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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January 18, 2006
06-03

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

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PRODUCT
aSpices Brand Basil Ground in a 1 oz clear plastic bag with English wording and aSPICES logo. The package is green, gold and white and approximately 6" x 1.5" in size. Bar code number 82699803113, Recall # F-051-6
CODE
Product sold after August 26, 2004.
RECALLING FIRM/MANUFACTURER
American Natural Herbs & Spice, Inc., Union City, CA, by telephone, letter and press release on May 25, 2005. Firm initiated recall is complete.
REASON
Sample analysis by the State of California found the product contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
85 bags
DISTRIBUTION
CA

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PRODUCT
Marzetti Fat Free Honey Mustard Dressing packaged in 1.5 oz foil individual packets, item #81966. Each case is identified as item #81958, Recall # F-052-6
CODE
Best buy lot code of BB030206 embossed in the upper side seal of each packet. Case labeling contains a best buy code of 03 02 06 X.
RECALLING FIRM/MANUFACTURER
Recalling Firm: T. Marzetti Co, Columbus, OH, by e-mail and fax dated October 25, 2005.
Manufacturer: Kroger Co., Cincinnati, OH. Firm initiated recall is ongoing.
REASON
The product contains undeclared anchovies, a sub-ingredient of the Worcestershire Sauce.
VOLUME OF PRODUCT IN COMMERCE
1,601/60 count cases
DISTRIBUTION
Nationwide

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PRODUCT
Shedd's Country Crock Macaroni & Cheese Side Dishes (mistakenly contain Home Style Mashed Potatoes). The affected Country Crock Macaroni & Cheese Side Dishes have a UPC #2740072531. The product comes in a 23 oz. plastic tube container with a cardboard sleeve. These chilled products are generally sold in the meat case or the deli section, Recall # F-053-6
CODE
Use by date of NOV 29 05 WPI
RECALLING FIRM/MANUFACTURER
Recalling Firm: Unilever United States, Inc., Englewood Cliffs, NJ, by telephone, press release and letter on November 11, 2005.
Manufacturer: Reser's Fine Foods, Pasco, WA. Firm initiated recall is ongoing.
REASON
Packages labeled as macaroni & cheese actually contain cheese mashed potatoes with undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
1,329 cases
DISTRIBUTION
Nationwide

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

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PRODUCT
a) Tuna Triple Wedge Sandwiches labeled
under the Deli Fresh or Mountain
Fresh Deli labels, individually
wrapped for retail sale,
Recall # F-054-6;
b) Egg Salad Triple Wedge Sandwiches
labeled under the Deli Fresh or
Mountain Fresh Deli labels,
individually wrapped for retail
sale, Recall # F-055-6;
c) British and ½ British Sandwiches
labeled under the Deli Fresh or
Mountain Fresh Deli labels,
individually wrapped for retail
sale, Recall # F-056-6
CODE
a) and b) Pull Date Codes of 12 23;
12 26; 12 27; 12 28 or 12 29;
c) Pull Date Codes of 12 23; 12 26;
12 27; 12 28; 12 29; 12 30; 1 2;
1 3; 1 4 or 1 5
RECALLING FIRM/MANUFACTURER
Airline Catering Company, Inc., Spanaway, WA, by visit beginning on December 22, 2005. Firm initiated recall is complete.
REASON
Sandwiches were distributed to wholesale and retail consignees with undeclared color, FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
1,179 individually wrapped sandwiches
DISTRIBUTION
WA

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

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PRODUCT
a) Cardioplegia infusion solutions including:
Cold Cardioplegia, Warm Cardioplegia,
Blood Cardioplegia 1, Blood Cardioplegia 2,
Cardioplegia Base 1, Cardioplegia Base 2,
Cardioplegia Base, Cardioplegia Reperfusion,
Cardioplegia High Potassium,
Cardioplegia Low Potassium,
Cardioplegia #1, Cardioplegia #2
Cardioplegia #3; Maintenance Cardioplegia,
Enriched Cardioplegia, Cardioplegia Base
Enriched. Products are manufactured
to order and packaged in clear,
plastic infusion bags in various
volumes, and additionally labeled
with component formula and the
specified consignee. Recall # D-109-6;
b) Oxytocin Infusion Bags, packaged as
Oxytocin 10 units, Oxytocin 20 units,
Oxytocin 30 units, Oxytocin D5 1/2 NS,
Oxytocin in Lactated Ringers.
Products are manufactured to order
and packaged in clear, plastic
infusion bags in various volumes,
and additionally labeled with
component formula and the specified
consignee, Recall # D-110-6;
c) Magnesium-containing injectable
products including: Magnesium 1 GM,
Magnesium 2 GM, Magnesium Sulfate
2 GM, Magnesium 4 GM, Hydration-
Magnesium in D5W, Magnesium Infusion,
Magnesium in Lactated Ringers.
Products are manufactured to order
and packaged in clear, plastic
infusion bags in various volumes,
and additionally labeled with
component formula and the specified
consignee. Recall # D-111-6;
d) Dialysate solutions including:
Citrate Dialysate, Heparin Dialysate,
Pediatric Dialysate, Hydration
Dialysate #1, Hydration Dialysate #2,
CRRT Dialysate, CVVHD (Dialysate)
300, CVVHD (Dialysate) 342, CVVHD
Pediatric Formula (Normocarb),
CVVHD Formalin #1, CVVHD Formalin #2,
CVVHD Formalin #3, CVVHD Non-Standard,
CVVHD D5W, CVVHD 1/2 NS, CVVHD NS.
Products are manufactured to order
and packaged in clear, plastic
infusion bags in various volumes
and additionally labeled with
component formula and the specified
consignee. Recall # D-112-6;
e) Antibiotic Irrigation, packaged
in 1 Liter clear plastic bags and
bottles. Products are manufactured
to order and additionally labeled with
component formula and the specified
consignee. Recall # D-113-6;
f) Bupivicaine 0.25 % and 0.5% Infusion
Solutions, also sold as Pain Bags
(Bupivicaine 0.25 %). Products are
manufactured to order and packaged
in clear, plastic infusion bags in
various volumes, and additionally
labeled with component formula and
the specified consignee.
Recall # D-114-6;
g) Diltiazem "piggyback" Infusion bags,
containing Diltiazem 5mg/ml injection.
Products are manufactured to order
and additionally labeled with
component formula and the specified
consignee. Recall # D-115-6;
h) Norepinephrine Bitartrate (piggyback)
Infusion Bags, 1 mg/ml. Products are
manufactured to order and additionally
labeled with component formula and the
specified consignee. Recall # D-116-6;
i) Promethazine, manufactured as 25 mg/ml
and 50mg/ml vials. Products are
manufactured to order and labeled
**FOR IM/IV USE ONLY** and
additionally labeled with component
formula and the specified consignee.
Recall # D-117-6
CODE
a) Expiration Date 9/1/05 to 10/15/05;
b) Expiration Date codes between
8/31/05 and 10/16/05;
c) Expiration date codes between
8/31/05 and 10/16/05;
d) Expiration date codes are between
8/21/05 and 10/16/05;
e) Expiration date codes between
8/31/05 and 10/16/05;
f) Expiration date codes between
8/31/05 and 10/16/05;
g) Expiration date codes between
8/31/05 and 10/16/05;
h) Expiration date codes between
8/15/05 and 9/30/05;
i) Expiration date codes between
8/15/05 and 9/30/05.
RECALLING FIRM/MANUFACTURER
Central Admixture Pharmacy Services, Inc., Lanham, MD, by telephone, e-mail and fax on September 16, 2005 and September 17, 2005. Firm initiated recall is complete.
REASON
Bacterial contamination.
VOLUME OF PRODUCT IN COMMERCE
33,682 units
DISTRIBUTION
MD, VA, DE and D.C.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

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PRODUCT
a) Hydrocodone Bitartrate/APAP,
5/500 mg, 15-unit dose packages,
NDC #0406035701, Recall # D-107-6;
b) Hydrocodone Bitartrate/APAP,
10/650 mg, 15-unit dose packages,
NDC #0406036101, Recall # D-108-6
CODE
a) Lot # 0357J50485, Exp. Date 12/05/06;
b) Lot # 0361J52296, Exp. Date 12/05/06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Murfreesboro Pharmaceutical Nursing Supply, Murfreesboro, TN, by telephone and letter on December 15, 2005.
Manufacturer: Tyco Healthcare Mallinckrodt, Inc., Hobart, NY. Firm initiated recall is complete.
REASON
Mispackaging: Two unit dose packaged drugs were placed into incorrectly labeled boxes.
VOLUME OF PRODUCT IN COMMERCE
598 units
DISTRIBUTION
TN

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS I

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PRODUCT
Human Tissue for Transplantation, Recall # B-0322-6
a) Alloquent CC Allograft (8, 9 & 10 mm);
b) Achilles Tendon;
c) Cancellous Bone 4-10 mm (15 & 30 cc);
d) Patella Tendon-Hemi;
e) Iliac Crest Wedge (14-17mm, 11-13mm,
<10mm, and 18+mm);
f) Tibialis Tendon
CODE
a) Code: BS30-4008, BS30-4009, BS30-4010;
b) Code: LATM;
c) Code: LCISM & LCIPM;
d) Code: LTTM;
e) Code: LIWXLM, LIWLM, LIWMM, LIWSM;
f) Code: LTTM
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lost Mountain Tissue Bank, Kennesaw, GA, by letters dated October 12, and October 21, 2005.
Manufacturer: Biomedical Tissue Services, Ltd., Fort Lee, NJ. Firm initiated recall is ongoing.
REASON
Human tissues, procured from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
283 tissues
DISTRIBUTION
Nationwide and Turkey

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PRODUCT
PUROS Allograft Bone;
Suspend Tutoplast Processed Fascia Lata,
Recall # B-0375-6
CODE
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U00000000043569 U00000000043570 U00000000043571 U00000000043572 U00000000043573 U00000000043574 U00000000043575 U00000000043576 U00000000043577 U00000000043578 U00000000043579 U00000000043580 U00000000043581 U00000000043720 U00000000043721 U00000000043722 U00000000043723 U00000000043724 U00000000043725 U00000000043726 U00000000043727 U00000000043728 U00000000043729 U00000000043730 U00000000043772 U00000000043773 U00000000043774 U00000000043775 U00000000043776 U00000000043777 U00000000043778 U00000000043779 U00000000043780 U00000000043781 U00000000043879 U00000000043880 U00000000043881 U00000000043882 U00000000043883 U00000000043884 U00000000043885 U00000000043886 U00000000043887 U00000000043888 U00000000043889 U00000000043890 U00000000043891 U00000000043892 U00000000043893 U00000000044013 U00000000044014 U00000000044015 U00000000044016 U00000000044017 U00000000044018 U00000000044019 U00000000044020 U00000000044021 U00000000044022 U00000000044023 U00000000044024 U00000000044025 U00000000044026 U00000000044027 U00000000044028 U00000000044029 U00000000044030 U00000000044031 U00000000044032 U00000000044033 U00000000044034 U00000000044035 U00000000045167 U00000000045168 U00000000045169 U00000000045170 U00000000045171 U00000000045172 U00000000045173 U00000000045178 U00000000045179 U00000000045180 U00000000045181 U00000000045278 U00000000045279 U00000000045280 U00000000045281 U00000000045282 U00000000045283 U00000000045284 U00000000045285 U00000000045286 U00000000045287 U00000000045288 U00000000045289 U00000000045290 U00000000045291 U00000000045292 U00000000045358 U00000000045359 U00000000045360 U00000000045361 U00000000045362 U00000000045363 U00000000045364 U00000000045365 U00000000045366 U00000000045367 U00000000045856 U00000000045857 U00000000045858 U00000000045859 U00000000045860 U00000000045861 U00000000045862 U00000000045863 U00000000045864 U00000000045865 U00000000045866 U00000000045867 U00000000045868 U00000000045869 U00000000045906 U00000000045907 U00000000045908 U00000000045909 U00000000045910 U00000000045911 U00000000045912 U00000000045913 U00000000045914 U00000000045915 U00000000045916 U00000000045917 U00000000045918 U00000000045919 U00000000045920 U00000000045921 U00000000045922 U00000000045940 U00000000045941 U00000000045942 U00000000045943 U00000000045944 U00000000045953 U00000000045954 U00000000045955 U00000000045956 U00000000045957 U00000000045958 U00000000045959 U00000000045960 U00000000045961 U00000000045969 U00000000045970 U00000000045971 U00000000045972 U00000000045973 U00000000045974 U00000000045975 U00000000045976 U00000000045977 U00000000045978 U00000000045979 U00000000045980 U00000000045981 U00000000045982 U00000000045983 U00000000045984 U00000000046043 U00000000046044 U00000000046051 U00000000046052 U00000000046053 U00000000046054 U00000000046055 U00000000046056 U00000000046057 U00000000083301 U00000000083302 U00000000083310 U00000000083313 U00000000083317 U00000000083324 U00000000083325 U00000000083326 U00000000083327 U00000000083331 U00000000083336 U00000000083337 U00000000083338 U00000000083339 U00000000083296 U00000000083300 U00000000083303 U00000000083304 U00000000083305 U00000000083306 U00000000083307 U00000000083308 U00000000083309 U00000000083311 U00000000083312 U00000000083314 U00000000083315 U00000000083316 U00000000083318 U00000000083319 U00000000083320 U00000000083321 U00000000083322 U00000000083323 U00000000083328 U00000000083329 U00000000083330 U00000000083332 U00000000083333 U00000000083334 U00000000083335 U00000000083297;
b) BM03L11421A012031504 BM03L11821A012031504 BM04A11421A012041204 BM03K10421A017031504 BM03K10421B017031504 BM03K10421C017031504 BM03L11221A017020904 BM03L11421A017031504 BM03L11421B017031504 BM03L12121A017031504 BM03L12221A017031504 BM04B10421A017051704 BM03K10421A018031504 BM03K10421B018031504 BM03K11021A018031504 BM03K11021B018031504 BM03K11021C018031504 BM03K11021D018031504 BM03L10421A018020904 BM03L10421B018020904 BM03L11621A018031504 BM03L11621B018031504 BM03L12121A018031504 BM03L12221A018031504 BM04A11221A018041204 BM04A11321A018041204 BM04B10421A018051704 BM03L11521A023020904 BM03L11521B023020904 BM03L11521D023020904 BM03L11821A024031504 BM03L12321A024031504 BM04A11221A024041204 BM03K10421A045031504 BM03K12121A045020904 BM03L10421A045020904 BM03L10621A045020904 BM03L11621A045031504 BM03L11621B045031504 BM03L12121A045031504 BM03J11421A048011904 BM03J11421B048011904 BM03K12121A048020904 BM03L10621A048020904 BM03L10621B048020904 BM03L11221A048020904 BM03L11521A048020904 BM03L11521B048020904
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tutogen Medical, Inc., Alachua, FL, by telephone, facsimile and letter on October 14, 2005 and by letter dated October 24, 2005.
Responsible Firm: Biomedical Tissue Services, Ltd., Fort Lee, NJ. Firm initiated recall is ongoing.
REASON
Human Tissues, procured from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 5,676 allografts;
b) 48 allografts
DISTRIBUTION
Nationwide, and Canada

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

_______________________________
PRODUCT
Plasma, Frozen, Recall # B-0365-6
CODE
Unit number: 03KK29245
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on February 9, 2003. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA

_______________________________
PRODUCT
Source Plasma, Recall # B-0392-6
CODE
Unit numbers: 0150062399, 0150062621, 0150063028, 0150063270, 0150063839, and 0150066870
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Kalamazoo, MI, by facsimile on or about November 3, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had engaged in multiple high risk behavior activities, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Spain

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0415-6
CODE
Unit numbers: 12KJ15689, 12KJ12263 (split unit), 12KJ12604 (split unit), 12KJ12971 (split unit), 12KJ13665 (split unit), 12KJ13997 (split unit), 12KJ14353 (split unit), 12KJ14705, 12KJ15362, 12KJ16047 (split unit)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on April 19, 2005. 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
17 units
DISTRIBUTION
AL, GA, NC, and SC

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0416-6
CODE
Unit numbers: 03KK29476, 03KK28606, 03KK27395, 03KK26550
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on May 7, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had lived in an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
GA

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0418-6
CODE
Unit number: T18289
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI, by facsimile or internet on September 20, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of surgery and travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI and Switzerland

_______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0436-6;
b) Red Blood Cells, Leukocytes
Reduced, Recall # B-0437-6;
c) Red Blood Cells, Leukocytes
Reduced, Irradiated,
Recall # B-0438-6;
d) Fresh Frozen Plasma,
Recall # B-0439-6
CODE
a) Unit number: 03LN26561;
b) Unit numbers: 03LN26555, 03LN26556,
03LN26558, 03LN26559, 03LN26562,
03LN26563, 03LN26564, 03LN26565,
03LN26566, 03LN26567;
c) Unit number: 03LN26568
d) Unit numbers: 03LN26558, 03LN26562,
03LN26563, 03LN26564, 03LN26566
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on September 19, 2002 and September 20, 2002. Firm initiated recall is complete.
REASON
Blood products, in which the sample tubes for viral marker testing were not maintained at an appropriate temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
GA

_______________________________
PRODUCT
Cryoprecipitated AHF, Recall # B-0444-6
CODE
Unit numbers: 411295, 413945, 419940
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, OH, by telephone or letter on February 18, 1999. Firm initiated recall is complete.
REASON
Blood products, which were not refrozen within one hour of preparation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0445-6
CODE
Unit numbers: 03GW32329, 03GW31195, 03GW30161
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on December 12, 2003. 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
3 units
DISTRIBUTION
GA

_______________________________
PRODUCT
Recovered Plasma, Recall # B-0446-6
CODE
Unit number: 03GH60796
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on August 18, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a history of Multiple Sclerosis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0447-6
CODE
Unit numbers: 03LS21901, 03LS21903, 03LS21904, 03LS21905, 03LS21908, 03LS21907, 03LS21909, 03LS21910, 03LS21911, 03LS21912
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on July 11, 2003. Firm initiated recall is complete.
REASON
Blood products, prepared from units of Whole Blood that exceeded the manufacturer's specification for volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
GA, and SC

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0451-6
CODE
Unit number: 2186850
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Lexington, KY, by telephone on April 3, 2005. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with coagulase-negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
Recall # B-0452-6;
b) Platelets Pheresis, Leukocytes
Reduced, Recall # B-0453-6
CODE
a) Unit number: 12F45910;
b) Unit number: 12W00161 (Parts 1 & 2),
12W01634
RECALLING FIRM/MANUFACTURER
American National Red Cross, Carolinas Region, Charlotte, NC, by telephone on May 18, 2005. 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
4 units
DISTRIBUTION
NC and SC

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0467-6
CODE
Unit number: 6969679
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, Inc., East Orange, NJ, by telephone on October 19, 2004. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Fresh Frozen Plasma that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0471-6
CODE
Unit number: 6734380
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, Inc., East Orange, NJ, by telephone on March 17, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Fresh Frozen Plasma that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0473-6
CODE
Unit number: 6973284
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, Inc., East Orange, NJ, by telephone on February 8, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Fresh Frozen Plasma that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ

_______________________________
PRODUCT
a) Red Blood Cell, Leukocytes Reduced,
Irradiated, Recall # B-0481-6;
b) Platelets, Irradiated, Recall # B-0482-6
CODE
a) and b) Unit number: R172781
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated December 29, 2003.
Manufacturer: Puget Sound Blood Center and Program, Everett, WA. 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
WA

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0483-6
CODE
Unit number: M164785
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated November 21, 2003.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. 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
WA

_______________________________
PRODUCT
Source Plasma, Recall # B-0484-6
CODE
Unit numbers: 96476468, 96446409, 96442524, 96434659, 96427767, 96422007, 96406779, 96401330, 96396780, 96390481, 96386026, 96380253, 96375051, 96369227, 96362051, 96356395, 96350935, 96345382, 96341711, 96335260, 96327234, 96324493, 96315804, 96312490, 96305614, 96302835, 96290743, 96281314, 96278093
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Gresham, OR, by facsimile on March 25, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Source Plasma, Recall # B-0485-6
CODE
Unit numbers: 66183792, 66168348, 66156048, 66149699, 66145295, 66137788, 66134992, 66128816, 66123408, 66119388, 66096412, 66093220, 66083832, 66079835, 66074014, 66069362, 66058069, 66047902, 66041665, 66030096, 66025320, 66020530, 66015161, 66010432, 65995426, 65990452, 65985830, 65981511, 65972922, 65964897, 65958094, 65950012, 65943915, 65930724, 65927618, 65921944, 65916995, 65911228, 66054894
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Gresham, OR, by facsimile on December 28, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
39 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Source Plasma, Recall # B-0486-6
CODE
Unit numbers: 81466702, 81459483, 81445448, 81439959, 81422128, 81410118, 81357802, 81353163, 81345878, 81340149, 81326952, 81322374, 66157533, 66144755, 66131274, 66127932, 66121442, 66117469, 66112969, 66106678, 66103509, 66079019, 66076100, 66058274, 66053101
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Gresham, OR, by facsimile on July 17, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Source Plasma, Recall # B-0487-6
CODE
Unit numbers: 11801535, 83991813, 83988547, 83982477, 83980756, 83908316, 83905391, 83902703, 83900075, 83897450, 83895159, 83891267, 83889448, 83885846, 83884566, 83880315, 83868740, 83864896, 83858949, 83857218, 83853241, 83847738, 83846083, 83841897, 83839795, 83835476, 83829185, 83827709, 83822933, 83821325, 83816857, 83812798, 83796487, 83792557, 83790867, 83786402, 83781322, 83778124, 83774867, 83771798, 83768644, 83765988, 83763144, 83759994, 83756856, 83753381, 83750250, 83747175, 83743863, 83741104, 83737725, 83731129, 83723513, 65460283, 65458006, 65452868, 65449752, 65445846, 65443286, 65440063, 65437537, 65434437, 65420621, 65419496, 65414361, 65409947, 65407134, 65402191, 65400593, 65395912, 65394069, 65389324, 65387740, 65383629, 65379288, 65374955, 65370858, 65366929, 65364895, 65359167, 65277805, 65274934, 65271544, 65268100, 65261286, 65254394, 65247617, 65245903, 65241356, 65238790, 65233764, 65230534, 65226797, 65223413, 65220139, 65215968, 65208625, 65206577, 65201947, 52554841, 52551765, 52548765, 52545795, 52542367, 52538711, 52535772, 52532917, 52529573, 52526213, 52521522, 52520297
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Spokane, WA, by facsimile on January 17, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
111 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0488-6
CODE
Unit number: E165768
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by letter dated September 5, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

_______________________________
PRODUCT
Red Blood Cells, Recall # B-0489-6
CODE
Unit number: F150894
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by letter dated September 17, 2003.
Puget Sound Blood Center and Program, Everett, WA. 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
WA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0491-6
CODE
Unit number: FG74677
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Center, Aurora, IL, by letter on September 8, 2005. 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
IL

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes
Reduced, Recall # B-0492-6;
b) Recovered Plasma, Recall # B-0497-6
CODE
a) and b) Unit number: 4101212
RECALLING FIRM/MANUFACTURER
Northwest Florida Blood Center, Inc., Pensacola, FL, by telephone and facsimile on March 7, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0501-6
CODE
Unit number: 84Q78767
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern California Region, Oakland, CA, by letter dated December 21, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to a history of Multiple Sclerosis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0509-6
CODE
Unit numbers: Y68733, Y68736, Y68731
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA, by telephone on October 15, 2001. Firm initiated recall is complete.
REASON
Blood products, labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0510-6
CODE
Unit number: 17KR79235
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by letter dated February 5, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

_______________________________
PRODUCT
Source Plasma, Recall # B-0554-6
CODE
Unit number: 05DILB9885
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., DeKalb, IL, by facsimile on September 8, 2005. Firm initiated recall is complete.
REASON
Blood product, not properly quarantined after the receipt of post donation information related to a recent tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MD

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0555-6
CODE
Unit numbers: 6532971 (split unit)
RECALLING FIRM/MANUFACTURER
BloodNet USA, Inc., Lakeland, FL, by facsimile on March 15, 2004. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL

_______________________________
PRODUCT
Platelets, Leukocytes Reduced, Recall # B-0556-6
CODE
Unit number: 17KS13595
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by telephone on May 21, 2003. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of red cells that was possibly contaminated with gram positive cocci, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0558-6
CODE
Unit number: 26924-2828
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on September 28, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX

_______________________________
PRODUCT
Source Plasma, Recall # B-0559-6
CODE
Unit numbers: 05HPAA3351, 05HPAA3148, 05HPAA2986, 05HPAA2765, 05HPAA2584, 05HPAA2206, 05HPAA1946, 05HPAA1772, SH041111, SH040835, SH040652, SH039894, SH039691, SH039395, SH040441, SH038942, SH038756, SH038520, SH038305, SH038008, SH037795, SH037400, SH036818, SH036618
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Harrisburg, PA, by facsimile on July 18, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom post donation information was provided regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
NY, PA, and France

_______________________________
PRODUCT
a) Platelets, Leukocytes Reduced,
Recall # B-0565-6;
b) Plasma, Frozen, Recall # B-0566-6
CODE
a) and b) Unit number: 17KV37011
RECALLING FIRM/MANUFACTURER
American National Red Cross, North Central Region, St. Paul, MN, by letter dated February 18, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of red cells that was possibly contaminated with Staphylococcus species and implicated in an adverse transfusion reaction, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MA and MN

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0567-6
CODE
Unit number: 4906429
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on September 23, 2004. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
Platelets Pheresis, Recall # B-0568-6
CODE
Unit number: 4079180 (split unit)
RECALLING FIRM/MANUFACTURER
Northwest Florida Blood Center, Inc., Pensacola, FL, by Telephone on June 11, 2005. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with Group B Streptococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0569-6
CODE
Unit number: 1310505
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Service, Elyria, OH, by letter dated June 24, 2005. Firm initiated recall is complete.
REASON
Blood product, associated with a unit of Platelets that was possibly contaminated with coagulase negative Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0413-6
CODE
Unit numbers: 042M15772, 042M15773, 042M15774, 042M15775, 042F61251, 042FG13941, 042FG13942, 042FG13943, 042FG13944, 042FG13945, 042FG13946, 042FX40820, 42FX40822, 042FX40823, 042GC13986, 042GC13987, 042GC13988, 042FX40821
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern Ohio Region, by
telephone on May 3, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have had a post-filtration hematocrit of greater than 80%, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
OH

_______________________________
PRODUCT
Recovered Plasma, Recall # B-0419-6
CODE
Unit number: T18289
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI, by facsimile or internet on September 20, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of surgery and travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI and Switzerland

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0430-6
CODE
Unit number: 2102131
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by in-person visit on May 20, 2004. Firm initiated recall is complete.
REASON
Blood product, manufactured without the entire quantity of additive solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY

_______________________________
PRODUCT
Platelets, Recall # B-0440-6
CODE
Unit number: 431060
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone or letter on March 6, 1999. Firm initiated recall is complete.
REASON
Platelets, which may not have been stored under continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CO

_______________________________
PRODUCT
Platelets, Recall # B-0441-6
CODE
Unit numbers: 0479158, 0479161, 0479164
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by telephone or letter on June 6, 1999. Firm initiated recall is complete.
REASON
Platelets, which may not have been stored under continuous agitation and controlled temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CO

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0442-6
CODE
Unit numbers: 03LX21668, 03LS17957
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on April 16, 2004. Firm initiated recall is complete.
REASON
Blood products, which had a post-filtration hematocrit of greater than 80%, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0443-6
CODE
Unit numbers: 03FQ23600, 03FQ23825, 03GG91527, 03GW27967, 03KY15784, 03LG19809
RECALLING FIRM/MANUFACTURER
American National Red Cross, Southern Region, Atlanta, GA, by telephone on March 19, 2004. Firm initiated recall is complete.
REASON
Blood products, which had a post-filtration hematocrit of greater than 80%, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
GA

_______________________________
PRODUCT
a) Red Blood Cells Pheresis, Leukocytes
Reduced, Recall # B-0448-6;
b) Platelets Pheresis, Leukocytes
Reduced, Recall # B-0449-6
CODE
a) and b) Unit number: 2184221
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Lexington, KY, by telephone on March 26, 2005. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium acnes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0450-6
CODE
Unit numbers: 2170531 (Parts A & B)
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Lexington, KY, by telephone on January 30, 2005. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Propionibacterium acnes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated, Recall # B-0466-6
CODE
Unit numbers: 22KG87846 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on July 13, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have been contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA

_______________________________
PRODUCT
a) Red Blood Cells, Pheresis,
Recall # B-0468-6;
b) Platelets Pheresis, Leukocytes
Reduced, Recall # B-0469-6
CODE
a) and b) Unit number: E27890
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rockford, IL, by telephone on June 16, 2005. Firm initiated recall is complete.
REASON
Blood products, which were possibly contaminated with Staphylococcus auricularis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL and NY

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0490-6
CODE
Unit numbers: 03LQ19421 (part 1) and 03LQ19855 (part 1)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southern Region, Atlanta, GA, by telephone on November 5, 2004, and by letter on November 8, 2004. Firm initiated recall is complete.
REASON
Blood products, stored at an incorrect temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA

_______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0493-6
CODE
Unit number: L28502
RECALLING FIRM/MANUFACTURER
Tacoma-Pierce County Blood Bank, Tacoma, WA, by telephone on February 5, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to the use of an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0494-6
CODE
Unit number: 40GR77399
RECALLING FIRM/MANUFACTURER
American National Red Cross, Heart of America, Peoria, IL, by telephone on August 5, 2005, and by letter on August 12, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer one of the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0505-6
CODE
Unit numbers: 26729-8539 (split unit), 26729-8538 (split unit)
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on September 1, 2004. Firm initiated recall is complete.
REASON
Blood products, which failed to meet the minimum specification for red blood cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
AR

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0506-6
CODE
Unit number: 8707608
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by facsimile on January 4, 2005. Firm initiated recall is complete.
REASON
Blood product, which was not properly quarantined after the receipt of post donation information related to a recent human tissue transplant, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

_______________________________
PRODUCT
Recovered Plasma, Recall # B-0557-6
CODE
Unit number: 2297968
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by letter dated February 18, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

_______________________________
PRODUCT
Vitros Immunodiagnostic HbsAg Confirmatory Kit 8 Ref 680 1324, UPC +H221680132412. Each kit contains: 1 x kit of reagents, and protocol card for HbsAg Confirmatory Kit. According to the firm (but not on label), there are 60 neutralization reactions per confirmatory kit. Recall # Z-0327-06
CODE
Lot 5140, exp. 4/13/2006; Lot 5150, exp. 5/31/2006; and Lot 5160, exp. 7/3/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ortho-Clinical Diagnostics, Rochester NY, by letters on December 15, 2005.
Manufacturer: Ortho-Clinical Diagnostics, Cardiff, UK. Firm initiated recall is ongoing.
REASON
Increased background signal of the sample diluent in the affected Confirmatory Kits could cause some results to be classified as "Not Confirmed".
VOLUME OF PRODUCT IN COMMERCE
436 kits
DISTRIBUTION
Nationwide, PR and the Caribbean

RECALLS AND FIELD CORRECTIONS: DEVICES- - CLASS II

_______________________________
PRODUCT
NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit, Recall # Z-0339-06
CODE
W050708, W050980, & W050997
RECALLING FIRM/MANUFACTURER
Integra Neuro Sciences, San Diego, CA, by letter on September 8, 2005. Firm initiated recall is ongoing.
REASON
Certain Model NS-P probes contained in the NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit may allow an Intracranial Pressure (ICP) drift of up to ± 5 mmHg during the first 24 hours of monitoring ICP. This is outside the products labeling specification of ± 2 mmHg maximum ICP drift within the first 24 hours of monitoring.
VOLUME OF PRODUCT IN COMMERCE
79 kits
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
a) Vaxcel Implantable Vascular Access
System - Titanium Mini Port with 7F
Polyurethane Catheter. Boston Scientific
Catalog # 45-305, M001453050.
Recall # Z-0340-06;
b) Silicone Central Venous Catheter with
PASV Valve and Polyester Cuff - 6.6F.
Boston Scientific Cat. #CVC661IK M001CVC661IK0.
Recall # Z-0341-06;
c) Silicone Central Venous Catheters with PASV
Valve and Polyester Cuff - 7F. Boston
Scientific Cat. #CVC702IK, M001CVC702IKO,
Recall # Z-0342-06;
d) Implantable Chest Ports labeled: Titanium Single
Lumen Port with PASV valve and 6.6F Silicone
Catheter. Boston Scientific Cat. # PRTA66P
M001PRTA66P0, Recall # Z-0343-06;
e) Implantable Chest Ports labeled: Titanium
Single Lumen Port with PASV Valve and 6.6F
Silicone Catheter. Boston Scientific Cat. #
PRTA66A M001PRTA66AO, Recall # Z-0344-06
CODE
a) 1007398, 1017115, 1018449;
b) 1009520, 1009824, 1011813, 1013925, 1018980,
1021339, 1022517, 1022952;
c) 1009522, 1009825, 1012337, 1013926, 1017134,
1017763, 1018161, 1018456, 1022953;
d) 1011815, 1020902, 1021341, 1021634;
e) 1012596, 1020903
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp, Natick, MA, by letter dated October 28, 2005.
Manufacturer: Boston Scientific Corp, Glens Falls, NY. Firm initiated recall is ongoing.
REASON
Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.
VOLUME OF PRODUCT IN COMMERCE
Nationwide: 1,041 units; Internationally: 293 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Introducer Set. Labeled as "Luer-Lock Peel-Away Introducer Set *** Model: LLP-7 *** Size: 7F (2.33mm)" Catalog # 06607 (Oscor) and 666089-201 (Guidant), Recall # Z-0345-06
CODE
BBraun Lot # 60710907 and 60710908 Oscor Lot # OL09342-1 and OL9645-01
RECALLING FIRM/MANUFACTURER
Oscor, Inc., Palm Harbor, FL, by letter on September 13, 2005. Firm initiated recall is ongoing.
REASON
Sheath size is larger than dilator size causing insertion difficulties.
VOLUME OF PRODUCT IN COMMERCE
6,985 sets
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
7F Locking Tearaway Introducers non-sterile. Part number 614006. The product is packaged as 50 units per pouch, 2 pouches per carton, Recall # Z-0346-06
CODE
Lot numbers 60710907 and 60710908
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by telephone on September 1, 2005 and September 14, 2005.
Manufacturer: B. Braun Medical, Inc., Cherry Hill, NJ. Firm initiated recall is complete.
REASON
Tear away sheath assembly may contain a sheath (8FR) that is not the correct French size for the dilator (7FR).
VOLUME OF PRODUCT IN COMMERCE
8,000 units
DISTRIBUTION
The product was shipped to two consignees that repack the product into their own kits. The OEM customers conducted recalls of the finished product.

_______________________________
PRODUCT
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and ARENA, product codes S1000L3, S1000L3P, S1000LC2, S1000L3T, S1000L3TD, S1000L3PR, ARENASP, ARENASPP, ARENASPX, ARENADPX, Recall # Z-0347-06
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., McGaw Park, IL, by letters dated November 18, 2005.
Manufacturer: Baxter Healthcare Corp., Largo, FL. Firm initiated recall is ongoing.
REASON
Potential for fluid or air to be passed through the venous line clamp if the tubing is not centered in the clamp and extends beyond the edge of the clamp's pinch zone. This could result in an air emboli condition.
VOLUME OF PRODUCT IN COMMERCE
29,173 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
A) IntelliSystem II Thermal Dot Matrix printer
110 V adapter and fiber optic serial interface
10m cable, Catalog Number IN1600,
Recall # Z-0348-06;
b) IntelliSystem II Thermal Dot Matrix
printer 110 V adapter and fiber optic
serial interface 10m cable,
Catalog Number IN1600/A, Recall # Z-0349-06;
c) IntelliSystem II Thermal Dot Matrix
printer 220 V 50 Hz adapter and fiber
optic serial interface 10m cable.
Catalog Number IN1615, Recall # Z-0350-06;
d) IntelliSystem II Thermal Dot Matrix printer
220 V 50 Hz adapter and fiber optic serial
interface 10m cable. Catalog Number IN1615/A,
Recall # Z-0351-06
CODE
a) Serial Numbers: T2370-0004, T2370-0007,
T2370-0013, T2370-0014, T2370-0018,
T2370-0019, T2370-0021, T2370-0023,
T2370-0029, T2370-0030, T2370-0031,
T2370-0032, T2370-0034, T2370-0041,
T2370-0043, T2370-0044, T2370-0045,
T2370-0047, T2370-0048, T2370-0049,
T2370-0050, T2370-0059, T2370-0063,
T2370-0064, T2370-0074, T2482-0029;
b) Serial Numbers: T2370-0008, T2370-0009,
T2370-0011, T2370-0016, T2370-0017,
T2482-0037, T2370-0039, T2370-0040,
T2370-0042, T2370-0051, T2370-0054,
T2370-0056, T2370-0060, T2370-0065,
T2482-0002, T2482-0025, T2482-0034,
T2482-0046, T2482-0049, T2482-0055,
T2482-0058, T2482-0068, T2482-0069,
T2482-0071, T2482-0073, T2482-00078,
T2482-0081, T2482-0084, T2482-0085,
T2482-0089, T2482-0091, T2482-0094,
T2483A-0018, T2483A-0019, T2483A-0022;
c) Serial Numbers: T2370-0025, T2370-0035,
T2370-0037, T2370-0046, T2370-0053,
T2370-0057, T2370-0058, T2370-0068,
T2370-0069, T2370-0071, T2370-0072,
T2370-0073, T2370-0075, T2370-0076,
T2370-0077, T2370-0078, T2482-0013,
T2482--0020, T2482-0030, T2482-0032,
T2482-0035, T2482-0041, T2482-0043,
T2482-0065;
d) Serial Numbers: T2482-0005, T2482-0006,
T2482-0009, T2482-0010, T2482-0017,
T2482-0018, T2483A-0025, T2483A-0026,
T2482-0028, T2482-0033, T2482-0048,
T2482-0050, T2482-0056, T2482-0059,
T2482-0064, T2482-0070, T2482-0074,
T2482-0076, T2482-0080, T2482-0082,
T2482-0086, T2482-0087, T2482-0090,
T2482-0093, T2483A-0004, T2483A-0015,
T2483A-0023, T2483A-0032, T2483A-0037,
T2483A-0042, T2483A-0046, T2483A-0074,
T2483A-0080, T2483A-0081, T2483-0082,
T2483A-0094, T2483A-0095, T2483A-0100
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by letter on November 7, 2005. Firm initiated recall is ongoing.
REASON
Dot matrix printer, as a component of a pressure monitoring system, may overheat and pose a fire hazard.
VOLUME OF PRODUCT IN COMMERCE
123 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
ADC Solo & Initia CR 1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP 100, image digitizer, components in Agfa's computed radiography product line, Recall # Z-0352-06
CODE
Serial Numbers: ADC Solo: Units with Serial numbers les than 4748, Initia CR1000, Path Speed CR SP1001, Centricity CR SP1001 and Centricity CR SP100: all serial numbers are considered affected unless they have been upgraded to software version SOL_2205 or later
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp, Greenville, SC, by letter on/about December 1, 2005.
Manufacturer: AGFA, Corp, Mortsel, Belgium. Firm initiated recall is ongoing.
REASON
Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis.
VOLUME OF PRODUCT IN COMMERCE
1,059 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
CR QS (versions 3.0.207, 2.0.210 SU1, 3.0.229) ADC QS and Centricity CR Online Processing Software (version 2.x), Recall # Z-0353-06
CODE
Software versions: ADC QS 2.0, CR QS 3.O.207, CR QS 3.O.210, CR QS 3.0.210SU1, CRQS 3.0.229, Centricity CR Online Processing software 2.x.
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp, Greenville, SC, by letter on/about December 1, 2005.
Manufacturer: AGFA, Corp, Mortsel, Belgium. Firm initiated recall is ongoing.
REASON
Users of affected systems may experience one or more of four (4) problems the clinical impact could be a loss of image(s), the need to repeat the imaging procedure and, possibly, a short delay in diagnosis.
VOLUME OF PRODUCT IN COMMERCE
2,630 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
The PL V Continuum ventilator is a microprocessor controlled, compressorbased, mechanical ventilator. It is intended to control or assist breathing by delivering room air to the patient. PL V Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software algorithms. The user interface on PL V Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings and for the display of alarm conditions. PL V Continuum is capable of providing the following types of ventilatory support: Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece). . Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or Continuous Positive Airway Pressure (CP AP) modes of ventilation. . Volume-Controlled (VC). Available in AlC and SIMV. . Pressure-Controlled (PC). Available in AlC and SIMV. . Pressure Support (PS). Available in SIMV and SPONT, Recall # Z-0354-06
CODE
Domestic Distribution Serial Numbers: VS4700581, VS4700661, VS4700631, VS4702578, VS4702507, VS4702551, VS4702583, VS4702589, VS4702590, VS470259], VS4702574, VS4702580, VS4702566, VS4700824, VS4702593, VS4700835, VS4700536, 1VS4700539, VS4700540, VS4700543, VS4700544, S4700546, VS4700548, VS4700549, VS4700550, VS4700552,VS4700554, VS4700555, VS4700558, VS4700565, VS4700566,VS4700567, VS4700569, VS4700573, VS4700574, VS4700577,VS4700578, VS4700580, VS4700581, VS4700585, VS4700588VS4700590, VS4700593, VS4700594, VS4700595, VS4700596, VS4700605, VS4700607, VS4700608, VS4700613, VS4700614, VS4700615, VS4700617, VS4700620, VS4700622, VS4700624, VS4700625, VS4700632, VS4700635, VS4700637, VS4700642, VS4700643, VS4700646, VS4700647, VS4700649, VS4700650, VS4700653, VS4700660, VS4700661, VS4700663, VS4700668, VS4700670, VS4700673, VS4700681, VS4700687, VS4700693, VS4700694, VS4700698, VS4700699, VS4700708, VS470071O, VS4700711, VS4700718, VS4700719, VS4700721, VS4700724, VS4700725, VS4700729, VS4700730, VS4700736, VS4700738, VS4700739, VS4700740, VS4700743, VS4700744, VS4700750, VS4700751, VS4700754, VS4700760, VS4700761, VS4700762, VS4700767, VS4700770, VS4700772, VS4700773, VS4700774, VS4700775, VS4700776, VS4700777, VS4700780, VS4700781, VS4700782, VS4700783, VS4700785, VS4700786, VS4700789, VS4700790, VS4700791, VS4700796, VS4700797, VS4700798, VS4700802, VS4700804, VS4700808, VS4700809, VS4700811, VS4700813, VS4700814, VS4700816, VS4700817, VS4700818, VS4700819, VS4700821, VS4700822, VS4700823, VS4700827, VS4700828, VS4700829, VS4700832, VS4700833, VS4700834, VS4700836, VS4700837, VS4700838, VS4700840, VS4700841, VS4700842, VS4700843, VS4700844, VS4700846, VS4700847, VS4700849, VS4700850, VS4700852, VS4700853, VS4700854, VS4700855, VS4700856, VS4702501, VS4702502, VS4702505, VS4702512, VS4702516, VS4702519, VS4702523, VS4702524, VS4702525, VS4702528, VS4702531, VS4702532, VS4702535, VS4702543, VS4702544, VS4702545, VS4702548, VS4702549, VS4702552, VS4702553, VS4702555, VS4702556, VS4702557, VS4702567, VS4702568, VS4702570, VS4702571, VS4702572, VS4702573, VS4702575, VS4702586, VS4702594, VS4702599, VS4702600, VS4702604, VS4702612, VS4702613, VS4702623, VS4702636, VS4702647, VS4702650, VS4702670, VS4702677, VS4702688, VS4702689, VS4702709, VS4702734, VS4702747, VS4702748, VS4702750, VS4702776, VS4702784, VS4702800, VS4702805, VS4702809, VS4702811, VS4702813, VS4702825, VS4702835, VS4702848, VS4702854, VS4702856, VS4702857, VS4702859, VS4702883, VS4702885, VS4702981, VS4703079, VS4703103 International Distribution Serial Numbers: VS4702605, VS4702608, VS4702609, VS4702631, VS4702632, VS4702634, VS4702642, VS4702643, VS4702659, VS4702719, VS4702754, VS4702759, VS4700792, VS4702722, VS4700563, VS4700696, VS4700820, VS4700601, VS4702645, VS4700839, VS4700644, VS4700589, VS4700703, VS4700723, VS4700746, VS4700553, VS4700628, VS4702962, VS4702983, VS4702995, VS4703006, VS4703023, VS4703041, VS4703056, VS4703064, VS4700717, VS4700645, VS4702915, VS4702500, VS4702828, VS4702858
RECALLING FIRM/MANUFACTURER
Respironics California, Inc., Carlsbad, CA, by telephone on November 18, 2005 and by fax, email, or letter on November 21, 2005. Firm initiated recall is ongoing.
REASON
During product testing of the PLY Continuum Ventilator's Safety Valve/Pressure Relief Valve (SV/PRV) at our manufacturing facility, Respironics found that when the PLY Continuum Ventilator is operated in the 'Face Up' orientation, the SV /PRV may stick in the open position, which may result in loss of delivered gas volume to the patient.
VOLUME OF PRODUCT IN COMMERCE
268 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam Shield and MEVATRON Linear Accelerator with optional Retractable Beam Shield, Recall # Z-0355-06
CODE
Serial numbers: 1941, 1944, 1953, 1991, 2014, 2029, 2093, 2111, 2113, 2163, 2182, 2238, 2281, 2295, 2329, 2389, 2407, 2429, 2431, 2435, 2443, 2455, 2471, 2486, 2487, 2489, 2495, 2497, 2504, 2527, 2549, 2553, 2557, 2558, 2572, 2586, 2594, 2603, 2605, 2607, 2635, 2637, 2642, 2653, 2675, 2689, 2699, 2712, 2728, 2731, 2736, 2737, 2744, 2746, 2772, 2793, 2795, 2805, 2809, 2843, 2845, 2853, 2865, 2873, 2879, 2926, 2942, 2946, 2949, 2969, 2972, 2976, 3007, 3138, 3152, 3157, 3167, 3184, 3187, 3196, 3247, 3286, 3325, 3337, 3352, 3379, 3439, 3442, 3463, 3512, 3527, 3528, 3532, 3535, 3538, 3559, 3647, 3648, 3652, 3664, 3674, 2174, 2176, 2178, 2187, 2188, 2209, 2215, 2253, 2259, 2266, 2285, 2296, 2298, 2303, 2308, 2356, 2359, 2365, 2377, 2381, 2386, 2409, 2416
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letters on January 8, 2003. Firm initiated recall is complete.
REASON
Incomplete installation of the optional Beam Shield may allow unexpected doses of radiation outside the radiation protected areas.
VOLUME OF PRODUCT IN COMMERCE
125 units
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Schuster Anorectal Manometry Probe.
Labeling applied to the balloon pouch reads
in part: "SANDHILL SCIENTIFIC SCHUSTER
ANORECTAL MANOMETRY PROBE Rectosphincteric
Manometry Balloon Probe P/N: A86-4050. ***
Size: Adult ... CAUTION: Balloons are made
of latex rubber. *** Do not use if latex
sensitivity exists." Additional labeling
found on the pouch reads in part: 'Cat.
92510 Convertors Self-Seal Pouch 51/4'x10'
*** Latex Free***, Product model # A86-4050,
Recall # Z-0356-06
b) Schuster Anorectal Manometry Probe.
Labeling applied to the balloon pouch
reads in part: "SANDHILL SCIENTIFIC
SCHUSTER ANORECTAL MANOMETRY PROBE
Rectosphincteric Manometry Balloon Probe
P/N: A86-5050. *** Size: Pediatric...
CAUTION: Balloons are made of latex rubber.
*** Do not use if latex sensitivity exists."
Additional labeling found on the pouch reads
in part: 'Cat. 92510 Convertors Self-Seal
Pouch 51/4'x10' *** Latex Free *** Product
model # A86-5050, Recall # Z-0357-06
CODE
a) and b) All lot numbers;
RECALLING FIRM/MANUFACTURER
Sandhill Scientific, Inc., Highlands Ranch, CO, by letter on December 13, 2005. Firm initiated recall is ongoing.
REASON
The product is mislabeled. The labeling on the front of the packaging states that product contains latex. However, the back of the package contains a latex- free symbol.
VOLUME OF PRODUCT IN COMMERCE
4,342 probes
DISTRIBUTION
Nationwide, Egypt, and the Netherlands

_______________________________
PRODUCT
Gyroscan NT MRI System rev 4.x, 5.x, and 6.x software. System, Nuclear Magnetic Resonance imaging. Recall # Z-0358-06
CODE
4397, 5257, 4176, 1052, 4222, 4064, 5024, 4009, 4241, 5313, 1139, 5484, 4328, 5201, 5246, 5381, 4296, 4258, 5277, 4246, 1240, 5297, 5311, 5434, 5512, 506, 4207, 1072, 4089, 5373, 1014, 1078, 4025, 5551, 4131, 5455, 5328, 5379, 5261, 4416, 4206, 1191, 4088, 5195, 5334, 5451, 4383, 5250, 5309, 5342, 4183, 4272, 5268, 5009, 4047, 4254, 4261, 5307, 4102, 5199, 5558, 5315, 5266, 5303, 1061, 4307, 5390, 4267, 4386, 5282, 1113, 5123, 5501, 1062, 4339, 5383, 5478, 5507, 4162, 1015, 5162, 1081, 4170, 5477, 4322, 5515, 4069, 5081, 4201, 354, 5345, 4374, 4146, 1097, 5519, 5314
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North America Co, Bothell, WA, by letter on December 9, 2005.
Manufacturer: Philips Medical Systems Ned Bv, Best, Netherlands. Firm initiated recall is ongoing.
REASON
The Gyroscan NT MRI system has a computer software problem which results in images from one patient being placed into another patient's image record.
VOLUME OF PRODUCT IN COMMERCE
96 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number. Recall # Z-0359-06
CODE
All replacement balloons. For use on probe models AB1, PB1, A86-1067, A86-1067-1, A86-5067, A86-5070 and A86-5050
RECALLING FIRM/MANUFACTURER
Sandhill Scientific, Inc., Highlands Ranch, CO, by letter on December 3, 2005 and December 14, 2005. Firm initiated recall is ongoing.
REASON
Labeling does not indicate that the product contains latex.
VOLUME OF PRODUCT IN COMMERCE
2,358 Probes
DISTRIBUTION
Nationwide and Internationally

_______________________________
PRODUCT
a) Roche brand Omni S2 Blood Gas Analyzer;
Catalog # 03337111001, Recall # Z-0361-06;
b) Roche brand Omni S4 Blood Gas Analyzer;
Catalog # 03337138001, Recall # Z-0362-06;
c) Roche brand Omni S6 Blood Gas Analyzer;
Catalog # 03337154001, Recall # Z-0363-06
CODE
All units with Co-Oximetry (COOX) modules
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated December 9, 2005.
Manufacturer: Roche Diagnostics GmbH, Graz, Austria. Firm initiated recall is ongoing.
REASON
Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb or HHb.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Nationwide

_______________________________
PRODUCT
LANTIS software with MedOnc Module; MedOnc module is an option of the LANTIS radiotherapy treatment planning software distributed as a component of the firm's linear accelerator used to deliver radiation therapy to cancer patients. The MedOnc module is distributed by Siemens Medical Solutions USA - Oncology Division, with their linear accelerators software package called LANTIS. The MedOnc module option is distributed with all LANTIS software copies, but the module must be turned on by an electronic key that is purchased by individual hospitals. Siemens Medical Solutions USA purchases the LANTIS software (code) from IMPAC Medical Systems, Inc., (REG#2950347, FEI: 1000123805). IMPAC distributes the same software under the name SEQUENCER. Recall # Z-0364-06
CODE
Serial #: 93-0001, 93-0016, 93-0027, 93-0289, 93-0304, 93-0306, 93-0333, 93-0368, 93-0430, 93-0436, 93-0549, 93-0639, 93-0641, 93-0652, 93-0664, 93-0703, 93-0718 and 93-0786
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Concord, CA, by letters by January 6, 2006.
Manufacturer: Impac Medical Systems, Inc., Mountain View, CA. Firm initiated recall is complete.
REASON
When using the Creatine Clearance dose calculations a software bug will allow the algorithm to assume a patients age to be in years when it is entered in months. This miscalculation may result in patients less than two years old to be seriously overdosed with radiation.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

_______________________________
PRODUCT
Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70, Recall # Z-0338-06
CODE
Lot G653628
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Gary, IN, by letter dated April 19, 2005. Firm initiated recall is complete.
REASON
The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.
VOLUME OF PRODUCT IN COMMERCE
11
DISTRIBUTION
CA, IN, and NC

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE -- CLASS I

_______________________________
PRODUCT
10% Grain Mix, supplement for the maintenance of horses, Item No.93638, Recall # V-012-6
CODE
Lot Nos.: 4276593638, 4283593638, 4287593638, and 4290593638
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tennessee Farmers Cooperative, La Vergne, TN, by telephone on November 8, 2005, and by press release on November 16, 2005.
Manufacturer: Tennessee Farmers Cooperative, Rockford, TN. Firm initiated recall is ongoing.
REASON
Horse feed was found to contain Monensin, an antibiotic toxic to horses.
VOLUME OF PRODUCT IN COMMERCE
751, 50 pound bags
DISTRIBUTION
TN and SC

END OF ENFORCEMENT REPORT FOR JANUARY 18, 2006

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