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U.S. Department of Health and Human Services

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Enforcement Report for October 19, 2005

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.

October 19, 2005
05-42

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

______________________________
PRODUCT
Nonfat dry milk in heavy brown paper bags labeled in part: WestFarm Foods Darigold Nonfat Dry Milk Grade A Spray Process Pasteurized, Net WT. 25 kg, Recall # F-002-6
CODE
LOT 10505 200 MFG DATE 19 JULY 05 EXP DATE 19 JULY 06
RECALLING FIRM/MANUFACTURER
Recalling Firm: WestFarm Foods, Seattle, WA, by telephone on August 8, 2005.
Manufacturer: WestFarm Foods, Jerome, ID. Firm initiated recall is ongoing.
REASON
Nonfat dry milk is contaminated with Salmonella based on the USDA's analysis.
VOLUME OF PRODUCT IN COMMERCE
184,635 lbs.
DISTRIBUTION
OR and ID

______________________________
PRODUCT
Hostess Cookies -- Oatmeal, approximately 14 g each. Four cookies are packaged in a clear wrapper. Twelve packages of cookies are placed in each box, Recall # F-003-6
CODE
NOV 7---56132---0604
RECALLING FIRM/MANUFACTURER
Recalling Firm: Interstate Brands Corp. Hdqtrs, Kansas City, MO, by email on August 3, 2005 and by press release on August 8, 2005.
Manufacturer: Interstate Brands Companies, Wayne, NJ. Firm initiated recall is ongoing.
REASON
Chocolate chip cookies containing milk and eggs are packaged in Oatmeal cookie boxes which declare no milk or eggs in ingredient panel.
VOLUME OF PRODUCT IN COMMERCE
6,665 boxes
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Crown brand Couque D'asse Cookie (Couque D'asse -- Coffee), Premium Couque D'asse Coffee, Net Wt. 2.26 oz (64g) and 5.08 oz. (144g) -- Product of Korea. The product is packed in individually sealed packages contained in a sealed box, Recall # F-004-6
CODE
2004.10.11A and 2005.10.10 (on side box panel)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Haemalkn Slkpoom, Inc., East Hills, NY, by press release on April 4, 2005, April 14, 2005 (includes eggs) and April 19, 2005 (includes hazelnuts).
Manufacturer: Crown Confectionery Co., Ltd, Seoul, Korea. Firm initiated recall is complete.
REASON
The product contained undeclared dairy ingredients, eggs and hazelnuts based on sampling analysis and inspectional findings by the New York Department of Agriculture and Markets and confirmed by the foreign manufacturer.
VOLUME OF PRODUCT IN COMMERCE
20 cases (24 boxes per case)
DISTRIBUTION
NY, CT, MA, NH, MD, and VA

_______________________________
PRODUCT
Peekay Best Quality brand Raisins, Net Wt. 7 oz. The product is packaged in a sealed plastic bag, Recall # F-005-6
CODE
Uncoded
RECALLING FIRM/MANUFACTURER
Peekay International Inc., Maspeth, NY, by press release and letter dated July 6, 2005. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (260 ppm) based on sampling & analysis by The New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY

_______________________________
PRODUCT
Ghirardelli Chocolate Syrup Brownies Premium Mix in 18.75 oz. box. Box contains dry brownie mix and separate packet of chocolate syrup. Cases are labeled to contain boxes of Ghirardelli Caramel Turtle Brownies. Product could have potentially been shipped as "mixed shipper" which is a display unit that contains 2 types of brownie mixes and is displayed by the store. The products in the mixed shipper/display unit contained Caramel Turtle Brownie mix and Double Chocolate brownie mix. However, when the Caramel Turtle Brownie mix is originally manufactured it is automatically cased in Caramel Turtle Brownie mix cases, then the retail boxes are removed and repacked into the mixed shipper. Since the cases of Caramel Turtle Brownie mixes could potentially contain the Chocolate Syrup Brownie mix, there is the potential for the mixed shipper/display units to contain the Chocolate Syrup Brownie Mix, Recall # F-006-6
CODE
K_5181_; K_5182_; K_5194_; K_5195_; K_5201_; and K_5231_. (Underscore could represent any letter). Code is embossed on the top flap of the box. Mixed shipper display case is coded K_5199_. The Syrup//Caramel Turtle Component is coded K_5181_.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Continental Mills, Seattle, WA, by press release, telephone and/or e-mail on September 2, 2005.
Manufacturer: Continental Mills, Hopkinsville, KY. Firm initiated recall is ongoing.
REASON
The product contains undeclared walnuts.
VOLUME OF PRODUCT IN COMMERCE
4,581 cases/12 boxes
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Honey Dijon Dressing: a) Garden Goodness Honey Dijon Dressing. b) Classic Sensations Honey Dijon Dressing. The products are sold in 16 oz clear plastic bottles, and are shipped in cases containing 12 bottles, Recall # F-007-6
CODE
a) UPC code 36294-10511 with use by dates 7/15/06 05C, 07/21/06 04C, 7/25/06 02C, 8/10/06 08C, and 8/18/06 08C. b) UPC code 36294-40006 with use by date of 8/10/06 08C
RECALLING FIRM/MANUFACTURER
E. D. Smith USA, Inc., North East, PA, by telephone and letter on August 31, 2005, and by letter and press release on September 1, 2005. Firm initiated recall is ongoing.
REASON
Product contains undeclared eggs and buttermilk.
VOLUME OF PRODUCT IN COMMERCE
4,444 cases
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Dancing Deer Baking Company Maple Pumpkin Cranberry Streusel Cake, 20 oz (576g), Recall # F-008-6
CODE
Use By Dates: From SEP 13 2005 through SEP 20 2005
RECALLING FIRM/MANUFACTURER
Dancing Deer Baking Company, Inc., Boston, MA, by telephone, e-mail, press release and letter on September 14, 2005. Firm initiated recall is ongoing.
REASON
Product contains undeclared pecans.
VOLUME OF PRODUCT IN COMMERCE
86 cakes
DISTRIBUTION
Nationwide and Internet Sales

_______________________________
PRODUCT
Product is ground basil, grounded and mixed, then packaged in zip-lock bags based on weight. The labels on the bags are written by hand, identifying who the product is going to, an identification number of the store it is going to and a lot number assigned by Firm, Recall # F-009-6
CODE
The lot code is a 6 digit number deciphered as the first 2 digits is the day of the month processed; next 2 digits identifies the lot of basil; and final 2 digits identifies the sequence of process on that day. Ex: 144501 = processed on the 14th day of the month, basil came from lot identified as 45th and it was the first batch processed on that day.
RECALLING FIRM/MANUFACTURER
California Blending Company, Inc, El Monte, CA, by letter dated August 30, 2005. Firm initiated recall is ongoing.
REASON
The basil distributed by Majestic International Spice Corp., was found to be contaminated with Salmonella by FDA.
VOLUME OF PRODUCT IN COMMERCE
240 lbs.
DISTRIBUTION
CA, CO, NV, and WA

_______________________________
PRODUCT
Basil Imported, Net Wt. is changed to reflect customer's order of either 2 lbs, 10 lbs, or 27.5 lbs, Recall # F-010-6
CODE
All product on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
MV Spice Distributor, El Cajon, CA, by letters on August 30 and 31, 2005. Firm initiated recall is ongoing.
REASON
The basil distributed by Majestic International Spice Corp., was found to be contaminated with Salmonella by FDA.
VOLUME OF PRODUCT IN COMMERCE
143.5 lbs.
DISTRIBUTION
CA

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

_______________________________
PRODUCT
UROCIT-K Potassium Citrate 10, 1080 mg. Tablets (10 mEq per tablet), Rx only, 100 Tablets, NDC 0178-0610-01, Recall # D-002-6
CODE
Lot Number: 4M113
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mission Pharmacal Co., San Antonio, TX, by letter on September 27, 2005.
Manufacturer: Mission Pharmacal Co., Boerne, TX. Firm initiated recall is ongoing.
REASON
Presence of particulate matter: Product may contain metal particles.
VOLUME OF PRODUCT IN COMMERCE
14,417 bottles of 100 tablets
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

_______________________________
PRODUCT
Premarin Tablets, (conjugated estrogen), 0.625 mg., 100 tablet bottles, Rx only, NDC 0046-0867-95, Recall # D-003-6
CODE
Lot A42766A, exp. date 9/05
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Zanesville, OH, by letter on December 13, 2004.
Manufacturer: Wyeth Pharmaceuticals, Rouses Point, NY. Firm initiated recall is ongoing.
REASON
Dissolution Failure
VOLUME OF PRODUCT IN COMMERCE
29/100 tablet bottles
DISTRIBUTION
MO

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

****CORRECTION****

In the September 21, 2005 -- 05-38 Enforcement Report. Recall # B-2133 -- 2135-5, The number 47721701, assigned to a unit of platelets in this recall is incorrect. The correct unit number is 4772170.

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced, Recall # B-2338-5
CODE
Unit numbers: 6585146 (2 units), 6868574 (2 units), 0757324 (2 units), and 6834350 (2 units)
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on April 22, 2004. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications for release, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CO, UT, CA, and VA

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-2418-5:
b) Red Blood Cells Leukocytes Reduced,
Recall # B-2419-5
CODE
a) Unit number: 6388237;
b) Unit number: 6602463
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on February 5, 2004. Firm initiated recall is complete.
REASON
Blood products, which were 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
CO and MS

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-2236-5
CODE
Unit numbers: 36265-8887 (parts 1&2), 36265-8917 (parts 1&2), 36266-0164 (parts 1&2), 36266-3820
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, Ventura, CA, by facsimile on November 5, 2002. Firm initiated recall is complete.
REASON
Red Cells, collected by pheresis without anticoagulant, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA

 RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
a) Stackhouse FreedomAire Lens/Hood; a sterile
disposable protective head garment for use
with the FreedomAire Surgical Helmet System,
providing a clear plastic bubble lens and
protective head hood to connect to the
surgical helmet; individually packaged hoods,
12 per case. Part #10450, Catalog # SA-500/US,
Recall # Z-0001-06;
b) Stackhouse Lens/Hood, Mark III Universal; a
sterile disposable protective head garment
for use with the Steakhouse Mark III Helmet,
providing a clear plastic bubble lens and
protective head hood to connect to the
surgical helmet; individually packaged hoods,
12 per case. Part #10567, Catalog # SA-300/US,
Recall # Z-0002-06
CODE
a) Lot number: 16963;
b) Lot number: 19253
RECALLING FIRM/MANUFACTURER
Recalling Firm: VIASYS Med Systems, Wheeling, IL, by telephone and fax on September 13, 2005.
Manufacturer: Servicios De Ensamble Internationales S.A. de C.V., Juarez, Mexico. Firm initiated recall is ongoing.
REASON
The packaging may be compromised such that sterility of the hoods cannot be guaranteed.
VOLUME OF PRODUCT IN COMMERCE
606 cases
DISTRIBUTION
Nationwide, Japan, Chile and Switzerland

______________________________
PRODUCT
D-Start Dry Hemostatic Bandage. The product is an adhesive bandage. Recall # Z-0003-06
CODE
Lot numbers: 301323A and 301393
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc, Allentown, PA, by letter dated September 15, 2005.
Manufacturer: Vascular Solutions, Minneapolis, MN. Firm initiated recall is ongoing.
REASON
Package sealing defect -- product may not be sterile.
VOLUME OF PRODUCT IN COMMERCE
60 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Hard shell carry case for the Lifepak 500 AED.
Catalog number 3005384-000 through 002,
Recall # Z-0004-06;
b) Hard shell carry case for the Lifepak CR Plus.
Catalog number 3201582-000 through --002,
Recall # Z-0005-06
CODE
Cases do not contain serial numbers or lot numbers.
RECALLING FIRM/MANUFACTURER
Medtronic Emergency Response Systems, Inc., Redmond, WA, by letter on July 12, 2005. Firm initiated recall is ongoing.
REASON
Some hard shell carry case for Lifepak 500 and Lifepak CR Plus automated external defibrillators may have blocked pressure vent which may make it difficult to open the case after a sudden decrease in altitude (such as in aircraft landing or mountain descent).
VOLUME OF PRODUCT IN COMMERCE
a) 4,608 cases;
b) 133 cases
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Nichols Advantage Invasive Trophoblast
Antigen (ITA) Assay Cartridges. Catalog
#62-7052, Recall # Z-0006-06;
b) Hyperglycosylated Human Chorionic Gonadotropin
(H-hCG) Assay Cartridges. Catalog # 62-7039,
Recall # Z-0007-06
CODE
a) Lot # 62-500261;
b) Lot # 62-500262
RECALLING FIRM/MANUFACTURER
Nichols Institute Diagnostics, San Clemente, CA, by letter on August 30, 2005. Firm initiated recall is ongoing.
REASON
Cartridge does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.
VOLUME OF PRODUCT IN COMMERCE
196 units
DISTRIBUTION
Nationwide, China, Germany and Australia

_______________________________
PRODUCT
Architect c800 for Conventional Units and
SI Units, Version 5.00, Recall # Z-0008-06
CODE
List number 08G98-07 for Conventional Units;
List number 04J62-07 for SI Units
RECALLING FIRM/MANUFACTURER
Abbott laboratories, Inc., Irving, TX, by letters on February 28, 2005. Firm initiated recall is ongoing.
REASON
Device has incorrect notation associated with therapeutic drug monitoring assays. These assays have an "IUO" notation after the results on the printed reports indicating that the results are for "Investigational Use Only". For both Conventional Units and SI Units, the ARCHITECT c8000 Assay Disk, Version 5.00 has the reagent name for Phenobarbital identified incorrectly as PHEN0 with a zero (()) instead of with the letter "O". This causes an error code to be generated during installation.
VOLUME OF PRODUCT IN COMMERCE
310 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Synchron LX Systems Version 4.5 Operating Software, Recall # Z-0009-06
CODE
Synchron LX 20 and PRO Version 4.5 Operating Software Part Number A21127 (Upgrade Kit) Software Versions V4.5N4.6 CDB (Chemistry Database). Synchron LXi Version 4.5 Operating Software A21128 (Upgrade Kit) Software Versions V4.5N4.6 CDB(Chemistry Database)
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letter dated September 6, 2005. Firm initiated recall is ongoing.
REASON
Synchron LX Systems Operating Software Version 4.5/v4.6 CBD (Chemistry Database) introduced an adjustment to the urine Uric Acid database calculation scheme which for some patients, depending on the volume of 24 hour urine sample, results may be reduced from above the upper limit of the laboratory's reference interval to below the limit.
VOLUME OF PRODUCT IN COMMERCE
868 units
DISTRIBUTION
Nationwide and Canada

_______________________________
PRODUCT
Architect c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations. List number 1G06-01, Recall # Z-0010-06
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Inc., Irving, TX, by letter on September 13, 2005.
Manufacturer: Toshiba Medical Systems Company, Tochigi-Ken, Japan. Firm initiated recall is ongoing.
REASON
Software deficiency causing potential shift in absorbance readings for test results.
VOLUME OF PRODUCT IN COMMERCE
1,107 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Allocraft TLIF Bone Inserter. Catalog No. 483600100, Recall # Z-0011-06
CODE
Lot Code: 04C570
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by telephone and letters on April 4, 2005.
Manufacturer: Stryke, Cestas, France. Firm initiated recall is ongoing.
REASON
The short arm of the bone inserter may fracture during use and potentially result in an adverse health consequence.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
EBI Trochanteric 11mm Long Nail, Recall # Z-0012-06
CODE
Catalog No./Lot Nos: 28226/164522; 28228/164523; 28230/175576; 28234/175583; 28238/175589; 28248/164527; 28324/164529; 28326/164531; 28328/164532; 28330/175614; 28332/170182; 28334/175621; 28338/175630; 28342/166415; 28344/164540; 28348/164545
RECALLING FIRM/MANUFACTURER
EBI, L.P., Parsippany, NJ, by e-mail on June 27, 205 and by letter on July 7, 2005. Firm initiated recall is ongoing.
REASON
Upon evaluation, the firm found that the fatigue strength of the nails was below the required value as specified in the design specification.
VOLUME OF PRODUCT IN COMMERCE
102 nails
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) TC-PLUS Tibial Insert Ultra-Congruent Size 10; 9 mm,
Model 25456, Recall # Z-0013-06;
b) TC-PLUS Tibial Insert 2; 15 mm, Model 25309,
Recall # Z-0014-06;
c) TC-PLUS Tibial Insert UC 4; 11 mm, Model 25427,
Recall # Z-0015-06;
d) TC-PLUS Tibial Insert UC 4; 13 mm, Model 25428,
Recall # Z-0016-06;
e) TC-PLUS Tibial Insert UC 6; 9 mm, Model 25436,
Recall # Z-0017-06;
f) TC-PLUS Tibial Insert UC 6; 13 mm, Model 25438,
Recall # Z-0018-06;
g) TC-PLUS Tibial Insert UC 10; 11 mm, Model 25457,
Recall # Z-0019-06
CODE
a) Lot code: 0204.13.2355;
b) Lot code: 0303.13.1623;
c) Lot code: 0501.13.0198;
d) Lot code: 0501.13.0263;
e) Lot code: 0501.13.0264;
f) Lot code: 0501.13.0199, 0303.13.1616;
g) Lot code: 0501.13.0200
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plus Orthopedics USA, San Diego, CA, by telephone on August 3, 2005.
Manufacturer: Plus Endoprothetik AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing.
REASON
Products did not meet specifications. The insert was produced with a smaller length dimension, resulting in micromotion experienced in preoperative assembly of a tibial insert and tibial baseplate.
VOLUME OF PRODUCT IN COMMERCE
108 units
DISTRIBUTION
AZ, CA, ID, NY, TX, and VA

_______________________________
PRODUCT
a) Pioneer Surgical brand Quantum Spinal Rod System
Polyaxial Screw, length 45 mm; Catalog number
10-575-PA-45. Recall # Z-0020-06;
b) Pioneer Surgical brand Quantum Spinal Rod System
Polyaxial Screw, length 40 mm; Catalog number
10-575-PA-40, Recall # Z-0021-06
CODE
a) Lot code: 306507;
b) Lot code: 308623
RECALLING FIRM/MANUFACTURER
Pioneer Surgical Technology, Marquette, MI, by letter dated July 29, 2005. Firm initiated recall is complete.
REASON
Screw may be incorrectly etched as to length. Screw that is etched "45mm" may be 40mm rather than 45mm. Manufacturer is recalling both lots because of a "potential of lot contamination".
VOLUME OF PRODUCT IN COMMERCE
234 screws
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Interis Allura BiPlane X-Ray System, Recall # Z-0022-06
CODE
The firm utilizes site numbers: 520582, 531926, 535761, 535775, 520949, 530660, 530654, 522136, 521325, 532241, 531939, 520721, 104949, 530396, 532152, 530653, 532383, 531649, 534756, 533290, 521525, 533397, 534786, 520688, 522456, 520964, 532218, 521149, 520275, 532240, 531758, 520666, 519196, 531799, 519981, 520756, 76992, 534131
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co. Phillips, Bothell, WA, by letter on July 25, 2005.
Manufacturer: Philips Medical Systems, Netherlands. Firm initiated recall is ongoing.
REASON
1) During positioning of the Lateral Stand the rotation and/or skew movement may travel unexpectedly in opposite direction; 2) movement may be faster than normal speed; 3) the stand may not stop immediately upon release of the joystick.
VOLUME OF PRODUCT IN COMMERCE
38 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Zimmer brand Bigliani/Flatow Total Shoulder
trabecular metal glenoid component, 40 mm dia.
articular surface, small, sterile, for cemented
use only in the USA, Cat. no. 00430604000.
Recall # Z-0023-06;
b) Zimmer brand Bigliani/Flatow Total Shoulder trabecular
metal glenoid component, 46 mm dia. articular surface,
small, sterile, for cemented use only in the USA,
Cat. no. 00430604046, Recall # Z-0024-06;
c) Zimmer brand Bigliani/Flatow Total Shoulder trabecular
metal glenoid component, 40 mm dia. articular surface,
med, sterile, for cemented use only in the USA, Cat. no.
00430604640, Recall # Z-0025-06;
d) Zimmer brand Bigliani/Flatow Total Shoulder trabecular
metal glenoid component, 46 mm dia. articular surface,
med, sterile, for cemented use only in the USA, Cat. no.
00430604600, Recall # Z-0026-06;
e) Zimmer brand Bigliani/Flatow Total Shoulder trabecular
metal glenoid component, 52 mm dia. articular surface,
med, sterile, for cemented use only in the USA, Cat. no.
00430604652, Recall # Z-0027-06;
f) Zimmer brand Bigliani/Flatow Total Shoulder trabecular
metal glenoid component, 46 mm dia. articular surface,
large, sterile, for cemented use only in the USA, Cat. no.
00430605246, Recall # Z-0028-06;
g) Zimmer brand Bigliani/Flatow Total Shoulder trabecular
metal glenoid component, 52 mm dia. articular surface,
large, sterile, for cemented use only in the USA, Cat.
no. 00430605200, Recall # Z-0029-06;
h) Zimmer brand Bigliani/Flatow Total Shoulder trabecular
metal glenoid component, 56 mm dia. articular surface,
small, sterile, for cemented use only in the USA, Cat.
no. 00430605256, Recall # Z-0030-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc., Warsaw, IN, by letter or e-mail dated August 23, 2005.
Manufacturer: Zimmer Trabecular, Allendale, NJ. Firm initiated recall is ongoing.
REASON
The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
VOLUME OF PRODUCT IN COMMERCE
723 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401 US, Recall # Z-0031-06
CODE
Lot number: 0011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rita Medical Systems, Fremont, CA, by letters on September 21, 2005.
Manufacturer: Rita Medical Systems, Manchester, GA. Firm initiated recall is ongoing.
REASON
Devices' sterility may be compromised as evidenced by a loss of package integrity.
VOLUME OF PRODUCT IN COMMERCE
262 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Baxter's Patient Care System (BPCS) software, composed of Pharmacy Management - Inpatient - product code 2M5013, Point of Care - product code 2M5014 and Management Reports - product code 2M5015, Recall # Z-0033-06
CODE
Software version 4.1-77, 4.0-66 and 3.4-18.24
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL, by letters dated June 16, 2005.
Manufacturer: Baxter Healthcare Corp./Patient Care System, Toronto, Canada.
REASON
If a pharmacy end user alters the Administration Unit of Measure (AUOM) of an ordered drug, the AUOM will display incorrectly on the Medication Administration Record for the patient, possibly leading to medication errors.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
MO, MA, VT, CA and Canada

_______________________________
PRODUCT
Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000, Recall # Z-0034-06
CODE
Serial numbers: 0428702183 through 0518008193
RECALLING FIRM/MANUFACTURER
Stryker Instruments, Division of Stryker Corporation, Kalamazoo, MI, by letter dated August 5, 2005. Firm initiated recall is ongoing.
REASON
The pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.
VOLUME OF PRODUCT IN COMMERCE
473 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Fetalgard Lite Fetal Monitors, Model APIS (Single
Fetus Monitoring), Recall # Z-0035-06;
b) Fetalgard Lite Fetal Monitors, Model HCS (Home Care Single
Fetus Monitoring), Recall # Z-0036-06
CODE
a) System Serial Numbers: FA002021 FA002022 FA002025
FA002027 FA002033 FA002020 FA002029 FA002005 FA002041
FA002044 FA002046 FA002112 FA002097 FA002117 FA002028
FA002047 FA002048 FA002118 FA002034 FA002093 FA002095
FA002116 FA002008 FA002023 FA002030 FA002031 FA002009
FA002098 FA002040 FA002092 FA002024 FA002114 FA002113
FA002115 FA002026 FA002032 FA001328;
b) Serial Numbers: FA002010 FA002051 FA002054 FA002059
FA002061 FA002062 FA002064 FA002011 FA002013 FA002014
FA002056 FA002065 FA002058
RECALLING FIRM/MANUFACTURER
Analogic Corporation, Peabody, MA, by letter dated September 13, 2005. Firm initiated recall is ongoing.
REASON
Unit may not power up due to faulty circuit board.
VOLUME OF PRODUCT IN COMMERCE
50 units
DISTRIBUTION
CT, PR, and Internationally

_______________________________
PRODUCT
a) Datex-Ohmeda S/5 Aespire Anesthesia System 7100,
Recall # Z-0037-06;
b) Datex-Ohmeda S/5 Aespire Anesthesia System 7900,
Recall # Z-0038-06;
c) Datex-Ohmeda Aespire Carestation. This device is not
marketed in the US, Recall # Z-0039-06
CODE
AMXJ00203, AMXJ00204, AMXJ00248 thru AMXJ00257,
AMXJ00259, AMXJ00260, AMXJ00262 thru AMXJ00305,
AMXJ00308 thru AMXJ00312, AMXJ00317, AMXJ00318,
AMXJ00333 thru AMXJ00335, AMXJ00338 thru AMXJ00342,
AMXJ00350 thru AMXJ00354, AMXJ00380 thru AMXJ00411,
AMXJ00416, AMXJ00419 thru AMXJ00425, AMXJ00429 thru
AMXJ00442, AMXJ00451 thru AMXJ00473, AMXJ00485 thru
AMXJ00576, ZMXJ00581 thru AMXJ00629, AMXJ00631 thru
AMXJ00639, AMXJ00641 thru AMXJ00699;
b) ANCJ00100 thru ANCJ00113, ANCJ00116, ANCJ00118;
c) AMZJ00111 thru AMZJ00146
RECALLING FIRM/MANUFACTURER
Datex-Ohmeda, Inc., Madison, WI, by letter dated September 23, 2005. Firm initiated recall is ongoing.
REASON
Two conditions may occur with the S/5 Aespire Anesthesia System. The internal auxiliary flowmeter tubing may become disconnected if the auxiliary oxygen supply tubing is occluded and the patient may not receive desired supplemental oxygen which could lead to serious injury if undetected. Also the O2 switch may leak or fail.
VOLUME OF PRODUCT IN COMMERCE
419 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS I

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PRODUCT
a) Salmon Snackers 100% Salmon, Net Wt. 108 oz packages.
Product is packaged under two labels:
a) Treats for Dogs, b) Treats for Cats.
T.W. Enterprises, Ferndale, WA. Ingredients: Salmon,
Vitamin E, Recall # V-096-5;
b) Shrimp Snackers 100% Shrimp, Net Wt. 1.0 oz. packages.
Product is packaged under two labels:
Treats for Dogs, b) Treats for Cats.
T.W. Enterprises, Ferndale, WA. Ingredients: Shrimp,
Recall # V-097-5;
c) Healthy K9 100% Natural Beef Jerky Dog Treats,
70 g packages, Aron Pet Food Abbotsford, BC V2T 6X4,
Made in CANADA This product is made from pizzle root).
Recall # V-098-5;
d) Healthy K9 Beef 100% Natural Beef Heart Dog Treats,
70 g packages, Aron Pet Food Abbotsford, BC V2T 6X4
Made in CANADA, Recall # V-099-5;
e) HEALTHY K9 ORIGINAL BEEF CHEW 100% Pure Beef Made in USA
product comes in following sizes: small 4", medium 6",
large 10.5", xlarge 14", mega 17", jumbo 28",
Recall # V-100-5;
f) HEALTHY K9 100% NATURAL BEEF LIVER DOG TREATS 70g
Made in CANADA Aron Pet Food Abbotsford, BC V3T 6X4 also
sold in bulk cases labeled HEALTHY K9 BEEF LIVER ONE
POUND NET, Recall # V-101-5;
g) HEALTHY K9 100% NATURAL VEAL CHEW DOG TREATS 5x5"
Made in CANADA Aron Pet Food Abbotsford, BC V2T 6X4,
Recall # V-102-5;
h) HEALTHY K9 100% NATURAL BEEF TRIPE Large Aron Pet Food
Surrey, BC V4N 4S1, Recall # V-103-5;
i) Bully Chew this bulk product in cardboard cartons with
product name of bully chew hand written on the carton,
Recall # V-104-5;
j) HEALTHY K9 BEEF JERKY ONE POUND NET. (This product is
made from weasand meat). This label is used on shipping
cartons of bulk product, Recall # V-105-5
CODE
Products are not coded.
RECALLING FIRM/MANUFACTURER
T. W. Enterprises, Inc., Ferndale, WA, by press release on June 8, 2005, telephone on June 9, 2005 and June 16, 2005 and by letters on June 16, and June 17, 2005. Firm initiated recall is ongoing.
REASON
Products contaminated with Salmonella species.
VOLUME OF PRODUCT IN COMMERCE
123,148 packages, 389 lbs. of bulk beef liver and beef jerky
DISTRIBUTION
Nationwide and Canada

END OF ENFORCEMENT REPORT FOR OCTOBER 19, 2005

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