FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
09/21/1994
Recalls and Field Corrections: Foods -- Class I -- 09/21/1994
September 21, 1994 94-38
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Snickers Ice Cream in 3 gallon paperboard containers.
Recall #F-782-4.
CODE All product manufactured during 2/19/94 through 5/19/94.
MANUFACTURER Reinhold Ice Cream Company, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by telephone beginning May 19, 1994, followed
by letter May 25, 1994. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY Firm estimates very little if any product remains on the
market.
REASON Product contained undeclared peanuts.
_______________
PRODUCT Ice cream in 3 gallon paperboard containers: (a) French
Vanilla; (b) Heath Crunch Ice Cream. Recall #F-826/827-4.
CODE All product manufactured during the 3 months prior to the
initiation of recall, 2/19/94 through 5/19/94.
MANUFACTURER Reinhold Ice Cream Company, Pittsburgh, Pennsylvania.
RECALLED BY Manufacturer, by telephone beginning May 19, 1994. Firm-
initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY Firm estimates very little if any product remains on the
market.
REASON Products contained undeclared eggs.
_______________
PRODUCT Frozen Rotini with Vegetables, in 5 pound poly bags.
Recall #F-828-4.
CODE 5H42148.
MANUFACTURER Norpac Foods, Inc., Stayton, Oregon.
RECALLED BY Manufacturer, by telephone June 10 and 11, 1994. Firm-
initiated recall has been completed at the retail level.
DISTRIBUTION National.
QUANTITY 730 cases (6 bags per case) were distributed.
REASON Product may be contaminated with Listeria monocytogenes, and
package contains instructions for preparation without
cooking.
_______________
PRODUCT Superior Pride Frozen Rotini with Vegetables in 5 pound
plastic bags. Recall #F-831-4.
CODE 4143LC 1, 4143LC 2, 4143LC 1.
MANUFACTURER Sunbelt Packing Company, San Antonio, Texas.
RECALLED BY Superior Foods, Watsonville, California, by telephone June
1, 1994, and confirmed by fax June 2, 1994. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 30 cases (6 bags per case) were distributed; firm estimates
none remains on the market.
REASON Product may be contaminated with Listeria monocytogenes, and
package contains instructions for preparation without
cooking.
_______________
PRODUCT Spence & Co. Limited Smoked Atlantic Salmon, in 4 ounce and
1-1/4 pound packages. Recall #F-834-4.
CODE Sell by date 8/1/94.
MANUFACTURER Spence & Company, Ltd., S. Easton, Massachusetts.
RECALLED BY Manufacturer, by letter August 16, 1994, followed by
telephone. Firm-initiated recall ongoing.
DISTRIBUTION Maryland, Illinois.
QUANTITY 50 packages of 1-1/4 pound size and 55 packages of 4 ounce
size were distributed.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Bulk ice cream and sherbet: (a) Mint Chocolate Chip Ice
Cream; (b) Lime Sherbet; (c) Rainbow Sherbet.
Recall #F-820/822-4.
CODE All lots beginning with 4.
MANUFACTURER R. Bruce Fike & Sons Dairy, Inc., Uniontown, Pennsylvania.
RECALLED BY Manufacturer, by letter July 18, 1994. Firm-initiated field
correction (relabeling) complete.
DISTRIBUTION Pennsylvania, Maryland.
-2- QUANTITY (a) None; (b) 86 containers.
REASON Products contained undeclared FD&C Yellow #5.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Toasted Almond Fudge Ice Cream, bulk. Recall #F-823-4.
CODE All lots beginning with 4.
MANUFACTURER R. Bruce Fike & Sons Dairy, Inc., Uniontown, Pennsylvania.
RECALLED BY Manufacturer, by letter July 18, 1994. Firm-initiated field
correction (relabeling) complete.
DISTRIBUTION Pennsylvania, Maryland.
QUANTITY 100 containers.
REASON Product contained undeclared almonds.
_______________
PRODUCT Butter Pecan Ice Cream, bulk. Recall #F-824-4.
CODE All lots beginning with 4.
MANUFACTURER R. Bruce Fike & Sons Dairy, Inc., Uniontown, Pennsylvania.
RECALLED BY Manufacturer, by letter July 18, 1994. Firm-initiated field
correction (relabeling) complete.
DISTRIBUTION Pennsylvania, Maryland.
QUANTITY 88 containers.
REASON Product contained undeclared pecans.
_______________
PRODUCT Kraft Velveeta Shells & Cheese, original, creamy velveeta
cheese sauce and shell pasta, in 12 ounce boxes.
Recall F-829-4.
CODE Cheese Sauce foil packets coded 158C4-* 22 and 159C4-* 23
contained in dinners coded Best Purchased By APR 11 95 S and
APR 12 95 S.
MANUFACTURER Kraft USA, Division of Kraft General Foods, Inc., Champaign,
Illinois.
RECALLED BY Kraft General Foods, Inc., Glenview, Illinois, by telephone
July 29, 1994, followed by visit. Firm-initiated recall
complete.
DISTRIBUTION Arkansas, California, Colorado, Georgia, Hawaii, Kansas,
Louisiana, Montana, North Carolina, Nevada, Oklahoma,
Oregon, Tennessee, Texas, Washington.
QUANTITY 12,900 cases were distributed; firm estimates that 20-25% of
the product remains on the market.
REASON Product was found positive for protease activity and
proteolysis was present.
_______________
PRODUCT Yoplait Natural Vanilla Custard Style Lowfat Yogurt, in 6
ounce containers. Recall #F-830-4.
CODE All product with sell by dates of 8/31/94 and earlier.
MANUFACTURER Yoplait USA Inc., Reed City, Michigan; Yoplait USA, Inc.,
Carson, California.
-3- RECALLED BY Yoplait USA, inc., Minneapolis, Minnesota, by electronic
mail message sent July 25, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 500,000 to 600,000 cups were distributed; firm estimated
that 250,000 cups remained on market at time of recall.
REASON Product contained undeclared cornstarch.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Albuterol Sulfate Tablets, USP, (a) 2 mg; (b) 4 mg, in
bottles of 100, for asthma relief. Recall #D-381/382-4.
CODE Lot numbers and EXP dates: (a) 18223L 2/95, 20123L 2/95,
22233L 4/95, 22333L 4/95, 33553L 5/95; (b) 18123L 2/95,
20223L 2/95, 22033L 4/95, 22133L 4/95, 24743L 4/95.
MANUFACTURER Warner Chilcott Laboratories, Division of Warner Lambert
Company, Lititz, Pennsylvania.
RECALLED BY Warner Chilcott Laboratories, Morris Plains, New Jersey, by
letter July 15, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 48,838 2-mg bottles and 37,000 4-mg bottles
were distributed.
REASON Possible discrepancies in ANDA data.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Augmentin Chewable Tablets, an oral antibacterial
combination: (a) Augmentin Chewable Tablets (125 mg.
Amoxicillin and 31.25 mg Clavulanate potassium), foil
strips, 3 tablet size (physician samples), and 30 tablet
size; (b) Augmentin Chewable Tablets, 250 mg Amoxicillin
and 62.5 mg Clavulanate Potassium, foil strips, 3 tablet
size (physician samples), and 30 tablet size.
Recall #D-383/384-4.
CODE Lot numbers and EXP dates: (a) WC0456/SEP 94, WN0859/FEB 95
WS0978/APR 95, AH1460/OCT 95 (3 tablet size); WC0457/SEP 94
WN0860/MAR 95, WT1041/MAY 95 (30 tablet size);
(b) 3 TABS. WT1072/MAY 95 (3 tablet size);
WC0458/SEP 94, WD0532/SEP 94, WD0580/NOV 94,
WH0671/NOV 94, WK0724/FEB 95, WM0824/FEB 95,
WN0861/MAR 95, WS0935/APR 95, WS0950/APR 95,
WW1089/JUN 95, AA1135/JUN 95, AB1203/JUL 95
AD1432/OCT 95, AM1571/JAN 96 (30 tablet size).
MANUFACTURER Smithkline Beecham Pharmaceuticals, Bristol Tennessee.
RECALLED BY Manufacturer, by letter August 31, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 105,631 of 30 tablets of the 125 mg/31.25 mg product and
464,864 packages of 30 tablets of the 250 mg/62.5 product
were distributed. The quantity of physician samples
distributed is undetermined.
-4- REASON Marginal subpotency of the clavulanate potassium ingredient.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Source Plasma. Recall #B-461-4.
CODE Unit numbers: 167614, 167954, 167980, 168030, 168041,
168099, 168125, 168176, 168206, 168452, 168488, 168526,
168572, 168333, 168374, 168612, 168657.
MANUFACTURER AM-RHO Laboratories, Inc., Jacksonville, Florida.
RECALLED BY Manufacturer, by letter October 29, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION New Jersey.
QUANTITY 17 units.
REASON Blood products which tested repeatedly reactive for the
hepatitis B surface antigen (HBsAg); or tested negative, but
were collected from a donor who previously tested repeatedly
reactive for HBsAg, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-449/450-4.
CODE (a) 49FJ24123, 49FJ24124, 49FJ24125, 49FJ24128, 49FJ24129,
49FJ24130, 49FJ24131, 49FJ24132, 49FJ24133, 49FJ24135,
49FJ24137, 49FJ24174, 49FJ24177, 49FJ24178, 49FJ24179,
49FJ24180, 49FJ24187, 49FJ24190, 49FJ24191, 49FJ24193,
49FJ24194, 49FJ24197, 49FJ24199, 49FJ24200, 49FJ24203,
49FJ24204, 49FJ24208, 49FJ24210, 49FJ24211, 49FJ24213,
49FJ24214, 49FJ24215, 49FJ24216, 49FJ24217, 49FJ24218,
49FJ24219, 49FJ24224, 49FJ24226, 49FJ24231, 49FJ24309,
49FJ24310, 49FJ24311, 49FJ24313, 49FJ24314, 49FJ24317,
49FJ24318, 49FJ24319, 49FJ24320, 49FJ24322, 49FJ24325,
49FJ24327, 49FJ24328, 49FJ24369, 49FJ24370, 49FJ24375,
49FJ24376, 49FJ24379, 49FJ24383, 49FJ24384, 49FJ24385,
49FJ24457, 49FJ24458, 49FJ24459, 49FJ24462, 49FJ24463,
49FJ24464, 49FJ24470, 49FJ24473, 49FJ24477, 49FJ24478,
49FM11016, 49FM11017, 49FM11018, 49FM11021, 49FM11023,
49FM11025, 49FM11026, 49FM11027, 49FM11028, 49FM11029,
49FM11030, 49FM11031, 49FM11034, 49FM11039, 49FM11040,
49FM11041, 49FM11042, 49FM11044, 49FM11047, 49FM11048,
49FM11049.
(b) 49FJ24123, 49FJ21124, 49FJ24125, 49FJ24126, 49FJ24127,
49FJ24128, 49FJ24129, 49FJ24130, 49FJ24131, 49FJ24132,
49FJ24133, 49FJ24135, 49FJ24136, 49FJ24137, 49FJ24174,
49FJ24175, 49FJ24176, 49FJ24177, 49FJ24178, 49FJ24179,
49FJ24180, 49FJ24183, 49FJ24185, 49FJ24187, 49FJ24188,
49FJ24190, 49FJ24191, 49FJ24192, 49FJ24193, 49FJ24194,
49FJ24195, 49FJ24196, 49FJ24197, 49FJ24198, 49FJ24199,
49FJ24200, 49FJ24201, 49FJ24202, 49FJ24203, 49FJ24204,
49FJ24205, 49FJ24206, 49FJ24208, 49FJ24209, 49FJ24210,
-5- 49FJ24211, 49FJ24212, 49FJ24213, 49FJ24214, 49FJ24216,
49FJ24217, 49FJ24218, 49FJ24219, 49FJ24222, 49FJ24223,
49FJ24224, 49FJ24225, 49FJ24226, 49FJ24227, 49FJ24228,
49FJ24230, 49FJ24231, 49FJ24309, 49FJ24310, 49FJ24311,
49FJ24312, 49FJ24313, 49FJ24314, 49FJ24315, 49FJ24316,
49FJ24317, 49FJ24318, 49FJ24319, 49FJ24320, 49FJ24322,
49FJ24323, 49FJ24325, 49FJ24326, 49FJ24327, 49FJ24328,
49FJ24368, 49FJ24369, 49FJ24370, 49FJ24372, 49FJ24373,
49FJ24374, 49FJ24375, 49FJ24376, 49FJ24378, 49FJ24379,
49FJ24381, 49FJ24382, 49FJ24383, 49FJ24384, 49FJ24385,
49FJ24455, 49FJ24456, 49FJ24457, 49FJ24458, 49FJ24462,
49FJ24464, 49FJ24465, 49FJ24467, 49FJ24468, 49FJ24469,
49FJ24470, 49FJ24473, 49FJ24475, 49FJ24476, 49FJ24477,
49FJ24478, 49FM11015, 49FM11016, 49FM11017, 49FM11018,
49FM11021, 49FM11022, 49FM11023, 49FM11024, 49FM11025,
49FM11026, 49FM11027, 49FM11028, 49FM11029, 49FM11030,
49FM11031, 49FM11032, 49FM11033, 49FM11034, 49FM11036,
49FM11037, 49FM11038, 49FM11039, 49FM11040, 49FM11041,
49FM11042, 49FM11044, 49FM11045, 49FM11047, 49FM11048,
49FM11049.
MANUFACTURER The American National Red Cross, Wichita Falls, Texas.
RECALLED BY Manufacturer, (a) by telephone March 26, 1994; (b) by letter
April 5, 1994. Firm-initiated recall complete.
DISTRIBUTION (a) Texas, Oklahoma; (b) California.
QUANTITY (a) 91 units; (b) 141 units.
REASON Blood products, collected in anticoagulant Citrate Phosphate
Dextrose Adenine Solution (CPDA-1 bags) in which the outside
was contaminated with mold, were distributed.
_______________
PRODUCT Platelets. Recall #B-460-4.
CODE Unit numbers: 50P06443, 50P06444, 50P06445, 50P06446,
50P06448, 50P06449, 50P06450, 50P06451, 50P06452, 50P06453.
MANUFACTURER The American National Red Cross, Toledo, Ohio.
RECALLED BY Manufacturer, by telephone January 7, 1994, followed by
letter January 11, 1994. Firm-initiated recall complete.
DISTRIBUTION Maryland, Massachusetts, Ohio, Washington, D.C.
QUANTITY 10 units.
REASON Blood products, incorrectly tested for the antibody to the
human immunodeficiency virus type 1/2 (anti-HIV-1/2), were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
========================
_______________
PRODUCT MicroScan Dried Gram Positive Panels, microtiter plates with
dried antimicrobial dilutions and supplemented broth that
are rehydrated with suspensions of test organisms:
(a) MicroScan Positive Combo Type 6;
(b) MicroScan Positive MIC Type 6;
(c) MicroScan Positive MIC Type 8;
(d) MicroScan Positive Breakpoint Combo Type 6.
Recall #Z-1154/1157-4.
-6- CODE All products with a Lot/EXP date of "29 JUN 95" or EARLIER.
MANUFACTURER Baxter Diagnostics, Inc., MicroScan, West Sacramento,
California.
RECALLED BY Manufacturer, by letter May 31, 1994. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON The panels do not detect penicillin resistant strains of
Streptococcus pneumoniae which can result in serious health
consequences, including death, if it is not detected.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Howmedica P.C.A. Hip System UHMWPE Acetabular Insert, Size #
28 mm I.D. 10o Hood, Fits 64 or 67 mm outer shell, Catalog
#6283-6-647, used to provide the articulating surface for
the femoral head following total hip replacement.
Recall #Z-1272-4.
CODE Lot #TFFTYA.
MANUFACTURER Howmedica, Inc., Rutherford, New Jersey.
RECALLED BY Manufacturer, by telephone April 13, 1994, followed by
letter May 6, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Ireland.
QUANTITY 59 units were distributed; firm estimated that 3 units
remained on market at time of recall.
REASON The device is labeled as a 28 mm I.D. acetabular insert when
the device actually measures 26 mm I.D.
________________
PRODUCT Povidone Iodine (PI) Solution packaged in Kendall Curity
Anesthesia Trays:
1. Curity Spinal Anesthesia Tray, Sterile, Reorder #4705
2. Curity Spinal Anesthesia Tray, Sterile, Reorder #4716
3. Curity Spinal Anesthesia Tray, Sterile, Reorder #4720
4. Curity Spinal Anesthesia Tray, Sterile, Reorder #4722
5. Curity Spinal Anesthesia Tray, Sterile, Reorder #4724
6. Curity Spinal Anesthesia Tray, Sterile, Reorder #4727
7. Curity Spinal Anesthesia Tray, Sterile, Reorder #4730
8. Curity Saddle Block Tray, Sterile, Reorder #4732
9. Curity Saddle Block Tray, Sterile, Reorder #4740
10. Curity Saddle Block Tray, Sterile, Reorder #4750
11. Curity Saddle Block Spinal Anesthesia Tray, Sterile,
Reorder #4763
12. Curity Saddle Block Spinal Anesthesia Tray, Sterile,
Reorder #4787
13. Curity Saddle Block Spinal Anesthesia Tray, Sterile
Reorder #4795
14. Curity Spinal Anesthesia Tray, Sterile Reorder #4920
15. Curity Single Shot Epidural Anesthesia Tray, Sterile
Reorder #5070
-7- 16. Curity Continuous Epidural Anesthesia Tray, Sterile
Reorder #5181
17. Curity Continuous Epidural Anesthesia Tray, Sterile
Reorder #5197
18. Curity Single Shot Epidural Anesthesia Tray, Sterile
Reorder #5554. Recall #Z-1282/1299-4.
CODE Lot Numbers: 1. CA8300KG
2. CA8304KG, CA8323KG
3. CA8303KG
4. CA8305KG
5. CA8306KG
6. CA8307KG
7. CA8308KG
8. CA8327KG, CA8301KG
9. CA8302KG
10. CA8335KG
11. BA8355KG, CA8309KG
12. BA8356KG
13. CA8311KG
14. BA8358KG
15. CA8322KG
16. CA8318KG, CA8319KG
17. CA8321KG
18. CA8337KG
MANUFACTURER Kendall Healthcare Products, Augusta, Georgia.
RECALLED BY Kendall Healthcare Products Company, Mansfield,
Massachusetts, by letter June 8, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,053 cases were distributed.
REASON Anesthesia trays contain packets of Povidone Iodine solution
which may be subpotent.
_______________
PRODUCT Feeding Tubes, 5 FR, 15 inches long, sterile, single patient
use, Rx device used for naso-gastric enteral feeding of
infants: (a) Baxter Feeding Tube, Catalog #K32; (b) Baxter
Infant Feeding Tube, with Radiopaque Stripe, Catalog #R32.
Recall #Z-1316/1317-4.
CODE All lots of both catalog numbers.
MANUFACTURER Baxter S.A., Cartago, Costa Rica.
RECALLED BY Baxter Healthcare Corporation, Round Lake, Illinois, by
letter July 21, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Singapore, Puerto Rico.
QUANTITY 251,670 tubes were distributed; firm estimated that 15
percent of the product remained on the market at time of
recall.
REASON Solvent bond failure between the tubing and the luer
connector may cause leakage.
-8- _______________
PRODUCT Puritan-Bennett Microprocessor Ventilator, 7200AE Series,
enables a respiratory care practitioner to provide a patient
with ventilatory assistance: (a) Model 7200AE Ventilator;
(b) Model 7200SPE Ventilator; (c) Model 7200E Ventilator.
Recall #Z-1375/1377-4.
CODE Serial numbers: 8340771, 8340856, 8942136, 9471103, 9471131
through 9471133, 9471136 through 9471139, 9471140 through
9471145, 9471154 through 9471159, 9471161 through 9471163,
9471169, 9471172, 9471173.
MANUFACTURER Puritan-Bennett Corporation, Carlsbad, California.
RECALLED BY Manufacturer, by letter June 29, 1994. Firm-initiated
correction complete.
DISTRIBUTION Arkansas, Texas, Florida, Alabama, Massachusetts,
Connecticut, California, Georgia, Colorado, New York.
QUANTITY 29 units were distributed; no defective units remain in
commerce.
REASON An intermittent wiring/pin connection in the pneumatic wire
harness assembly could cause the ventilators to go into
safety valve open (SVO) position, resulting in bagging of
the patient and a ventilator change.
_______________
PRODUCT Endo-P Transducer, a diagnostic ultrasound transducer
compatible with the Sonoline series ultrasound system
(SI200/250, SI400/450/450D): (a) Part #874000;
(b) Part #5725270. Recall #Z-1385/1386-4.
CODE Serial numbers below 3000.
MANUFACTURER Siemens AG, UB MED., Erlangen, Germany.
RECALLED BY Siemens Medical Systems, Inc., Ultrasound Group, Issaquah,
Washington, by letter May 20, 1994. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 283 transducers were distributed.
REASON The transducers fail to properly change from axial to
longitudinal scanning planes, resulting in misguided biopsy
punctures.
_______________
PRODUCT (a) Endoflex Lumbar Discectomy Kit, Catalog #2-6080,
intended for lumbar disc herniations; (b) 3.5 mm EndoProbe,
Catalog #2-6088, the cutting instrument for the removal of
nucleus materials, sold individually or as part of a kit;
(c) 3 mm Flexible Ring Curette, Catalog #5-1020, manually
used to decompress a herniated nucleus pulposus during
microdiscectomy and laminectomy surgery; (d) 3 mm Flexible
Rectangular Curette, Catalog #5-1030, manually used to
decompress a herniated nucleus pulposus during
microdiscectomy and laminectomy surgery.
Recall #Z-1379/1382-4.
CODE All lots.
MANUFACTURER Surgical Dynamics, Inc., Concord, California.
-9- RECALLED BY Manufacturer, by telephone May 16, 1994, followed by letter
May 19, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Australia, Italy, Peoples Republic of China,
Spain, South Korea.
QUANTITY 547 units were distributed.
REASON The sterilization parameters used by the contract sterilizer
had not been validated thereby compromising the sterility of
the devices.
_______________
PRODUCT Cosgrove-Edwards Annuloplasty System, Model 4600, indicated
for mitral valvuloplasty. Recall #Z-1394-4.
CODE All lots.
MANUFACTURER Edwards CVS Division, Baxter Healthcare Corporation, Irvine,
California.
RECALLED BY Manufacturer, by letter June 29, 1994. Firm-initiated
recall complete.
DISTRIBUTION California, Massachusetts, Michigan, Minnesota, Missouri,
Ohio.
QUANTITY 419 units were distributed; firm estimates none remains on
the market.
REASON Sterility may be compromised due to defective packaging
seals.
_______________
PRODUCT Baxter Univox Membrane Oxygenation System, used in
cardiopulmonary bypass surgery for 02/C02 exchange.
Recall #Z-1405-4.
CODE Various lot numbers manufactured between September 23, 1993
and May 12, 1994 with UV adhesive lots 08313 or 12283A.
MANUFACTURER Baxter Healthcare Corporation, Anasco, Puerto Rico.
RECALLED BY Baxter Healthcare Corporation, Irvine, California, by letter
June 3, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 11,955 systems were distributed.
REASON The UV adhesive bond may detach between the gas manifold and
the oxygenator housing, allowing oxygen to be released into
the environment instead of replacing the carbon dioxide in
the blood returning to the patient.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
______________
PRODUCT Aldetect Formaldehyde Test Reagent, in 2 cc glass ampules,
an in-vitro diagnostic used to detect aldehydes in dialysis
devices. Recall #Z-1357-4.
CODE Lot #5202 EXP 5/94.
MANUFACTURER Pochemco, Inc., Chicopee, Massachusetts.
RECALLED BY Manufacturer, telephone February 2 and 3, 1994. Firm-
initiated recall complete.
DISTRIBUTION Massachusetts, New York, New Jersey, Ohio.
QUANTITY Firm estimates that little if any product remains on market.
-10- REASON The device failed finished product testing, and the
expiration date was incorrectly labeled as 2 years instead
of 1 year.
_______________
PRODUCT Microaire Surgical Oscillating Sawblade, Part #MO-124, power
instruments for orthopedic surgery. Recall #Z-1363-4.
CODE Lot #04942901.
MANUFACTURER Microaire Surgical Instruments, Inc., Valencia, California.
RECALLED BY Manufacturer, by letter June 20, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Arizona, California, Florida, Illinois, Minnesota, New
Mexico.
QUANTITY 99 blades were distributed.
REASON Mislabeled. The blade was labeled as 0.6 mm thick when it
was really 1.0 mm thick.
_______________
PRODUCT Howmedica Centrax Biopolar Prosthesis, the Acetabular
component of hip implant, used in orthopedic surgery implant
procedures. Recall #Z-1378-4.
CODE Catalog #6225-3-245, Lot #CIFGAA, Sterility #9332391.
MANUFACTURER Howmedica, Inc., Rutherford, New Jersey.
RECALLED BY Manufacturer, by telephone April 27, 1994, and May 12, 1994,
followed by letter June 1, 1994. Firm-initiated recall
complete.
DISTRIBUTION California, New York, Florida, Wisconsin.
QUANTITY 6 units were distributed; firm estimates none remains on the
market.
REASON Product was incorrectly packaged in a pre-printed carton
identifying the device as a Precision Hip System Sterile
Acetabular Component. The device in the package matched the
label, Howmedica Centrax Bipolar Prosthesis, which was
affixed to the side of the carton.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I
============
_______________
PRODUCT Bulk Milo Distillers Dried Grains with Solubles.
Recall #V-059-4.
CODE None. Production between 3/28/94 and 4/7/94.
MANUFACTURER High Plains Corporation, Colwich, Kansas.
RECALLED BY Manufacturer, by telephone April 11, 1994, followed by
letter April 25, 1994. Firm-initiated recall complete.
DISTRIBUTION Kansas, Texas, Oklahoma, Missouri, Nebraska, Colorado,
Arkansas, New Mexico.
QUANTITY Approximately 2,500 tons were distributed between 3/28/94
and 4/7/94.
REASON Feed contaminated with antibiotic residues.
-11- RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
==========
_______________
PRODUCT Lay Powder 17 TL-50 for laying chickens. Recall #V-061-4.
CODE 7/29/94 (date of production).
MANUFACTURER Molinos De Puerto Rico, Inc., Guaynabo, Puerto Rico.
RECALLED BY Manufacturer, by telephone July 30, 1994. Firm-initiated
recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 361.20 CWTS were distributed
REASON Possible cross contamination with broiler starter AB which
contains amprolium plus ethopabate and Bacitracin methylene
disalicylate.
-12-
END OF ENFORCEMENT REPORT FOR SEPTEMBER 21, 1994. BLANK PAGES MAY
FOLLOW.
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