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U.S. Department of Health and Human Services

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Enforcement Report for April 28, 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.


April 28, 2004
04-17

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Tuna noodle casserole. Product is packed in aluminum tray
with styrene lid, labeled and frozen. Product is packed in
11 oz. and 2 lb. packages. Product labeling states "TUNA
NOODLE (Serves 2-4) KEEP REFRIGERATED. MAY BE FROZEN."
Recall # F-186-4.
CODE
Julian code for date of manufacture is used, no year designation.
RECALLING FIRM/MANUFACTURER
Pasta & Co., Seattle, WA, by visit on February 4, 2004. FDA initiated recall is complete.
REASON
The product contained undeclared eggs.
VOLUME OF PRODUCT IN COMMERCE
1,939 approx.
DISTRIBUTION
WA.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
DURAGESIC 75 ug/h CII (FENTANYL TRANSDERMAL SYSTEM), 75
ug/h fentanyl and 0.3 mL alcohol USP, 75 mcg patches,
Rx only. Recall # D-134-4.
CODE
Lot Numbers: 0327192, 0327193, 0327294, 0327295, and 0330362.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Janssen Pharmaceutica Products, L.P., Titusville, NJ, by press release and letters on February 16, 2004, Dear Physician letters on March 12, 2004 and Dear Pharmacist letters on March 15, 2004.
Manufactured by: Alza Corporation, Mountain View,
CA. Firm initiated recall is ongoing.
REASON
Defective Container: Due to a seal breach on one edge of the system, product has the potential to release higher or too little medication than intended amount.
VOLUME OF PRODUCT IN COMMERCE
438,888 patches/2,043,364 patches.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS I

_______________________________
PRODUCT
Human Cornea Tissue. Recall # B-0772-4.
CODE
Number 03-0668-100 and 03-0668-200.
RECALLING FIRM/MANUFACTURER
Rocky Mountain Lions Eye Bank, Aurora, CO, by telephone and by letter dated May 16, 2003. Firm initiated recall is complete.
REASON
Human tissues for transplantation, procured from a donor who tested negative for antibody to hepatitis C virus (anti-HCV), but was subsequently found to have tested positive for the hepatitis C virus by PCR testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
CO and Mexico.

_______________________________
PRODUCT
Human Cornea Tissues for Transplantation. Recall # B-0984-4.
CODE
Unit numbers: 2003-12-6013 and 2003-12-6014.
RECALLING FIRM/MANUFACTURER
Heartland Lions Eye Banks, Columbia, Missouri, by telephone on February 4, 2004, and by letter dated February 4, 2004. Firm initiated recall is complete.
REASON
Human corneas were distributed from a donor who tested
reactive for HCV (antibody and PCR), and the likely cause
was a mix-up of samples at the recalling firm.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
Kansas and Greece.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_____________________________
PRODUCT
Recovered Plasma. Recall # B-1075-4.
CODE
Unit 20LN16611.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Lewis and Clark Region, Boise, ID, by fax on December 17, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who is considered at increased risk of exposure to Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_____________________________
PRODUCT
Red Blood Cells, Leucocytes Removed. Recall # B-1088-4.
CODE
Unit 042GE06541.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone and letter on December 16, 2003.Firm initiated recall is complete.
REASON
Blood product, collected from a donor who disclosed travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.

________________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1148-4;
b) Recovered Plasma. Recall # B-1149-4.
CODE
a) and b) Unit number 0427300.
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by facsimile on November 6, 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 new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KS and Switzerland.

_______________________________
PRODUCT
Source Plasma. Recall # B-1151-4.
CODE
Unit number 01GMID0777.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Walker, MI, by facsimile on February 7, 2003. Firm initiated recall is complete.
REASON
Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Source Plasma. Recall # B-1152-4.
CODE
Unit numbers 01GMIE8556, 01GMIE5683, 01GMID1586, 01GMIC5645, 01GMIE3993, 01GMIF9041, and 01GMIA3370.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Walker, MI, by facsimile on February 4, 2003. Firm initiated recall is complete.
REASON
Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced. Recall # B-1154-4.
CODE
Unit numbers 22FS16537, 22KJ92301, 22KR96133, 22KW51632, and 22LV93955.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on October 21, 2003, and by letter on October 30, 2003. Firm initiated recall is complete.
REASON
Blood products that failed to meet the minimum specification for product volume were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1155-4.
CODE
Unit number 2516311.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by letter on February 20, 2002. Firm initiated recall is complete.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1156-4;
b) Platelets Pheresis, Leukocytes Reduced.
Recall # B-1157-4;
c) Platelets Pheresis, Leukocytes Reduced Irradiated.
Recall # B-1158-4;
d) Recovered Plasma. Recall B-1159-4.
CODE
a) Unit number 1700904;
b) Unit numbers 2514413, 2514571, 2514758, 2515054,
2515350, 2515616, 2516353, 2518161, 2518481, 2519479,
2519933, 2520165, 2520555, 2520793, 2521271, 2521724,
2525425, and 2525628;
c) Unit numbers 2515908 and 2518918;
d) Unit number 1700904.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by facsimile on August 27, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
TX, FL, and DC.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Source Plasma. Recall # B-1150-4.
CODE
Unit number GPFWSF.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Flint, MI, by letter on December 10, 2003. 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
NC.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1153-4.
CODE
Unit number 18FT84951.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on February 4, 2004. Firm initiated recall is complete.
REASON
Blood product, that did not have the additive solution included, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
a) Medtronic Micro Jewel II Implantable Cardioverter
Defibrillators, Model 7223Cx. Recall # Z-0811-04;
b) Medtronic GEM DR Implantable Cardioverter
Defibrillators, Model 7271. Recall # Z-0812-04.
CODE
a) Manufacturing dates from November 1996 to December 1997;
and Use Before Dates from May 1998 to June 1999;
b) Manufacturing Dates from May 1997 to August 1998; and
Use Before Dates from November 1998 to February 2000.
RECALLING FIRM/MANUFACTURER
Medtronic Inc., Cardiac Rhythm Management, Fridley, MN, by letter on April 5, 2004. Firm initiated recall is ongoing.
REASON
Some of the devices with suspect capacitors (high voltage capacitors associated with prior notifications in 1999 and in 2000) have had unexpected charge circuit time-outs or charge circuit inactive conditions as the battery voltage nears the level for Elective Replacement of the devices.
VOLUME OF PRODUCT IN COMMERCE
6,200 defibrillators.
DISTRIBUTION
Nationwide and Internationally.
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
DUO Laser System, Class IV laser diode material processing machine. Recall # Z-0540-04.
CODE
Not supplied.
RECALLING FIRM/MANUFACTURER
Coherent, Inc., Santa Clara, CA, by representative visit on or before April 2, 2004. Firm initiated recall is complete.
REASON
Unintended emission of laser radiation.
VOLUME OF PRODUCT IN COMMERCE
95.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Stat Profile Critical Care Xpress (CCX) Analyzer.
Catalog Number: 35942. Recall # Z-0826-04;
b) Stat Profile Critical Care Xpress CCX+ Analyzer.
Catalog Number: 37413. Recall # Z-0827-04;
c) Stat Profile Critical Care Xpress CCX (R) Analyzer.
Catalog Number: 37562 R=Refurbished. Recall # Z-0828-04;
d) Stat Profile Critical Care Xpress CCX+(R) Analyzer.
Catalog Number: 37555 R=Refurbished. Recall # Z-0829-04;
e) ABG Replacement Pump Assembly Catalog Number: 37092.
Recall # Z-0830-04.
CODE
a) Domestic S/N: Y01C03200 Y01C03130 Y01104030 Y01104040
Y01104100 Y01104110 Y01304150 Y01304120 Y01104150
Y01104130 Y01104050 Y01104190 Y01104160 Y01104220
Y01204020 Y01204100 Y01204010 Y01204130 Y01204150
Y01204160 Y01703120 Y01304040 Y01304010 Y01304110
International S/N: Inst. S/N Y01204200 Y01304030
Y01304130 Y01304140 Y01304090 Y01304100 Y01104140
Y01204070 Y01204170 Y01104120 Y01C03150;
b) Domestic Serial Numbers: Y02C03170 Y02C03140 Y02C03180
Y02104060 Y02104180 Y02104070 Y02104210 Y02104080
Y02204180 International S/N: Y02204030 Y02204040
Y02204050 Y02204110 Y02204120 Y02204140 Y02204190
Y02304020 Y02C03190 Y02C03160 Y02C03090 Y02204060
Y02C03070 Y02304050 Y02C03050 Y02104090 Y02104230
Y02104170 Y02104020 Y02304070;
c) Serial Numbers: Inst. S/N Y01902211 Y01203021 Y01B02101;
d) Domestic S/N: Y02902141 Y0290211Z Y02103141 Y02303101
Y02503281 International S/N: Y02603111 Y02603091;
e) Devices shipped between March 30-31, 2004.
RECALLING FIRM/MANUFACTURER
Nova Biomedical Corporation, Waltham, MA, by telephone and letter on March 31, 2004. Firm initiated recall is ongoing.
REASON
Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems.
VOLUME OF PRODUCT IN COMMERCE
73 units.
DISTRIBUTION
Nationwide and International.

_______________________________
PRODUCT
a) Henry Schein (r) Product Code/Mfr. Part Code 101-0913
Explorer #2 D/E. Made in China. For professional use
Only. Instruments must be cleaned and sterilized prior
to use. This product is a dental explorer made of
stainless steel packaged individually within a sleeve
and containing a cardboard insert (labeling). 510 (k)
exempt, Class I device, Device Listing #B057701.
Recall # Z-0832-04;
b) Henry Schein (r) Product Code/Mfr. Part Code 100-3620
Explorer-Single End #23 SE. Made in China. For
professional use only. Instruments must be cleaned and
sterilized prior to use. This product is a dental
explorer made of stainless steel packaged individually
within a sleeve and containing a cardboard insert
(labeling). 510 (k) exempt, Class I device, Device
Listing #B057701. Recall # Z-0833-04;
c) Henry Schein (r) Product Code/Mfr. Part Code 100-8008
Explorer-Double End #5. Made in China. For professional
Use only. Instruments must be cleaned and sterilized
prior to use. This product is a dental explorer made of
stainless steel packaged individually within a sleeve
and containing a cardboard insert (labeling). 510 (k)
exempt, Class I device, Device Listing #B057701.
Recall # Z-0834-04;
CODE
a) Date Codes/Lot Numbers: 1102, 0103 (1102 represents
November 2002, & 0103 represents January 2003);
b) Date Codes/Lot Numbers: 1102, 1202, 0103 (1102
represents November 2002, 1202 represents December 2002,
&& 0103 represents January 2003), Product Code/Mfr. Part
Code 100-3620;
c) Date Codes/Lot Numbers: 0902, 1202, 0103 (0902
represents September 2002, 1202 represents December
2002, && 0103 represents January 2003), Product
Code/Mfr. Part Code 100-8008.
RECALLING FIRM/MANUFACTURER
Hu-Friedy Mfg., Co., Inc., Chicago, IL, by telephone on March 29, 2004, and by letter on April 2, and April 5, 2004. Firm initiated recall is ongoing.
REASON
The tips of the instruments may have been improperly heat treated and have the potential for unexpected tip fracture.
VOLUME OF PRODUCT IN COMMERCE
30,534 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Gyrus PlasmaKinetic Super Pulse Generator is a micro-computer based radio frequency generator with electrical and software components made of biocompatible materials for medical applications. Recall # Z-0841-04.
CODE
Model 744000.
RECALLING FIRM/MANUFACTURER
Gyrus Medical, Inc., Maple Grove, MN, by letter on December 5, 2003. Firm initiated recall is ongoing.
REASON
The generator may malfunction when used in close proximity to a monopolar generator.
VOLUME OF PRODUCT IN COMMERCE
14.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Boston Scientific MEDI-TECH***VASCULAR DILATOR***Order No./REF:48-151 M001481510, 5 Fr. Product in clear plastic pouch. Recall # Z-0842-04.
CODE
929123, Exp. 12/2006.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corp., Glens Falls, NY, by letter dated April 2, 2004 flagged as an addendum to a letter dated March 18, 2004. Firm initiated recall is ongoing.
REASON
Product labeled at Vascular Dilator Set 5 Fr contains 5 dilators ranging from 6 Fr to 14 Fr.
VOLUME OF PRODUCT IN COMMERCE
43 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Suction Instrument with Tubing, Catalog No. 302.
Instrument: Yankauer without Vent. *Tubing: 6" x 1/4" I.D.
Non-Conductive. Sterile, Single Use, Latex Free. Rx
ONLY. Packaged and Sterilized in the U.S.A. *Tubing Made
in Mexico. Classification Name: Unit, Suction Operatory.
Class I device, 510(k) exempt, Device Listing Number
A715729. Product comprises 2 components: a Yankauer made
from K-Resin and tubing made from PVC. Each instrument
is packed in a flexible packaging comprising Tyvek(R)
and plastic film. There are 20 units per shipping
carton. Recall # Z-0843-04;
b) Suction Instrument with Tubing, Catalog No. 303.
Instrument: Yankauer with Vent. *Tubing: 6" x 1/4" I.D.
Non-Conductive. Sterile, Single Use, Latex Free. Rx
ONLY. *Tubing Made in Mexico. Classification Name:
Unit, Suction Operatory. Class I device, 510 (k) exempt,
Device Listing Number A715729. Product comprises 2
components: a Yankauer made from K-Resin and tubing made
from PVC. Each instrument is packed in a flexible
packaging comprising Tyvek(R) and plastic film. There
are 20 units per shipping carton. Recall # Z-0844-04;
c) Suction Instrument with Tubing, Catalog No. 305.
Instrument: Yankauer without Vent. *Tubing: 10" x 1/4"
I.D. Non-Conductive. Sterile, Single Use, Latex Free. Rx
ONLY. Classification Name: Unit, Suction Operatory.
Class I device, 510 (k) exempt, Device Listing Number
A715729. Product comprises 2 components: a Yankauer made
from K-Resin and tubing made from PVC. Each instrument
is packed in a flexible packaging comprising Tyvek(R)
and plastic film. There are 20 units per shipping
carton. Recall # Z-0845-04.
CODE
a) Lots: 0020404, 0020421, 0020539, 0020567, 0020578,
0020578, 0020641, 0020933, 0020982, 0021060, 0021067,
0021262, 0021366, 0022027, 0120089, 0120146, 0120217,
0120285, 0120342, 0120427, 0120491, 0120626, 0120697,
0120753, 0120866, 0120968, 0121063, 0121172, 0121403,
0220079, 0220201, 0220305, 0220348, 0220424, 0220474,
0220509, 0220522, 0220673, 0220683, 0220847, 0220927,
0220956, 0320185, 0320194, 0320208, 0320243, 0320267,
0320335, 0320343, 0320391, 0320392, 0320412, 0320438,
0320438, 0320485, 0320504, 0320536, 0320558, 0320582,
0320609, 0320642;
b) Lots: 0020337, 0020564, 0020577, 0020642, 0020897,
0020961, 0020986, 0021349, 0021367, 0021414, 0120065,
0120218, 0120394, 0121062, 0121169, 0121225, 0121414,
0220162, 0220213, 0220436, 0220510, 0220596, 0220970,
0221058, 0320169, 0320180, 0320205, 0320410, 0320660,
0321116, 0321180, 0321204;
c) Lots: 0020491, 0020510, 0020607, 0021386, 0120147,
0120211, 0120265, 0120377, 0120585, 0120904, 0121194,
0121312, 0220006, 0220200, 0220302, 0220550, 0220779,
0220925, 0221006, 0320104, 0320179, 0320230, 0320408,
0320556, 0320680, 0320973.
RECALLING FIRM/MANUFACTURER
Busse Hospital Disposables, Hauppauge, NY, by letters on April 13, 2004. Firm initiated recall is ongoing.
REASON
Firm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a slower rate of suction.
VOLUME OF PRODUCT IN COMMERCE
292,840 units.
DISTRIBUTION
Nationwide and Internationally.
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
ARCHTECT System RS-232 Manual, product list number 06F71-
04, for the ARCHITECT i2000 Processing Module and the
ARCHITECT C8000 Processing Module. Recall # Z-0818-04.
CODE
The RS-232 Manual is not controlled by control or lot numbers.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on March 23, 2004. Firm initiated recall is ongoing.
REASON
When using a LIS the software system will send up a test result of up to 20 characters although the field is set to display only 15 characters per the RS-232 Manual.
VOLUME OF PRODUCT IN COMMERCE
101.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
AEROSET Analyzer System, Model 9D05-01. Recall # Z-0846-04.
CODE
All Serial Numbers.
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on March 22, 2004. Firm initiated recall is ongoing.
REASON
Change of level 3 error log messages to level 1 to prevent suspect assay results.
VOLUME OF PRODUCT IN COMMERCE
656 systems.
DISTRIBUTION
Nationwide and Internationally.
 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

_______________________________
PRODUCT
Cloverbelt 38% (38% protein concentrate for use in animal feed) in bulk. Recall # V-127-4.
CODE
The recall product is a bulk feed commingled in a bin prior to sale - no lot number.
RECALLING FIRM/MANUFACTURER
Cloverbelt Lumber & Feed Co., Conrath, WI, by telephone on February 23, 2004. Firm initiated recall is complete.
REASON
Possible cross contamination of the 38% protein concentrate with prohibited material (bone meal).
VOLUME OF PRODUCT IN COMMERCE
18 tons.
DISTRIBUTION
WI.

END OF ENFORCEMENT REPORT FOR APRIL 28, 2004

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