apr-06 5535410 Apr-06 5544983 May-06 5069189 Oct-05 5069190 Oct-05 5069331 Oct-05 5069332 Oct-05 5095334 Oct-05 5096199 Oct-05 5096200 Oct-05 5349106 Feb-06 5349107 Feb-06 5429990 Mar-06 5429991 Mar-06 5492492 Apr-06 5513351 Apr-06 5513835 Apr-06 5070102 Oct-05 5070103 Oct-05 5070109 Oct-05 5376638 Mar-06 5429993 Mar-06 5492970 Apr-06
5.0 mm - Lot #'s/Expiration date: 5098665 Oct-05 5098666 Oct-05 5098667 Oct-05 5142577 Nov-05 5151186 Nov-05 5215027 Dec-05 5226015 Dec-05 5251037 Dec-05 5251119 Dec-05 5286298 Jan-06 5286381 Jan-06 5324032 Jan-06 5324033 Jan-06 5324034 Jan-06 5362764 Feb-06 5480319 Apr-06 5480321 Apr-06 5495221 Apr-06 5529742 Apr-06 5529743 Apr-06 5544984 May-06 5545843 May-06 5072556 Oct-05 5072557 Oct-05 5072558 Oct-05 5073462 Oct-05 5073463 Oct-05 5097892 Oct-05 5145194 Nov-05 5206978 Dec-05 5248171 Dec-05 5267771 Jan-06 5286552 Jan-06 5286553 Jan-06 5307284 Jan-06 5313277 Jan-06 5313278 Jan-06 5313459 Jan-06 5413381 Mar-06 5413382 Mar-06 5417190 Mar-06 5070347 Oct-05 5070348 Oct-05 5070349 Oct-05 5070350 Oct-05 5070351 Oct-05 5073464 Oct-05 5073465 Oct-05 5073466 Oct-05 5096878 Oct-05 5314258 Jan-06 5314280 Jan-06 5359557 Feb-06 5359558 Feb-06 5370216 Feb-06 5382900 Feb-06 5511217 Apr-06 5340573 Feb-06 5340574 Feb-06 5340577 Feb-06 5349108 Feb-06 5428029 Mar-06 5503169 Apr-06 5342112 Feb-06 5342113 Feb-06 5342114 Feb-06 5513836 Apr-06.
RECALLING FIRM/MANUFACTURER
Boston Scientific Scimed, Maple Grove, MN, by letter on July 16, 2004. Firm initiated recall is ongoing.
REASON
Due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure. Problem is exhibited on implantation. Stent should perform as intended after successful implantation.
VOLUME OF PRODUCT IN COMMERCE
11,000.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

*****CORRECTION*****

Enforcement Report 04-26 for June 30, 2004, Recall # Z-1033/1034-04, has been modified. The recall is Firm initiated recall not FDA initiated recall.
______________________________
PRODUCT
a) Cook brand Zenith AAA Converter with the H&L-B One-Shot
Introducer System, preloaded converter - proximal
diameter 24 mm - distal diameter 12 mm - length 80 mm;
Reorder no. ESC-24-12-80. Recall # Z-1160-04;
b) Cook brand Zenith AAA Endovascular Graft Iliac Leg
Extensions - diameter 14 mm - length 55 mm -introducer
sheath size 14 FR; Reorder no. ESLE-14-55-TAG. Recall
# Z-1161-04;
c) Cook brand Reorder # PLVTW-14.0-38-30-BNS. Silhouette Transitionless Peel-Away Introducer. Recall # Z-1162-04;
d) Cook brand Zenith AAA Bifurcated main body graft with
the H&L-B One-Shot Introducer System, preloaded
bifurcated main body graft - aortic graft diameter 22
mm - iliac leg diameters 11 mm - main body lengths
contralateral limb 103mm ipsilateral limb 133 mm ,
delivery system 18 FR; Catalog no. TFB-22-103.
Recall # Z-1163-04;
e) Cook brand Zenith AAA Bifurcated main body graft with
the H&L-B One-Shot Introducer System, preloaded
bifurcated main body graft - aortic graft diameter 22
mm - iliac leg diameters 11 mm - main body lengths
contralateral limb 74mm ipsilateral limb 133 mm ,
delivery system 18 FR; Catalog no. TFB-22-74.
Recall # Z-1164-04;
f) Cook brand Zenith AAA Bifurcated main body graft with
the H&L-B One-Shot Introducer System, preloaded
bifurcated main body graft - aortic graft diameter
22 mm - iliac leg diameters 11 mm - main body lengths
contralateral limb 88mm ipsilateral limb 133 mm ,
delivery system 18 FR; Catalog no. TFB-22-88.
Recall # Z-1165-04;
g) Cook brand Zenith AAA Bifurcated main body graft with
the H&L-B One-Shot Introducer System, preloaded
bifurcated main body graft - aortic graft diameter 24
mm - iliac leg diameters 11 mm - main body lengths
contralateral limb 103mm ipsilateral limb 133 mm ,
delivery system 18 FR; Catalog no. TFB-24-103. Recall
# Z-1166-04;
h) Cook brand Zenith AAA Bifurcated main body graft with
the H&L-B One-Shot Introducer System, preloaded
bifurcated main body graft - aortic graft diameter
24 mm - iliac leg diameters 11 mm - main body lengths
contralateral limb 117 mm ipsilateral limb 133 mm ,
delivery system 18 FR; Catalog no. TFB-24-117.
Recall # Z-1167-04;
i) Cook brand Zenith AAA Bifurcated main body graft with
the H&L-B One-Shot Introducer System, preloaded
bifurcated main body graft - aortic graft diameter
24 mm - iliac leg diameters 11 mm - main body lengths
contralateral limb 132mm ipsilateral limb 133 mm ,
delivery system 18 FR; Catalog no. TFB-24-132.
Recall # Z-1168-04;
j) Cook brand Zenith AAA Bifurcated main body graft with
the H&L-B One-Shot Introducer System, preloaded
bifurcated main body graft - aortic graft diameter
24 mm - iliac leg diameters 11 mm - main body lengths
contralateral limb 74mm ipsilateral limb 133 mm ,
delivery system 18 FR; Catalog no. TFB-24-74. Recall
# Z-1169-04;
k) Cook brand Zenith AAA Bifurcated main body graft with
the H&L-B One-Shot Introducer System, preloaded
bifurcated main body graft - aortic graft diameter 24
mm - iliac leg diameters 11 mm - main body lengths
contralateral limb 88mm ipsilateral limb 133 mm ,
delivery system 18 FR; Catalog no. TFB-24-88. Recall
# Z-1170-04;
l) Cook brand Zenith AAA Bifurcated main body graft with
the H&L-B One-Shot Introducer System, preloaded
bifurcated main body graft - aortic graft diameter
26 mm - iliac leg diameters 11 mm - main body lengths
contralateral limb 103mm ipsilateral limb 133 mm ,
delivery system 18 FR; Catalog no. TFB-26-103.
Recall # Z-1171-04;
m) Cook brand Zenith AAA Bifurcated main body graft with
the H&L-B One-Shot Introducer System, preloaded
bifurcated main body graft - aortic graft diameter
26 mm - iliac leg diameters 11 mm - main body lengths
contralateral limb 117mm ipsilateral limb 133 mm ,
delivery system 18 FR; Catalog no. TFB-26-117.
Recall # Z-1172-04;
n) Cook brand Zenith AAA Bifurcated main body graft with
the H&L-B One-Shot Introducer System, preloaded
bifurcated main body graft - aortic graft diameter
26 mm - iliac leg diameters 11 mm - main body length
contralateral limb 132mm ipsilateral limb 133 mm ,
delivery system 18 FR; Catalog no. TFB-26-132.
Recall # Z-1173-04;
o) Cook brand Zenith AAA Bifurcated main body graft with
the H&L-B One-Shot Introducer System, preloaded
bifurcated main body graft - aortic graft diameter
26 mm - iliac leg diameters 11 mm - main body lengths
contralateral limb 74mm ipsilateral limb 133 mm ,
delivery system 18 FR; Catalog no. TFB-26-74.
Recall # Z-1174-04;
p) Cook brand Zenith AAA Bifurcated main body graft
with the H&L-B One-Shot Introducer System,
preloaded bifurcated main body graft - aortic
graft diameter 26 mm - iliac leg diameters 11 mm ,
main body lengths contralateral limb 88mm ipsilateral
limb 133 mm - delivery system 18 FR; Catalog no.
TFB-26-88. Recall # Z-1175-04;
q) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 10 mm - usable
length 105mm - delivery system 14 FR; Catalog no.
TFLE-10-105. Recall # Z-1176-04;
r) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 10 mm - usable
length 122mm - delivery system 14 FR; Catalog no.
TFLE-10-122. Recall # Z-1177-04;
s) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 10 mm - usable
length 37mm - delivery system 14 FR; Catalog no.
TFLE-10-37. Recall # Z-1178-04;
t) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 10 mm - usable
length 54mm - delivery system 14 FR; Catalog no.
TFLE-10-54. Recall # Z-1179-04;
u) Cook brand Zenith AAA Iliac leg graft with
the H&L-B One-Shot Introducer System, preloaded
iliac leg graft - distal cuff diameter 10 mm ,
usable length 71mm - delivery system 14 FR;
Catalog no. TFLE-10-71. Recall # Z-1180-04;
v) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 10 mm - usable
length 88mm - delivery system 14 FR; Catalog no.
TFLE-10-88. Recall # Z-1181-04;
w) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 12 mm - usable
length 105mm - delivery system 14 FR; Catalog no.
TFLE-12-105. Recall # Z-1182-04;
x) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 12 mm - usable
length 122mm - delivery system 14 FR; Catalog no.
TFLE-12-122. Recall # Z-1183-04;
y) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 12 mm - usable
length 37mm - delivery system 14 FR; Catalog no.
TFLE-12-37. Recall # Z-1184-04;
z) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 12 mm - usable
length 54mm - delivery system 14 FR; Catalog no.
TFLE-12-54. Recall # Z-1185-04;
aa) Cook brand Zenith AAA Iliac leg graft with
the H&L-B One-Shot Introducer System, preloaded
iliac leg graft - distal cuff diameter 12 mm ,
usable length 71mm - delivery system 14 FR;
Catalog no. TFLE-12-71. Recall # Z-1186-04;
bb) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 12 mm - usable
length 88mm - delivery system 14 FR; Catalog no.
TFLE-12-88. Recall # Z-1187-04;
cc) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 14 mm - usable
length 37mm - delivery system 14 FR; Catalog no.
TFLE-14-37. Recall # Z-1188-04;
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 14mm - usable
length 54mm - delivery system 14 FR; Catalog no.
TFLE-14-54. Recall # Z-1189-04;
ee) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 14 mm - usable
length 71mm - delivery system 14 FR; Catalog no.
TFLE-14-71. Recall # Z-1190-04;
ff) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 14mm - usable
length 88mm - delivery system 14 FR; Catalog no.
TFLE-14-88. Recall # Z-1191-04;
gg) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 16 mm - usable
length 37mm - delivery system 14 FR; Catalog no.
TFLE-16-37. Recall # Z-1192-04;
hh) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 16 mm - usable
length 54mm - delivery system 14 FR; Catalog no.
TFLE-16-54. Recall # Z-1193-04;
ii) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 16 mm - usable
length 71mm - delivery system 14 FR; Catalog no.
TFLE-16-71. Recall # Z-1194-04;
jj) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 16 mm - usable
length 88mm - delivery system 14 FR; Catalog no.
TFLE-16-88. Recall # Z-1195-04;
kk) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 18 mm - usable
length 37mm - delivery system 16 FR; Catalog no.
TFLE-18-37. Recall # Z-1196-04;
ll) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 18 mm - usable
length 54mm - delivery system 16 FR; Catalog no.
TFLE-18-54. Recall # Z-1197-04;
mm) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 18 mm - usable
length 71mm - delivery system 16 FR; Catalog no.
TFLE-18-71. Recall # Z-1198-04;
nn) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 18 mm - usable
length 88mm - delivery system 16 FR; Catalog no.
TFLE-18-88. Recall # Z-1199-04;
oo) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 20 mm - usable
length 37mm - delivery system 16 FR; Catalog no.
TFLE-20-37. Recall # Z-1200-04;
pp) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 20 mm - usable
length 54mm - delivery system 16 FR; Catalog no.
TFLE-20-54. Recall # Z-1201-04;
qq) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 20 mm - usable
length 71mm - delivery system 16 FR; Catalog no.
TFLE-20-71. Recall # Z-1202-04;
rr) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One-Shot Introducer System, preloaded iliac
leg graft - distal cuff diameter 20 mm - usable
length 88mm - delivery system 16 FR; Catalog no.
TFLE-20-88. Recall # Z-1203-04;
ss) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One Shot Introducer System, Preloaded iliac
leg graft , distal cuff diameter 22 mm , usable
length 37mm , delivery system 16 FR; Catalog no.
TFLE-22-37. Recall # Z-1204-04;
tt) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One Shot Introducer System, Preloaded iliac
leg graft , distal cuff diameter 22 mm , usable
length 54mm , delivery system 16 FR; Catalog no.
TFLE-22-54. Recall # Z-1205-04;
uu) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One Shot Introducer System, Preloaded iliac
leg graft , distal cuff diameter 22 mm , usable
length 71mm , delivery system 16 FR; Catalog no.
TFLE-22-71. Recall # Z-1206-04;
vv) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One Shot Introducer System, Preloaded iliac
leg graft , distal cuff diameter 22 mm , usable
length 88mm , delivery system 16 FR; Catalog no.
TFLE-22-88. Recall # Z-1207-04;
ww) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One Shot Introducer System, Preloaded iliac
leg graft , distal cuff diameter 24 mm , usable
length 37mm , delivery system 16 FR; Catalog no.
TFLE-24-37. Recall # Z-1208-04;
xx) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One Shot Introducer System, Preloaded iliac
leg graft , distal cuff diameter 24 mm , usable
length 54mm , delivery system 16 FR; Catalog no.
TFLE-24-54. Recall # Z-1209-04;
yy) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One Shot Introducer System, Preloaded iliac
leg graft , distal cuff diameter 24 mm , usable
length 71mm , delivery system 16 FR; Catalog no.
TFLE-24-71. Recall # Z-1210-04;
zz) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One Shot Introducer System, Preloaded iliac
leg graft , distal cuff diameter 24 mm , usable
length 88mm , delivery system 16 FR; Catalog no.
TFLE-24-88. Recall # Z-1211-04;
aaa) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One Shot Introducer System, Preloaded iliac
leg graft , distal cuff diameter 8 mm , usable
length 105mm , delivery system 14 FR; Catalog no.
TFLE-8-105. Recall # Z-1212-04;
bbb) Cook brand Zenith AAA Iliac leg graft with the
H&L-B One Shot Introducer System, Preloaded iliac
leg graft , distal cuff diameter 8 mm , usable
length 88mm , delivery system 14 FR; Catalog no.
TFLE-8-88. Recall # Z-1213-04;
ccc) Cook brand Keller-Timmermans Introducer Set,
straight with Rutner adapter includes: sheath
18.0 FR, 65 cm long without wire guide; Catalog no.
VSSW-18.0-38-65-0-KTI. Recall # Z-1214-04;
ddd) Cook brand Keller-Timmermans Introducer Set,
curved with Rutner adapter includes: sheath
18.0 FR, 85 cm long without wire guide; Catalog no.
VSSW-18.0-38-65-0-KTI-BNS. Recall # Z-1215-04;
eee) Cook brand Keller-Timmermans Introducer Set,
straight with Rutner adapter includes: sheath
18.0 FR, 85 cm long without wire guide; Catalog no.
VSSW-18.0-38-85-0-KTI. Recall # Z-1216-04;
fff) Cook brand Keller-Timmermans Introducer Set,
curved with Rutner adapter includes: sheath
18.0 FR, 85 cm long without wire guide; Catalog no.
VSSW-18.0-38-85-C-KTI. Recall # Z-1217-04;
ggg) Cook brand Zenith rupture main body graft,
preloaded graft measuring 22 mm diameter at
promial end and 12 mm diameter at distal end,
with the H&L-B One shot Introducer System,
non-sterile, export only for further processing;
Catalog no. ZRB-22-WCE. Recall # Z-1218-04;
hhh) Cook brand Zenith rupture main body graft,
preloaded graft measuring 26 mm diameter at
promial end and 12 mm diameter at distal end,
with the H&L-B One shot Introducer System,
non-sterile, export only for further processing;
Catalog no. ZRB-26-WCE. Recall # Z-1219-04.
CODE
a) Lots 1356524, 1356532, 1356519, 1356525, 1356523, 1356522
and 1356529;
b) Lot F1575173;
c) Lot F1581379;
d) Lots 1351975, F1563256, F1576435 and 1349754;
e) Lots F1545880, F1545881, F1555822, F1556920, F1560071 and
F1560072;
f) Lots 1349235, F1548657, F1545296, F1552607, F1548658,
F1552608, F1552609, F1552610, F1549743, F1549241,
F1560040, F1560039, F1560041, 1349236 and 1349237;
g) Lots 1348491, F1530610, F1535660, F1537428, F1537429,
F1537430, F1537431, F1539286, F1539287, F1539275,
F1548106, F1548107, F1541878, F1541879, F1546892,
F1550308, F1552063, F1550309, F1548073, F1554819,
F1548074, F1552064, F1554805, F1554806, F1554807,
F1550307, F1549747, F1555823, F1560055, F1559969,
F1562104, F1562105, F1562106, F1562107, F1562108,
F1562109, F1562085, F1562086, F1571599, F1571600,
F1572864, F1572865, F1571598, F1575127 and F1575129;
h) Lots F1538656, F1539277, F1539288, F1541887, F1552065,
F1541889, F1554812, F1554813, F1541888, F1563270 and
1342653;
i) Lot F1571627;
j) Lots 1352808, 1357063, F1537398, F1538637, F1539268,
F1541241, F1549741, F1543305, F1545887, F1553587,
F1560030, F1560031, F1565092, F1567916, F1565091,
F1570152, 1357066 and 1357065;
k) Lots 1364666, 1353961, 1367854, F1537400, F1537401,
F1538639, F1538638, F1537402, F1528735, F1541861,
F1539270, F1541860, F1541862, F1545882, F1545883,
F1543306, F1543307, F1542762, F1542763, F1542764,
F1542765, F1541863, F1541864, F1550301, F1550302,
F1550303, F1545884, F1556701, F1556702, F1546890,
F1548094, F1548095, F1554818, F1556700, F1565060,
F1565058, F1565059, F1567223, F1567224, F1567225,
F1572841, F1572842, F1572843, F1572844, F1575176,
F1575177, F1575115, F1575116, F1575117, 1353962,
1360730, 1363309 and 1343884;
l) Lots F1537433, F1538051, F1538050, F1538052,
F1537432, F1542776, F1543318, F1542777, F1538643,
F1538644, F1546894, F1543317, F1548659, F1548660,
F1546893, F1560057, F1548661, F1545886, F1543316,
F1560056, F1538645, F1560059, F1559970, F1565072,
F1560063, F1562087, F1565073, F1565074, F1562110,
F1562111, F1562088, F1567226, F1560060, F1560061,
F1568421, F1568422, F1570156, F1567227, F1567228,
F1567229, F1560062, F1571602, F1571603 and F1571601;
m) Lots 1336659, F1538657, F1538658, F1542748,
F1552614, F1552615, F1545297, F1554814, F1548665,
F1545298, F1542749, F1542750, F1542751, F1554815,
F1560087, F1562119, F1565100, F1565101, F1568425,
F1567914, F1567915, F1572879, F1572878, F1574755,
F1575142, 1323159 and 1351978;
n) Lots F1545891, F1541892, F1553589, F1549244,
F1548112, F1560064, F1560065 and F1560066;
O) Lots F1541242, F1548093, F1546888, F1549742,
F1548656, F1560035, F1554798, F1550300, F1560033,
F1560032, F1560034, F1563249, F1563250, F1567917,
F1567220, F1571588, F1575111 and F1575112;
p) Lots 1356570, 1352816, F1532289, F1530605,
F1530606, F1530607, F1530608, F1537420, F1537421,
F1535722, F1535723, F1532174, F1532175, F1537387,
F1541243, F1543309, F1538047, F1543310, F1538048,
F1538049, F1537422, F1537423, F1539271, F1539272,
F1543308, F1548065, F1548066, F1548067, F1546891,
F1549744, F1552056, F1548096, F1548097, F1548098,
F1552057, F1552059, F1556703, F1556705, F1556706,
F1554799, F1554800, F1554801, F1552058, F1556704,
F1560042, F1560043, F1560044, F1560046, F1560045,
F1565064, F1565094, F1565095, F1565096, F1565062,
F1567253, F1569227, F1565093, F1567905, F1567906,
F1567907, F1565063, F1570153, F1567252, F1567254,
F1572847, F1572849, F1572850, F1572851, F1571623,
F1572845, F1572846, F1572848, F1575180, F1575182,
F1575118, 1361941, 1356566, 1356572, 1356569,
1343123, 1349758, 1352814, 1361944, 1352811 and
1365178;
q) Lots F1564137, F1565736, F1569307, F1569229,
F1572912 and 1364190;
r) Lot F1575219;
s) Lots F1575186 and F1575187;
t) Lots F1571025, F1571026, F1572913 and
F1576461;
u) Lots 1367425, F1549282, F1555392, F1542425,
F1542426, F1542427, F1565796, F1572914, F1572915,
F1572916, F1572918, F1572919, F1572920, F1572921,
F1572922, F1572923, F1572924, F1572925, F1572926,
F1572927, F1572928, F1572929, 1367427, 1367426,
1363753 and 1363351;
v) Lot F1559007;
w) Lots 1366558, 1366557, F1548671, F1548672,
F1548673, F1552559, F1552558, F1552560, F1556413,
F1558972, F1556414, F1556415, F1559009, F1561366,
F1561367, F1559010, F1559011, F1564328, F1564329,
F1564330, F1564331, F1564332, F1564138, F1564139,
F1564140, F1564141, F1571027, F1564101, F1564102,
F1565783, F1565784, F1565785, F1564333, F1564334,
F1571028, F1571029, F1575220, F1575221, F1571558,
F1572934, F1572936, F1572935, 1366554 and 1366555;
x) Lots F1559013, F1556417, F1559012, F1559014,
F1559015, F1565737, F1565738, F1569231, F1569308,
F1569299, F1569300, F1570165, F1569230 and
F1571559;
y) Lots F1564335, F1564336, F1566686, F1566687,
F1566688, F1575226, F1575227, F1575228, F1572941,
F1572942, F1575278, F1575279, F1575280, F1575281,
F1578412 and F1578414;
z) Lots 1359073, 1359079, 1359064, 1359076, F1550328,
F1550329, F1550330, F1549761, F1552568, F1552569,
F1552570, F1552571, F1554548, F1556419, F1556420,
F1554547, F1555390, F1556418, F1556421, F1556422,
F1559022, F1559023, F1559024, F1559025, F1559026,
F1564339, F1564144, F1564145, F1564146, F1564147,
F1564148, F1564149, F1564150, F1564136, F1561373,
F1561374, F1561375, F1561376, F1564337, F1564338,
F1564340, F1564341, F1565723, F1565724, F1565725,
F1565726, F1565727, F1565786, F1565787, F1565788,
F1565789, F1565790, 1359080, 1359074, 1354034,
1359067, 1363354, 1357534, 1357533 and 1359081;
aa) Lots 1359093, 1359087, 1359095, 1359096, 1365218,
1362945, 1362958, 1362946, 1362954, 1365215,
1359089, 1362957, 1362959, 1359085, F1559029,
F1559031, F1559032, F1559033, F1559030, F1564220,
F1564221, F1564222, F1564223, F1564342, F1564154,
F1564218, F1564219, F1565728, F1565729, F1565730,
F1565731, F1565732, F1569301, F1571566, F1571567,
F1569302, F1572948, F1572949, F1571568, F1571569,
F1571570, F1578364, F1576373, F1576374, F1576375,
F1576377, 1359088, 1362955, 1362960, 1359083,
1362961, 1359084, 1359082, 1359091, 1359090,
1359086 and 1359097;
bb) Lots 1361357, 1361354, 1361350, 1361352,
F1550333, F1550334, F1552156, F1552157, F1552158,
F1552159, F1553437, F1553438, F1559037, F1554676,
F1554677, F1554678, F1554679, F1559034, F1559035,
F1559036, F1554551, F1554552, F1559038, F1564155,
F1564156, F1561382, F1561383, F1561384, F1561385,
F1561386, F1565792, F1565793, F1569239, F1569303,
F1569304, F1565794, F1565795, F1571032, F1571033,
F1571571, F1569238, F1571034, F1575229, F1575230,
F1575232, F1578416, F1578365, F1578366, F1578367,
1365242, 1365243 and 1365241;
cc) Lots F1559043, F1559044, F1559045, F1559046,
F1565734, F1565735, F1564343, F1564344, F1569241,
F1569242, F1570167, F1570168, F1571038, F1571039,
F1571040, F1572951, F1572952, F1575289, F1575290,
F1575291, F1575192, F1575193, F1575194, F1569243,
F1569309, F1571037, F1570166, F1572950, F1576379,
F1576381 and F1576382;
dd) Lots 1363760, 1363754, 1360456, 1360455, 1363755,
F1564106, F1564348, F1564224, F1564225, F1564226,
F1564227, F1564228, F1564229, F1564230, F1564231,
F1564160, F1564161, F1564162, F1564163, F1564345,
F1564346, F1564347, F1564349, F1564350, F1564351,
F1564352, F1564353, F1564354, F1564355, F1564356,
F1565767, F1565768, F1565769, F1565770, F1565772,
F1565766, F1565771, F1570169, F1570170, F1569305,
F1569306, F1569232, F1569233, F1569234, F1569235,
F1569236, F1572961, F1572962, F1572963, F1572964,
F1572953, F1572954, F1571572, F1572955, F1572956,
F1572957, F1572958, F1572959, F1572960, F1575292,
F1575293, F1575295, F1575296, F1575297, F1575298,
F1575299, F1575300, F1575233, F1575234, F1575235,
F1575236, F1575294, F1576383, F1576384, 1363764,
1363761, 1363768, 1363769, 1360453, 1363771,
1363762, 1363770 and 1360454;
ee) Lots F1559058, F1559059, F1556394, F1556395,
F1558965, F1561387, F1564361, F1564109, F1564110,
F1561388, F1561389, F1561390, F1561391, F1564164,
F1564165, F1564111, F1564112, F1564357, F1564358,
F1564359, F1564360, F1564362, F1564363, F1564364,
F1569244, F1567294, F1567295, F1565708, F1565709,
F1565711, F1565712, F1565713, F1565710, F1569245,
F1569246, F1569247, F1569270, F1569271, F1569272,
F1569273, F1571573, F1571574, F1575240, F1575241,
F1578419, F1575301, F1575302, F1575303, F1575304,
F1575305, F1575306, F1575307, F1571575, F1576392,
F1576396, F1576397, F1576398, F1572966, F1572967,
F1572968, F1572970 and F1572971;
ff) Lots 1359997, 1359996, F1548692, F1550342,
F1550343, F1550344, F1550345, F1550346, F1548694,
F1548695, F1548696, F1549764, F1542546, F1542547,
F1555397, F1555398, F1553439, F1553440, F1553441,
F1553442, F1553443, F1559075, F1559076, F1550342,
F1561392, F1561393, F1559077, F1559078, F1559079,
F1559080, F1559081, F1559082, F1564166, F1564167,
F1561394, F1561395, F1561396, F1564366, F1564365,
F1564367, F1564368, F1566689, F1565773, F1565774,
F1565775, F1565776, F1565777, F1569274, F1570171,
F1566690, F1566691, F1566692, F1571041, F1571042,
F1570172, F1570173, F1570175, F1572974, F1571044,
F1571045, F1575308, F1575312 and F1570174;
gg) Lots 1374872, 1367891, 1367891, 1360460, 1367892,
F1561397, F1561398, F1561399, F1561400, F1561401,
F1564235, F1564232, F1564233, F1564234, F1564236,
F1564168, F1564169, F1565714, F1565715, F1567297,
F1567296, F1569275, F1569276, F1569248, F1569249,
F1569250, F1572975, F1572976, F1572977, F1572978,
F1572979, F1575314, F1575315, F1575317, F1575318,
1367891 and 1370819;
hh) Lots 1368286, 1359156, 1359168, 1359166, 1359111,
1359114, 1359149, 1368284, 1359103, 1359186,
1359116, 1359163, 1359120, F1559090, F1559091,
F1559092, F1559094, F1558977, F1558978, F1558979,
F1558980, F1552163, F1558981, F1558982, F1564172,
F1564175, F1564176, F1564237, F1564239, F1564240,
F1564238, F1564241, F1564242, F1564243, F1564170,
F1564171, F1564173, F1564174, F1564177, F1564178,
F1565658, F1565660, F1565661, F1565662, F1565663,
F1565717, F1565720, F1566694, F1566696, F1564369,
F1564370, F1564372, F1564373, F1564374, F1564375,
F1565654, F1565655, F1565656, F1565657, F1565659,
F1565716, F1565718, F1565719, F1566693, F1566695,
F1566697, F1566698, F1564371, F1569277, F1569278,
F1569279, F1569310, F1572980, F1572981, F1572982,
F1572983, F1572984, F1572987, F1572988, F1572990,
F1572991, F1572992, F1571576, F1571577, F1571578,
F1575319, F1575320, F1575322, F1575323, F1575244,
F1575245, F1575247, F1572985, F1572986, F1572989,
F1575243, F1575246, F1575321, F1576406, F1576407,
F1576408, F1576409, F1576410, F1576414, 1359181,
1359158, 1359192, 1359159, 1359144, 1359180,
1359160, 1359117, 1359153, 1359107, 1359147,
1359173, 1359170, 1359108, 1359143, 1359150,
1359151 and 1359112;
ii) Lots 1366580, 1366579, 1366582, 1360764,
1360766, 1366578, 1360760, F1558983, F1558984,
F1558986, F1556851, F1556852, F1559095, F1559096,
F1559097, F1559098, F1558985, F1558987, F1564117,
F1564118, F1564119, F1564183, F1564376, F1565664,
F1565665, F1565666, F1565667, F1565668, F1565669,
F1565670, F1565671, F1564179, F1564180, F1564181,
F1564182, F1564184, F1564185, F1564186, F1564187,
F1564188, F1564189, F1564377, F1564378, F1564379,
F1564380, F1565778, F1565779, F1565780, F1565781,
F1565782, F1570176, F1570177, F1569280, F1569281,
F1569282, F1569283, F1571046, F1571047, F1571048,
F1571049, F1571050, F1571053, F1569251, F1569252,
F1569253, F1569254, F1572993, F1572994, F1572995,
F1572996, F1572997, F1572998, F1572999, F1575325,
F1575326, F1575327, F1575328, F1575195, F1575196,
F1575197, F1575198, F1575199, F1569311, F1573000,
F1573001, F1575324, 1360758, 1360761, 1360762
1360754 and 1360767;
jj) Lots 1353429, 1351407, 1360778, 1351410, 1353439,
1353440, F1550349, F1547868, F1547869, F1547870,
F1547871, F1550350, F1550351, F1550352, F1553454,
F1553455, F1553456, F1553457, F1552172, F1554704,
F1554705, F1559100, F1559101, F1554559, F1554560,
F1556400, F1552173, F1558988, F1558966, F1561402,
F1561403, F1561404, F1561405, F1561406, 1353437,
1351406, 1351412 and 1360776;
kk) Lots F1571581, F1570179, F1575249, F1575334,
F1575335, F1575336, F1574757, F1574758, F1574760,
F1574761, F1574762 and F1574763;
ll) Lots 1365980, 1365985, F1569284, F1569285,
F1573011, F1573012, F1570180, F1570181, F1570182,
F1570183, F1569256, F1569257, F1571582, F1576420,
F1576421, F1576422, F1576423, F1575250, F1575251,
F1575253, F1578444, F1578445, F1578447, F1578448,
F1578449, F1575338, F1578373, F1575339, F1578375,
F1575342, F1576417, F1576418, F1576419, 1368364
and 1368371;
mm) Lots F1564404, F1564405, F1569313, F1569314,
F1573013, F1573014, F1573017, F1564406, F1564407,
F1566706, F1566707, F1566708, F1569258, F1569259,
F1565697, F1565698, F1565699, F1565696, F1569260,
F1569312, F1566709, F1573015, F1573016, F1573018,
F1573019, F1573020, F1567298, F1567299, F1578450,
F1578377, F1575346, F1578378, F1575347, F1578379,
F1575348, F1575208 and F1575209;
nn) Lots F1571583 and F1570184;
oo) Lots F1565739, F1565740, F1564410, F1564411,
F1564412, F1575257, F1575258, F1578380 and
F1575349;
pp) Lots F1569286, F1569287, F1569315, F1571584,
F1571585, F1571586, F1575259, F1578462, F1578463,
F1578464, F1578465, F1575210, F1575212 and F1575213;
qq) Lots 1364675, 1357624, 1364677, 1357622,
1359195, F1552588, F1552589, F1552590, F1549286,
F1550367, F1550368, F1550369, F1550370, F1552174,
F1552175, F1554564, F1564207, F1564209, F1559111,
F1559001, F1564263, F1555400, F1556404, 1357625,
1357623 and 1364676;
rr) Lots F1573030, F1573032, F1573031, F1561414,
F1561415, F1558970 and F1559113;
ss) Lots F1567302, F1567303, F1564421, F1576428,
F1575269 and F1575270;
tt) Lots F1564212, F1564213, F1573033, F1573034,
F1573035, F1573036, F1573037, F1564266, F1564267,
F1564268, F1564269, F1566711, F1566712, F1569316,
F1564422, F1564423, F1564424 and F1564425.
uu) LotsF1569291, F1569292, F1565746, F1565683,
F1565684, F1565747, F1565748, F1571066, F1571067,
F1571068, F1575359, F1575360 and F1570185;
vv) Lots F1569293, F1569294, F1565749, F1569261,
F1569262, F1564274 and F1570186;
ww) Lots F1571587, F1565752, F1569263, F1569264,
F1569265, F1565751, F1575271 and F1575272;
xx) Lots1372418, 1361968, 1366103, F1564275,
F1564132, F1564133, F1564134, F1564276, F1564277,
F1565677, F1565678, F1565679, F1571069, F1569295,
F1569296, F1575361, F1575362, F1575363 and 1366093;
yy) Lots F1573048, F1571074, F1561902, F1569266,
F1565685, F1569268, F1565686, F1565687, F1565689,
F1573057, F1573058, F1573059, F1573060, F1573061,
F1573049, F1573050, F1565688, F1571072, F1571073,
F1571075, F1561419, F1573052, F1575274, F1575275,
F1575365, F1575366, F1575367 and F1575368;
zz) Lots F1573056, F1565690, F1564135, F1559145
and F1559146;
aaa) Lot F1566717;
bbb) Lots F1566718 and F1566719;
ccc) Lot F1546695;
ddd) Lot F1548535;
eee) Lots F1546697, F1553352, F1559930 and F1566601;
fff) Lots F1546696, F1559929 and F1566600;
ggg) Lots F1544275, F1544271, F1544272, F1544273,
F1544274, F1554507, F1554509, F1554510, F1554511,
F1554512, F1554513 and F1554514;
hhh) Lots F1544276, F1544277, F1544279, F1544280,
F1544278, F1554515, F1554516, F1554517, F1554518,
F1554519, F1554520, F1554521, F1554523, F1554524,
F1554525, F1554522, F1554526, F1554527 and F1554528.
RECALLING FIRM/MANUFACTURER
Cook, Inc., Bloomington, IN, by letters on June 10, 2004 and June 23, 2004. Firm initiated recall is ongoing.
REASON
Introducer tubing may contain a vein of unextruded material and carbon black or a strand of tubing material may be displaced from the introducer during use.
VOLUME OF PRODUCT IN COMMERCE
1,547 units.
DISTRIBUTION
Nationwide, Canada, Denmark and Japan.

_______________________________
PRODUCT
Battery Pack Respironics Model 915 for use in the 900 Series SmartMonitor and the 900 Series Pulse Oximeter. Recall # Z-1220-04.
CODE
Lot Number 45-03.
RECALLING FIRM/MANUFACTURER
Respironics, Inc., Murrysville, PA, by letter on June 4, 2004. Firm initiated recall is ongoing.
REASON
A product complaint was received that the lead wire from Model 915 battery was not connected.
VOLUME OF PRODUCT IN COMMERCE
2,726 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Mayfield Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020. Recall # F-1221-04.
CODE
Lot # 42358.
RECALLING FIRM/MANUFACTURER
Integra LifeSciences Corp, Cincinnati, OH, by facsimile and letter on June 29, 200. Firm initiated recall is ongoing.
REASON
Skull pins, which fractured below device specifications during QC testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
69 pins = 23 boxes (3 pins per box).
DISTRIBUTION
NY, TX, MD, and CO.

_______________________________
PRODUCT
TDx/TDxFLx Opiates Reagent, Product list number: 9673-60. Recall # Z-1229-04.
CODE
Lot/Unit numbers Exp. Date 10750Q100 9/22/04; 09650Q100 9/15/04.
RECALLING FIRM/MANUFACTURER
Abbott Health Products, Inc., Barceloneta, PR, by letter dated May 28, 2004. Firm initiated recall is ongoing.
REASON
Abbott Diagnostics Div. Has found that the oxymorphone cross-reactivity information in the "Specific Performance Characteristics" section of the TDx/TDxFLx Opiates Reagent package insert (commodity number 32-2087/R5) does not match the current product performance.
VOLUME OF PRODUCT IN COMMERCE
941 kits.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
DataLink 2000 Data Manager. Version 6.3. Recall # Z-1096-04.
CODE
Version 6.3
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter on November 3, 2003. Firm initiated recall is complete.
REASON
Software anomaly allows results to be archived prior to validation or to be uploaded to the lab information system.
VOLUME OF PRODUCT IN COMMERCE
361 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Esprit Ventilator. Recall # Z-1230-04.
CODE
Too numerous to include.
RECALLING FIRM/MANUFACTURER
Respironics California, Inc., Carlsbad, CA, by service technician visit beginning on February 20, 2002. Firm initiated recall is complete.
REASON
Flow sensors would exhibit drift.
VOLUME OF PRODUCT IN COMMERCE
1,137.
DISTRIBUTION
Nationwide and Internationally.

END OF ENFORCEMENT REPORT FOR AUGUST 4, 2004

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