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U.S. Department of Health and Human Services

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Enforcement Report for April 21, 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 21, 2004
04-16

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Sterile Diluent for Humulin L, Humulin U and Lente Iletin, Lilly, 10 ml. Vial. Warning: Use ONLY with insulins listed on side panel. Recall # D-146-4.
CODE
Lot Number/Expiration Date: 7SD70P (09/01/04).
RECALLING FIRM/MANUFACTURER
Lilly, Eli & Co., Indianapolis, IN, by letter dated March 30, 2004. Firm initiated recall is ongoing.
REASON
Particulates: White particulates or white precipitate on vial wall which does not resuspend.
VOLUME OF PRODUCT IN COMMERCE
1,535 vials.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

_______________________________
PRODUCT
MD-Gastroview(, Diatrizoate Meglumine and Diatrizoate
Sodium Solution U.S.P., 367 mg/mL Organically Bound Iodine
for Gastrointestinal Radiography, 25 mL Bottle, Not for
Parenteral use, Rx Only. Recall # D-144-4.
CODE
Lot #E425A, Expiration Date: September 30, 2004.
RECALLING FIRM/MANUFACTURER
Tyco Healthcare, Raleigh, NC, by letter on March 25, 2004. Firm initiated recall is ongoing.
REASON
Product exceeds the Iodine/Iodide specification (9-month stability).
VOLUME OF PRODUCT IN COMMERCE
137 cases (3,425 bottles).
DISTRIBUTION
Nationwide, and Columbia, SA.

_______________________________
PRODUCT
Trihexyphenidyl Hydrochloride Tablets, USP, 5 mg, 1000
Tablet bottles, Rx only. Recall # D-145-4.
CODE
Lot #068062A, Exp. Date: 07/04;
Lot #123072A, Exp. Date: 07/04;
Lot #056013B, Exp. Date: 02/05.
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals, Inc., Charlotte, NC, by letters on January 20, 2004 and January 21, 2004. Firm initiated recall is complete.
REASON
Mislabeled; side panel of label incorrectly indicates that each tablet contains Trihexyphenidyl HCI 2 mg rather than correctly containing Trihexyphenidyl HCI 5 mg.
VOLUME OF PRODUCT IN COMMERCE
1,525 bottles.
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1094-4;
b) Platelets, Leukocytes Reduced. Recall # B-1095-4.
CODE
a) Unit numbers: 042J49705, 042R70778, 042FS80957;
b) Unit numbers: 042J49705, 042FS80957.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern Ohio Region, Cleveland, OH, by telephone on December 1, 2003, and by letter dated December 4, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
OH.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed. Recall # B-1113-4.
CODE
Unit number: 41LH49633.
RECALLING FIRM/MANUFACTURER
American Red Cross, Alabama Region, Birmingham, AL, by letters, dated May 9, 2002, and June 10, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1115-4.
CODE
Unit number: 4229211.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Inc., Indianapolis, IN, by telephone and by facsimile on February 27, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1117-4.
CODE
Unit number: 5155662.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by facsimile on July 12, 2001. 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
a) Red Blood Cells. Recall # B-1123-4;
b) Recovered Plasma. Recall # B-1124-4.
CODE
a) and b) Unit number 2276871.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by letter on March 28, 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
2 units.
DISTRIBUTION
TX and FL.

_______________________________
PRODUCT
Platelets Pheresis. Recall # B-1126-4.
CODE
Unit number: 2513823.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by facsimile on July 12, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to use of the drug Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.

_______________________________
PRODUCT
Source Plasma. Recall # B-1131-4.
CODE
Unit number 08093332.
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Columbus, OH, by letter dated January 8, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Allergenic Extracts Vials. Non-glycerin allergenic products
in 5 mL, 10 mL, and 50 mL vials. The name of the specific
extract is stated on the vial. 17 products include:
a) Acacia Golden;
b) Bahia Grass;
c) Cedar Mountain;
d) Cedar Red;
e) Elm American;
f) Maple, Hard/Sugar;
g) Mulberry Mix RW;
h) Pecan Tree;
i) Sagebrush, Mugwort;
j) Sheep Sorrel;
k) Walnut, Black;
l) AP Housedust Mix;
m) Alternaria tenuis;
n) Candida albicans;
o) Epicoccum nigrum;
p) PMG #4 Grass;
q) PMG Mite Mix.
Recall # B-1052-4.
CODE
a) Lot # A43C2180, exp. 7/01/2005;
b) Lot #s A43G3905 & A43C2299, exp. 7/01/2005;
c) Lot # A43D2458, exp. 7/01/2005;
d) Lot #s A43F3492, A4314533, A4314535, exp. 7/01/2005;
e) Lot #s A43A1158, A43J5006, A43B1876, A43G3710,
exp. 7/01/2005;
f) Lot #s A43C2295, A43J5010, exp. 7/01/2005;
g Lot #s A4314819, A43G3719, exp. 7/01/2005;
h) Lot #s A43C1976, A43F3351, A43B1633, exp. 7/01/2005
i) Lot # A43K5605, exp. 7/01/2005;
j) Lot #s A43F3340, A43D2376, exp. 7/01/2005;
k) Lot #s A4314645, A43F3359, A43E3131, exp. 7/01/2005;
l) Lot #s A43B1925, A43C2128, exp. 7/01/2005;
m) Lot #s A43E3130, A4314725, A43G3906, A43G3810,
A43G3812, A43E3133, exp. 7/01/2005;
n) Lot #s A43D2633, A43H4195, A43C2127, exp. 7/01/2005;
o) Lot #s A43G3707, A43J5339, A43E3203, A43A1469,
A4219616, exp. 7/01/2005;
p) Lot # G33G3807, exp. 7/01/2004;
q) Lot # G33G3805, exp. 7/01/2004.
RECALLING FIRM/MANUFACTURER
Hollister Stier Laboratories LLC, Spokane, WA, by letter dated March 12, 2004. Firm initiated recall is complete.
REASON
Misbranded Allergenic Extracts were distributed.
VOLUME OF PRODUCT IN COMMERCE
232 vials.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1119-4.
CODE
Unit number: KE98810.
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Dba BloodSource Sacramento, Sacramento, CA, by telephone on October 29, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1120-4.
CODE
Unit number: 41FT63166.
RECALLING FIRM/MANUFACTURER
American Red Cross, Alabama Region, Birmingham, AL, by telephone on March 13, 2002, and by letter, dated April 2, 2002. Firm initiated recall is complete.
REASON
Blood products, which were produced from a Whole Blood lacking phlebotomy documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-1125-4.
CODE
Unit number: 1633025.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by telephone on August 20, 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
TX.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1127-4;
b) Recovered Plasma. Recall # B-1128-4.
CODE
a) and b) Unit numbers: 5197872 and 6103177.
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood and Tissue Center, Austin, TX, by facsimile on September 9, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibody to hepatitis C virus (anti-HCV), but were collected from a donor that previously tested repeatedly reactive to anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX, Switzerland, and Austria.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
a) BD L-Cath NN (24ga x 30cm), L-Cath Catheter System.
Recall # Z-0783-04;
b) BD L-Cath EX (20ga x 15cm), L-Cath Catheter System.
Recall # Z-0784-04;
c) BD L-Cath EX (28ga x 20cm), L-Cath Catheter System.
Recall # Z-0785-04.
CODE
a) REF 384522, Lot numbers 2226035, 3274339, 3240808,
3294199, 3365138, 3220423, 3192307, 3073801;
b) REF 384703, Lot Number 3007152;
c) REF 384510, Lot Numbers 2158054, 2158055.
RECALLING FIRM/MANUFACTURER
Becton Dickinson Infusion Therapy, Sandy, UT, by telephone and letter on March 9, 2004. Firm initiated recall is ongoing.
REASON
Catheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion.
VOLUME OF PRODUCT IN COMMERCE
7,810 units.
DISTRIBUTION
Nationwide, Australia, Canada and Japan.

_______________________________
PRODUCT
a) Philips MX8000 IDT CT Scanner System, 10 & 16 slice
images. Recall # Z-0786-04;
b) Philips Brilliance CT Scanner System, 6, 10 & 16 slice
images. Recall # Z-0787-04.
CODE
a) Serial Numbers: 2501 to 2554; 3006; 3008 to 3337;
b) Serial Numbers: 2555 to 2568; 3335 to 3392; 9701 to
9725.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on March 8, 2004. Firm initiated recall is ongoing.
REASON
The CT couch may move downward to its lower limit without command.
VOLUME OF PRODUCT IN COMMERCE
453 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Transcranial Doppler Ultrasound System with 2 MHz Transducer: TCD 100M Digital Transcranial Doppler Ultrasound System & PMD 100 Digital Transcranial Doppler Ultrasound System (these systems are the same hardware and software - the change from TCD 100M to PMD 100 is a marketing change). Software version 1.3.0 Model numbers 10119, 10863, 10919, 10968, 11016, 11052, 11090, 11091, 11235, 11236. Recall # Z-0788-04.
CODE
Serial numbers 0001-0016, 0018-0035, 0037-0043, 0045-0048, 0050-0060, 0062-0064, 0066-0080, 0082-0157.
RECALLING FIRM/MANUFACTURER
Spencer Technologies, Inc., Seattle, WA, by letter dated February 17, 2004. Firm initiated recall is ongoing.
REASON
Potential for saved blood flow velocity values to not agree with actual velocity values as shown on the spectrogram axis.
VOLUME OF PRODUCT IN COMMERCE
147.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Bemis Two-Gallon Sharps Container, Models #102 020, #102 030, and #102 040. (The only difference between the models is in color. Model 102 040 is yellow, Model 102 020 is beige and Model 102 030 is red.). Recall # Z-0789-04.
CODE
Lot #20040001 and Lot #20040004.
RECALLING FIRM/MANUFACTURER
Bemis Manufacturing Co., Sheboygan Falls, WI, by letters dated February 25, 2004. Firm initiated recall is ongoing.
REASON
The closure flap of the recalled sharps containers have two tabs that fit into slots on the cover for final closure and locking but some of the covers have one of the tabs that will not fit into the designated slot because the slot is occluded with plastic.
VOLUME OF PRODUCT IN COMMERCE
1,290 containers (43 cases with 30 sharps containers per case).
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
a) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Length 54 cm, CS Wide
Tip Shape, CS-W, REF 6705. Recall # Z-0790-04;
b) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Length 44 cm, Coronary
Sinus - Multi-Purpose Tip Shape, CS-MP, REF 6716.
Recall # Z-0791-04;
c) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Length 49 cm, Coronary
Sinus - Multi-Purpose Tip Shape, CS-MP, REF 6717.
Recall Z-0792-04;
d) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Length 49 cm, Coronary
Sinus - Multi-Purpose Hook Tip Shape, CS-MPH, REF 6752.
Recall # Z-0793-04.
e) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Length 49 cm, Coronary
Sinus - Hook Tip Shape, CS-H, REF 6754. Recall Z-0794-
04;
f) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Length 49 cm, Coronary
Sinus - Multi-Purpose Long Tip Shape, CS-MPL, REF 6756.
Recall Z-0795-04;
g) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Length 49 cm, Coronary
Sinus - Amplatz 6.0 Tip Shape, CS-A6, REF 6758. Recall
# Z-0796-04;
h) Guidant Rapido 8 French Guiding Catheter, Inner Diameter
.087", 2.21 mm, Overall Length 54 cm, Coronary Sinus -
Extended Hook Tip Shape, CS-Extended H, REF 6778.
Recall # Z-0797-04;
i) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Length 54 cm, Coronary
Sinus - Multi-Purpose Tip Shape, CS-MP, REF 7300.
Recall # Z-0798-04;
j) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Length 54 cm, Coronary
Sinus - Multi-Purpose Hook Tip Shape, CS-MPH, REF 7369.
Recall # Z-0799-04;
k) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Length 54 cm, Coronary
Sinus - Hook Tip Shape, CS-H, REF 7438. Recall # Z-
0800-04;
l) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Length 54 cm, Coronary
Sinus - Multi-Purpose Long Tip Shape, CS-MPL, REF 7507.
Recall # Z-0801-04;
m) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Lenght 54 cm, Coronary
Sinus - Amplatz 6.0 Tip Shape, CS-A6, REF 7576. Recall
Z-0802-04;
n) Guidant EasyTrak 8 French Guiding Catheter, Inner
Diameter .087", 2.21 mm, Overall Length 54 cm, Coronary
Sinus - Amplatz 6.0 Tip Shape, CS-A6, REF 7576. Recall #
Z-0803-04;
o) Guidant Rapido 8 French Guiding Catheter, Inner Diameter
.087", 2.21 mm, Overall Lenght 54 cm, Coronary Sinus -
Extended Hook Right Tip Shape, CS-EH R, REF 7592. Recall
# Z-0804-04;
p) Guidant Rapido 8 French Guiding Catheter, Inner Diameter
.087", 2.21 mm, Overall Length 54 cm, Coronary Sinus -
Extended Hook Right Tip Shape, CS-EH R, REF 7592.
Recall # Z-0805-04;
q) Guidant Rapido 8 French Guiding Catheter, Inner Diameter
.087", 2.21 mm, Overall Length 54 cm, Coronary Sinus -
Extended Hook Straight Right Tip Shape, CS-EH ST R, REF
7593. Recall # Z-0806-04.
CODE
a) Lots 4012251, 4012451, 4012851, 4012951, 4020451,
4021951, and 4022551;
b) Lot 4021651;
c) Lots 4011451, 4012451, 4012951, 4020451, 4021151,
4021751, 4021951, 4022351, and 4022551;
d) Lots 4012451, 4020651, 4021651, and 4021951;
e) Lots 4012051, 4020551, 4020551, 4021151, 4022151,
4022151, and 4022551;
f) Lots 4012851, 4021151, 4021751, 4021951 and 4022351;
g) Lots 4012151, 4012251, 4021951, and 4022151;
h) Lots 4011251, 4012151, 4012451, 4012951, 4020551,
4021051, 4021851, and 4021851;
i) Lots 4011451, 4012151, 4012451, 4020451, 4020651,
4021251, 4021751, 4022351, and 4022551;
j) Lots 4011251, 4012151, 4012851, 4020551, 4020651,
4022151, and 4022551;
k) Lots 4011251, 4012151, 4012851, 4020551, 4020651,
4021651, 4021851, 4021951, and 4022551;
l) Lots 4020551, 4021151, 4021251, and 4022551;
m) Lots 4012151, 4012451, 4012451, 4020451, 4020651,
4021851, and 4022151;
n) Lots 4012151, 4012451, 4012451, 4020451, 4020651,
4021851, and 4022151;
o) Lots 4011451 and 4020551;
p) Lots 4011451 and 4020551;
q) Lots 4012051, 4012851, 4021651, 4022151, and 4022351.
RECALLING FIRM/MANUFACTURER
Guidant Corp-Cpi Division, Saint Paul, MN, by visit starting on March 11, 2003. Firm initiated the recall is ongoing.
REASON
The terminal hub component in some of the catheters has an unintended abrupt transition between the entry port and the catheter lumen which can result in difficulty introducing or removing delivery system components during lead placement.
VOLUME OF PRODUCT IN COMMERCE
2,090 catheters.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) One-level Ant-Cer Plates (Assembly Level). 1706-1024,
1706-1026, 1706-1028, 1706-1030, 1706-1032, and product
literature. Recall # Z-0807-04;
b) 1757-1: Compressor/Distractor Instrument (aka Plate
Distractor Forceps), and product literature. Recall #Z-
0808-04.
CODE
All lots on the market.
RECALLING FIRM/MANUFACTURER
Spinal Concepts, Inc., Austin, TX, by telephone on March 1, 2004 and by letter on March 5, 2004. Firm initiated recall is ongoing.
REASON
Design has insufficient articulating distance between the two component plates to prevent disassociation in vivo.
VOLUME OF PRODUCT IN COMMERCE
87
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes. Recall # Z-0809-04.
CODE
Lot numbers: 1548942, 1548943, 1548944, 1548947, 1548948, 1548949, 1548950, 1553246, 1553248, 1553251, 1553252, 1553254, 1553259, 1553261, 1553262, 1553265, 1553266, 1553268, and 1553269.
RECALLING FIRM/MANUFACTURER
Centerpulse Orthopedics, Inc., Austin, TX, by telephone and letters on September 30, 2003 and by letter on March 8, 2004. Firm initiated recall is ongoing.
REASON
Complaints of acetabular shell disassociating with the bone.
VOLUME OF PRODUCT IN COMMERCE
145 units.
DISTRIBUTION
CA, DC, MD, LA, ID, and WA.

_______________________________
PRODUCT
Magnum II Bariatric Patient Care System. Recall # Z-0810-04.
CODE
Serial No. FTxxxxxx (where xxxxxx is a 6-digit number sequence).
RECALLING FIRM/MANUFACTURER
Hill-Rom Manufacturing, Inc, Charleston, SC, by letter on March 9, 2004. Firm initiated recall is ongoing.
REASON
Bed may pose a health hazard due to:
a) Inability to articulate the frame during transport;
b) Exposed sharp edge of footplate;
c) Shear point between seat section and lymph panel and
d) Patient fall.
VOLUME OF PRODUCT IN COMMERCE
1,424 units.
DISTRIBUTION
Nationwide and Canada.

_______________________________
PRODUCT
CryoValve, Pulmonary Valve and Conduit. Model # PV00.
Donor #69347. Recall # Z-0814-04.
CODE
Serial #8022177.
RECALLING FIRM/MANUFACTURER
Cryolife, Inc., Kennesaw, GA, by telephone on January 30, 2004. Firm initiated recall is complete.
REASON
CryoLife was notified by the Tennessee Department of Health, that a recipient had contracted a Group A Streptococcus infection from orthopedic tissue originating from the same donor as CryoLife donor 69347.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.

_______________________________
PRODUCT
a) Bacchus brand Trellis(tm) Plus, Peripheral Infusion
System, 6.0 Fr Catalog Numbers: BAC TRR 006 140 10, BAC
TRR 006 140 20. Recall # Z-0816-04;
b) Bacchus brand Trellis(tm) Reserve, Peripheral Infusion
System, 6.0 Fr Catalog Numbers: BAC TRE 06 100 10, BAC
TRE 06 100 20, BAC TRE 06 140 10, BAC TRE 06 140 20.
Recall # Z-0817-04.
CODE
a) Lot Numbers: M02-50216, M02-50217, M02-50219, M02-50220,
M02-50227, M02-50228, P02-30014, P02-30013;
b) Lot Numbers: M02-50380, M02-50381, M02-50382, P03-30000,
P03-30006, P03-30007, P03-30010, P03-30011, P03-30012,
P03-30014, P03-30019, P03-30030, P03-30031, P03-30032,
P03-30035, P03-30036, P03-30037, P03-30041, P03-30043,
P03-30045, P03-30051, P03-30052, P03-30053, P03-30055,
P03-30056, P03-30059, P03-30061, P03-30062, P03-30063,
P03-30067, P03-30069, P03-30071, P03-30072, P03-30073,
P03-30076, P03-30077, P03-30078, P03-30079, P03-30080,
P03-30081, P03-30085, P03-30086, P03-30087, P03-30088,
P03-30091, P03-30093, P03-30095, P03-30096, P03-30100,
P03-30101, M03-50338, M03-50339, P03-30107, P03-30108,
P03-30113, P03-30114.
RECALLING FIRM/MANUFACTURER
Bacchus Vascular, Inc., Santa Clara, CA, by telephone and/or visit on November 24, 2003. Firm initiated recall is ongoing.
REASON
The device has the potential for fractures at the distal end during use.
VOLUME OF PRODUCT IN COMMERCE
1,260 units.
DISTRIBUTION
Nationwide and Internationally.
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Medex 3000 Series Syringe Infusion Pumps.
Recall # Z-0813-04.
CODE
Model numbers: 3010 (General use pump for use with 3cc to 60cc syringes, 3010a (Pump for use with 1 cc to 60cc syringes), 3010aE (Use with 1cc to 60cc syringes in UK), 3010aVX (Evaluation pump for use with 1cc to 60cc syringes), 3010aZE (Refurbished pump for use with 1cc to 60cc syringes), 3010E (Pump for use with 3-60cc used in the UK), 3010SD (Model 3010 pump used for demonstrations), 3010VX (Evaluation pump for use with 3-60cc syringes), 3010E, 3500 (Pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits), 3500BC (Not currently in distribution, 3500E (Pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits used I the UK), 3500G (Pump with face plates and software for rapid occlusion detection and upper and lower programmable infusion dose limits in the German language), 3500SD (Model 3500 pump used for demonstrations, 3500VX (Evaluation pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits.
RECALLING FIRM/MANUFACTURER
Medex, Inc., Duluth, GA, by letter starting on February 2, 2004. Firm initiated recall is ongoing.
REASON
Inadequate warning label: It is possible for an Extracorporeal Membrane Oxygenation (ECMO) circuit to generate high negative pressures on the inlet side.
VOLUME OF PRODUCT IN COMMERCE
7,896 units.
DISTRIBUTION
Nationwide, China, Hong Kong & UK.

_______________________________
PRODUCT
Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R. Recall # Z-0815-04.
CODE
Lot 0402000017.
RECALLING FIRM/MANUFACTURER
Medtronic Perfusion Systems, Brooklyn Park, MN, by letter on March 25, 2004. Firm initiated recall is ongoing.
REASON
An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product.
VOLUME OF PRODUCT IN COMMERCE
132 units.
DISTRIBUTION
FL, IA, LA, ME, MN, and NY.
 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS II

______________________________
 

PRODUCT
Custom dairy cattle feed made for two customers. Recall # V-123-4.
CODE
None.
RECALLING FIRM/MANUFACTURER
Maribel Grain Co., Maribel, WI, by visit on February 25, 2004. Firm initiated recall is complete.
REASON
Possible cross contamination of cattle feed by steamed bone meal which is prohibited material.
VOLUME OF PRODUCT IN COMMERCE
2,040 pounds.
DISTRIBUTION
WI.
______________________________
PRODUCT
Suppressor( brand Flunixin Meglumine Injection 50 mg/mL in 100mL & 250mL bottles for animal use only. Recall # V-125-4.
CODE
All codes (NADA # 200-124).
RECALLING FIRM/MANUFACTURER
Walco International, Inc., Ceres, CA, by letters on March 16, 2004 and March 17, 2004. FDA initiated recall is ongoing.
REASON
The animal drug product is mistakenly labeled with route of administration as "IM or IV," it is for IV use only and is likely to cause violative residues if used as IM.
VOLUME OF PRODUCT IN COMMERCE
Bottles are labeled at sale (upon filling client's order).
DISTRIBUTION
CA.

_______________________________
PRODUCT
B & G Seed Co., PIG GROWER, 50 lbs. Recall # V-126-4.
CODE
All.
RECALLING FIRM/MANUFACTURER
B & G Seed Company, Inc., Hull, GA, by telephone on March 30, 2004. Firm initiated recall is ongoing.
REASON
Feed contains meat & bone meal (prohibited material), without the mandatory ruminant warning on the label.
VOLUME OF PRODUCT IN COMMERCE
25/50 lb. bags.
DISTRIBUTION
GA.
 

RECALLS AND FIELD CORRECTIONS: VETERINARY MEDICINE - CLASS III

______________________________
PRODUCT
Dexium 0.25 mg Dexamethasone Tablets, 1000 tablets/bottle. Recall # V-124-4.
CODE
Lot 22060004.
RECALLING FIRM/MANUFACTURER
Bimeda, Inc., Le Sueur, MN, by letter on February 24, 2004. Firm initiated recall is ongoing.
REASON
Failure to meet USP dissolution requirements during product stability testing.
VOLUME OF PRODUCT IN COMMERCE
606 bottles, 1000 tablets/bottle.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR APRIL 21, 2004

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