Enforcement Report

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

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September 7, 2005
05-36

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

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PRODUCT
Assi Brand Dried Bellflower Root, net wt. 16 oz, packaged in plastic bags***Product of China, Recall # F-419-5
CODE
Item code "06034K" printed on the package. The product is not coded by lot number
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rhee Brothers Inc., Columbia, MD, by press release on April 28, 2005 and by letters on April 30, 2005.
Manufacturer: Zibo Juyuan Food Co., Ltd, Zibo, China. Firm initiated recall is complete.
REASON
Imported food product contains undeclared sulfites. Sensitized individuals may run risk of serious life-threatening allergic reactions if they consume product.
VOLUME OF PRODUCT IN COMMERCE
4,640 packages
DISTRIBUTION
Nationwide and Canada

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PRODUCT
a) Veggie Golden Roast -- YTS; Net wt. 1 lb.
(16 oz.), ready to eat appetizers,
Recall # F-604-5;
b) Veggie Smoked Duck -- KIMBO brand; Net wt.
1 lb. (16 oz.), ready to eat appetizers,
Recall # F-605-5;
c) Vegetarian Steamboat Flavoring -- YTS and
KIMBO brand; Net wt. 10 oz. (283 g),
Recall # F-606-5;
d) Vegetarian Smoked Duck Stick -- YTS and
KIMBO brands; Net wt. 10 oz. (283 g),
Recall # F-607-5;
e) Vegetarian Lamb -- YTS and KIMBO brands;
Net wt. 10 oz. (283 g), Recall # F-608-5;
f) YTS brand Liang Zen Golden Ham; Net wt.
2.2 lb (335.3 oz.), Recall # F-609-5;
g) KIMBO brand Veggie Golden Ham; Net wt.
2.2 lb. (35.3 oz.). Recall # F-610-5;
h) Mushroom Cake -- YTS and KIMBO brands;
Net wt. 12 oz. (340 g), Recall # F-611-5;
i) YTS brand New Century Veggie; Net wt. --
12 oz., Recall # F-612-5;
j) YTS brand Curry Veggie Ham, Net wt. 2.2 lb.
(35.3 oz.) Recall # F-613-5
CODE
Exp Dated 4/27/04 thru 4/27/06
RECALLING FIRM/MANUFACTURER
YTS Group Inc., El Monte, CA, by letter and press release on May 2, 2005. Firm initiated recall is complete.
REASON
Product contains undeclared egg.
VOLUME OF PRODUCT IN COMMERCE
Approximately 3,166
DISTRIBUTION
Nationwide and Canada

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PRODUCT
12.5 kg paper bags labeled as "Extra Fancy Basil", Recall # F-620-5
CODE
No lot codes. The firm is recalling all bags from the import entry sampled by FDA
RECALLING FIRM/MANUFACTURER
Recalling Firm: Majestic Int'l Spice Corporation, Montebello, CA, by telephone on July 8, 2005 and by letters dated July 11, and 12, 2005.
Manufacturer: Al Dahlia Company, Cai, Egypt. Firm initiated recall is ongoing.
REASON
Imported whole dried basil labeled as "Extra Fancy Basil" is contaminated with Salmonella based on FDA's analysis.
VOLUME OF PRODUCT IN COMMERCE
292 bags
DISTRIBUTION
CA, AL, (and possibly other locations)

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PRODUCT
Nature's Plus® brand Animal Parade Children's Chewable Calcium Tablets, Natural Vanilla Sundae Flavor, Recall # F-621-5
CODE
90-count bottles: Product #s 29996, E2999601, E2999602; Lot numbers 1021176, 1026101, 1027564, 1031816, 1034956, 1036178, 1037365, 1040904, 1042758, 1044825, 1047386, 1047393, 1047525, 1048517,1050151, 1050154, 1051997, 1053348, 1053973, 1054445, 1057193, 1057397, 1057707, 1060047, 1060499, 1060500,1060806, 1061489, 1061901, 1061981, 1063812, 1064562, 1064940, 1065113, 1066328, 1066447, 1069110, 1070316, 1073315, 1074734, 1075490, 1076653, 1070724, 1077869, 1079306, 1081876, 1082099. Sample packets: Product # 79996, Lot numbers 03703A, 1037089, 14204A, 19703C, 27203A, 32103A, A31902.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Natural Organics, Melville, NY, by press release on December 2, 2004, and by letters dated December 3, 2004.
Manufacturer: Organics Laboratories, Inc., Amityville, NY. Firm initiated recall is ongoing.
REASON
Product contains undeclared sodium caseinate, a milk derivative which poses a health risk to individuals that are allergic to milk
VOLUME OF PRODUCT IN COMMERCE
128,915 bottles and 73,134 sample packets
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
CYI brand Dried Vegetable, Net wt. 6 oz (170g). Product of China -- Serving Per Container 15 -- Serving Size 1 cup (11g), UPC barcode # 8 37385 00110 6, Recall # F-624-5
CODE
UPC Barcode and no other coding
RECALLING FIRM/MANUFACTURER
Recalling Firm: New Land Trading Inc., Brooklyn, NY, by Consumer Alert and letters on/about June 16, 2005.
Manufacturer: Benefit Express Trading Inc., Guangzhou, China. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (3674 ppm) based on sampling & analysis by the New York State Department of Agriculture. The specific type of vegetable is also not identified.
VOLUME OF PRODUCT IN COMMERCE
5,200 plastic bags
DISTRIBUTION
NY

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PRODUCT
Lu Cao Di brand Cabbage Dried Vegetable, Net Wt. 8.8 oz (250 g). Product of China -- Ingredients: Dehydrated Cole -- Serving size 1 bowl (63g) Servings Per Container 4 --The product is packaged in a sealed flexible plastic bag. Barcode # 6 920433 007084, Recall # F-625-5
CODE
UPC Barcode and no other coding
RECALLING FIRM/MANUFACTURER
Lion Pavilion Ltd., Brooklyn, NY, by press release on June 15, 2005 and July 7, 2005. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (326 ppm) based on sampling & analysis by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
30 cartons (40 --250 g plastic bag per carton)
DISTRIBUTION
NY and NJ

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
Nature Throid NT-1, Thyroid, U.S.P. (TAN, C.T.), 1 Grain (64-8 MG), 100 Tablets, Recall # D-473-5
CODE
Lot # M012Q-5D11
RECALLING FIRM/MANUFACTURER
Recalling Firm: RSJ Inc, Phoenix, AZ, by telephone and letters on May 5, 2005.
Manufacturer: Time-Cap Labs, Farmingdale, NY. Firm initiated recall is ongoing.
REASON
Mislabeled; bottles labeled to contain Nature-Throid NT-1 actually contain Nature-Throid NT-1/2.
VOLUME OF PRODUCT IN COMMERCE
94 Bottles
DISTRIBUTION
Nationwide

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PRODUCT
a) Pain Reliever - Infant Drops, Acetaminophen 160 mg per
1.6 ml ½ fl oz (15 mL), Cherry Flavor, Use Only With
Enclosed Syringe. Directions: Weight under 24 lb or Age
Under 2 years - ask a doctor. Product is distributed
under the following brand names: Best Choice brand
Infants' Non-Aspirin, by Valu Merchandisers; Brooks
brand Infants' Acetaminophen Concentrated Suspension
Drops, Dist. by Maxi Drug Inc.; CVS brand Concentrated
Infants' Pain Relief Suspension Drops, Dist. by CVS
Pharmacy, Inc.; Eckerxd brand Non-Aspirin Infant's
Drops, Dist. by Eckerd Drug Company, NDC 19458-9081-1;
equaline brand Infants' Pain Relief Concentrated
Suspension Drops, Dist. by Albertsons, Inc., NDC 41163-
008-05; Food Lion brand Infant's Drops Pain Relief
Concentrated Suspension Drops, Dist. by Food Lion, LLC,
NDC 55316-008-10; Good Neighbor Pharmacy brand
Concentrated Pain Relief Infants' Drops, Dist. by
AmerisourceBergen, NDC 24385-313-15; GoodSense brand
Infants' Pain Relief Concentrated Suspension Drops,
Dist. by Perrigo Company, NDC 0113-0008-10; Healthy
Generations brand Infants' Drops Non-Aspirin Pain
Relief, Dist. by Supervalu, Inc., NDC 38045-008-05;
H-E-B brand Infants' Pain Relief Infants' Concentrated
Suspension Drops, Dist. by H-E-B, NDC 37808-008-10;
HyVee brand Concentrated Pain Relief Infants' Drops,
Dist. by Hy-Vee, Inc., NDC 42507-008-10; Kroger brand
Infant's Pain Relief Concentrated Suspension Drops,
Dist. by The Kroger Co., NDC 30142-008-05; Leader brand
Infants' Drops Pain Reliever Concentrated Suspension
Drops, Dist. by Cardinal Health, NDC 37205-008-05;
Longs brand Infants' Pain Relief, Dist. by Longs Drugs,
NDC 12333-9749-1; Major brand Infants' Mapap
Concentrated Suspension Drops, Dist. by Major
Pharmaceuticals, NDC 0904-5255-35; Medic brand Infants'
Acetaminophen Pain Reliever Infants' Concentrated
Suspension Drops, Dist. by Winn-Dixie Stores, Inc.,
NDC 56039-008-05; The Medicine Shoppe brand Infants'
Drops Medi-Tabs Concentrated Suspension Drops, Dist. by
Medicine Shoppe International, Inc., NDC 49614-313-10;
Meijer brand Infant's Pain Relief Concentrated
Suspension Drops, Dist. by Meijer Dist. Inc.,
NDC 41250-008-10; Publix brand Pin Relief Concentrated
Infants' Drops, Dist. by Publix Super Markets, Inc.,
NDC 56062-008-05; Rite Aid brand Infants' Pain Relief
Concentrated Suspension Drops, Dist. by Rite Aid Corp.;
Safeway brand Infants' Non-Aspirin Concentrated
Suspension Drops, Dist. by Safeway Inc.,
NDC 21130-008-05; Sunmark brand Pain Reliever Infants'
Concentrated Suspension Drops, Dist. by McKesson,
NDC 49348-268-27; Target brand Infants' Drops
Acetaminophen Concentrated, Dist. by Target Corp.;
NDC 11673-008-10; Today's Health brand Infants' Pain
Reliever Concentrated Suspension Drops, Dist. by
Warehouse Concepts, Inc., NDC 38309-008-05; Walgreens
brand Infant's Non-Aspirin Infants' Concentrated
Suspension Drops, Dist. by Walgreen Co., NDC 0363-008-10
and Western Family brand Infant's Acetaminophen
Concentrated Suspension Drops, Dist. by Western Family
Foods, Inc., Recall # D-474-5;
b) Pain Reliever - Infant Drops, Acetaminophen 160 mg per
1.6 ml ½ fl oz (15 mL), Grape Flavor, Use Only With
Enclosed Syringe, Directions: Weight under 24 lb or Age
Under 2 years - ask a doctor. Product is distributed
under the following brand names: American Fare brand
Infants' Pain Relief Infants' Concentrated Suspension
Drops, Made for Kmart Corporation, NDC 49738-289-10;
Berkley & Jensen brand Infant's Pain Relief, Distributed
by BJWC; Brooks brand Infants' Acetaminophen
Concentrated Suspension Drops, Dist. by Maxi Drug Inc.;
Carxe One brand Infant's Pain Relief Concentrated
Suspension Drops, Dist. by American Sales Co.;
CVS brand Concentrated Infants' Pain Relief Suspension
Drops, Dist. by CVS Pharmacy, Inc.; DG Guarantee brand
Infants' Pain Relief Concentrated Suspension Drops,
Dist. by Dolgencorp Inc.; Eckerxd Pharmacy brand Non-
Aspirin Infant's Drops, Dist. by Eckerd Drug Company,
NDC 19458-9082-1; equaline brand Infants' Pain Relief
concentrated suspension drops, Dist. by Albertsons,
Inc., NDC 41163-289-05; equate brand Infants' Drops
Pain Reliever, Dist. by Wal-Mart Stores, Inc.,
NDC 49035-289-05; Family Dollar brand Infants' Pain
Reliever, Dist. by Family Dollar Services Inc.,
NDC 55319-289-05; Good Neighbor Pharmacy brand
Concentrated Pain Relief Infants' Drops, Dist. by
Amerisource Bergen, NDC 24385-289-10; GoodSense brand
Infants' Pain Relief Concentrated Suspension Drops,
Dist. by Perrigo Company, NDC 0113-0289-05; Health
Pride brand Infants' Pain Reliever, Dist. by The
Great Atlantic & Pacific Tea Company; H-E-B brand
Infants' Pain Relief Infants' Concentrated Suspension
Drops, Dist. by H-E-B, NDC 37808-289-05; Healthy
Generations brand Infants' Drops Non-Aspirin Pain
Relief, Dist. by Supervalu, Inc., NDC 38045-289-05;
Kroger brand Infant's Pain Relief Concentrated
Suspension Drops, Dist. by The Kroger Co., NDC 30142-
289-05; Leader brand Infants' Drops Pain Reliever
Concentrated Suspension Drops, Dist. by Cardinal
Health, NDC 37205-319-05; Medic brand Infants'
acetaminophen Pain Reliever Infants' Concentrated
Suspension Drops, Dist. by Winn-Dixie Stores, Inc.,
NDC 56039-289-05; Rite Aid brand Infants' Acetaminophen
Pain Relief Concentrated Suspension Drops, Dist.
by Rite Aid Corporation; Shop Rite brand Infants'
Concentrated Pain-Relief Infants' Suspension Drops,
Dist. by Wakefern Food Corp.; Sunmark brand Pain
Reliever Infants' Concentrated Suspension Drops, Dist.
by McKesson, NDC 49348-267-29; Target brand Infants'
Drops Acetaminophen Concentrated, Dist. by Target Corp.,
NDC 11673-289-10; Today's Health brand Infants' Pain
Reliever, Dist. by Warehouse Concepts, Inc., West
NDA 38309-289-05; Top Care brand Infants' Pain Reliever
Concentrated Suspension Drops, Dist. by Topco
Associates, LLC, NDC 36800-289-10; Walgreens brand
Infants' Non-Aspirin Infants' Concentrated Suspension
Drops, Dist. by Walgreen Co., NDC 0363-0289-05 and
Western Family brand Infant's concentrated Suspension
Drops, Dist. by Western Family Foods, Inc.,
Recall # D-475-5;
c) Cough & Cold Concentrate Infant Drops, Acetaminophen
160 mg per 1.6 ml, Dextromethorphan BBr 5 mg per 1.6 ml,
Pseudoephedrine HCl 15 mg per 1.6 ml; ½ fl oz (15 mL),
Cherry Flavor, Use Only With Enclosed Syringe,
Directions: Weight under 24 lb or Age Under 2 years --
ask a doctor. Product is distributed under the following
brand names: American Fare brand Infants' Pain Relief
Cold Concentrated Infants' Drops Cold plus Cough,
Distributed by Kmart Corporation, NDC 49738-514-05; DG
Guarantee brand Infants' Drops Pain Relief Plus Cold &
Cough, Distributed by Dolgencorp Inc.; Equaline brand
Infants' Drops Pain Relief plus Cold & Cough,
Distributed by Albertsons, Inc., NDC 41163-514-05;
Family Dollar brand Infants' Concentrated Cold & Cough,
Distributed by Family Dollar Services Inc., NDC 55319-
514-05; Healthy Generations brand Infants' Cold & Cold,
Distributed by Supervalu, Inc., NDC 38045-514-05;
Kroger brand Infants; Pain Relief plus Cold & Cough
Concentrated Drops, Distributed by The Kroger Co., NDC
30142-514-05; Leader brand Infants' Pain Relief Cold
plus Cough Concentrated Drops, Distributed by Cardinal
Health, NDC 37205-293-05; The Medicine Shoppe brand
Infants; Concentrated Medi-Drops Cold & Cough,
Distributed by Medicine Shoppe, NDC 49614-122-05;
Rite Aid brand Infants' Cold & Cough Concentrated Drops,
Distributed by Rite Aid Corp,; Top Care brand Infants;
Drops Cold plus Cough Concentrated, Distributed by Topco
Associates, LLC, NDC 36800-514-05 and Walgreens brand
Concentrated Non-Aspirin Plus Cold & Cough Infants'
Drops, Distributed by Walgreen Co., NDC 0363-0514-05.
Recall # D-476-5;
d) Decongestant & Cough Infant Drops, Dextromethorphan
BBr 5 mg per 1.6 ml, Pseudoephedrine HCl 15 mg per 1.6
ml; ½ fl oz (15 mL), Cherry Flavor, Use Only With
Enclosed Syringe, Directions: Age Under 2 years - ask a
doctor. Product is distributed under the following brand
names: CVS brand Infants' Decongestant & Cough, Dist.
by CVS Pharmacy, Inc.; equaline brand Infants'
Decongestant & Cough Oral Drops, Dist. by
Albertsons, Inc., NDC 41163-487-05; GoodSense brand
Infants Decongestant & Cough Oral Drops, Dist. by
Perrigo Co., NDC 0113-0487-05; Healthy Generations
brand Infants' Cough & Cold, Dist. by Supervalu, Inc.,
NDC 38045-487-05; Longs brand Infants' Decongestant &
Cough, Dist. by Longs Drugs, NDC 12333-9870-1; Major
brand Infants' Drops Decongestant and Cough, Dist. by
Major Pharm., NDC 0904-5552-35; Meijer brand Infants'
Decongestant & Cough Oral Drops, Dist. by Meijer Dist.
Inc., NDC 41250-487-05; Publix brand Infants' Drops
Decongestant Plus Cough, Dist. by Publix Super Markets,
Inc., NDC 56062-487-05; Rite Aid brand Pedia Relief
Decongestant plus Cough Drops for Infants, Dist. by Rite
Aid Corp.; Sunmark brand Infants' Drops Pedia Relief
Decongestant Plus Cough, Dist. by McKesson, NDC 49348-
290-69; Top Care brand Pediatric Nasal Decongestant Plus
Cough Infants' Drops, Dist. by Topco Ass., LLC, NDC
36800-487-05 and Walgreens brand Infants' Wal-Care
Decongestant Plus Cough, Dist. by Walgreen Co., NDC
0363-0487-05. Recall # D-477-5
CODE
All lots with a syringe for dosing
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan, MI, by press release on August 1, 2005, and by letters on August 4, 2005. Firm initiated recall is ongoing.
REASON
Although the labeled directions for use are consistent with the labeled dosage directions; the product is also intended for use by infants under 2 years of age, and the dosing syringe included with the product is not appropriate for the dosage levels generally directed by doctors for infants under 2 years of age.
VOLUME OF PRODUCT IN COMMERCE
1,072,098 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
Source Plasma, Recall # B-1612-5
CODE
Unit numbers: NF168058, NF167915, NF167568, NF167161, NF167035, NF166687, NF166036, NF165892, NF160612, NF160119, NF159987, NF159731, NF159582, NF159071, NF158849, NF157986, NF157674, NF157405, NF157292, NF157003, NF156836,
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Nutter Fort, WV, by fax on February 1, 2001. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who disclosed a history of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT
Red Blood Cells, Recall # B-1878-5
CODE
Unit number: 7135927
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., Bradenton, FL, by telephone on July 2, 1999. Firm initiated recall is complete.
REASON
Blood product, with incomplete anti-HTLV-1 testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

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PRODUCT
Fresh Frozen Plasma, Recall # B-2017-5
CODE
Unit number: FC2010145
RECALLING FIRM/MANUFACTURER
Community Blood Council of New Jersey, Trenton, NJ, by fax on January 12, 2005. Firm initiated recall is complete.
REASON
Blood product, prepared from whole blood with an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
a) Baxter System 1000 Single Patient Hemodialysis
Systems, product codes SYS1000L3, SYS1000L3P,
SYS1000L3T, SYS1000L3TD, SYS1000L2C2;
Recall # Z-1394-05;
b) Baxter Arena Hemodialysis Systems, product codes
ARENADPX, ARENASP, ARENADPP, ARENASPX;
Recall # Z-1395-05
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Deerfield, IL, by letters dated June 14, 2005.
Manufacturer: Baxter Healthcare Corp., Largo, FL. Firm initiated recall is ongoing.
REASON
Operator's Manuals addenda are being issued to provide correct information concerning the correct syringe size to use for heparin infusion, the use of chemical disinfectants in the System 1000, TMP Advise, and Bicarbonate Value calculations.
VOLUME OF PRODUCT IN COMMERCE
15,540 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button, Recall # Z-1396-05
CODE
HSK-2038, HSK-2043. All lots are affected by this recall.
RECALLING FIRM/MANUFACTURER
Guidant Cardiac Surgery, Santa Clara, CA, by letter on July 5, 2005. Firm initiated recall is ongoing.
REASON
Incomplete or no aortotomy may occur with use of the aortic cutter on unaltered tissue, or incomplete aortotomy may result when the cutter is used on altered tissue. Use of the cutter on altered tissue has caused the aortic plug to not be captured by the device.
VOLUME OF PRODUCT IN COMMERCE
7,391 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) MyLab30CV Ultrasound Imaging System; model 9807300000,
Recall # Z-1401-05;
b) MyLab30CV Ultrasound Imaging System; model 9807300001,
Recall # Z-1402-05;
c) MyLab25 Ultrasound Imaging System; model 9807300002,
Recall # Z-1403-05
CODE
a) All units using software version 3.02:
Serial numbers 53, 58, 60, 67, 70,
72, 73, 75 and 79;
b) All units using software version 3.02:
Serial numbers 102-112, 114-120, 122,
134-141, 149-167, 169, 172, 279-190,
196-210, 212-218, 220-222, 224-226,
228-247, 251-295, 317. 319. 322-329,
339, 340, 367, 368, 370-387, 393, 400,
410, 414-432, 478, 480-483, 485-488,
509-522 and 569-582;
c) All units using software version 3.02:
Serial numbers 530-539.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biosound Esaote, Inc., Indianapolis, IN, by letters dated May 2, 2005, May 6, May 9 and May 13, 2005.
Manufacturer: Esaote Biomedica S.P.A., Firenze, Italy. Firm initiated recall is ongoing.
REASON
Data maybe corrupted upon re-opening archived files.
VOLUME OF PRODUCT IN COMMERCE
195 units
DISTRIBUTION
Nationwide, Canada and Venezuela

______________________________
PRODUCT
Radiomat Lightweight Cassettes, Product Code: EHYG2, Model: 14x17 Green RE 400 Screens and Cassettes, Product Code: EHYCT, Model: 14x17 Green RE 100 Screens and Cassettes, Product Code: EHX5C, Model: 14x17 Blue RE 800 Screens and Cassettes, Recall # Z-1404-05
CODE
Batch number are a combination of 4 letters/numbers xxyy, where xx varies alphabetically form 6N and 6Z and from 7A to &N and yy is a number from 01 through 31. Batch numbers are located both on the cassette shell and on the outer label.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp, Greenville, SC, by letter on/about July 29, 2005
Manufacturer: Agfa-Gevart NV, Mortsel, Belgium. Firm initiated recall is ongoing.
REASON
Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.
VOLUME OF PRODUCT IN COMMERCE
9,055 units
DISTRIBUTION
Nationwide and Canada

_______________________________
PRODUCT
a) ITW Dymon Medaphene Plus Disinfectant
Spray, Pseudomonacidal, Virucidal, Mildewcidal,
Fungicidal, Staphylocidal, Tuberculocidal,
packaged in 20-oz. steel aerosol cans, net wt
16-oz. (1-lb.), 12 cans/case, containing 0.19% o-
phenylphenol and 68.00% ethyl alcohol, Product
34720. The firm name on the label is ITW Dymon.
The product is also sold under the following
private labels: (1) Renown Disinfectant Deodorant
II, Product REN05013, Distributed by AmSan, LLC;
(2) Decon Aerosol Disinfectant, Catalog #8617;
(3) New Jax Medaphene Plus Disinfectant Spray;
(4) San-O-Phene Plus Disinfectant Spray,
Sold By San Joaquin Supply Co.;
(5) Sterling Quality Hospital Use Micro II
Disinfectant Spray, Distributed By Sterling
Sanitary Supply Corporation; (6) Ball-Phene
Spray Disinfectant, Reorder #3U037;
(7) Area Two-In-One Disinfectant Spray Original,
Sold By Area Distributors, Inc.;
(8) Benefax Disinfectant Spray, Exclusively S
Sold By Biotek Corporation; (9) Pheno-Cen Spray
Disinfectant/Deodorant, Sold By Central
Solutions, Inc.; (10) Clark Bio-Phene Plus
Disinfectant/Spray, Sold By Clark Paper Plus
Inc.; (11) LOGIChem Hosp-I-Septic Disinfectant
Spray, Distributed Exclusively For Edmar;
(12) Morcept Hospital Disinfectant, Sold By Moore
Research, Inc.; (13) Pro Chem Deocept Purity
Hospital Disinfectant, Sold By Pro-Chem, Inc.,
(14) Select Specialty Products Spectrum II
Hospital Type Disinfectant, Sold By Select
Specialty Products, Recall # Z-1405-05;
b) ITW Dymon Medaphene Plus Orange Disinfectant Spray,
Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal,
Staphylocidal, Tuberculocidal, packaged in 20-oz.
steel aerosol cans, net wt 16-oz. (1-lb.), 12
cans/case, containing 0.19% o-phenylphenol and
68.00% ethyl alcohol, Product 52920. The firm
name on the label is ITW Dymon. The product is also
distributed under the following private labels:
O.D.S. Orange Disinfectant Spray, Continental
Research Corporation; (2) Drummond American Bristol Orange Disinfectant Spray, Product DR8561, Sold by Drummond American Corporation; (3) Romaine Medaphene Plus Disinfectant Spray Orange Fragrance, Manufactured For Romaine Companies; (4) State Discover Aerosol Disinfectant Citrus, Stock #109566 and #109567, Sold By State Industrial Products; (5) Medisan Disinfectant Spray, Orange Scent, Distributed by Cape Janitor Supply; (6) DETCO Industries Germ Defense Disinfectant Spray, Orange Fragrance, Sold by DETCO Industries; (7) Orange Disinfectant Spray, Manufactured for MASSCO, Inc.; (8) Meyer Tri Power, Sold By Meyer Laboratory Inc.; (9) Orange Surfacidal Disinfectant Spray, Packed for Check Mark, A Division of DM Resources, Inc.; (10) Citrus-Cidal Disinfectant Spray, Orange Fragrance, Sold By navy brand Manufacturing Company; (11) Pro Chem Deocept Citra Disinfectant Spray, Orange Fragrance, Sold By Pro-Chem, Inc.; (12) Ricmar Industries Tang-I-Cide Tangerine Fragrance Disinfectant, Sold Exclusively By Ricmar Industries, Inc.; (13) Neutron NI-712 Disinfectant Spray, Stock #104787, A product of Neutron Industries, Recall # Z-1406-05;
c) ITW Dymon Medaphene Plus Lemon Disinfectant Spray,
Pseudomonacidal, Virucidal, Mildewcidal, Fungicidal,
Staphylocidal, Tuberculocidal, packaged in 20-oz.
steel aerosol cans, net wt. 16 oz (1 lb), 12 cans/
case, containing 0.19% o-phenylphenol and 68.00%
ethyl alcohol, Product #52820. The firm name on the
label is ITW Dymon. The product is also distributed
under the following private labels: (1) Renown Lemon
Disinfectant Deodorant, Distributed by AmSan, LLC;
Concept Lemon Scented Disinfectant Deodorant,
Product 5282057750, Sold By Manny's Sanitary Supplies, Inc., Recall # Z-1407-05;
d) ITW Dymon Medaphene Plus Country Garden Disinfectant
Spray, Pseudomonacidal, Virucidal, Mildewcidal,
Fungicidal, Staphylocidal, Tuberculocidal, packaged
in 20-oz. steel aerosol cans, net wt 16-oz. (1-lb.),
12 cans/case, containing 0.19% o-phenylphenol and
68.00% ethyl alcohol, Product #42620. The firm name
on the label is ITW Dymon. The product is also
distributed under the following private labels:
Area Two-In-One Disinfectant Spray Country,
Reorder #ADI-531, Sold By Area Distributors, Inc.;
(2) Lawson Fresh Air Disinfectant Spray, Product 90386, Manufactured for Lawson Products, Inc.; (3) Major Envirocide Country Fresh Disinfectant Spray, Sold By Major Chemical Company; (4) Concept Potpourri Disinfectant Deodorant, Sold By Manny's Sanitary Supplies, Inc.; (5) Meyer Century Zip Hospital Disinfectant, A Product of Meyer Laboratory, Inc; (6) Pro Chem Deocept Passion Hospital Disinfectant, Sold By Pro-Chem, Inc.; (7) State Discover Aerosol Disinfectant Country Garden, Stock #109568 and and #109569, Sold By State Industrial Products; (8) Sterling Quality Nature's Country Garden Disinfectant Spray, Distributed By Sterling Sanitary Supply Corporation; (9) North Woods TB Plus Spray Disinfectant Spray, Sold By Superior Chemical Corp.; (10) Renown Potpourri Disinfectant Deodorant, Product REN05056, Distributed by: AmSan, LLC; (11) Asepsis Asepticide Disinfectant Spray, Handpiece Disinfectant, Country Garden, Distributed By Asepsis International, Inc.; (12) Dazzle "D" Disinfectant Spray Country Garden, Sold By Henry Kraft Inc.; (13) TB-Cide Country Garden Hospital Disinfectant, Sold By Industrial Distributors, Inc.; (14) G-Sep Aromatic Disinfectant Spray, Sold By Moore Research, Inc; (15) Mt. Hood Chemical Hospit-all New Country Garden Fragrance Disinfectant Spray, Sold By Mt. Hood Chemical Corp.; (16) IDS Medi-Spray Country Garden Disinfectant Deodorant, Manufactured For Sold By International Distribution System, Inc.; (17) Neutron Country Garden Disinfectant Spray, Stock #110030, A product of Nuetron Industries; (18) Sunrise Environmental Scientific Disinfectant Spray Country Garden, Sold By Sunrise Environmental Scientific; (19) United Laboratories Flower Power Disinfectant Spray, United 135, Sold By United Laboratories, Inc. One private label is packaged in a 16-oz. steel aerosol can, Watkins Sanisol Disinfectant Spray, Product 42616, Manufactured for Watkins Incorporated; Recall # Z-1408-05
CODE
a) Initially recalled lot numbers: ITW Dymon brand --
A56241, A56242, and A87242; private labels - A17241,
A27241, A30141, A31141, A31142, A75241, A85241,
A85244, A57241, A57242, A87241, A95241, and A99041;
Expanded recall lot numbers: ITW Dymon brand --
A84141, A84142, A18143, A98141, A09141, A09142,
A80342, A90341, A14342, A14343, A66341, and A66342;
private labels - A91141, A91142, A23141, A74141,
A84141, A65141, A65142, A65143, A18141, A18142,
A18143, A98141, B89141, B89142, A60241, A80241,
A80242, A21241, A91241, A91242, A85242, A85243,
A49241, A59241, A59242, A70341, A80341, A80342,
A61341, A71341, A71342, A82341, A83341, A14341,
A14342, A55341, A55342, A56341, A56342, A66341,
A70051, A01051, A81051, A13051, and A13052;
b) Initially recalled lot numbers: ITW Dymon brand
A66244 and A58241; private labels - A66241,
A66243, A66244, A87241, and A58241. Expanded recalled lot numbers: ITW Dymon brand - A96141, A88241, A00341, A10341, A24342, A24343, A25341; private labels - A81141, A81142, A91141, A91142, A02141, A02142, A23141, A94141, A65141, A28141, A09141, A19141, A19142, A90241, A90242, A21241, A21242, A32241, A42241, A66242, A88241, A00341, A61341, A42341, A72341, A24341, A24342, A25341, A56341, A01051, A01052, A01053, A11051, A81051, A21051, A82051, A23051, and A23052;
c) Initially recalled lot number: Private label - A66241,
Expanded recalled lot numbers: Private label - A23141
and A28141;
d) Initially recalled lot numbers: ITW Dymon brand
A66241 and A87241; private labels - A31141,
A74241, A75241, A75242, A56241, A66241, and A88241 Expanded recall lot numbers: ITW Dymon brand - A04141, A04142, A14141, A09141, A91241, A02241, A10341, A82341, A92341, A15341, A15342, and A25341; private label - A81141, B42141, A23141, A23142, A23143, A04141, A84141, A95141, A96141, A96142, A18141, A09141, A80241, A21241, A91241, A42241, A33241, A10341, A90341, C02341, A42341, A42342, A24341, A34341, A34342, A15341, A55341, A70051, A71051, and A12051
RECALLING FIRM/MANUFACTURER
ITW Dymon, Olathe, KS, by telephone on February 15, 2005 and by letters on February 21, 2005 and April 29, 2005. Firm initiated recall is ongoing.
REASON
Failed EPA required efficacy testing; may not perform as intended.
VOLUME OF PRODUCT IN COMMERCE
4,372/12-can cases
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Brilliance CT System, 40 channel configuration
using version 1.2 software, Recall # Z-1409-05;
b) Brilliance CT System, 16 Power configuration
using version 1.2 or 1.2.1 software,
Recall # Z-1410-05;
c) Brilliance 16, 10, and 6 configuration
(water cooled version) using 1.0. 1.1, 1.2,
1.2.2, or 1.2.4 software, Recall # Z-1411-05;
d) Brilliance CT system, 16, 10, and 6 configuration
(air cooled version) using version 1.2 or
1.2.1 software, Recall # Z-1412-05;
e) MX8000IDT CT Scanner using version 2.5.5,
3.0, 3.1, 3.2, 3.2.2, or 3.2.4 software,
Recall # Z-1413-05;
f) MX8000 Dual v.EXP CT Scanner using version 2.5.
software, Recall # Z-1414-05;
g) Extended Brilliance Workspace using 1.x or 2.x
software, Recall # Z-1415-05;
h) MxView using version 5.0, 5.0.1, or 4.1
software, Recall # Z-1416-05;
i) Gemini PET/CT system, Dual Configuration,
Recall # Z-1417-05;
j) Gemini 16 PET/CT system, Slice Configuration,
Recall # Z-1418-05
CODE
All codes
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letters dated March 11, 2005. Firm initiated recall is ongoing.
REASON
When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.
VOLUME OF PRODUCT IN COMMERCE
2,130 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
PTT-LA Lupus anticoagulant-sensitive APTT reagent. Diagnostica Stago, 6x 2mL, Cat. No. 00599, Recall # Z-1419-05
CODE
Lot Number 041755, exp. 06/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diagnostica Stago, Inc., Parsippany, NJ, by letters on April 13, 2005.
Manufacturer: Diagnostica Stago, Franconville, France. Firm initiated recall is complete.
REASON
Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.
VOLUME OF PRODUCT IN COMMERCE
740 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
C-Vision Angiographic X-Ray System, Model IVS-100, Recall # Z-1420-05
CODE
Software versions before 3.0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shimadzu Medical Systems, Torrance, CA, by letter in April 2002.
Manufacturer: Shimadzu Corporation, Kyoto, Japan. Firm initiated recall is complete.
REASON
Fluro exposure stuck open, will not terminate.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide and Canada

______________________________
PRODUCT
GE Healthcare Centricity Cardiology A11000 Workstation Recall # Z-1421-05
CODE
Version 4.2.6 and version 4.2.7.05
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems Information Technologies, Mount Prospect, IL, by letter, dated July 18, 2005.
Manufacturer: Camtronics Medical Systems, Ltd, Hartland, WI. Firm initiated recall is ongoing.
REASON
The potential exists for the A11000 workstation to mix images from one study with images from another study. Mixed studies could be from the same patient or from different patients. Mixed patient images could compromise patient condition or diagnosis and treatment.
VOLUME OF PRODUCT IN COMMERCE
1,287 devices
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
STA-R blood coagulation analyzer. Catalog Number 57160, Recall # Z-1422-05
CODE
All units distributed under Catalog Number 57160
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diagnostica Stago, Inc., Parsippany, NY, by letter on June 20, 2005.
Manufacturer: Diagnostica Stago, Franconville, France. Firm initiated recall is ongoing.
REASON
Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process.
VOLUME OF PRODUCT IN COMMERCE
215 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
BD Vacutainer Blood Transfer Device. It consists of a Luer attached via a hub to a needle covered with a sleeve, Catalog #364880, Recall # Z-1423-05
CODE
Lot #5076799, Exp 2/2008; #50076797, exp. 2/2008; #5976798, Exp 2/2008; #5098260, Exp 3/2008; #5112114, Exp 3/2008.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, on letter on July 26, 2005.
Manufacturer: Becton Dickinson Caribe Ltd, San Lorenzo, PR. Firm initiated recall is ongoing.
REASON
Customer complaints state the needle had separated from the hub, resulting in blood exposure and/or dislocation of the needle.
VOLUME OF PRODUCT IN COMMERCE
641,200 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Baxter Interlink System Non-DEHP Y-Type Catheter
Extension Set, product code 2N3371; An Rx sterile,
nonpyrogenic fluid pathway, 5.7", 0.8 mL Vol.,
with 2 injection sites and a male Luer Lock adapter;
Recall # Z-1424-05;
b) Baxter Minivolume Extension Set, 72", product code
2C5687; An Rx sterile, nonpyrogenic fluid pathway,
72", 1.6 mL Vol., with a male Luer Lock adapter,
Recall # Z-1425-05;
c) Baxter Minivolume Extension Set, 36", product code
2C5685; An Rx sterile, nonpyrogenic fluid pathway,
36", 0.9 mL Vol., with a male Luer Lock adapter,
Recall # Z-1426-05;
d) Baxter Mini-Infuser Microbore Extension Set,
product code 2C9201; An Rx sterile, nonpyrogenic
fluid pathway, 61", 0.5 mL Vol., with Luer Lock
adapters, Recall # Z-1427-05;
e) Baxter Tamper Resistant Anti-Siphon PCA Extension Set,
60", product code 2C9205; An Rx sterile, nonpyrogenic
fluid pathway, 60", 1.2 mL Vol., with Luer Lock
adapters, Recall # Z-1428-05;
f) Baxter Tamper Resistant Anti-Siphon PCA Extension Set,
96", product code 2C9206; An Rx sterile, nonpyrogenic
fluid pathway, 96", 1.6 mL Vol., with Luer Lock
adapters, Recall # Z-1429-05;
g) Baxter Tamper Resistant Anti-Siphon Combination Set,
101", product code 2L3507; An Rx sterile, nonpyrogenic
fluid pathway, 101", 2.5 mL Vol., with male Luer Lock
adapter, Recall # Z-1430-05;
h) Baxter Extension Set, product code 2C9219; An Rx
sterile, nonpyrogenic fluid pathway, 61", 1.4 mL Vol.,
with Luer Lock adapters, Recall # Z-1431-05;
i) Baxter Interlink System Huber Needle Extension Set,
product code 2N3703; An Rx sterile, nonpyrogenic
fluid pathway with Needle Gauge 22, Needle Length 3/4",
Total Volume 0.40 mL, Total Length 9",
Recall # Z-1432-05;
j) Baxter Interlink System Huber Needle Extension Set,
product code 2N3706; An Rx sterile, nonpyrogenic fluid
pathway with Interlink Y-Injection Site, Needle Gauge
19, Needle Length ¾", Total Volume 0.75 mL, Total
Length 10", Recall # Z-1433-05;
k) Baxter Interlink System Huber Needle Extension Set,
product code 2N3707; An Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site,
Needle Gauge 20, Needle Length 3/4", Total Volume
0.75 mL, Total Length 10", Recall # Z-1434-05;
l) Baxter Interlink System Huber Needle Extension Set,
product code 2N3709; An Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site,
Needle Gauge 22, Needle Length 3/4", Total Volume
0.75 mL, Total Length 10", Recall # Z-1435-05;
m) Baxter Interlink System Huber Needle Extension Set,
product code 2N3710; An Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site,
Needle Gauge 19, Needle Length 1", Total Volume
0.75 mL, Total Length 10", Recall # Z-1436-05;
n) Baxter Interlink System Huber Needle Extension Set,
product code 2N3712; An Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site,
Needle Gauge 20, Needle Length 1", Total Volume
0.75 mL, Total Length 10", Recall # Z-1437-05;
o) Baxter Interlink System Huber Needle Extension Set,
product code 2N3714; An Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site,
Needle Gauge 22, Needle Length 1", Total Volume
0.70 mL, Total Length 10", Recall # Z-1438-05;
p) Baxter Interlink System Huber Needle Extension Set,
product code 2N3716; An Rx sterile, nonpyrogenic
fluid pathway with Interlink Y-Injection Site,
Needle Gauge 19, Needle Length 1-1/2", Total
Volume 0.75 mL, Total Length 10",
Recall # Z-1439-05
CODE
a) Lot numbers UR247189, UR268656, UR268920,
UR270256;
b) Lot numbers UE107920, UE108480, UE108696,
UE108704, UE108977, UE108985;
c) Lot numbes UE107936, UE108019, UE108712,
UE109140;
d) Lot number UR249987;
e) Lot number UR251058;
f) Lot numbers UR254185, UR254524, UR273987;
g) Lot numbers UR251389, UR272328, UR272781,
UR274704;
h) Lot numbers UR266387, UR277061, UR277848;
i) Lot numbers FC04055, FC05013;
j) Lot numbers FC04057, FC05001, FC05010,
FC05017;
k) Lot numbers FC04053, FC05000, FC05005,
FC05012;
l) Lot numbers FC04052, FC04058, FC04059,
FC05006, FC05009;
m) Lot numbers FC04050, FC05007, FC05014;
n) Lot numbers FC04054, FC05003, FC05021;
o) Lot numbers FC04056, FC05004, FC05011;
p) Lot number FC05002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letters dated August 3, 2005.
Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibonito, PR. Firm initiated recall is ongoing.
REASON
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
VOLUME OF PRODUCT IN COMMERCE
208,306 sets
DISTRIBUTION
Nationwide and Internationally.

______________________________
PRODUCT
Aqueduct Hematology Workflow Manager, software, Part Number AQDCT, Recall # Z-1440-05
CODE
Not specified
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA, by letter August 8, 2005.
Manufacturer: Orchard Software Corp, Carmel, IN. Firm initiated recall is ongoing.
REASON
Potential for misidentification of historical patient results within the Aqueduct Hematology Workflow Manager software. In instances where the workflow manager software receives the same patient identifier for more than one patient the Aqueduct Workflow Manager software merges all results into one Patient File. This may cause test results to be associated with the wrong patient.
VOLUME OF PRODUCT IN COMMERCE
36 units
DISTRIBUTION
Nationwide.

______________________________
PRODUCT
a) Guidant ENDOTAK SQ Array models 0048,
0049, 0085. Subcutaneous Lead Array.
Cardioversion/Defibrillation Lead.
Sterilized with gaseous ethylene oxide.
Recall # Z-1441-05;
b) Guidant Lead Tunneler Kit model 6927.
Accessory Kit for use with the Endotak SQ
Lead Array. Contains one tunneler and
four sheaths. Sterilized with gaseous
ethylene oxide, Recall # Z-1442-05;
c) Oscor Introducer Kits Model LLP series.
Luer-Lock Peel-Away Introducer Set.
Each set contains: 1 peel-away sheath
with built-in-luer-lock; 1 vessel dilator;
1-50-cm guidewire 1 18-G needle; 1 10-cc
syringe. Sterile EO. Models 6089, 6091,
6092, 6093, 6094, 6663 and 6664,
Recall # Z-1443-05
CODE
a) Serial numbers 200652 and 200655,
Serial numbers 202864 thru 202900,
Serial numbers 102087 thru 103287;
b) Lot number 104029 thru 105078;
c) Lot numbers C4-03103 thru C4-03707;
Lot numbers: C4-03601 thru C4-03691,
Lot numbers: C4-03110 thru C4-03684,
Lot numbers: C4-03136 thru C4-03607,
Lot numbers: C4-03501 thru C4-03610,
Lot numbers: C4-03055 thru C4-03741,
Lot numbers: C4-03280 thru C4-03445
RECALLING FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, Saint Paul, MN, by telephone on June 13, 2005.
Manufacturer: B. Braun Medical, Inc, Cherry Hill, NJ. Firm initiated recall is ongoing.
REASON
A manufacturer for Guidant Introducers has received reports of introducer sheaths with cracked hubs/handles and/or improper peeling of the sheath during use.
VOLUME OF PRODUCT IN COMMERCE
870 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
a) Alsius CoolGard 3000 Temperature Regulation
System, Recall # Z-1397-05;
b) Alsius CoolGard 3000 Temperature Regulation
System, Recall # Z-1398-05;
CODE
All units manufactured before April 12, 2005
RECALLING FIRM/MANUFACTURER
Alsius Corporation, Irvine, CA, by letters beginning July 25, 2005. Firm initiated recall is ongoing.
REASON
Firm wants users to be aware not to leave the units in standby mode for more than an hour in rooms in excess of 75 F due to risk of an alarm mode being generated due to overheating.
VOLUME OF PRODUCT IN COMMERCE
207 Units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Abbott TestPack + Plus hCG Combo, list 3A60-16; the kit contains 20 reaction discs, anti-beta hCG (Goat) and anti-alpha hCG (Mouse, Monoclonal) coated, and 20 transfer pipettes, Recall # Z-1399-05
CODE
Lot 17297M200, exp. 10/25/05
RECALLING FIRM
Abbott Laboratories MPG, Abbott Park, IL, by e-mail on August 7, 2005. Firm initiated recall is ongoing.
REASON
False Positive results may be obtained with the identified lot of list 3A60-16 when using a negative patient sample or a negative control.
VOLUME OF PRODUCT IN COMMERCE
3,049 kits
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Abbott Clinical Chemistry Bilirubin Calibrator, List # 1E66-03, Recall # Z-1400-05
CODE
Lot #20881M100
RECALLING FIRM/MANUFACTURER
Abbott Laboratories Diagnostic Div., South Pasadena, CA, by letter dated August 5, 2005. Firm initiated recall is ongoing.
REASON
The value sheet for the Clinical Chemistry Bilirubin Calibrator, lot #20881M100 calibrator value sheet, has the calibrator values transposed for the Total Bilirubin Assay LN 7D60, Total Bilirubin Assay LN 8G62, and Neonatal Bilirubin Assay LN 9D88.
VOLUME OF PRODUCT IN COMMERCE
836 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR SEPTEMBER 7, 2005

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