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U.S. Department of Health and Human Services

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Enforcement Report for November 24, 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.

November 24, 2004
04-2479

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Solutions IE Ageless Formula II, Ultra-Vitamins in Vegetable, Fruit and Herbal Base, All 5 Network Anti-Oxidants, Folic Acid, Omega3 and 6, Noni Extract. Recall #F-076-5.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Aloe Commodities International, Inc., Carrolton, TX, by letter on March 19, 2004. Firm initiated recall is complete.
REASON
The product contains excessive level of vitamin D. The product, labeled to contain 400 IU per the recommended dosage of 6 capsules daily, actually contains 188,640 IU per 6 capsules. The firm miscalculated the ingredient quantities during manufacture and reportedly added 8% Vitamin D3 instead of 0.08%.
VOLUME OF PRODUCT IN COMMERCE
1,600 bottles.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Apple Valley Vegetarian Foods Emporium brand almonds , whole raw natural, sold in one pound plastic bags. Recall # F-077-5.
CODE
Codes of 3214 through 4154 printed on the label.
RECALLING FIRM/MANUFACTURER
Apple Valley Natural Foods, Berrien Springs, MI, by telephone on May 28, 2004 and by a press release on June 9, 2004. Firm initiated recall is complete.
REASON
The product was manufactured using almonds that were recalled by Paramount Farms due to their association with an outbreak of Salmonella Enteriditis infection.
VOLUME OF PRODUCT IN COMMERCE
5,000 pounds.
DISTRIBUTION
IL, and MI.
 

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II

_______________________________
PRODUCT
a) FrutaReal Frozen Fruit Bars Mango Ice Milk Bar, Recall # F-078-5;
b) FrutaReal Frozen Fruit Bars Pineapple (PINA)Ice Water Bar, Recall # F-079-5.
CODE
All products on the market at the time recall was initiated.
RECALLING FIRM/MANUFACTURER
Cordova, Inc., Nampa, ID, by visit beginning on September 16, 2004. Firm initiated recall is complete.
REASON
a) The product contains undeclared color , FD&C Yellow #5 and #6;
b) The product contains undeclared color , FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
a) Mango , 160 boxes (12 bars/box);
b) Pineapple , 184 boxes (12 bars/box).
DISTRIBUTION
ID, OR and UT.

_______________________________
PRODUCT
Big Y Milk Chocolate Raisin Almond Bar, Net Wt. 5 oz. (142G) Naturally and Artificially Flavored UPC 18894-41236. Recall # F-080-5.
CODE
Lot number: 072605.
RECALLING FIRM/MANUFACTURER
Hebert Candies, Shrewsbury, MA, by telephone on October 26, 2004. Firm initiated recall is complete.
REASON
The product fails to list almonds in the ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
246 cases.
DISTRIBUTION
MA and CT.
 

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
Xopenex (levalbuterol HC1) Inhalation Solution Concentrate, 1.25 mg/0.5 mL, 30 Sterile Unit Dose Vials, Dilution required, For Oral Inhalation Only, Rx only, NDC 63402-515-30. Recall # D-058-5.
CODE
Lot numbers: S4F162, S4F163, S4F164, S4F165, S4F166, S4G005, S4G006, S4G007, and S4G008.
RECALLING FIRM/MANUFACTURER
Sepracor, Inc., Marlborough, MA, by letter dated October 22, 2004. Firm initiated recall is ongoing.
REASON
Good Manufacturing Practice (GMP) deviation (process validation).
VOLUME OF PRODUCT IN COMMERCE
669,000 vials.
DISTRIBUTION
Nationwide and PR.

_______________________________
PRODUCT
Premarin (conjugated estrogens tablets USP), 0.625 mg, 1,000 tablet bottles, Rx. NDC 0046-0867-91. Recall # D-060-5.
CODE
A48207, Exp. 9/05.
RECALLING FIRM/MANUFACTURER
Richmond Division of Wyeth Pharmaceuticals, Richmond, VA, by letters dated October 27, 2004. Firm initiated recall is ongoing.
REASON
Dissolution failures (stability).
VOLUME OF PRODUCT IN COMMERCE
15,230 bottles.
DISTRIBUTION
AR, VA and TN.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Ortho a Assay Software; (For Use with the Ortho Summitä Sample Handling System). Recall # B-0118-5.
CODE
Version 2.0.
RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics, Inc, Raritan, NJ, by letter dated May 13, 2004. Firm initiated recall is ongoing.
REASON
Defects in the design of instrument software where sample or reagent could be dispensed twice.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0147-5;
b) Fresh Frozen Plasma. Recall # B-0148-5.
CODE
a) Units 32GR59875, 32GR59876, 32GR59877, 32GR59878, 32GR59879,
32GR59880, 32GR59881, 32GR59882, 32GR59883, 32GR59884,
32GR59885, 32GR59886, 32GR59887, 32GR59888, 32GR59889,
32GR59901, 32GR59902, 32GR59903, 32GR59906, 32GR59908,
32GR59909, 32GR59911, 32GR59912, 32GR59914, 32GR59917,
32GR59918, 32GR59919, 32GR59921, 32GR59924, 32GL94842,
32GL94844, 32GL94845, 32GL94846, 32GL94847, 32GL94849,
32GL94905, 32GL94906, 32GL94909, 32GL94910, 32GL94911,
32GL94918, 32GL94920, 32GL94922, 32GL94927, 32GL94929,
32GL94932, 32GL94933, 32GL94936, 32GL94938, 32GL94940,
32GL94942, 32GL94948, 32GL94950, 32GL94952, 32GL94954,
32GL94957, 32GL94964, 32GL94966, 32GL94968, 32GL94970,
32GE47086, 32GE47087, 32GE47091, 32GE47095, 32GE47100,
32GE47103, 32GE47104, 32GE47114, 32GE47115, 32GE47132,
32GE47136, 32GE47137, 32GE47138, 32GE47143, 32GE47144,
32GE47145, 32GE47152, 32GR60226, 32GR60230, 32GR60235,
32GR60236, 32GR60240, 32GR60242, 32GR60245, 32GR60247,
32GR60250, 32GR60254, 32GR60259, 32GR60260, 32GR60262,
32GR60263, 32GR60267, 32GE47155, 32GE47165, 32GE47167,
32GE47168, 32GE47170, 32GE47173, 32GL94975, 32GL94976,
32GL94981, 32GF56324, 32GF56333, 32GF56341, 32GF56348,
32GL95038, 32GL95058, 32GL95060, 32GL95062, 32GR59891,
32GR59893, 32GR59896, and 32GR59897;
b) Units 32GR59874, 32GR59875, 32GR59876, 32GR59877,
32GR59878, 32GR59879, 32GR59880, 32GR59882, 32GR59884,
32GR59885, 32GR59886, 32GR59887, 32GR59888, 32GR59889,
32GR59901, 32GR59906, 32GR59907, 32GR59909, 32GR59910,
32GR59911, 32GR59912, 32GR59914, 32GR59915, 32GR59916,
32GR59919, 32GR59920, 32GR59922, 32GR59923, 32GR59924,
32GR59925, 32GL94843, 32GL94844, 32GL94846, 32GL94847,
32GL94848, 32GL94905, 32GL94907, 32GL94908, 32GL94910,
32GL94911, 32GL94912, 32GL94914, 32GL94916, 32GL94921,
32GL94924, 32GL94931, 32GL94933, 32GL94939, 32GL94941,
32GL94942, 32GL94947, 32GL94948, 32GL94970, 32GE47103,
32GL94954, 32GL94955, 32GL94960, 32GL94962, 32GL94963,
32GL94966, 32GE47104, 32GE47106, 32GE47108, 32GE47109,
32GE47113, 32GE47118, 32GE47120, 32GE47122, 32GE47124,
32GE47125, 32GE47128, 32GE47132, 32GE47135, 32GE47139,
32GE47141, 32GE47142, 32GE47144, 32GE47150, 32GE47151,
32GR60245, 32GR60253, 32GR60256, 32GR60261, 32GR60265,
32GR60266, 32GE47157, 32GE47160, 32GE47161, 32GE47162,
32GE47164, 32GE47165, 32GE47166, 32GE47168, 32GE47173,
32GE47178, 32GE47182, 32GE47183, 32GE47184, 32GL94971,
32GL94972, 32GL94973, 32GL94974, 32GL94977, 32GL94979,
32GL94982, 32GL94983, 32GL94985, 32GL94987, 32GL94988,
32GF56323, 32GF56333, 32GF56334, 32GF56335, 32GF56336,
32GF56341, 32GF56345, 32GF56346, 32GF56347, 32GF56348,
32GF56349, 32GF56350, 32GF56351, 32GF56352, 32GF56353,
32GF56357, 32GF56358, 32GF56360, 32GL95045, 32GR59890,
32GR59891, 32GR59892, 32GR59893, 32GR59894, 32GR59896,
32GR59897, 32GR59898, 32GR59899, and 32GR59900.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Service, Madison, WI, by telephone on February 1, 2002 and by letter dated February 13, 2002. Firm initiated recall is complete.
REASON
Blood products, which were manufactured from whole blood units that were collected in 450 mL collection bags instead of 500 mL collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
251 units.
DISTRIBUTION
IA, WI, IL, CA, AL, GA, MI, and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0162-5;
b) Platelets. Recall # B-0163-5.
CODE
a) and b) Unit 4201504.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by letters dated November 5, 21, and 26, 2001. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to human T-lymphotropic virus type I/II (anti-HTLV-I/II), but were collected from a donor who on two occasions previously tested repeatedly reactive for anti-HTLV-I/II, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI and VT.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0190-5.
CODE
Unit 01FP29379.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY, by telephone on November 5, 2003. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets that was implicated in a transfusion reaction and found to be contaminated with Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0191-5.
CODE
Units 4904186 (parts A & B).
RECALLING FIRM/MANUFACTURER
LifeSource, Glenview, IL, by telephone on September 3, 2004. Firm initiated recall is complete.
REASON
Platelets, possibly contaminated with Micrococcus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0204-5;
b) Platelets. Recall # B-205-5.
CODE
a) and b) Unit number FW20450.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on October 1, 2003. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of Fresh Frozen Plasma possibly contaminated with coagulase negative Staphylococcus sp. Bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA and MA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0206-5;
b) Recovered Plasma. Recall # B-207-5.
CODE
a) and b) Unit number 17199-8537.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by letters on April 9 and 24, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a recent blood exposure, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and Switzerland.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0208-5.
CODE
Unit number 27P69000.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on May 27, 2004, and by letter on June 2, 2004. Firm initiated recall is complete.
REASON
Blood product, that was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm?s standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0209-5.
CODE
Unit numbers 27GE16810 and 27GE16868.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Alleghenies Region, Johnstown, PA, by telephone on November 25, 2003, and by letter on December 4, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the medication Feldene, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA and KY.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0210-5.
CODE
Unit number 15022-0687.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by telephone on August 25, 2003, and by letter on September 17, 2003. Firm initiated recall is complete.
REASON
Blood product, that initially tested negative for West Nile Virus (WNV), was subsequently re-tested and found reactive for WNV.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Source Plasma. Recall # B-0213-5.
CODE
Unit number: 04HWVA2021.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Huntington, WV, by facsimile on May 5, 2004. Firm initiated recall is complete.
REASON
Source Plasma was not properly quarantined and was distributed after the discovery that the donor had been previously permanently deferred.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0214-5.
CODE
Unit 4127437.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone on March 8, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured without a white blood cell count having been performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0217-5.
CODE
Unit 4129673.
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by telephone on May 26, 2004. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0218-5.
CODE
Unit 102980283.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on August 19, 2004. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AZ.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0219-5;
b) Platelets Leukocytes Reduced. Recall # B-0220-5
CODE
a) Units 27GM83140 and 27GS67070;
b) Unit 27GS67070.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA, by telephone on January 8, 2004, and by letter dated January 12, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
PA, OH, and WV.

_______________________________
PRODUCT
Platelets. Recall # B-0221-5.
CODE
Unit V15595.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated May 21, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which clots were noted in the associated red blood cells unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0222-5.
CODE
Units 20522586, 20522401, 20522091, 20521926, 20521613, 20521425, 20521064, 20520898, 20520575, 20520432, 20519930, 20519825, 20519252, 20518996, 20517289, 20517049, 20516657, 20516073, 20515915, 20515558, 20514616, 20514383, 20514162, 20513892, 20513659, 20513427, 20513225, 20512900, 20512811, 20512518, 20512417, 20512131, 20511899, 20511720, 20511440, 20510948, 20509034, 20508794, 20508633, 20508322, 20508190, 20506224, 20506032, 20505734, 20505411, 20505163, 20505014, and 20504745.
RECALLING FIRM/MANUFACTURER
Portsmouth Blood Plasma, LLC, Portsmouth, VA, by facsimile on June 24, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
48 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0223-5;
b) Fresh Frozen Plasma. Recall # B-0224-5.
CODE
a) and b) Unit # LX08901.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Annandale, VA, by facsimile on May 28, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD and VA.

_______________________________
PRODUCT
a) Platelet Pheresis, Recall # B-0225-5;
b) Platelets Pheresis Irradiated. Recall # B-0226-5.
CODE
a) Units 35Z15187 (split units), 35Z15188, 35Z15189,
35Z15191 (split units), 35Z15196 (split units),
35Z15198 (split units), 35Z15199, 35Z15216 (split units),
35Z15217, 35Z15222, 35Z15227, 35Z15230 (split units),
35Z15231 (split units), 35Z15232 (split units),
35Z15233, 35Z15241 (split units), 35Z15242, 35Z15244,
35Z15247 (split units), 35Z15248 (split units),
35Z15254, 35Z15260 (split units), 35Z15264 (split units),
35Z15267 (split units), 35Z15270, 35Z15274 (split units),
35Z15277 (split units);
b) Units 35Z15189, 35Z15199, 35Z15217, 35Z15222, 35Z15227,
35Z15242, 35Z15244, 35Z15254, and 35Z15270.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Roanoke, VA, by facsimile on June 16, 17, and 21, 2004, and July 15, 2004. Firm initiated recall is complete.
REASON
Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
52 units.
DISTRIBUTION
PA, NJ, WV, VA, MD, GA, and D.C.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0227-5.
CODE
Unit K91415.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by telephone on July 28, 2004, and by letter dated August 4, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets. Recall # B-0228-5.
CODE
Unit K30461.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by telephone on May 12, 2004, and by letter dated June 8, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which clots were noted in the associated red blood cells unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets. Recall # B-0229-5.
CODE
Unit V07224.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by telephone on May 11, 2004, and by letter dated May 18, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which clots were noted in the associated red blood cells unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0230-5;
b) Recovered Plasma. Recall # B-0231-5.
CODE
a) and b) Unit KT22280.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Annandale, VA, by facsimile and letter dated June 11, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD and NJ.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0238-5;
b) Fresh Frozen Plasma. Recall # B-0239-5;
c) Recovered Plasma. Recall # B-0240-5.
CODE
a) Units 153971933, 153978224, and 150211210;
b) Unit 153971933;
c) Units 153978224 and 150211210.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by telephone and by letter dated October 22, 2003. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who had tested positive for hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
TX and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-0244-5;
b) Fresh Frozen Plasma. Recall # B-0245-5
CODE
a) and b) Unit 150250065.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by telephone on April 24, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was taking the medication Enbrel, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and MS.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0246-5.
CODE
Unit 150260048.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by telephone on June 16, 2004. Firm initiated recall is complete.
REASON
Platelets, with a positive bacterial culture, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0247-5.
CODE
Unit numbers 15022-1959 and 15022-2089.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX, by telephone on August 5, 2003. Firm initiated recall is complete.
REASON
Blood products, that initially tested negative for West Nile Virus (WNV), were subsequently re-tested and found reactive for WNV.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0249-5.
CODE
Unit number V08821.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter on June 7, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to use of the medication Vioxx, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Human tissue for transplantation of the following types:
Ground human bone, AlloPac. Recall # B-0251-5.
CODE
Part Code 10216050, lot numbers 045236-101 and 045236-106.
RECALLING FIRM/MANUFACTURER
AlloSource, Inc., Centennial, CO, by telephone on September 22, 2004. Firm initiated recall is complete.
REASON
Human tissue for transplantation was incorrectly tested for human immunodeficiency virus (HIV) in that the blood sample used for testing was hemodiluted.
VOLUME OF PRODUCT IN COMMERCE
2 lots.
DISTRIBUTION
MN and FL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0252-5.
CODE
Unit number 5480671.
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Eastern Maine Medical Center, Bangor, ME, by telephone on July 20, 2004, and by letter on July 27, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
ME.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0253-5.
CODE
Unit number 9030343.
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Scarborough, ME, by telephone on August 4, 2004, and by letter on August 10, 2004. 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
ME.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS , CLASS III

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0054-5;
b) Fresh Frozen Plasma. Recall # B-0055-5.
CODE
a) and b) Unit 12811-3944.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Albuquerque, NM, by telephone on April 21, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of von Willebrand's disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NM.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0150-5.
CODE
Unit 2050371.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter dated June 16, 2004. Firm initiated recall is complete.
REASON
Red Blood Cells, that may have contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Red Blood Cells, Autologous. Recall # B-0161-5.
CODE
Units 7502161, 7502163, 7502168.
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by telephone on October 31, 2003. Firm initiated recall is complete.
REASON
Blood products, not tested for HCV, HIV and HBV NAT, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OR.

_______________________________
PRODUCT
Source Plasma. Recall # B-0175-5.
CODE
Unit numbers CS0202560, CS0202955, CS0203442, CS0203770, CS0204006, CS0204618, and CS0204952.
RECALLING FIRM/MANUFACTURER
Westgate Biologicals, LLC, College Station, TX, by facsimile on February 19, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to recent surgery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-0187-5.
CODE
Unit 181424.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Austin, TX, by facsimile dated January 25, 2002. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor whose health history screening was inadequately documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Source Plasma. Recall # B-0212-5.
CODE
Unit number: 04HVAA2598  
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P, Harrisonburg, VA, by facsimile on May 5, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose medical history was not determined at the time of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0215-5.
CODE
Unit DSMMVC.
RECALLING FIRM/MANUFACTURER
International Bio-Resources, L.L.C., Tuscaloosa, AL, by facsimile on September 17, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-0216-5.
CODE
Unit DSMVTD.
RECALLING FIRM/MANUFACTURER
International Bio-Resources, L.L.C., Tuscaloosa, AL, by facsimile on September 10, 2003. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which a satisfactory arm inspection was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Platelets Pheresis, Irradiated Washed. Recall # B-0248-5.
CODE
Unit number 40P01173.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of America Region, Peoria, IL, by telephone on September 8, 2004. Firm initiated recall is complete.
REASON
Blood product that was possibly out of controlled storage for more than 30 minutes was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0250-5.
CODE
Unit number K36758.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by electronic mail on August 31, 2004. Firm initiated recall is complete.
REASON
Blood product, that was not properly quarantined after the donor of the product reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0256-5.
CODE
Unit 224310746.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on May 26, 2002. Firm initiated recall is complete.
REASON
Blood product, which was stored at unacceptable storage temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NV.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0257-5.
CODE
Unit 224304431.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on April 15, 2002. Firm initiated recall is complete.
REASON
Blood product, which was stored at unacceptable storage temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NV.

_______________________________
PRODUCT
Red Blood Cells Washed. Recall # B-0258-5.
CODE
Unit 224340812.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on September 22, 2002. Firm initiated recall is complete.
REASON
Blood product, which was stored at unacceptable storage temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NV.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Coherent brand DUO Diode Laser Systems. A Non-medical, class IV industrial materials processing machine. Recall # Z-0540-04.
CODE
The following Model---Serial Numbers (S/N) are affected: P/N 1024403---S/Ns 10026 Through 10088; P.V. , 4240/4475---S/Ns 2, 7, 3053, and 10002 through 10024; and P.V. ,4458 - S/Ns 10019, 10019, 10020, 10043, and 10052.
RECALLING FIRM/MANUFACTURER
Coherent, Inc, Santa Clara, CA, by letters on January 19, 2004. Firm initiated recall is ongoing.
REASON
Software problem that may cause unintended emission of laser radiation.
VOLUME OF PRODUCT IN COMMERCE
93 units.
DISTRIBUTION
NC, Canada, Germany, and Japan.

_______________________________
PRODUCT
a) HomeChoice and Yume Automated Peritoneal Dialysis Systems;
catalog numbers 5C4471, 5C4471R, T5C4441,T5C4441R.
Recall # Z-0188-05;
b) HomeChoice PRO and Yume Plus Automated Peritoneal Dialysis
Systems; catalog numbers 5C8310, 5C8310R, T5C8300, T5C8300R.
Recall # Z-0189-05.
CODE
All units that do not bear the CE marking.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Div., McGaw Park, IL, by letters on November 1, and 2, 2004. Firm initiated recall is ongoing.
REASON
The on/off power switch is not grounded as a separate component in the device, and can loosen from its housing, which may result in an electrical shock to the user.
VOLUME OF PRODUCT IN COMMERCE
23,00 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Safety Paracentesis Procedure Tray. Recall # Z-0190-05;
b) Custom Convenience Kit. Recall Z-0191-05.
CODE
a) Catalog # SPPT-100, Lot #?s A343633, A344897, A349218.
Catalog # SPPT-5F-10, Lot #?s A343629, A343630, A344898,
A347256. Catalog # SPPT-5F-7, Lot #?s A343631, A343632,
A347254, A349221;
b) Catalog # K09-00318FP, Lot # A348888. Catalog # K09-00378R,
Lot #?s A335890, A337933, A339213, A342799, A345077, A347860.
Catalog # K09-00946MP, Lot # A353710. Catalog # K09-01732HP,
Lot #?s A341495, A348992. Catalog # K09-03251TP,
Lot # A347976. Catalog # K09-05064D, Lot # A343197.
Catalog # K09-05218BP, Lot # A347495. Catalog # K09-05475DP,
Lot #?s A340512, A343609, A350138. Catalog # K09-05588C,
Lot # A342348. Catalog # K09-05604DP, Lot #A339243.
Catalog # K09-05608DP, Lot #?s A339690, A349600.
Catalog # K09-05894F, Lot # A342805.
Catalog # K09-07970A, Lot #?s A342665, A345567.
Catalog # K09-08150AP, Lot #A340352. Catalog # K09-90100T,
Lot # A353161. Catalog # K10-00091MP, Lot # A349569.
Catalog # K10-01684BP, Lot # A352021. Catalog # K10-02936CP,
Lot # A349696. Catalog # K10-03091B, Lot # A347572.
Catalog # K10-03237AP, Lot #?s A339280, A348945.
Catalog # K10-03247P, Lot # A347910. Catalog # K10-03256P,
Lot #?s A345788, A350183. Catalog # K10-03281P,
Lot #?s A346956, A348009. Catalog # K12-01191C,
Lot # A347022. Catalog # K12-01242P, Lot # A350194.
Catalog # K12-01304P, Lot #?s A346945, A349053, A350907.
Catalog # K12-01356P, Lot #?s A343540, A351436.
Catalog # K12-01372P, Lot #?s A343539, A346944.
Catalog # K12-01402P, Lot # A352329.
Catalog # K12-01427P, Lot # A352036.
Catalog # K12-01507P, Lot #?s A349066, A351446.
Catalog # K12-01512, Lot # A348216. Catalog # K12-01560,
Lot # A347564.
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by visit or telephone beginning October 18, 2004. Firm initiated recall is ongoing.
REASON
Merit Safety Paracentesis Procedure Trays and Merit Custom Convenience Kits contain Monoject Magellan safety needles which have been recalled by Tyco Healthcare. These needles may detach from their hub during use.
VOLUME OF PRODUCT IN COMMERCE
12,821 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
APL Valve used on some Fabius GS (Catalog number 4117110), Fabius Tiro (Catalog number 4118350) and Narkomed 6000 (Catalog number 4118070) series Anesthesia Machines. Recall # Z-0192-05
CODE
APL Valve part number MK00625.
RECALLING FIRM/MANUFACTURER
Draeger Medical Inc., Telford, PA, by letter on September 15, 2004. Firm initiated recall is ongoing.
REASON
Rotating knob of the rotary style APL valve can become separated from the assembly.
VOLUME OF PRODUCT IN COMMERCE
2,321 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Baxter Clearlink Intravenous (IV) Delivery System;
the system consists of solution sets, extension sets and
blood sets that have a luer activated valve for IV access,
which allows the administration of medications/solutions
with a needleless luer syringe. Recall # Z-0193-05;
b) Baxter Clearlink System Luer Activated Universal VIal
Adapter, product code 2N8395. Recall # Z-0194-05.
CODE
All lots of product code 2N8399, 1C8678, 1C8680, 1C8683,
1C8684, 1C8687, 1C8693, 1C8702, 1C8704, 1C8705, 1C8706,
1C8707, 1C8712, 1C8722, 1C8723, 1C8727, 2C0168, 2C6254,
2C6255, 2C6256, 2C7461, 2C7462, 2C8401, 2C8402, 2C8419,
2C8425, 2C8428, 2C8515, 2C8519, 2C8537, 2C8541, 2C8546,
2C8548, 2C8571, 2C8593, 2C8606, 2C8607, 2C8610, 2C8612,
2C8632, 2C8634, 2C8671, 2C8700, 2C8720, 2C8750, 2C8751,
2C8819, 2C8851, 2C8857, 2C8858, 2C8860, 2C8862, 2C8864,
2C8865, 2C8875, 2C8891, 2C8895, 2C8920, 2C8921, 2C8930,
2C8931, 2H7462, 2H7463, 2H8401, 2H8480, 2H8486, 2H8519,
2H8603, 2H8720, 2H8750, 2H8819, 2H8860, 2H8862, 2H8864,
2H8865, 2N8300, 2N8334, 2N8335, 2N8341, 2N8371, 2N8373,
2N8374, 2N8377, 2N8378, 2N9204K, 2N9205K, 3C0122, 3C0134,
3C0139, 3C0143, 3C0148, 3C0150, 3C0151, 3C0157, 3C0158,
3C0159, 3C0160, 3C0162, 3C0165, 4C8714, 4C8723, 4H8723;
b) Product code 2N8395, all lots.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL, by letter dated April 28, 2004. Firm initiated recall is ongoing.
REASON
Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the Clearlink needleless device.
VOLUME OF PRODUCT IN COMMERCE
29,492,8006 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
MX20170: Pediatric 40 In Sampling Kit w/10cc syringe, MX20443: LogiCal Single Pressure Kit, MX20470: Pressure Monitoring Kit, MX20477: LogiCal Double Kit, MX20730: Double LogiCal Kit, MX20760: Neonatal 18'' Add-On Kit, MX20822: TranStar Monitoring Set, MX4033: Kids Kit 18in (45.7cm) Add-on Blood Sampling Kit, MX4037: Kids Kit Add-On Blood Sampling Kit, MX700376: TranStar Triple Monitoring Kit, MX700377: Double TranStar Kit, MX7781R1: St Judes Secure Kit, MX8004CSTT: Novatrans Mtring Kit 60 (152.4cm) Single Line, MX8033T: Novatrans Kids Kit Neonatal Mtring, MX9502CSTT: TranStar 72in (183cm) Secure Double Kit, MX9504CSTT: TranStar 60in (152cm) Secure Monitoring Kit, MX9505CSTT: TranStar 84in (213) Secure Monitoring Kit, MX9506CSTT: TranStar 72in Secure Triple Kit, MX9533T: TranStar Kids Kit Neonatal Monitoring Kit, MX9534T: TranStar Kids Kit, MX9537T: TranStar Kids Kit, MX9602CSTA: LogiCal 72in (183cm) Secure Double Kit, MX9604CSTA: LogiCal 60in (152cm) Secure Monitoring Kit, MX9605CSTA: LogiCal 84in (213cm) Secure Monitoring Kit, MX9606CSTA: LogiCal 72in (183cm) Secure Monitoring Kit, MX9607CSTA: LogiCal Triple Secure Kit, MX9634A: LogiCal Kids Kit Neonatal Monitoring Kit, MX9637A: LogiCal Kids Kit Neonatal Monitoring Kit, SX02: Sterile Sample. Recall # Z-0198-05.
CODE
MX20170: Lot #'s 33D160090, 33J100011,34A12D017, 34D28D092. MX20443: Lot #'s 32J240054, 32K140054, 32L110056, 32L260051, 33A160015, 33B120027, 33B260040, 33C200060, 33D090064, 33D230066, 33E210102, 33E290113, 33F110010, 33G240058, 33H080024, 33I040010, 33J020029, 33J160008, 33J230033, 33K120027, 33L030054, 34B04D092, 34B16D019, 34B26D023, 34C11D001. MX20470: Lot 34A22D075. MX20477: Lot #'s 33D020091, 33K120026. MX20730: Lot #'s 33C050084, 33D110030, 33E010093, 33F030094, 33G030104, 34A12D137, 34C31D055. MX20760: Lot #'s 33C270065, 33I230822, 33K100055, 33K240050, 34A12D082, 34B26D099, 34C04D029. MX20822: Lot #'s 33I090048, 34A22D110. MX4033: Lot #'s 32L120073, 33A06143, 33A080077, 33B040079, 33C040104, 33C270062, 33D250039, 33E050044, 34B02D072, 34C08D038. MX4037: Lot #'s 33A080069, 33B110006, 33C270063, 33D220026, 33F020063, 33G080019, 33G230005, 33J140016, 34A26D108, 34C08D034. MX700376: Lot 33A2220390. MX700377: Lot #'s 33A2220392, 33A2920402. MX7781R1: Lot #'s 32L040106, 33H080048. MX8004CSTT: Lot 33K140086. MX8033T: Lot #'s 32L040021, 33B040050, 33H220097, 34B03D044. MX9502CSTT: Lot #'s 32K150075, 33A310026, 33G150105, 33K250018, 34B04D014. MX9504CSTT: Lot #'s 32J250089, 32L050045, 33A240034, 33B130060, 33C060003, 33D280078, 33F040042, 33H140037, 33H200018, 34A26D097. MX9505CSTT: Lot #'s 33D2322860, 34C22D067. MX9506CSTT: Lot 33L020058. MX9533T: Lot #'s 32K260078, 33A090065, 33C140050, 33E290013, 33H070093, 33I090014, 33K040033, 33L020068, 34A26D098, 34B25D049, 34C30D034, 34D27D047. MX9534T: Lot #'s 33A160085, 33B250064, 33D100061, 33F250042, 33H140048, 33J070023. MX9537T: Lot #'s 33A090071, 33B250065, 33D230022, 33F100153, 33G090033, 33H070089, 33I020046, 33J070024, 33K180032, 34A15D040, 34B04D022, 34B16D081, 34C03D039. MX9602CSTA: Lot #'s 32K150073, 33A240039, 33D160033, 33G090027, 33G230029. MX9604CSTA: Lot #'s 33A240037, 33A310028, 33C140029, 33D100058, 33F040040, 33L190038. MX9605CSTA: Lot #'s 32J310063, 32L270023, 33B250063, 33C140031, 33D100054, 33E290017, 33F100155, 33F250061, 33G300021, 33H140043, 33I300032, 33K180035, 33L190036, 34A26D089, 34B19D098. MX9606CSTA: Lot #'s 32L050050, 33A090069, 33A310031, 33C060008, 33C200010, 33D230031, 33E130048, 33F250040, 33G230030, 33H140044, 33I170051, 33K040035, 33K250040, 34A12D037, 34A26D083, 34B16D083, 34C03D040. MX9607CSTA: Lot #'s 32J300018, 33E050037, 33J280007, 34B02D043. MX9634A: Lot #'s 33A160083, 33A310034, 33C200011, 33D100072, 33E280100, 33G230025, 33I170052, 33K180034, 33L190040, 34A26D099, 34B25D046. MX9637A: Lot #'s 33A160084, 33B130050, 33D230021, 33E200059, 33F170096, 33K250042, 34A26D086, 34C03D036. SX02: Lot 33G080023.
RECALLING FIRM/MANUFACTURER
Medex, Inc., Dublin, OH, by letters on October 20 and 21, 2004. Firm initiated recall is ongoing.
REASON
Sampling port bodies on the device are cracking which can allow the sampling site to become dislodged from the body.
VOLUME OF PRODUCT IN COMMERCE
71,132 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) Terumo Advanced Perfusion System 1; 100V -120V, 15 A
(circuit breaker), 50/60 Hz (20A power source required);
Model 801763. Recall # Z-0208-05;
b) Terumo Advanced Perfusion System 1; 220V -240V, 7A
(circuit breaker), 50/60 Hz (10A power source required);
Model 801764. Recall # Z-0209-05.
CODE
All units bearing serial numbers 20 through 109.
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by service bulletin dated August 12, 2003. Firm initiated recall is ongoing.
REASON
The central control monitor screen may go blank during use because of a bad wiring connection in the wiring harness or a low voltage setting on the potentiometer.
VOLUME OF PRODUCT IN COMMERCE
90 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Deltec Cozmo Insulin Pump. Recall # Z-0210-05.
CODE
Pump Serial Numbers A20721; A20722; A20723; A20724; A20741; A20742.
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN, by telephone, on September 18, 2004. Firm initiated recall is ongoing.
REASON
The vibratory alarm motor installed in a small number of Deltec Cozmo Insulin Pumps may function intermittently.
VOLUME OF PRODUCT IN COMMERCE
36.
DISTRIBUTION
Nationwide and France.

_______________________________
PRODUCT
IR1200 Insulin Pump. IPX8 Rx only. Label P/N 400-125-00 Revision C. Recall # Z-0211-05.
CODE
Model IR 1200.
RECALLING FIRM/MANUFACTURER
Animas Corp., West Chester, PA, by letter dated September 28, 2004. Firm initiated recall is ongoing.
REASON
Suspend mode not functioning properly.
VOLUME OF PRODUCT IN COMMERCE
7,395 units.
DISTRIBUTION
Nationwide and Israel.
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
a) POLYSTAR, Angiographic X-Ray System, Model 1148902.
Recall # Z-0195-05;
b) POLYSTAR T.O.P., Angiographic X-Ray System,
Model Numbers 1148902 and 4784505. Recall # Z--0196-05.
CODE
a) Serial Numbers 01000 through 01267 and 02001 through 02117;
b) Serial Numbers for model 1148902: 01000 through 01267,
02001 through 02117. Serial numbers for model 4784505:
03001 through 035158, 04001 through 04136, and
05001 through 05098.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on September 23, 2004. Firm initiated recall is ongoing.
REASON
Orbital gears may exhibit excess wear.
VOLUME OF PRODUCT IN COMMERCE
125 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Tosoh brand AIA-PACK CA 19-9 Test Cup Set used in TOSOH AIA Immunoassay Analyzers, A pack contains 10 trays of 20 test cups, Catalog #: 020271, For IN VITRO Diagnostic Use. Recall # Z-0197-05.
CODE
Lot #: DX10789, Expiration Date 10/31/2004.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tosoh Biosience, Inc., South San Francisco, CA, by letters on October 30, 2004.
Manufacturer: Tosoh Corporation, Tokyo, Japan. Firm initiated recall is ongoing.
REASON
The Product may produce high reading in patient?s values, which may lead to inappropriate treatment.
VOLUME OF PRODUCT IN COMMERCE
22 boxes/10 trays of 20 test cups.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Medtronic CapSureFix Novus Lead Model 5076. Recall Z-0207-05.
CODE
Model 5076 45 cm leads (PJN631011V and PJN631012V).
RECALLING FIRM/MANUFACTURER
Medtronic Inc, Cardiac Rhythm Management, Fridley, MN, by letter on October 20, 2004. Firm initiated recall is ongoing.
REASON
A specific lot of leads are labeled incorrectly. The leads are 45 cm in length and labeled as 52 cm lead length.
VOLUME OF PRODUCT IN COMMERCE
35 leads.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS I

_______________________________
PRODUCT
Fort Dodge ProHeart 6 (moxidectin) Sustained Release Injectable for Dogs, Sterile Vehicle 17 ml. to be used to constitute moxidectin microspheres, 10% w/w moxidectin microspheres, packaged in 5- and 10-unit packs 20/5-packs per case and 10/10-packs per case, RX, NADA 141-189. Recall # V-004-5.
CODE
All lots within expiry.
RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories Inc, Fort Dodge, IA, by Talk Paper and Press Release on September 3, 2004, by letter on September 7, 8, 15, 17, 2004 and October 19, 2004. Firm initiated recall is ongoing.
REASON
FDA requested due to serious health concerns.
VOLUME OF PRODUCT IN COMMERCE
U.S.: 17,207/5/20-ml vial packs and 26,364/10/20-ml vial packs; Foreign: 19,971/10-ml vials; 43,357/20-ml vials; 300/5 packs & 80/10 packs.
DISTRIBUTION
Nationwide and Internationally.

END OF ENFORCEMENT REPORT FOR November 24, 2004

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