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Enforcement Report for July 14, 2004

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


July 14, 2004
04-28


RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
a) Raw Whole Almonds, packaged in 8 oz and 16 oz clear
cellophane bags, and 25 lb. bulk cartons, all labeled
in part. Recall # F-279-4;
b) Raw Diced Almonds, packaged in 16 oz bags.
Recall # F-280-4;
c) Koala Bear Mix, in 16 oz. clear cellophane packages
and 22 pound bulk cartons, labeled in part. Recall
# F-281-4;
d) "#82 Mix", in 8 oz., 16 oz. clear cellophane packages
and 22 pound bulk cartons. Recall # F-282-4.
CODE
a) and d) Cases bear lot numbers A0504 to E2404 on the
bottom of carton, where A=January (month), 05=date
and 04=year;
b) and c) There are no lot numbers on the product.
RECALLING FIRM/MANUFACTURER
Jeppi Nut Co., Inc., Timonium, MD, by telephone on May 25, 2004, and by press release and letter on June 7, 2004. Firm initiated recall is ongoing.
REASON
The products were manufactured using almonds that were recalled by Paramount Farms due to their association with an outbreak of Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
150 lbs.
DISTRIBUTION
MD, PA and VA.

_______________________________
PRODUCT
a) Barcelona brand Raw Whole Almonds, packaged in 2 oz. and
10 oz. cellophane bags, 6 or 12 bags per case. Recall
# F-283-4;
b) Barcelona brand California Mix, a fruit and nut mix,
packaged in 3 oz. and 12 oz. cellophane bags, 6 or 12
bags per case. Recall # F-284-4;
c) Barcelona brand Cashew Almond & Raisin Mix, packaged
in 2.5 oz, 4.5 oz and 12 oz cellophane bags, 6 or 12
bags per case. Recall # F-285-4;
d) Barcelona brand Almond and Raisin Mix, packaged in 2.5
oz cellophane bags, 6 or 12 bags per case. Recall
#F-286-4;
e) Barcelona brand Mojo Mix, a blend of fruit and nuts,
packaged in 3 oz cellophane bags, 6 or 12 bags per case.
Recall # F-287-4.
CODE
Code dates 082104 through 052505.
RECALLING FIRM/MANUFACTURER
Barcelona Nut Processing Co., Baltimore, MD, by letter on May 25, 2004 and by press release on June 2, 2004. Firm initiated recall is ongoing.
REASON
The products were manufactured using almonds that were recalled by Paramount Farms due to their association with an outbreak of Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
8,951 cases.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Raw Whole Almonds as follows: (1) Kirkland Signature
brand Raw Almonds in 3 lb. plastic bag; (2) Trader Joe?s
brand Nonpareil Variety Raw Almonds in 1 lb. plastic
bags; (3) Sunkist brands brand Raw Natural Whole Almonds
in 10 oz. plastic bags; (4) Paramount brand Whole
Natural Raw Almonds in 50 lb. and 25 lb. bags. Recall #
F-288-4;
b) Raw Natural Diced Almonds as follows: (1) Sunkist Brands
brand Raw Natural Diced Almonds in 10 oz. plastic bag;
(2) Paramount brand Raw Natural Diced Almonds in 50 lb.
and 25 lb. bags. Recall # F-289-4.
CODE
a) (1) ?best before? dates from 8/21/04 through 3/16/05;
(2) ?best before? dates of 8/21/04 through 5/20/05;
?best before? dates of 8/21/04 through 5/20/05;
lots with first three digits ranging from 252-338
(covering products produced from 8/21/04 through
8/20/04.
b) (1) ?best before? dates of 8/21/04 through 5/20/05;
lots with first three digits ranging from 252-338
(covering products produced from 8/21/03 through
8/20/04.
RECALLING FIRM/MANUFACTURER
Paramount Fafms Inc., Lost Hills, CA, by press release on May 18, 2004 and May 22, 2004 and by letters on May 19, 2004 and May 24, 2004. Firm initiated recall is ongoing.
REASON
The almonds were associated with an outbreak of Salmonella enteritidis infection.
VOLUME OF PRODUCT IN COMMERCE
Approximately 13.1 million pounds.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
Bulk American Ginseng 648 mg Capsules containing 100% American Ginseng Powder (PANAX Ginseng Root). Product: American Ginseng Caps, Lot #: 034632, Quantity: 13m, Product #: VS-2064. IMPORTANT: This container is intended for BULK SHIPPING ONLY. The contents should be repacked WITHIN 90 DAYS into tightly closed containers. The manufacturer does not assume responsibility for any changes in physical appearance or potencies when these instructions are disregarded. -- Labeling for repacked product: The Vitamin Shoppe brand American Ginseng 648 mg, 100 CAPSULES, Herbal Supplement, Lot 169-1006-1021 EXP 10-2006. Recall # F-276-4.
CODE
Bulk Product No. VS-2064, Bulk Lot No. 034632.
RECALLING FIRM/MANUFACTURER
Nature?s Value, Inc., Bay Shore, NY, by letter on May 7, 2004. FDA initiated recall is ongoing.
REASON
American Ginseng 648 mg capsules Bulk Lot No. 034632 were analyzed by SRL and found to be contaminated with pesticides.
VOLUME OF PRODUCT IN COMMERCE
95,000 capsules.
DISTRIBUTION
NJ.

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III

_______________________________
PRODUCT
a) Atkins Hood Carb Countdown Reduced Sugar Lowfat
Yogurt - STRAWBERRY flavor, 6 ounce carton.
Recall # F-277-4;
b) Atkins Hood Carb Countdown Reduced Sugar Lowfat
Yogurt - STRAWBERRY BANANA flavor, 6 ounce carton.
Recall # F-278-4.
CODE
APR 28 04, APR 29 04, MAY 01 04;
RECALLING FIRM/MANUFACTURER
H. P. Hood. Inc, Chelsea, MA, by letter dated April 6, 2004. Firm initiated recall is complete.
REASON
Premature spoilage (yeast and mold contamination).
VOLUME OF PRODUCT IN COMMERCE
14,836 cases x 12 units.
DISTRIBUTION
Nationwide.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Maxifed DM Tablets, Each sustained-release tablet contains: Guaifenesin 580mg, Pseudoephedrine HCl 60mg, Dextromethorphan HBr 30mg, 100 count bottles, Rx Only,
NDC 58605-626-01. Recall # D-179-4.
CODE
3M05.
RECALLING FIRM/MANUFACTURER
Pharmakon Laboratory, Inc, Tampa, FL, by letter dated June 17, 2004. Firm initiated recall is ongoing.
REASON
The caplets are embossed as ?MAXIPHEN DM? rather than ?MAXIFED DM?.
VOLUME OF PRODUCT IN COMMERCE
2,010.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5mg/500mg per 15mL, unit dose cups, For Institutional Use Only, Rx Only, a) NDC 0121-4655-15, b) NDC 0121-0655-15. Recall # D-212-4.
CODE
a) Lot numbers 2L33, 3B53, 3D03, 3F06, 3F11, 3H36 & 3J48 and b) Lot numbers 3L05 & 4A45.
RECALLING FIRM/MANUFACTURER
Pharmaceutical Associates, Inc, Greenville, SC, by letter on April 22, 2004. Firm initiated recall is ongoing.
REASON
Stability failure (hydrocodone).
VOLUME OF PRODUCT IN COMMERCE
1,350,150 unit dose cups.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Loxitane Capsules, (Loxapine Succinate) 10 mg base, 100 count bottles, Rx only, NDC 52544-495-01. Recall # D-213-4.
CODE
49501K02, Expiration Date 9/2005.
RECALLING FIRM/MANUFACTURER
Watson Laboratories, Inc, Corona, CA, by letter on or about June 10, 2004. Firm initiated recall is ongoing.
REASON
Capsule Defect; split or broken capsules.
VOLUME OF PRODUCT IN COMMERCE
6,480.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
PREMARIN (conjugated estrogens tablets USP), 1.25 mg, 1000-count bottles, Rx only, NDC 0046-0866-91. Recall # D-214-4.
CODE
Lots: A28811 and A49547, Exp Date: May 2005.
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth, Richmond, VA, by letters on June 18, 2004. Firm initiated recall is ongoing.
REASON
Dissolution Failure; (18 month stability).
VOLUME OF PRODUCT IN COMMERCE
16,871 bottles (1000s).
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1299-4.
CODE
Unit numbers: 311345919, split units.          
RECALLING FIRM/MANUFACTURER
Recalling Firm:            Blood Systems, Inc., Scottsdale, AZ, by telephone on February 18, 2003.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS. Firm initiated recall is complete.
REASON
Blood products, manufactured in a manner that may have compromised the sterility of the unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
a) Red Blood Cells, Irradiated. Recall # B-1556-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1557-4;
c) Platelets Pheresis, Leukocytes Reduced. Recall # B-1558-4;
d) Recovered Plasma. Recall # B-1559-4.
CODE
a) Unit number 49LE01482;
b) and d) Unit numbers 49LF50316, 49LH51129, and 49LJ47232;
c) Unit number 49LP08923.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by facsimile on October 12, 2001 and by letters on December 31, 2001, and January 30, 2002. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
TX, CA, MD, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1565-4;
b) Platelets, Leukocytes Removed. Recall # B-1566-4.
CODE
a) and b) Unit numbers: 49GW02364, 49GW04399.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southwest Region, Tulsa, OK, by letter, dated June 4, 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
4 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1567-4. 
CODE
Unit number: 49GV13288.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southwest Region, Tulsa, OK, by letter dated, May 9, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Platelets. Recall # B-1571-4.
CODE
Unit V16129.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on March 25, 2004. Firm initiated recall is complete.
REASON
Blood Product, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1572-4.
CODE
Unit V00919.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by telephone on March 2, 2004 and letter on March 4, 2004. Firm initiated recall is complete.
REASON
Blood Product, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets. Recall # B-1577-4.
CODE
Unit V03839.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on March 24, 2004. Firm initiated recall is complete.
REASON
Blood Product, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
a) Platelet pheresis, leukoreduced. Recall # B-1578-4;
b) Platelet pheresis, leukoreduced, irradiated. Recall #
B-1579-4.
CODE
Unit 18KT00457.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lansing, MI, by fax and letter on April 2, 2004. Firm initiated recall is complete.
REASON
Blood Products, which were collected in an apheresis collection kit that may have exceeded the acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.

_______________________________
PRODUCT
Platelets. Recall # B-1588-4.
CODE
Unit V04079.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter, dated April 12, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets. Recall # B-1589-4.
CODE
Unit numbers: K54162, K54160.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Harrisonburg, VA, by telephone on March 4, 2004, and by letter, dated March 12, 2004. Firm initiated recall is complete.
REASON
Blood products, without platelet quality control being performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-1630-4;
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall # B-1631-4;
c) Platelets Pheresis, Leukocytes Reduced.
Recall # B-1632-4;
d) Platelets Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-1633-4;
e) Fresh Frozen Plasma. Recall # B-1634-4;
f) Plasma, Frozen. Recall # B-1635-4;
g) Red Blood Cells, For Manufacturing Use Only.
Recall # B-1636-4;
h) Recovered Plasma. Recall # B-1637-4.
CODE
a) Unit numbers: 40FF51296, 40FF51405, 40FF51479,
40FF51604, 40FF51657, 40FF51800, 40FF51838, 40FF51877,
40FF51968, 40FF51998, 40FF52129, 40FF52254, 40FF52264,
40FF52289, 40FF52457, 40FF52659, 40FF52674, 40FF52766,
40FF52771, 40FF53014, 40FF53115, 40FF53274, 40FF53342,
40FF53648, 40FF53690, 40FF53731, 40FF53757, 40FF53955,
40FF54040, 40FF54053, 40FF54211, 40FF54214, 40FF54346,
40FF54350, 40FF54372, 40FF54381, 40FF54440, 40FF54576,
40FF55054, 40FF55105, 40FF55120, 40FF55131, 40FF55190,
40FF55492; 40FQ31137, 40FQ31160, 40FQ31258, 40FQ31317,
40FQ31357, 40FQ31366, 40FQ31489, 40FQ31564, 40FQ31575,
40FQ31594, 40FQ31642, 40FQ31686, 40FQ31753, 40FQ31772,
40FQ31817, 40FQ31853, 40FQ31926, 40FQ31970, 40FQ32061,
40FQ32085, 40FQ32195, 40FQ32253, 40FQ32279, 40FQ32337,
40FQ32341, 40FQ32363, 40FQ32430, 40FQ32460, 40FQ32526,
40FQ32555, 40FQ32606, 40FQ32721, 40FQ32736, 40FQ32753,
40FQ32768, 40FQ32843, 40FQ33067, 40FQ33152, 40FQ33183,
40FQ33427, 40FQ33609, 40FQ33658, 40FQ33673, 40FQ33787,
40FQ33798, 40FQ33973;
b) Unit numbers: 40FF51164, 40FQ31378, 40FQ31694;
c) Unit numbers: 40FP16037-2, 40FP16497-1, 40FP16746-1,
40FP17118-1, 40FP17118-2, 40FP18019-1, 40FP18019-2;
d) Unit numbers: 40FP15763-1, 40FP16746-2;
e) Unit numbers: 40FQ31694, 40FQ32061, 40FQ32768,
40FQ33658, 40FQ33673, 40FQ33787;
f) Unit numbers: 40FF52129, 40FF54440, 40FF55105,
40FF55120, 40FQ32279, 40FQ32341;
g) Unit number: 40FQ32200;
h) Unit numbers: 40FF51164, 40FF51174, 40FF51296,
40FF51405, 40FF51479, 40FF51604, 40FF51657, 40FF51800,
40FF51838, 40FF51877, 40FF51968, 40FF51998, 40FF52254,
40FF52264, 40FF52289, 40FF52457, 40FF52655, 40FF52659,
40FF52674, 40FF52766, 40FF52771, 40FF53014, 40FF53115,
40FF53274, 40FF53342, 40FF53648, 40FF53690, 40FF53731,
40FF53757, 40FF53955, 40FF54040, 40FF54053, 40FF54211,
40FF54214, 40FF54346, 40FF54350, 40FF54372, 40FF54381,
40FF54576, 40FF55054, 40FF55131, 40FF55190, 40FF55492,
40FQ31137, 40FQ31160, 40FQ31258, 40FQ31317, 40FQ31357,
40FQ31366, 40FQ31378, 40FQ31489, 40FQ31564, 40FQ31575,
40FQ31594, 40FQ31642, 40FQ31686, 40FQ31753, 40FQ31772,
40FQ31817, 40FQ31853, 40FQ31926, 40FQ31970, 40FQ32085,
40FQ32195, 40FQ32200, 40FQ32253, 40FQ32337, 40FQ32363,
40FQ32430, 40FQ32460, 40FQ32526, 40FQ32555, 40FQ32606,
40FQ32721, 40FQ32736, 40FQ32753, 40FQ32843, 40FQ33067,
40FQ33152, 40FQ33183, 40FQ33427, 40FQ33609, 40FQ33973,
40FQ33798.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Heart of America, Peoria, IL, by telephone on March 23-24, 2004 and by letter dated March 31, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose medical history screening regarding risk factors for variant Creutzfeldt-Jacob disease (vCJD) was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
199 units.
DISTRIBUTION
Nationwide and Switzerland.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Recovered Plasma. Recall # B-1561-4.
CODE
Unit number 49LQ35151.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by facsimile on September 28, 2001, and December 13, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1580-4.
CODE
Unit numbers 49GQ40739, 49GQ40744, 49GQ40749, 49GQ40750, and 49GQ40751.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southwest Region, Tulsa, OK, by telephone on May 3, 2002. Firm initiated recall is complete.
REASON
Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
TX, and OK.

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
Alenti Lift Hygiene Chair; a non-AC-powered patient lift; Model numbers CDB8003-01-US and CDB8053-01-US (with scale). Recall # Z-1046-04.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Arjo, Inc., Roselle, IL, by letters dated June 8, 2004. Firm initiated recall is ongoing.
REASON
There has been an increased number of tipping incidents and subsequent patient injuries.
VOLUME OF PRODUCT IN COMMERCE
1,032 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
TAXUS? Express2? Paclitaxel-Eluting Coronary Stent System. Recall # Z-1052-04.
CODE
6294706 (Exp date June 2004), 6365192 (Exp date July 2004).
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Natick, MA, by press release on July 2, 2004. Firm initiated recall is ongoing.
REASON
The problem consists of affected delivery catheters having resulted in slow or no balloon deflation during coronary angioplasty procedures.
VOLUME OF PRODUCT IN COMMERCE
200 devices.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
Surgical powered laser instrument, used for photocoagulation of ocular tissues in the treatment of diseases of the eye. Recall # Z-1066-04.
CODE
Serial numbers: 871480, 871481, 871485, 861961, 871483, 871477, 865932, 871484, 865928, 865934, 865933, 871478, 865937, 871482, 872571, 871479, 871476, 865930, 865935.
RECALLING FIRM/MANUFACTURER
Carl Zeiss Ophthalmic Systems, Inc, Dublin, CA, by telephone or fax on June 3, 2004. Firm initiated recall is ongoing.
REASON
The coating of laser mirrors in a defined manufacturing lot of the Visulink 532/U devices may partially tear open and loosen from the base plate. The mirror may misdirect the laser beam to an unintended target in or on the eye.
VOLUME OF PRODUCT IN COMMERCE
17 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

*****CORRECTION*****
ENFORCEMENT REPORT 04-26, JUNE 30, 2004, CLASS II ? INFANT VENTILATORS WITH ELECTRONIC MANOMETER, RECALL # Z-1032-4, UNDER CODES, IT IS MANOMETERS WITH PRODUCTION SERIAL NUMBERS BEGINNING WITH A ?00? PREFIX ? NOT VENTILATORS.

_______________________________
PRODUCT
VIDASÃ’ CMV IgG Assay, Catalog #30 204. Recall # Z-1047-04.
CODE
Lot #782887501.
RECALLING FIRM/MANUFACTURER
BioMerieux, Durham, NC, by letter on June 9, 2004. Firm initiated recall is ongoing.
REASON
The product may give false positive results.
VOLUME OF PRODUCT IN COMMERCE
148 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
ABBOTT TestPack+Plus Strep A with On Board Controls (OBC) II, list numbers 5C63-16 (20 test kit) and 5C63-21(40 test kit). Recall # Z-1048-04.
CODE
List 5C63-16 [20 test kit lots]: 04671M300, 10138M200, 10139M200, 10140M200, 10141M200, 10142M200, 10143M200, 12224M100, 12225M100, 12792M200, 12794M200, 13063M200, 13066M200, 13165M200, 13166M200, 13167M200, 13168M200, 13725M100, 13921M100, 14153M100, 14154M100, 14898M200, 14906M200, 14908M200 and 14911M200. List 5C63-21 [40 test kit lots]: 10148M200, 10149M200, 10150M200, 10151M200, 10152M200, 12796M200, 12129M200, 12222M100, 12223M100, 13064M200, 13065M200, 13162M200, 13163M200, 13164M200, 13925M100, 14146M100, 14147M100, 14148M100 and 14149M100.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL, by letter on June 11, 2004. Firm initiated recall is ongoing.
REASON
False positive results may be obtained with the identified lots when using a negative patient sample or a negative control.
VOLUME OF PRODUCT IN COMMERCE
75,368 kits.
DISTRIBUTION
Internationally.

_______________________________
PRODUCT
Model 509M Pulse Oximetry Interface Module Software. Recall # Z-1049-04.
CODE
Software versions 2.0 or 2.5.
RECALLING FIRM/MANUFACTURER
Respironics Novametrix, Inc., Wallingford, CT, by letter dated September 3, 2002 and February 24, 2004. Firm initiated recall is complete.
REASON
Audio alarm may fail to sound when Sp02 limits drop below the set limits.
VOLUME OF PRODUCT IN COMMERCE
901 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Clintec Micromix Compounder, an I.V. solution compounder; product code 2M8290 - 1.0 mL accuracy, and product code 2M8290L - less than 1.0 mL accuracy. Recall # Z-1054-04.
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL, by telephone beginning on April 26, 2004. FDA initiated recall is ongoing.
REASON
The Micromix compounder may have ingredient delivery outside of the stated accuracy limits if the Vlier pin is not properly adjusted.
VOLUME OF PRODUCT IN COMMERCE
500 devices.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
LIGACLIP ERCA Endoscopic Rotating Multiple Clip Applier (Product Code: ER320) and assorted Flex Trays(Convenience Kits), containing ER320, LIGACLIP ERCA Endoscopic Rotating Multiple Clip Appliers. Recall # Z-1055-04.
CODE
Multiple lot codes of Model ER320, LIGACLIP ERCA Endoscopic Rotating Multiple Clip Appliers and multiple varieties and Lot Numbers of Flex Trays incorporating the clip appliers are subject to recall. The recalled codes represent all ER320 LIGACLIPS and/or kits containing ER320 LIGACLIPS, manufactured by the firm?s plant in Juarez, Mexico from 12/10/2003 thru 2/5/2004. Model ER320, LIGACLIP ERCA Endoscopic Rotating Multiple Clip Appliers - Lot Codes: U4YV53 U4YV54 U4YV54 U4YV54 U4YX01 U4YX07 U4YX07 U4YX2Z U4YX2Z U4YX2Z U4YX2Z U4YX2Z U4YX7Y U4YX7Y U4YX7Y U4YX84 U4YY5R U4YY5R U4YY5T U4YY5T U4YY5T V4YZ0C V4YZ0C V4YZ82 V4YZ82 V4YZ84 V4YZ8H V4YZ8H V4Z02U V4Z106 V4Z106 V4Z106 V4Z111 V4Z111 V4Z111 V4Z14R V4Z14R V4Z14R V4Z14R V4Z14W V4Z15U V4Z15U V4Z215 V4Z215 V4Z21F V4Z333 V4Z333 V4Z335 V4Z335 V4Z388 V4Z388 V4Z52V V4Z52V V4Z52Z V4Z57M V4Z62M V4Z62M V4Z66A V4Z66A V4Z66C V4Z66C V4Z724 V4Z724 V4Z837 V4Z838 V4Z882 V4Z882 V4Z883 V4Z883 V4Z95F V4Z95F V4Z964 V4Z964 V4Z964 V4Z99R V4Z99R V4Z99W V4Z99W V4Z99W V4ZA0X V4ZA0X V4ZA3V V4ZA3V V4ZA53 V4ZA53 V4ZA53 V4ZC1D V4ZC1D V4ZC1U V4ZC1U V4ZD02 V4ZD06 V4ZD06 V4ZD3X V4ZD3X V4ZD3X V4ZD52 V4ZD52 V4ZD52 V4ZD9E V4ZD9E V4ZE0H V4ZE0H V4ZE0H V4ZE61 V4ZE61 V4ZE7L V4ZE7L Flex Tray Gastric Trays - Kit Code: Lot Numbers: CBG17 V4Z63R CK017 U4YU9L CK017 U4YV4G CK017 U4YX3J CK017 U4YX5A CK017 U4YX5A CK017 U4YX5A CK017 U4YY23 CK017 V4YY8D CK017 V4YZ47 CK017 V4YZ47 CK017 V4Z00L CK017 V4Z24X CK017 V4Z36Y CK017 V4Z36Y CK017 V4Z45G CK017 V4Z52P CK017 V4Z52P CK017 V4Z52P CK017 V4Z52P CK017 V4Z60U CK017 V4Z77E CK017 V4Z88G CK017 V4Z932 CK017 V4ZA59 CK017 V4ZA9R Flex Tray Bariatric Trays - Kit Code: Lot Numbers: FBW48 U4YX04 FBW48 V4Z344 FBW48 V4Z65G FBW48 V4ZD1C FBW64 V4Z829 FBW64 V4Z829 FBW64 V4ZE7K FBW79 U4YV5T FBW79 V4YZ53 FBW79 V4YZ53 FBW79 V4Z47T FBW79 V4Z62K FBW79 V4ZD1D FBW83 V4Z771 FBW83 V4Z771 FBW87 V4Z50Z KBW21 V4Z66D KBW21 V4ZC9T KBW21 V4ZC9T KBW29 V4Z797 KBW31 V4ZD48 KBW33 U4YV26 KBW33 U4YV26 KBW33 V4ZA3R KBW33 V4ZD1Y KBW47 V4Z16C KDW07 V4Z59L KDW07 V4Z59L KDW13 V4YZ3G KDW13 V4Z20W Flex Tray Access Trays - Kit Code: Lot Numbers: FDA47 U4YV2K FDA47 V4Z209 FDA47 V4Z789 FDA47 V4ZA4G FDA47 V4ZA4G Flex Tray Cholecsystectomy Trays: Kit Code: Lot Numbers: FDC10 U4YU37 FDC10 U4YX1K FDC10 U4YY1L FDC10 V4Z26M FDC10 V4Z29H FDC10 V4Z49H FDC10 V4Z49H FDC10 V4Z49H FDC10 V4Z514 FDC10 V4Z65C FDC10 V4Z65C FDC10 V4Z86F FDC10 V4Z86F FDC10 V4Z93N FDC10 V4ZA8D FDC10 V4ZD6U FDC10 V4ZE0N FDC10 V4ZF23 FDC11 U4YX9N FDC11 V4Z910 FDC12 U4YV02 FDC12 U4YV02 FDC12 U4YX29 FDC12 U4YX29 FDC12 U4YX29 FDC12 U4YX29 FDC12 V4Z23A FDC12 V4Z945 FDC12 V4Z945 FDC12 V4ZA8M FDC12 V4ZA8M FDC13 U4YV03 FDC13 U4YV03 FDC13 V4Z137 FDC13 V4Z208 FDC13 V4Z208 FDC13 V4Z78C FDC13 V4ZC9Z FDC14 U4YU9X FDC14 V4Z83R FDC14 V4Z83R FDC15 U4YX27 FDC15 U4YX27 FDC15 V4Z22K FDC15 V4Z29E FDC15 V4Z37V FDC15 V4Z37V FDC15 V4Z93R FDC15 V4Z93R FDC15 V4Z957 FDC15 V4ZA62 FDC15 V4ZE0R FDC15 V4ZE0R FDC16 U4YU6G FDC16 U4YY4X FDC16 V4Z37A FDC16 V4Z49K FDC16 V4Z68K FDC16 V4Z68K FDC21 U4YW2T FDC21 V4Z93L FDC21 V4Z93L FDC22 U4YY52 FDC22 V4Z827 FDC22 V4ZC2M FDC22 V4ZC2M FDC22 V4ZC2M FDC22 V4ZC2M FDC32 U4YU3D FDC32 U4YX1L FDC32 U4YY6R FDC32 U4YY6R FDC32 V4Z59E FDC32 V4Z68H FDC32 V4Z68H FDC32 V4Z83U FDC32 V4Z83U FDC32 V4Z958 FDC32 V4Z958 FDC32 V4ZD55 FDC32 V4ZD57 FDC42 V4Z091 FDC42 V4Z95W FDC42 V4Z95W FDC42 V4Z95W FDC42 V4ZD5T FDC44 V4YY73 FDC46 V4Z150 FDC46 V4Z963 FDC46 V4Z963 FDC50 U4YV1Z FDC50 V4Z08G FDC50 V4ZE3D FDC56 V4Z83N FDC58 V4Z04A FDC58 V4Z04A FDC58 V4Z244 FDC58 V4Z86J FDC70 U4YX2A FDC70 V4Z896 FDC70 V4Z896 FDC70 V4ZD9U FDC70 V4ZF6F FDC79 U4YW3N FDC79 V4Z59H FDC79 V4Z59H FDC79 V4Z71X FDC79 V4Z71X FDC79 V4Z71X FDC80 V4Z39K FDC80 V4Z39K FDC80 V4Z39K FDC80 V4Z39K FDC81 U4YY0G FDC81 U4YY58 FDC81 U4YY58 FDC81 V4Z984 FDC81 V4Z984 FDC81 V4ZD5R FNC10 U4YW33 FNC10 V4Z27Y FNC10 V4Z71F FNC13 U4YV77 FNC13 V4Z561 FNC14 V4ZE3J FNC23 U4YU2F FNC23 U4YY47 FNC23 U4YY47 FNC23 V4Z50Y FNC23 V4ZD14 FNC28 U4YY0J FNC28 U4YY0J FNC28 V4Z20P FNC28 V4Z44R FNC28 V4Z44R FNC28 V4Z78A FNC28 V4ZC3V FNC28 V4ZC3V FNC29 U4YU03 FNC29 V4Z153 FNC29 V4Z17R FNC29 V4Z17R FNC29 V4ZC12 FNC29 V4ZC12 FNC30 U4YU21 FNC30 V4YZ3L FNC30 V4YZ3L FNC30 V4ZC17 FNC40 U4YW7K FNC40 V4Z181 FNC40 V4Z88N FNC40 V4ZE7T FNC40 V4ZE7T FNC41 U4YV01 FNC41 U4YV01 FNC41 V4Z26L FNC41 V4Z26L FNC41 V4Z515 FNC41 V4Z563 FNC41 V4Z69M FNC41 V4Z69M FNC41 V4Z86E FNC41 V4Z86E FNC41 V4Z86E FNC41 V4ZA2G FNC41 V4ZA2G FNC41 V4ZA2G FNC41 V4ZA2G FNC41 V4ZC1F FNC41 V4ZC1F FNC42 U4YV3T FNC42 V4Z04D FNC42 V4ZD4A FNC43 U4YW3M FNC43 U4YW3M FNC43 V4Z028 FNC43 V4Z028 FNC43 V4Z028 FNC43 V4Z612 FNC43 V4Z75G FNC43 V4ZE64 FNC62 V4Z26C FNC62 V4Z26C FNC62 V4Z71U FNC62 V4ZC5L FNC69 V4Z37W FNC69 V4ZC1P FNC72 U4YU9Z FNC72 V4Z56J FNC73 U4YY4D FNC73 U4YY4D FNC90 U4YT8L FNC90 V4YZ3R FNC90 V4YZ8W FNC90 V4YZ8W FNC90 V4Z89J FNC90 V4Z89J FNC90 V4ZC3W FNC92 U4YV5A FNC92 U4YV5A FNC92 V4Z891 FNC94 V4YY8L FNC94 V4YY8L FNC94 V4YY8L FNC94 V4YY8L FNC94 V4Z88M FNC94 V4Z88M FNC94 V4ZC3T FNC94 V4ZC3T FNC94 V4ZC3T FNC99 V4Z63M FTC10 V4Z15D FTC10 V4Z94A FTC11 U4YU01 FTC11 V4Z94C FTC15 U4YX03 FTC15 U4YX03 FTC15 V4YZ2A FTR12 U4YU06 FTR12 V4YZ7N FTR12 V4YZ7N FTR12 V4ZE26 FTR12 V4ZE26 FTR13 V4ZD1T FTR32 U4YU05 FTR32 U4YY06 FTR32 V4YY8M FTR32 V4YY8M FTR32 V4YY8M FTR72 U4YY4F FTR72 U4YY4F FTR72 V4Z12A FTR72 V4ZD49 FTR72 V4ZD49 FTR73 V4Z88P KBC01 U4YW7C KBC01 V4ZD9D KBC06 V4Z79A KBC06 V4ZG3Y KBC07 U4YW94 KBC07 U4YW94 KBC07 V4Z29D KBC07 V4Z67H KBC07 V4Z758 KBC11 V4Z30H KBC23 V4Z635 KDC01 U4YX23 KDC03 V4Z14P KDC06 V4YZ7J KDC25 V4Z23N KDC26 U4YV3V KDC26 V4YZ2H KDC26 V4YZ2H KDC26 V4Z20H KDC26 V4Z897 KDC27 V4YZ2M KDC27 V4Z914 KDC32 V4Z13P KDC32 V4Z898 KDC32 V4ZC6M KDC32 V4ZC6M KDC33 V4Z796 KDC33 V4ZD01 KDC35 U4YU9Y KDC39 U4YV5V KDC39 V4Z17M KDC39 V4Z81U KDC40 U4YV1R KDC40 U4YV1R KDC40 U4YV1R KDC40 V4Z08E KDC51 V4Z47R KDC53 V4Z227 KDC61 U4YV75 KDC61 V4YZ7H KDC61 V4Z23E KDC61 V4Z68M KDC61 V4ZC84 KDC68 U4YW76 KDC68 U4YY07 KDC68 U4YY1A KDC68 U4YY1A KDC68 V4ZE68 KDC84 U4YW32 KDC84 V4Z56H KDC84 V4Z83M KDC84 V4Z83M KDC84 V4ZD71 KDC94 V4Z73N KNC03 U4YW3H KNC03 V4Z243 KNC03 V4Z243 KNC03 V4ZE7V KNC03 V4ZE7V KNC04 V4Z072 KNC04 V4Z072 KNC04 V4Z610 KNC07 U4YU6A KNC07 V4Z047 KNC07 V4Z047 KNC07 V4Z351 KNC07 V4Z65K KNC07 V4Z65K KNC07 V4ZD66 KNC08 U4YV1T KNC09 V4Z56G KNC09 V4Z56G KNC09 V4Z62J KNC09 V4ZE57 KNC19 U4YV9C KNC19 V4Z119 KNC19 V4Z772 KNC19 V4ZD5N KNC35 U4YX06 KNC35 U4YX06 KNC35 V4Z26K KNC35 V4ZD5L KNC35 V4ZD5L KNC60 U4YT6N KNC60 V4Z63K KNC60 V4Z63K KNC60 V4Z83P KNC74 U4YV9D KNC74 U4YV9D KNC74 V4Z26D KNC74 V4Z62N KNC76 V4YZ5P TDC04 V4Z04N TDC07 V4Z71Z TDC07 V4Z71Z TDC07 V4Z71Z TDC09 V4Z29F TDC27 U4YT89 TDC27 V4Z427 TDC27 V4Z427 TDC27 V4ZD16 TDC34 U4YU04 TDC34 V4Z44H TDC34 V4Z44H TDC37 V4Z238 TDC37 V4Z238 TDC37 V4ZD5K TDC39 V4YZ3P TDC39 V4YZ3P TDC41 V4Z26A TDC45 V4Z27N TDC49 V4Z324 TDC51 V4Z326 TDC51 V4Z326 TDC52 U4YU69 TDC54 U4YX3C TDC54 U4YX3C TDC54 V4Z34Y TDC54 V4ZD4D TDC59 V4Z346 TDC59 V4Z346 TDC59 V4ZA48 TDC61 U4YV2D TDC64 U4YV9W TDC64 U4YV9W TDC72 U4YW2J TDC72 V4ZD6C TNC07 U4YV60 TNC07 V4Z22J TNC12 U4YU29 TNC12 V4Z50R TNC12 V4Z50R TNC18 U4YT88 TNC18 V4Z42X TNC18 V4ZF1P TNC18 V4ZF1P TNC20 U4YT8E TNC20 U4YX05 TNC20 U4YX05 TNC20 V4Z350 TNC20 V4Z350 TNC20 V4Z68L TNC23 V4Z12K TNC23 V4Z12K TNC23 V4Z13M TNC23 V4ZE3E TNC23 V4ZE3E TNC24 U4YV3Z TNC24 V4YY8V TNC24 V4YY8V TNC29 V4ZD17 TNC36 V4Z560 TNC36 V4ZE28 TNC36 V4ZE28 TNC36 V4ZE28 TNC45 V4YZ6P TNC45 V4YZ6P TNC49 V4Z239 TNC49 V4Z239 TNC49 V4Z56K TNC49 V4ZD15 TNC56 V4Z83K TNC61 U4YV76 TNC61 V4Z21X TNC63 V4YZ28 TNC63 V4YZ28 TNC63 V4YZ28 TNC63 V4YZ28 TNC63 V4Z62Y TNC63 V4ZD9C TNC71 U4YW8M TNC71 V4Z09F TNC71 V4Z37C TNC80 V4Z37G TNC80 V4Z54F TNC80 V4ZD13 TNC81 V4Z34Z TNC85 V4Z65J TNC85 V4Z65J TNC87 V4Z12D TNC87 V4ZC6Y TNC88 V4Z95T TNC90 V4YZ6N TNC90 V4YZ6N TNC90 V4Z60V TNC90 V4ZC85 TNG92 U4YW31 TNG92 V4Z12C TNG92 V4Z68F VDC10 U4YW3G VDC10 U4YY4E VDC10 V4Z599 VDC10 V4Z65F VDC10 V4Z949 VDC15 U4YW72 VDC15 U4YW72 VDC15 V4Z513 VDC15 V4Z71R VDC15 V4Z71R VDC32 U4YV00 VDC32 U4YY1M VDC32 U4YY1M VDC32 V4Z83T VNC41 U4YV3U VNC41 V4Z30L VNC41 V4Z30L VNC41 V4Z614 VNC41 V4Z75L VNC42 V4Z04C VNC42 V4Z356 VNC42 V4Z356 VNC42 V4ZC1R VNC43 U4YV41 VNC43 U4YV41 VNC43 V4Z569 VNC43 V4Z569 VNC43 V4Z965 VNC94 V4Z14Z Flex Tray General Laparoscopy Trays - Kit Code: Lot Numbers: TGL21 U4YU02 TGL21 V4Z049 TGL21 V4Z049 TGL21 V4Z54D TGL32 V4Z029 TGL32 V4Z163 TGL44 V4Z449 TGL52 V4Z90Y.
RECALLING FIRM/MANUFACTURER
Ethicon Endo-Surgery, Cincinnati, OH, by letter on June 7, 2004. Firm initiated recall is ongoing.
REASON
This device is subject to recall due to an increased possibility of clip scissoring which can result in less than optimal clip formation which may or may not securely ligate tubular structures.
VOLUME OF PRODUCT IN COMMERCE
1,204,015.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) CryoValve Pulmonary Valve SG. Recall # Z-1056-04;
b) CryoValve Pulmonary Valve and Conduit.
Recall # Z-1057-04;
c) CryoValve Aortic Valve and Conduit.
Recall # Z-1058-04.
CODE
a) Device Donor number: 64212, Serial Number: 7887101.
Model Number: SGPV10;
b) Donor Number: 64208, Serial Number: 7887057, Model
Number: SGPV00, Donor Number: 64222, Serial Number:
7894333, Model Number: SGPV00 and Donor Number:
64224, Serial Number: 7894298, Model Number: SGPV00;
c) Donor number: 64233, Serial Number: 7869358,
Model Number: SGAV00.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by letter on June 17 and 18, 2004. Firm initiated recall is ongoing.
REASON
The Amphotericin B Intermediate (G10030), one of the components of the antimicrobial solution, had reached expiration at the time it was utilized to manufacture the Combo Antibiotic Stock Solution (G10070).
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
CA, OH, OR, and PA.

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PRODUCT
a) ACCU-CHEK Inform meter; catalog No. 3035123.
Recall # Z-1060-04;
b) ACCU-CHEK Inform base unit; catalog No. 3035131.
Recall # Z-1061-04.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by a recall notice dated June 30, 2004. Firm initiated recall is ongoing.
REASON
Exposure to excessive disinfectant or cleaning solution may cause overheating, melting, or smoke.
VOLUME OF PRODUCT IN COMMERCE
41,544 units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of
kit: 1- 2 x 17 ml phenytoin conjugate and 2- 2 x 18 ml
anti-phenytoin antibody (mouse monoclonal); latex
microparticle. Product 03800458190. Recall # Z-1062-04;
b) Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of
kit: 1- 1 x 37 ml phenytoin conjugate and 2- 1 x 38 ml
anti-phenytoin antibody (mouse monoclonal); latex
microparticle. Product 03516989190. Recall # Z-1063-04.
CODE
a) and b) Lot 14608300.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter dated June 17, 2004. Firm initiated recall is ongoing.
REASON
Device may report falsely decreased patient results.
VOLUME OF PRODUCT IN COMMERCE
312 kits.
DISTRIBUTION
Nationwide, Canada, Germany and Spain.

_______________________________
PRODUCT
Osmetech OPTI-CCA Blood Gas Analyzer, Single Use, BP7564 OPTI?E-Glu Cassettes.The cassettes are labeled, Roche OPTICCA Cassettes E-Glu. There are 25 cassettes in each box. Catalog Number BP7564, Lot #351601, 401600, 401601, 405600, 405601, 406600, 406601, 405600, 405601, 410600, 412600, 415600, 415601, 417600, 419600, 419601, 419602 and 419603. Recall # Z-1064-04.
CODE
All OPTI-CCA Analyzers with software version 2.20 through 2.24 are affected.
RECALLING FIRM/MANUFACTURER
Osmetech, Inc., Roswell, GA, by letter on June 22, 2004. Firm initiated recall is ongoing.
REASON
Patient samples with high glucose concentrations, above the reportable range of the OPTI-CCA Analyzer, may be erroneously reported as ?Low?.
VOLUME OF PRODUCT IN COMMERCE
1,012 boxes/25 cassettes per box.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Passport 2/Passport 2LT Vital Signs Monitor. Multi-parameter patient monitoring system. Recall # Z-1050-04.
CODE
Serial Numbers: CM16830-E2; CM17664-C3; CM02100-D0; CM21267-B3; CM01262-B0; CM17728-F3; CM14167-L1; CM15062-B2; TM05314-D3; TM03604-A3; TM03630-A3; TM03642-A3; TM04059-B3; CM11122-F1; CM02057-D0; CM10756-F1; CM01376-B0; CM06107-K0; CM08770-C1; CM04116-H0; CM03838-G0; CM15058-B2; CM10359-F1; TM04721-C3; CM03958-G0; CM12388-I1; CM11462-G1; TM04175-B3; CM04386-H0; CM04445-H0; CM12571-I1; CM12778-I1; CM11479-G1; CM11776-H1; CM03556-F0; CM17319-E2; TM03982-A3; CM10360-F1; CM13887-K1; TM06058-F3; CM07526-B1; CM17683-F3; CM17715-F3; CM14479-A2; CM04265-H0; CM04703-I0; CM16756-E2; TM04809-C3; TM01569-H2; TM03602-A3; TM03603-A3; TM04091-B3; CM14979-B2; CM14986-B2; CM09445-D1; CM09479-D1; CM09935-E1; CM10117-E1; CM16268-D2; CM16451-D2; CM16540-D2; CM20116-F2; CM20117-F2; CM20130-F2; CM20160-F2; CM20196-F2; CM20203-F2; CM20216-F2; CM20218-F2; CM20219-F2; CM20220-F2; CM20221-F2; CM20529-F2; CM20531-F2; CM20533-F2; CM20537-F2; CM20538-F2; TM03635-A3; TM03639-A3; TM03647-A3; TM05447-E3; TM05457-E3; TM06085-G3; TM06109-G3; TM06119-G3; TM06129-G3; TM06152-G3; TM06154-G3; TM06170-G3; TM06270-H3; TM06280-H3; TM06282-H3; TM06317-H3; TM06337-H3; TM06363-H3; TM06386-H3; CM12173-H1; CM03670-F0; CM10041-E1; CM10721-F1; CM17422-E2; CM14065-L1; CM01200-L9; CM10711-F1; CM13006-J1; CM09686-D1; CM16023-C2; CM07488-B1; CM06584-L0; CM14498-A2; CM11945-H1; CM09924-E1; CM10163-E1; TM0555733-E3; CM12712-I1; TM04453-B3; TM03615-A3; CM04707-I0; CM08494-C1; TM04593-B3; TM06051-F3; CM04641-I0; CM12252-H1; CM16585-D2; CM04089-H0; CM09094-D1; TM06056-F3; TM06057-F3; TM06060-F3; YM06061-F3; CM06521-L0; CM04176-H0; TM01305-H2; TM03623-A3; TM03637-A3; TM03631-A3; CM04739-I0; CM13335-J1; CM05366-J0; CM05379-J0; CM07674-B1; CM12608-I1; CM04078-H0; TM01934-I2; TM03605-A3; TM03614-A3; CM05787-K0; CM12519-I1; CM16699-E2; CM09685-D1; CM10622-F1; CM13227-J1; CM17680-E3; TM02741-K2; CM05243-J0; CM05992-K0; CM13985-L1; TM05504-E3; TM03338-L2; CM11689-H1; TM04360-B3; CM03934-G0; CM10757-F1; CM10768-F1; CM10771-F1; TM05692-E3; TM05710-E3; CM1099-L9; CM17684-F3; CM16059-C2; CM03133-E0; CM01660-C0; CM15956-C2; CM14371-LI; CM06098-K0; CM07733-B1; CM09173-D1; CM06805-L0; CM10013-E1; CM04005-G0; CM07697-B1; TM05835-F3; TM05840-F3; TM05854-F3; TM05872-F3; TM05905-F3; TM05912-F3; TM05921-F3; TM05947-F3; TM05956-F3; CM01797-C0; TM02210-J2; CM05139-J0; CM11127-F1; TM01614-H2; CM09611-D1; TM05714-E3; TM03476-A3; TM03627-A3; TM03684-A3; TM05824-E3; CM07628-B1.
RECALLING FIRM/MANUFACTURER
Datascope Corp., Mahwah, NJ, by Service Representatives visits in February, 2004. Firm initiated recall is ongoing.
REASON
Potential inaccurate printed information in the upper and lower margins of a print strip.
VOLUME OF PRODUCT IN COMMERCE
244 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Clinitek 50 Urine Chemistry Analyzer; Product codes 6509C, 6513K, 6514C, 6515C, 6516F and 6518C. [The different product codes are for the various countries where the product is distributed). Recall # Z-1051-04.
CODE
Serial numbers 166837 through 168088.
RECALLING FIRM/MANUFACTURER
Bayer Healthcare LLC, Elkhart, IN., by letter on or about March 12, 2003. Firm initiated recall is ongoing.
REASON
Some units may only have had 1 read head screw installed instead of the three required by the firm?s specifications.
VOLUME OF PRODUCT IN COMMERCE
424 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Pinhole Collimator (NDCL709A) for Digital Gamma Cameras GCA-7100A series and CGA-7200A series. Regulation Number 21 CFR 892.1200, Class 2 device. Recall # Z-1059-04.
CODE
Various serial numbers.
RECALLING FIRM/MANUFACTURER
Toshiba American Med Sys Inc., Tustin, CA, by letter on May 31, 2004. Firm initiated recall is ongoing.
REASON
Pinhole collimator defective.
VOLUME OF PRODUCT IN COMMERCE
40 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) NxStage Cartridge Express. A disposable extracorporeal
blood and fluid pathway and a hemo filter.
Model #CAR-124, 6 units per case. Recall # Z-1069-04;
b) NxStage Cartridge Express. A disposable extracorporeal
blood and fluid pathway and a hemo filter.
Model #CAR-153 Cartridge Express. 6 units per case.
Recall # Z-1070-04;
c) NxStage Cartridge Express. A disposable extracorporeal
blood and fluid pathway and a hemo filter. Model #
CAR-154 Cartridge Express, 6 units per case.
Recall # Z-1071-04.
CODE
a) Lot Numbers from and including FG-031216-01 to
FG-040322-01;
b) Lot Numbers from and including FG-031216-01 to
FG-040322-01;
c) Lot Numbers from and including FG-031216-01 to
FG-040322-01.
RECALLING FIRM/MANUFACTURER
NxStage Medical, Inc., Lawrence, MA, by recall notice dated April 14, 2004. Firm initiated recall is ongoing.
REASON
Pinhole leaks on the replacement (RF) side FMP bag in certain lots of its disposable cartridge balance chambers resulting in loss of dialysate or ultrafiltrate.
VOLUME OF PRODUCT IN COMMERCE
1,188 units.
DISTRIBUTION
CA, IL, IN, MD, IA, MO, NJ, OH, and VT.

_______________________________
PRODUCT
Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001. Recall # Z-1072-04.
CODE
Lots affected 305025 308126 309091 311067 308184 312083 403055 404065 405079 406083 406218 306299 308125 309092 308185 308124 310115 306150 309093 305165 311069 312146 401048 403054 403099 404084 406084 312146R 307177 305027 308183 3010378 311066 401104 403084 405074 307177B 305027B 308183B 310378B 305027C 311066B 311066C 401104B 403084B 405074B.
RECALLING FIRM/MANUFACTURER
Gen Probe, Inc., San Diego, CA, by fax and/or letter on June 11, 2004. Firm initiated recall is ongoing.
REASON
Reduced stability.
VOLUME OF PRODUCT IN COMMERCE
4,533 units.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR JULY 14, 2004

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