Enforcement Report

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

rule

January 19, 2005
05-03

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
Assi Brand Dried Sweet Potato, 1 lb, packaged in clear view plastic bag. Product of China. Recall # F-136-5.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Rhee Brothers Incorporated, Columbia, MD, by press release on October 5, and October 6, 2004. Firm initiated recall is complete.
REASON
Imported product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
971 cases.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

_______________________________
PRODUCT
NeoPICC 1.9 FR Catheter. Percutaneous Implanted long term intravascular catheter. Product is shipped in cases of 5 units. Catalog numbers S1PIC1-9-S, S1PIC1.9-N, S1PIC1.9-SMK, and S1PIC1.9-C. Recall # Z-0349-05.
CODE
All lots higher than number 3231.
RECALLING FIRM/MANUFACTURER
Arrow International, Inc., Reading, PA, by letters dated November 23, 2004 and December 7, 2004 and by press release on December 3, 2004. Firm initiated recall is ongoing.
REASON
Complaints of vessel erosion when using this product.
VOLUME OF PRODUCT IN COMMERCE
36,340 units.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

*****CORRECTION*****
Recall # Z-0263-05, from Enforcement Report dated December 15, 2004, Product was described as "Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotropin (HCG) test system." The correct product description is "Immulite 2500 Automated Immunoassay Analyzer, Homocysteine (HCY) test system."

From Enforcement Report dated December 22, 2004,
PRODUCT: Baxter System 1000 Single Patient Hemodialysis
Delivery System, Model SYS1000; all series 1000 instruments
labeled as System 1000. AltraTouch 1000, Baxter Tina and
Baxter Aurora; Recall # Z-0274-05. The correct Recall
number is Z-0395-05.
_______________________________
PRODUCT
a) Spinbrush Pro Whitening Ex Soft battery operated
toothbrush, UPC 7 66878 00191 3. Recall # Z-0375-05;
b) Spinbrush Pro Whitening Medium battery operated
toothbrush, UPC 7 66878 00193 7. Recall # Z-0376-05;
c) Spinbrush Pro Whitening Ex Soft refill heads for
battery powered toothbrushs, UPC 7 66878 00192 0.
Recall # Z-0377-05;
d) Spinbrush Pro Whitening Medium refill heads for
battery powered toothbrushs, UPC 7 66878 00194 4.
Recall # Z-0378-05
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
Proctor & Gamble Co, Cincinnati, OH, by letter on November 11, 2004. Firm initiated recall is ongoing.
REASON
Market withdrawal of Crest Spinbrush Pro-Whitening. The firm has determined that there is a quality issue in certain production that may allow the circular brush at the tip of the brush head to become detached over time in a very small number of brushes.
VOLUME OF PRODUCT IN COMMERCE
7.5 million toothbrushes.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Mammo Test Breast Biopsy System. Recall # Z-0379-05.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Fischer Imaging Corp., Denver, Co, by letter on July 9, 2004. Firm initiated recall is ongoing.
REASON
X-ray tube actuator shaft may fail, allowing the mechanism to drop without warning.
VOLUME OF PRODUCT IN COMMERCE
1,081 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
a) Victory Motorized Vehicle, 3 wheel.
Recall # Z-0380-05;
b) Victory Motorized Vehicle, 4 wheels.
Recall # Z-0381-05.
CODE
a) Model number SC1600;
b) Model number SC1700.
RECALLING FIRM/MANUFACTURER
Pride Mobility Product Corp., Exeter, PA, by a safety alert notification dated July, 2004. Firm initiated recall is ongoing.
REASON
Intermittent operation.
VOLUME OF PRODUCT IN COMMERCE
17,000 units.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
Medication Bottle (U22-3), a component of the MicroAir Vibrating Mesh Nebulizer, Model NE-U22V/NE-22VAC. Recall # Z-0382-05.
CODE
Bottle lots 43A, 53A, 63A, 73A, 83A, 93A, X3A, Y3A and Z3A, a component of Nebulizer model NE-U22 serial numbers 34300001A and highter, 3500001A and higher, 3600001A and higher, 3700001A and higher, 3800001A and higher, 3900001A and higher, 3X00001A and higher, 3Y00001A and higher, and 3Z00001A through 3Z00696A. Medication bottles with either a blue dot or a blue O-ring were manufactured after corrections were made and are not subject to the recall.
RECALLING FIRM/MANUFACTURER
Omron Healthcare, Inc., Bannockburn, IL, by Removal Notices dated November 2, 2004. Firm initiated recall is ongoing.
REASON
A potential failure of the vibrating mechanism of the medication bottle which causes a failure to transmit vibration and results in no nebulization.
VOLUME OF PRODUCT IN COMMERCE
63,560 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Roche brand Cardiac Reader. Recall # Z-0383-05.
CODE
All units.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics, Corp., Indianapolis, IN, by telephone, letter and fax beginning on December 3, 2004, and by press release on December 8, 2004. Firm initiated recall is ongoing.
REASON
Potential for false negative Troponin T or falsely decreased Troponin T and Myoglobin results.
VOLUME OF PRODUCT IN COMMERCE
128 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Ultrasound Probe Drape Tapered to 1.5’ Sterile 8’ x 60’, Product Number 781-983. Recall # Z-0384-05.
CODE
Lot Number A 7611.
RECALLING FIRM/MANUFACTURER
Hydro Med Products, Inc., Dallas, TX, by letter on September 28, 2004. Firm initiated recall is complete.
REASON
Defective packaging, potential for breech in sterility.
VOLUME OF PRODUCT IN COMMERCE
35 cases/10 units per case.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Baxter labeled 6060 Solution Sets with AutoClamp;
For use with model 6060 multi-therapy pumps only;
a prescription, sterile, non-pyrogenic fluid pathway;
A) the following sets were made in Costa Rica:
a) Baxter Solution Set, 76” (1.9 m), Volume 3.7 mL,
Cassette with AutoClamp Device, Male Luer Lock
Adapter, product code 2M9856 and 2M9856K;
b) Baxter Solution Set, 109” (2.8 m), Volume 4.8 mL,
Cassette with AutoClamp Device, Male Luer Lock
Adapter, product code 2M9857;
c) Baxter Solution Set, 112” (2.9 m), Volume 7.9 mL,
Cassette with AutoClamp Device, 1.2 Micron
Downstream Filter, Male Luer Lock Adapter,
product code 2M9858 and 2M9858K;
d) Baxter Solution Set, 112” (2.9 m), Volume 7.9 mL,
Cassette with AutoClamp Device, 0.22 Micron
Downstream Filter, Male Luer Lock Adapter,
product code 2M9859;
e) Baxter Solution Set, 76” (1.9 m), Volume 3.7 mL,
Non-DEHP Tubing, Cassette with AutoClamp Device,
Male Luer Lock Adapter, product code 2M9860;
f) Baxter Solution Set, 112” (7.9 m), Volume 3.7 mL,
Non-DEHP Tubing, Cassette with AutoClamp Device,
1.2 Micron Downstream Filter, Male Luer Lock
Adapter, product code 2M9861;
g) Baxter Solution Set, 112” (7.9 m), Volume 3.7 mL,
Non-DEHP Tubing, Cassette with AutoClamp Device,
0.22 Micron Downstream Filter, Male Luer Lock
Adapter, product code 2M9862;
h) Baxter Solution Set, 111” (2.9 m), Volume 7.4 mL,
Cassette with AutoClamp Device, 1.2 Micron
Downstream Filter, Male Luer Lock Adapters,
product code 2M9874K;
i) Baxter Solution Set, 75” (1.9 m), Volume 3.1 mL,
Cassette with AutoClamp Device, Male Luer Lock
Adapters, product code 2M9875K;
j) Baxter Epidural Set, 115” (2.9 m), Volume 5.0 mL,
Cassette with AutoClamp Device, Male Luer Lock
Adapter, product code 2L9003;
k) Baxter Epidural Set, 112” (2.9 m), Volume 7.9 mL,
Cassette with AutoClamp Device, 0.22 Micron
Downstream Filter, Male Luer Lock Adapter, product
code 2L9004;
l) Baxter Epidural Set, 92” (2.3 m), Volume 6.7 mL,
Cassette with AutoClamp Device, 0.22 Micron
Downstream Filter, Male Luer Lock Adapters,
product code 2L9005;
m) Baxter Solution Set with Spike, 88” (2.2 m),
Volume 4.1 mL, Non-DEHP Tubing, Cassette with
AutoClamp Device, Male Luer Lock Adapter,
product code 2L9006. Recall # Z-0385-05.
B) Sabraset Administration Sets with AutoClamp;
for use with model 6060 multi-therapy pumps only;
a prescription, sterile, non-pyrogenic fluid pathway;
the following sets were made in Mexico:
a) Sabraset 56050 – 100 Administration Set with
100 mL Bag and Cassette, 56”, Volume 3 mL,
100 mL Bag with Fill Port, Cassette with
AutoClamp Device, Slide Clamp, Male Luer Lock
Adapter;
b) Sabraset 56050 – 250 Administration Set with
2500 mL Bag and Cassette, 53”, Volume 3 mL,
250 mL Bag with Fill Port, Cassette with
AutoClamp Device, Slide Clamp, Male Luer Lock
Adapter. Recall # Z-0386-05.
CODE
A) Product codes 2M9859, 2M9856, 2M9856K, 2M9857,
2M9858, 2M9858K, 2M9860, 2M9861, 2M9862, 2M9874K,
2M9875K, 2L9003, 2L9004, 2L9005, 2L9006;
all sets with lot numbers below R03K25200.
The lot number R03XXXXXX (format RYYMDDNNC) is
broken down as follows: R = manufacturing plant
location; YY = numeric year (01, 02, 03);
M = alpha month, A = January through L = December;
DD = numeric day of month; NN = numeric batch
number for the day, 01 - 99; C = numeric check
digit generated by computer;
B) Product codes 560500-100 and 560500-250,
all lot numbers other than lots produced
within the range of 417519 to 499999, or
those with an adhesive circular colored
sticker (Avery dot) at the top of the
individual package on the Tyvek side or on
the shipper label. Any lot numbers from the
following obsolete Sabraset product codes
are also being recalled: 5600PM, 560100,
560101, 560110, 560111, 560112, 560112-GEL,
560112-L, 560113, 560115, 560116, 560122-L,
561101, 567100, 567100-L, 567112-L, 567122-L,
569100, 569111, 569122, 560200-100, 560522-100.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp, Round Lake, IL, by letters dated November 19, 2004. Firm initiated recall is ongoing.
REASON
A missing platen assembly in the cassette of the solution sets results in the infusion pump being unable to occlude the tubing of the set. This can lead to free-flow of the solution and a possible overdose of medication to the patient.
VOLUME OF PRODUCT IN COMMERCE
4,419,179 sets.
DISTRIBUTION
Nationwide and Internationally.
_______________________________
PRODUCT
a) Zimmer™ Orthopaedic Surgical Products,
Disposable Cuff, 42in (107cm), Single Port,
Single Bladder Sterile. The cuff is a sterile,
single use product equipped with an integral
fill line. The product is packed 10 cuffs
per unit. Cat #60-7075-007-00. Recall # Z-0388-05;
b) Zimmer™ Orthopaedic Surgical Products,
Disposable Cuff, 12” (30cm), Single Port,
Single Bladder Sterile. The cuff is a sterile,
single use product equipped with an integral
fill line. The product is packed 10 cuffs
per unit. Cat #60-7075-002-00.
Recall # Z-0389-05;
c) Zimmer™ Orthopaedic Surgical Products,
Disposable Cuff, 12” (30cm), Dual Port,
Single Bladder Sterile. The cuff is a sterile,
single use product equipped with an integral
fill line. The product is packed 10 cuffs
per unit. Cat #60-7070-002-00. Recall # Z-0390-05.
CODE
a) Lot #60171355;
b) Lot #60153745;
c) Lot #60156865.
RECALLING FIRM/MANUFACTURER
Zimmer Orthopaedic Surgical Products, Statesville, NC, by letters on October 27, 2004 and November 11, 2004. Firm initiated recall is ongoing.
REASON
The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
VOLUME OF PRODUCT IN COMMERCE
235 units (10 cuffs per unit).
DISTRIBUTION
Nationwide, Australia, Demark, and Germany.

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Vitros CRP (C-Reactive Protein) Slides. Catalog # 1926740 contains 250 slides, Catalog #809 7990 contains 90 slides. Recall # Z-0387-05.
CODE
Coatings 401 thru 419.
RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letters dated November 22, 2004. Firm initiated recall is ongoing.
REASON
Results may be negatively biased due to a non-linear response at the upper end of the Reportable (Dynamic) Range.
VOLUME OF PRODUCT IN COMMERCE
55,780 boxes.
DISTRIBUTION
Nationwide and Internationally.

RECALLS AND FIELD CORRECTIONS: VETERNINARY MEDICINE - CLASS I

_______________________________
PRODUCT
SSC-37-780400 Sheep Mineral packed and distributed in 50 Lb bags. Recall # V-005-5.
CODE
Lot #W4140 manufactured on 5/19/2004.
RECALLING FIRM/MANUFACTURER
Southern States Coop, Inc., Winchester, KY, by telephone on August 16, 2004. Firm initiated recall is ongoing.
REASON
Free Choice mineral feed supplement for sheep was found to contain a high cooper content which contributed to multiple sheep deaths.
VOLUME OF PRODUCT IN COMMERCE
176/50 lb. Bags.
DISTRIBUTION
KY, PA, and WV.

RECALLS AND FIELD CORRECTIONS: VETERNINARY MEDICINE - CLASS II

_______________________________
PRODUCT
Product is a complete grain mix for preconditioned calves fed in confinement, packaged in 50 lb. Bags. Recall # V-037-5.
CODE
Lot RV1134.
RECALLING FIRM/MANUFACTURER
ADM Alliance Nutrition, Inc., Quincy, IL, by telephone on August 11, 2004. Firm initiated recall is ongoing.
REASON
The product contains less active drug ingredients than is identified on the product label.
VOLUME OF PRODUCT IN COMMERCE
160/50 lb. Bags.
DISTRIBUTION
PA.

RECALLS AND FIELD CORRECTIONS: VETERNINARY MEDICINE - CLASS III

_______________________________
PRODUCT
a) Fort Dodge Torbutrol Butorphanol Tartrate
Veterinary Tablets, each tablet contains 10 mg.
Butorphanol base as butorphanol tartrate,
packaged in 100-tablet bottles, 24 bottles/case,
RX, NDC 0856-2027-60, NADA 103-390.
Recall # V-038-5;
b) Fort Dodge Torbutrol Tablets, each tablet
contains 5 mg. butorphanol, as butorphanol
tartrate, USP, packaged in 50-tablet bottles,
24 bottles/case, For Animal Treatment Only,
RX, NADA 103-390. Recall # V-039-5;
CODE
a) Lot #636170, exp. Dec 05;
b) Lot # 635170, exp. Dec 04.
RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories, Inc., Fort Dodge, IA, by letters dated December 3, 2004. Firm initiated recall is ongoing.
REASON
The tablets contain unidentified black particles.
VOLUME OF PRODUCT IN COMMERCE
2,013/100/10-mg. Tablet bottles and 916/50/5-mg. Tablet bottles.
DISTRIBUTION
Nationwide and UK.

END OF ENFORCEMENT REPORT FOR January 19, 2005

###

rule