FDA

Enforcement Report

November 20, 2002
02-46

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

****CORRECTION****

On Enforcement Report 02-38 dated September 25, 2002 Recall # F-771-2 had an incorrect entry under "reason". It should read: The products were manufactured using cantaloupes that I. Kunik, McAllen, TX recalled due to their association with an outbreak of Salmonella poona infection.

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PRODUCT
Fruzel assorted Natural Fruit Jelly candy, packaged in plastic jars/88(apprx)/16.5 grams each cup, assorted flavors (aka:"Fruzel"), brand Neo USA.Imported and distributed by Neo USA, Los Angeles, CA. The product is manufactured in Taiwan. Recall # F-082-3.
CODE
Exp date: 360 days from the manufacturing date; Item number: 18202; UPC code: 8 17815 00920 9.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Thomas Diaz, Inc., Toa Baja, Puerto Rico, by letter on October 16, 2002.
Manufacturer: Loadstar International Trade LTD., Taipei, Taiwan, R.O.C,
Firm initiated recall is ongoing.
REASON
The product is unfit for food due to the characteristics that result in a serious choking hazard.
VOLUME OF PRODUCT IN COMMERCE
1500 ctns/6 jar/88 units.
DISTRIBUTION
Puerto Rico.

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PRODUCT
J.C. Taste brand Apricots packed in a rigid plastic container (tub), Net Wt. 6.4 oz. Ingredients: Cashews Roasted in Cotton-seed Oil. Recall # F-083-3.
Firm on label: Hy-Grade Nut, Brooklyn, NY.
CODE
Sell by 09/09/02, container code 08-24-02.
RECALLING FIRM/MANUFACTURER
Hong Young Suk DBA Hy-Grade Nut Corp., Brooklyn, NY, by letter on April 25, 2002.
State initiated recall is complete.
REASON
The product contains undeclared sulfites (2406 ppm) and is also misbranded.
VOLUME OF PRODUCT IN COMMERCE
11 - 6.4 oz. packages were distributed. 8 packages were relabeled at the retail level.
DISTRIBUTION
NY.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

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PRODUCT
Miyako Brand Fukujin Zuke (a preserved vegetable mix)in a plastic tub, Net Wt. 6 oz. Recall # F-080-3.
CODE
No codes are applied to products.
RECALLING FIRM/MANUFACTURER
Mutual Trading Co. Inc., Los Angeles, CA, by visit on October 7, 2002.
FDA initiated recall is complete.
REASON
The product contained undeclared ingredients, including the colors FD&C Yellow No. 5 and FD&C Red No. 40.
VOLUME OF PRODUCT IN COMMERCE
768.
DISTRIBUTION
CA.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III

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PRODUCT
Retail unit boxes labeled as "Swanson Great Starts Egg, Cheese, & Bacon on a Biscuit" and Shipping cases labeled "Sausage, Egg, & Cheese on a Biscuit". Recall # F-069-3.
CODE
Shipping Case ID: Labeled "Sausage, Egg, & Cheese on a Biscuit"; UPC Code- # 0 51000 06356; Shipping case code PF09103DL 09 Oct. 03.
Retail Unit Package ID: Labeled "Egg, Cheese & Bacon on a Biscuit"; UPC Code- #0 51000 06381; Retail unit code: Recommended Use by: OCT 03 07162.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pinnacle Foods Corp, Swanson Frozen Foods, Mt. Lakes, NJ, by press release on August 23, 2002.
Manufacturer: Pierre Foods, Claremont, NC.
Firm initiated recall is ongoing.
REASON
Retail unit boxes labeled as Egg, Cheese, and Bacon on a Biscuit actually contained a second product, Sausage, Egg, and Cheese on a Biscuit.
VOLUME OF PRODUCT IN COMMERCE
4515.
DISTRIBUTION
Nationwide.

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PRODUCT
Kellogg's Frosted Flakes, 20 oz. retail pack. Recall # F-081-3.
CODE
Better if used before date code (on case): KC 09043 B09
Better if used before date code (on consumer pkg.):
SEP 04 2003
KCB 009
20:00 to 23:00 (Note: There will only be one time stamp.
The affected product will have a time stamp between 20:00
and 23:00).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kellogg Company, Battle Creek, MI, by letter on October 16, 2002.
Manufacturer: Kellogg Company, London, Ontario, Canada,
REASON
Boxes labeled as Frosted Flakes cereal actually contained Frosted Bite-Size Mini-Wheat cereal.
VOLUME OF PRODUCT IN COMMERCE
403 cases/ 14 per case.
DISTRIBUTION
AL, FL, MS, NC, SC, TN and TX.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
PRO-RED Syrup Antitussive, Nasal Decongestant, Antihistamine, Alcohol Free, (Hydrocodone bitartrate 2mg, Phenylephrine hydrochloride 5mg, Pyrilamine maleate 8.33mg) 4 FL.OZ. (118 mL) and 16 FL.OZ. (473 mL) bottles, Rx Only. Recall # D-047-3.
CODE
Lot# 01092 Exp 06/2004.
RECALLING FIRM/MANUFACTURER
Great Southern Laboratories, Houston, TX, by meeting on September 10, 2002.
Firm initiated recall is ongoing.
REASON
Yeast contamination (saccromyces cervisiae) causing bottles to swell
VOLUME OF PRODUCT IN COMMERCE
3913 (16 oz bottles) and 315 (4 oz bottles).
DISTRIBUTION
MO, IA, and IL.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

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PRODUCT
1) Cefuroxime for Injection, USP, 1.5g, Novaplus brand,
Infusion Bottle, For Intravenous Use, Rx only, Recall # D-050-3.
2 A) Cefuroxime for Injection USP, 7.5g, Novaplus brand,
Pharmacy Bulk Package, For Intravenous Use,
Not For Direct Infusion, Rx only, Recall # D-051-3;
2 B) Cefuroxime for Injection USP, 7.5g, AmeriNet Choice brand, Pharmacy Bulk Package, For Intravenous Use,
Not For Direct Infusion, Rx only.
3) Kefurox (Cefuroxime for Injection USP), 7.5g, Lilly brand, Pharmacy Bulk Package, For Intravenous Use,
Not For Direct Infusion, Rx only, Recall # D-052-3.
CODE
Lot No. (Exp. date)
Cefuroxime for Injection, USP, 1.5g
W8740Y3(1-Jan-03)

Cefuroxime for Injection USP, 7.5g
F3530Y2 (1-Mar-03), Z4420Y1 (1-Apr-03), Z4460Y1 (1-Apr-03),
Z4460Y6 (1-Apr-03), F0290Y2 (1-Jan-03), F3530Y1 (1-Mar-03),
Z4430Y5 (1-May-03).

Kefurox (Cefuroxime for Injection USP), 7.5g
F0290Y3 (1-Jan-03), F3530Y3 (1-Mar-03), Z4420Y2 (1-Apr-03).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eli Lilly and Co., Indianapolis, IN, by letters on October 7, 2002.
Manufacturer: Eli Lilly Italia, S.P.A., Sesto Fiorentino, Italy.
Firm initiated recall is ongoing.
REASON
Discoloration: product exceeded specification for color level (18 month stability).
VOLUME OF PRODUCT IN COMMERCE
25,500 units.
DISTRIBUTION
Nationwide.

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PRODUCT
Premarin Tablets (conjugated estrogens tablets, USP) 1.25 mg, 100, 1000 and 5000 count bottles, Rx, only. Recall # D-053-3.
CODE
100s: Lot 9981205, Exp. 3/02
1000s: Lot 9981348, Exp. 3/03
5000s: Lot 9981207, Exp. 3/03.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Richmond, VA, by letters dated October 14, 2002.
Manufacturer: Ayerst Laboratories, Inc., Rouses Point, NY.
Firm initiated recall is ongoing.
REASON
Failure to meet dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE
100s: 1,487 btls; 1000s: 1,514 btls; 5000s: 1,800 btls.
DISTRIBUTION
Nationwide.

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PRODUCT
Pyrethrin Lice Treatment (Piperonyl Butoxide 4% and Pyrethrum Extract (equivalent to 0.33% Pyrethrins), Kinray Preferred Plus brand, A Creme Rinse Application, 2 fl. oz. (59 mL) bottles, single and twin packs. Recall # D-054-3.
CODE
2F15A, exp. June 2004 (single unit)
2G02A, exp. July 2004 (twin pack)
2G25D, exp. July 2004 (twin pack).
RECALLING FIRM/MANUFACTURER
Qualis, Inc., Des Moines, IA, by telephone on October 28, 2002.
Firm initiated recall is ongoing.
REASON
Mislabeling; one active ingredient is incorrectly declared on the bottle label as Permethrin rather than correctly as Pyrethrin.
VOLUME OF PRODUCT IN COMMERCE
504 single units and 384 twin packs; 118 single packs and 245 twin packages have been quarantined at the own-label distributor awaiting return to Qualis.
DISTRIBUTION
NY.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

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PRODUCT
Source Plasma, Recall # B-0176-3.
CODE
Unit number HV015463.
RECALLING FIRM/MANUFACTURER
Sera-Tec Biologicals Limited Partnership (now BioLife Plasma Services, L.P.), Huntsville, AL, by fax on October 9, 2000.
Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that subsequently admitted to multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

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PRODUCT
Source Plasma, Recall # B-0177-3.
CODE
Unit numbers HV006189, HV006900, and HV007003.
RECALLING FIRM/MANUFACTURER
Sera-Tec Biologicals Limited Partnership (now BioLife Plasma Services, L.P.), Huntsville, AL, by fax on July 14, 2000.
Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of residing in the United Kingdom for more than 6 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NC.

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PRODUCT
Human Tissue for Transplantation, Skin Tissue Recall # B-0179-3.
CODE
Tissue number WS030902.
RECALLING FIRM/MANUFACTURER
New York Firefighters Skin Bank at New York, Presbyterian Hospital, New York, NY, by letter dated March 13, 2002.
Firm initiated recall is complete.
REASON
Human tissue for transplantation that tested repeatedly reactive for antibodies to hepatitis C virus (anti-HCV) was distributed.
VOLUME OF PRODUCT IN COMMERCE
15 tissues.
DISTRIBUTION
NY.

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PRODUCT
a) Red Blood Cells, Recall # B-0180-3;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0181-3;
c) Fresh Frozen Plasma, Recall # B-0182-3;
d) Recovered Plasma, Recall # B-0183-3.
CODE
a) Unit number 39E26569;
b) Unit numbers 27LX04404 and 27LV00370;
c) Unit number 39E26569;
d) Unit number 27LX04404 and 27LV00370.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by letter on May 10, 2001 and by telephone on May 11, 2001.
Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
KY, NY and WV.

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PRODUCT
a) Red Blood Cells, Recall # B0184-3;
b) Platelets, Recall # B-0185-3;
c) Recovered Plasma, Recall # B-0186-3.
CODE
a) Unit numbers 27LY00662 and 39K01452;
b) Unit numbers 27LY00662 and 39K01452;
c) Unit number 27LY00662 and 39K01452.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by letter on August 21, 2001 and by telephone on August 23, 2001.
Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis and human immunodeficiency virus (HIV), but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis and HIV testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
NY and WV.

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PRODUCT
a) Red Blood Cells, Recall # B-0187-3;
b) Recovered Plasma, Recall # B-0188-3.
CODE
a) Unit numbers 39J90887, 39J77026, and 39J39964;
b) Unit numbers 39J90887, 39J77026, and 39J39964.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by letters on June 18 and 19, 2001.
Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
WV and CA.

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PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated, Recall # B-0191-3.
CODE
Unit number 26170-0593.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on October 20, 2001 and by letter dated November 16, 2001.
Firm initiated recall is complete.
REASON
Blood product, that tested negative for Cytomegalovirus (CMV), but was collected from a donor who previously tested CMV positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AR.

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0192-3;
b) Platelets, Recall # B-0193-3.
CODE
a) Unit number 26167-6600;
b) Unit number 26167-6600.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by letter dated December 4, 2001.
Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AR.

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0194-3.
CODE
Unit number 26166-9437.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by letter dated November 26, 2001.
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
AR.

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0197-3;
b) Fresh Frozen Plasma, Recall # B-0198-3.
CODE
a) Unit number 26169-8802;
b) Unit number 26169-8802.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on December 3, 2001.
Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor based on the reported use of medications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AR.

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PRODUCT
Red Blood Cells, Recall # B-0200-3.
CODE
Unit 311276629.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Tupelo, MS, by letter dated May 17, 2000.
Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

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PRODUCT
Red Blood Cells, Recall # B-0201-3.
CODE
Unit 311281421.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Tupelo, MS, by telephone on June 6, 2000 and by letter dated June 16, 2000.
Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

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PRODUCT
Platelets Pheresis Leukocytes Removed, Recall # B-0202-3.
CODE
Unit 311294359.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Tupelo, MS, by telephone on January 2, 2001 and by letter dated January 6, 2001.
Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

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PRODUCT
Fresh Frozen Plasma, Recall # B-0204-3.
CODE
Unit 311278228.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Tupelo, MS, by telephone on October 19, 2000 and by letter on November 14, 2000.
Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.

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PRODUCT
Red Blood Cells Leukocytes Removed, Recall # B-0207-3.
CODE
Unit 311298643.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Tupelo, MS, by letter dated November 14, 2001.
Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

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PRODUCT
Red Blood Cells, Recall # B-0208-3.
CODE
Unit 163537950.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Jackson, MS by telephone on June 8, 2000.
Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had no hemoglobin check performed during screening, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

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PRODUCT
a) Red Blood Cells Leukocytes Removed, Recall # B-0209-3;
b) Recovered Plasma, Recall # B-0210-3.
CODE
a) Unit 163610679;
b) Unit 163610679.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Jackson, MS, by fax or letter on December 26, 2001 and January 11, 2002.
Firm initiated recall is complete.
REASON
Blood products, which were not tested for syphilis as required by the manufacturer's test kit instructions, were distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS and VA.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

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PRODUCT
Source Plasma, Recall # B-0178-3.
CODE
Unit numbers GM096924, GM096800, GM096612, GM096489, GM096123, GM095947, GM095709, and GM095614.
RECALLING FIRM/MANUFACTURER
Sera-Tec Biologicals Limited Partnership (now BioLife Plasma Services, L.P.), Greenville, MS, by fax on April 18, 2000.
Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor based on previous elevated testing for alanine aminotransferase (ALT), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
NC.

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0189-3.
CODE
Unit numbers 27LE36463, 27LE36465, 27GM54347, 27LM09975, and 27GY40032.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by letters on October 26, 2001 and November 19, 2001.
Firm initiated recall is complete.
REASON
Blood products, that tested out of specification for red blood cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
PA.

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0190-3.
CODE
Unit numbers 27FS16762, 27GT61728, 27GT61738, 27FN90555, 27GC70017, 27GC70021, 27GC70022, 27GC70035, 27GC70084, 27GY40196, 27GY40220, 27GY40241, 27GY40245, 27LF39006, 27S53059, 27LM10124, 27LJ20931, 27LJ20933, 27S53013, 27LG40588, 27LJ20926, 27GL24785, 27GS46972, 27GL25521, 27LF38856, 27LF38902, 27GL24805, 27H40815, 27LC16808, 27LG40626, 27FN90584, 27GG15082, 27GY40212, 27LC16826, 27LJ20942, 27GL24819, 27GS46979, 27GG15084, 27GL24833, 27LE36616, 27LM10044, 27GS46817, 27GS46854, 27GS46788, 27GS46849, 27GS46851, 27GS46959, 27LM10089, 27GL24818, 27GS46910, 27GS46927, 27GS46934, and 27LM10064.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by letter on October 23, 2001.
Firm initiated recall is complete.
REASON
Blood products exposed to unacceptable storage temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE
53 units.
DISTRIBUTION
PA, OH and WV.

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated, Recall # B-0195-3;
b) Platelets Pheresis, Leukocytes Reduced, Recall # B-0196-
3.
CODE
a) Unit number 26169-5142;
b) Unit numbers 26169-5139 (distributed as two split units)
and 26169-5141.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on October 24, 2001 and by letter dated November 8, 2001.
Firm initiated recall is complete.
REASON
Blood products, aliquoted using tubing from expired component bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
AR.

_____________________________
PRODUCT
Red Blood Cells Leukocytes Removed, Recall # B-0203-3.
CODE
Unit 311298691.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Tupelo, MS, by telephone on January 24, 2001.
Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

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PRODUCT
Red Blood Cells Pheresis Leukocytes Removed, Recall # B-0205-3.
CODE
Unit 311302561.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Tupelo, MS, by telephone on June 15, 2001 and by letter dated July 12, 2001.
Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MS.

_____________________________
PRODUCT
Red Blood Cells Pheresis Leukocytes Removed, Recall # B--206-3.
CODE
Units 311304006 and 311304007.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Tupelo, MS, by telephone on August 1, 2001 and by letter dated August 9, 2001.
Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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PRODUCT
Steris Quick Connect Kits, catalog nos. #QCL1629 and #QLC1646. Recall # Z-0246-3/Z-0247-3.
#QCL1629 is for Olympus 40/140/240 Series Non-Therapeutic GI Endoscopes in the STERIS SYSTEM 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray; and #QLC1646 is for Olympus 40/140/240 Series Duodenoscopes and Therapeutic GI Endoscopes in the STERIS SYSTEM 1 Sterile Processing System with the C1160 Universal Flexible Processing C1160 Tray.
CODE
Lot Numbers #3437936 and #343795, for Quick Connect Kit QLC1629;
Lot Number #3438074, for Quick Connect Kit QLC1646.
RECALLING FIRM/MANUFACTURER
Steris Corp., Mentor, OH, by telephone on October 3,2002 and by fax on October 4, 2002.
Firm initiated recall is complete.
REASON
Incorrect adapter component may affect the sterilization process of scopes.
VOLUME OF PRODUCT IN COMMERCE
90 units.
DISTRIBUTION
Nationwide and Australia.

_____________________________
PRODUCT
Invacare Venture HomeFill I Home Oxygen System. Recall # Z-0257-3/Z-0258-3.
CODE
Models: IOH100 and IOH100RU
Serial Numbers: 97A - 01L.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Invacare Corp., Elyria, OH, by letters on October 3, 2002.
Firm initiated recall is complete.
REASON
The high-pressure hose may separate from unit and cause injury to operator.
VOLUME OF PRODUCT IN COMMERCE
724.
DISTRIBUTION
Nationwide and Internationally.

_____________________________
PRODUCT
HFJV Patient Circuit Kit (Includes 2 ea. Circuits with 2 ea. 2.5mm and 2 ea. 3.5mm LifePort Endotracheal Tube Adapters) CAT: #937 Disposable - Single Patient Use Only. (Lots 2D0087, 2D0102, 2E0116, 2E0132, 2F0151, or 2G0155). Recall # Z-0259-3.
Contained in these kits are Individual Life Pulse HFV Humidifier Cartridge Patient Breathing Circuits (Lots 2C0074, 2D0093, 2D0105, 2E0115, or 2E0118).
CODE
HFJV Patient Circuit Kit Box Lot #'s 2DO087, 2DO102,
2EO116, 2EO132, 2FO151, 2GO155 containing Individual Life
Pulse HFV Humidifier Cartridge Patient Breathing Circuit
Lot #'s 2C0074, 2D0093, 2D0105, 2E0115, 2E0118.
RECALLING FIRM/MANUFACTURER
Bunnell, Inc., Salt Lake City, UT, by letter on August 5, 2002.
Firm initiated recall is complete.
REASON
Reported failures of pinch tubing in Patient Circuit Kit.
VOLUME OF PRODUCT IN COMMERCE
845 units.
DISTRIBUTION
Nationwide, Australia and Canada.

_____________________________
PRODUCT
McGee Piston, Ossicular Replacement Prosthesis, Catalogue No.: 140332. Recall # Z-0260-3.
CODE
0211105284.
RECALLING FIRM/MANUFACTURER
Gyrus ENT, LLC., Bartlett, TN, by letter on July 25, 2002.
Firm initiated recall is ongoing.
REASON
Lack of sterility assurance.
VOLUME OF PRODUCT IN COMMERCE
24.
DISTRIBUTION
OH, LA, CA, NV, CO, DC, MN, MI, AK, RI, NY, United Kingdom and France.

_____________________________
PRODUCT
5 mm Preloaded AxyaLoop Titanium Bone Anchor in the following single or 3 driver kit configuration:
a) 5 mm Preloaded AxyaLoop Titanium Bone Anchor Polypropylene Suture, CAT#1221. Recall # Z-0261-3;
b) 5 mm Preloaded AxyaLoop Titanium Bone Anchor Nylon Suture, CAT#1227. Recall # Z-0262-3;
c) Mini-Open Rotator Cuff Procedural Kit,CAT#1501-3. Recall # Z-0263-3;
d) Arthroscopic Rotator Cuff Procedural Kit,CAT#1502-3. Recall # Z-0264-3;
e) Arthrocopic Rotator Cuff Procedural Kit, CAT#1506-3. Recall # Z-0265-3.
CODE
a) Catalog Number: 1221
Lot Number: 201827, 202049
b) Catalog Number: 1227
Lot Numbers: 201990, 201991
c) Catalog Number: 1501-3
Lot Numbers: 202051, 202066, 202183, 202192
d) Catalog NUmber: 1502-3
Lot Numbers: 202052, 202067, 202193
e) Catalog Number: 1506-3
Lot Number: 202138.
RECALLING FIRM/MANUFACTURER
Axya Medical Inc., Beverly, MA, by letter on October 24, 2002.
Firm initiated recall is ongoing.
REASON
Driver Shaft May Break and Not Engage with Head of Anchor.
VOLUME OF PRODUCT IN COMMERCE
256.
DISTRIBUTION
AZ, CA, MO, NV, NY, NJ, TX and VA.

_____________________________
PRODUCT
RZ152 Digital Holter Recorder with Removable Flashcard. Recall # Z-0266-3.
NOTE: the affected part was the 7-Lead cable, Part Number CBL-113.
RZ152 Digital Holter Recorder applications include 3-channel Holter recording for up to 48 hours. RZ152 can perform all three recording applications simultaneously.
CODE
RZ 152R Digital Holter Recorder labeled as Rozinn with 7-Lead cables, Part Number CBL-113 (a component to the recorder).
RECALLING FIRM/MANUFACTURER
Rozinn Electronics, Inc., Glendale, NY, by letters and fax dated January 23, 1998.
Firm initiated recall is complete.
REASON
RZ 152 Digital Holter Recorders were distributed with defective lead cables.
VOLUME OF PRODUCT IN COMMERCE
31 units worldwide: 24 units within USA; 7 units to foreign accounts in Chile, China, Italy, Poland, Germany & Venezuela.
DISTRIBUTION
NY, CA, MI, OH, NM and Puerto Rico, Chile, China, Italy,
Poland, Germany and Venezuela.

_____________________________
PRODUCT
Davol EndoAvitene Microfibrillar Collagen Hemostat. Recall # Z-0267-3.
CODE
Product Code: 1010260
Lot Number: 52CMND12.
RECALLING FIRM/MANUFACTURER
Davol Inc., Subsidiary of C. R. Bard Inc., Cranston, RI, by letter on October 29, 2002.
Firm initiated recall is complete.
REASON
Device not manufactured in conformance with the Device Master Record.
VOLUME OF PRODUCT IN COMMERCE
645 units.
DISTRIBUTION
Nationwide and Belgium.

_____________________________
PRODUCT
Narkomed 6000 (NM6000), Anesthesia Machines, Catalog Numbers
4114586-001 and 4116660. Recall # Z-0268-3/Z-0269-3.
CODE
Serial numbers distributed in US: 10864, 11006, 11009, 11066,
11067, 11069, 11071, 11072, 11073, 11074, 11075, 11076, 11077,
11078, 11079, 11080, 11081, 11082, 11083, 11085, 11086, 11087,
11088, 11089, 11090, 11091, 11092, 11095, 11096, 11097, 11098,
11099, 11101, 11106, 11107, 11108, 11109, 11110, 11111, 11112,
11113, 11117, 11118, 11119, 11120, 11121, 11122, 11123, 11124,
11125, 11127, 11128, 11129, 11130, 11131, 11132, 11133, 11134,
11136, 11138, 11139, 11140, 11141, 11142, 11143, 11144, 11145,
11146, 11147, 11149, 11150, 11151, 11152, 11153, 11154, 11155,
11156, 11157, 11158, 11159, 11160, 11161, 11166, 11167, 11168,
11169, 11170, 11171, 11172, 11173, 11174, 11179, 11180, 11182,
11183, 11184, 11185, 11186, 11187, 11188, 11189, 11190, 11191,
11192, 11193, 11194, 11204, 11207, 11220, 11229, 11234, 11235,
11244, 11245, 11248, 11249, and 11250.

Serial numbers distributed in Canada: 10141, 10143, 10146, 10511,
10645, 10684, 10685, 10771, 10775, 10786, 10787, 10788, 10789,
10797, 10798, 10819, 10820, 10821, 10822, 10823, 10825, 10827,
10828, 10829, 10830, 10831, 10833, 10835, 10837, 10839, 10841,
10843, 10844, 10852, 10860, 11115, and 11116.
RECALLING FIRM/MANUFACTURER
Draeger Medical Inc., Telford, PA, by letters on/about November 1, 2002.
Firm initiated recall is ongoing.
REASON
Malfunction - sparks and smoke.
VOLUME OF PRODUCT IN COMMERCE
154 units.
DISTRIBUTION
Nationwide and Canada.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

_____________________________
PRODUCT
In-Health Blom-Singer Humidifier Holder, Cat. No. BE1060. Recall # Z-0256-3.
CODE
Lot Number 667623. Catalog Number BE 1060.
RECALLING FIRM/MANUFACTURER
Helix Medical, Inc., Carpinteria, CA, by letters sent on June 19, 2002.
Firm initiated recall is complete.
REASON
Mispackaging. Caps were labeled as holders.
VOLUME OF PRODUCT IN COMMERCE
36.
DISTRIBUTION
CA, CT, PA, GA, KY and Italy and Germany.