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
04/03/1996

ENFORCEMENT REPORT FOR 04/03/96

April 3, 1996 96-14

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Betty Crocker brand (a) Cheddar Cheese Melt
Hamburger Helper, in 8 ounce boxes; (b)
Homestyle Salisbury Hamburger Helper, in 7.25
ounce boxes. Recall #F-370/371-6.
CODE Lot numbers: (a) G529KA14, G529KB14,
H602KA14, H602KB14, and H603KA14; (b) G529KA3,
H602KA3, and H602KB3.
MANUFACTURER Crest Food Company, Inc., Ashton, Illinois
(hamburger helper); Borden, Inc., St. Louis,
Missouri (pasta component).
RECALLED BY General Mills, Inc., Minneapolis, Minnesota,
by telephone on January 12, 1996, followed by
letter January on January 13, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,000 cases (12 boxes per case) were
distributed.
REASON Product contains undeclared eggs.

_______________
PRODUCT Knirps brand Limburger Cheese, in 6.5 ounce
tins, soft ripened cheese from Germany.
Recall #F-372-6.
CODE Item #922. 37-3 on shipping carton.
Individual foil-wrapped package has no code
markings.
MANUFACTURER J. Bauer, KG, Wasserburg, Germany.
RECALLED BY Swissrose International, Inc., Moonachie, New
Jersey, by letter on February 29, 1996. FDA-
initiated recall ongoing.
DISTRIBUTION Florida, Indiana, Maine, Massachusetts, New
Jersey, New York, Ohio, Utah, Virginia.
QUANTITY 200 cases (10 tins per case) were distributed.
REASON Product is contaminated with Listeria
monocytogenes.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Regular Lay's Potato Chips, in 6 ounce bags.
Recall #F-362-6.
CODE MAR12 4351C27 $149.
MANUFACTURER Frito-Lay, Inc., Orlando, Florida.
RECALLED BY Frito-Lay, Inc., Plano, Texas, by computer
notification on February 13, 1996. Firm-
initiated recall complete.
DISTRIBUTION Florida.
QUANTITY 420 cases (12 bags per case) were distributed;
firm estimates none remains on the market.
REASON The product contains dairy ingredients but the
label fails to disclose this fact. The
product bears an inappropriate identity
statement.

_______________
PRODUCT Gummi Rabbits, Easter candy in 8 ounce clear
plastic bags. Recall #F-365-6.
CODE None.
MANUFACTURER Trolli, Inc., Plantation, Florida.
RECALLED BY Maggie Lyons, Inc., Norcross, Georgia, by
telephone. Firm-initiated recall ongoing.
DISTRIBUTION Northeast and Southeast United States.
QUANTITY 480 pounds were distributed; firm estimates
none remains on the market.
REASON Product contained undeclared FD&C Yellow
No. 5.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Zinc Lozenges, dietary supplement.
Recall #F-361-6.
CODE 7698.
MANUFACTURER Magno-Humphries, Inc., Tigard, Oregon.

-2-RECALLED BY Manufacturer, by telephone and letter on
January 10, 1996. Firm-initiated recall
complete.
DISTRIBUTION Washington state.
QUANTITY 298 bottles were distributed.
REASON The "plain" zinc lozenges are packaged in
containers labeled "Cherry flavored).

_______________
PRODUCT On the Border brand Salsa in 16 and 32 ounce
jars. Recall #F-373-6.
CODE Lot numbers: 031097A, 031197B, 032197B,
032697A, 032797A/5358, 090197B, 5258/020897A,
5336 and 5354.
MANUFACTURER National Food and Beverage, Inc. (NFBI),
Row, Dallas, Texas.
RECALLED BY Manufacturer, by telephone and letter on
October 18, 1995. Firm-initiated recall
complete.
DISTRIBUTION Texas, Arkansas.
QUANTITY 26,496 jars were distributed; firm estimates
none remains on the market.
REASON Product is contaminated with yeast.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Spacol Tablets, Rx anti-cholinergic agent in
bottles of 100, packaged under the Dayton
Laboratories label. Recall #D-098-6.
CODE Lot #70A1282.
MANUFACTURER Wildflower Pharmacal Corporation, Mineola, New
York.
RECALLED BY Propharma, Inc., Miami, Florida, by telephone
on March 12, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Florida, Puerto Rico.
QUANTITY Firm estimates none remains on market.
REASON Product does not meet content uniformity
specifications.

_______________
PRODUCT TMP/SMZ Oral Suspension, Rx synthetic
antibacterial combination product repackaged
in the following bottle sizes: 100 ml, 120
ml, 150 ml, 180 ml, and 200 ml.
Recall #D-101-6.
CODE Lot numbers: RP5779-A, RA4032, RS3848 .
MANUFACTURER CompuMed, Inc., Harahan, Louisiana (repacker).
RECALLED BY Repacker, by letter on February 19, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Louisiana.

-3-QUANTITY 364 bottles were distributed; firm estimates
none remains on the market.
REASON Subpotency of trimethoprim ingredient.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Oxygen, USP, refrigerated liquid in a
cryogenic cylinder. Recall #D-102-6.
CODE Lot #0616596A EXP 3/2001.
MANUFACTURER National Welders Supply Company, Inc.,
Knoxville, Tennessee.
RECALLED BY Manufacturer, by visit on March 23, 1996.
FDA-initiated recall complete.
DISTRIBUTION Tennessee.
QUANTITY 1 cylinder was distributed and retrieved.
REASON Unit not tested for purity and identity.

_______________
PRODUCT (a) Urodol Caplets, containing Phenazopyridine
HCl, USP 200 mg per caplet, used to treat
urinary tract infections, in bottles of 100
and 30 caplets, Rx under the Dayton
Laboratories label; (b) Serenitas Tablets, in
bottles of 60, gives indications for aiding in
sleep, OTC under the Propharma label.
Recall #D-099/100-6.
CODE Lot numbers: (a) 70E1305; (b) 70C1299.
MANUFACTURER Wildflower Pharmacal Corporation, Mineola, New
York.
RECALLED BY Propharma, Inc., Miami, Florida, by telephone
on March 12, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Florida and Puerto Rico.
QUANTITY Firm estimates none remains on the market.
REASON Urodol product do not meet assay and content
uniformity specifications. Serenitas product
do not meet content uniformity specifications.

_______________
PRODUCT Docusate Sodium 100 mg Soft Gelatin Capsules,
non-prescription single ingredient stool
softener under the Schein label.
Recall #D-103-6.
CODE Lot #s: 67126 and 67127 labeled for Schein
(only 67127 was distributed) EXP 3/98.
MANUFACTURER Banner Pharmacaps, Inc., Elizabeth, New
Jersey.
RECALLED BY Manufacturer, by telephone on November 12,
1995, followed by letters on December 1, 1995,
and January 16, 1996. Firm-initiated recall
complete.
DISTRIBUTION New York, Arizona.
-4-QUANTITY 12,492 bottles were distributed.
REASON Discrepancy in label and carton text in
directions section.

_______________
PRODUCT Bactocill (oxacillin sodium for injection) 1
gram in 20ml vial, Rx antibiotic.
Recall #D-104-6.
CODE Lot #94507DA EXP 11/1/96.
MANUFACTURER SmithKline Beecham Pharmaceuticals,
Piscataway, New Jersey.
RECALLED BY Manufacturer, by letter sent December 18,
1995. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 15,380 vials were distributed.
REASON Marginally subpotent.

_______________
PRODUCT North O/H Pak Alcohol Wipes, wound cleanser,
antiseptic containing 70% Isopropyl Alcohol,
packaged for North Health Care, 100 foil
packed wipes per carton. Recall #D-105-6.
CODE Lot #5F3880, item #03-25-25.
MANUFACTURER Professional Disposables, Inc., Orangeburg,
New York.
RECALLED BY North Health Care, Rockford, Illinois
(repacker), by telephone on August 24, 1995.
Firm-initiated field correction complete.
DISTRIBUTION Hawaii, Michigan, Pennsylvania, Texas,
Illinois, Louisiana.
QUANTITY 57 cartons were distributed.
REASON Some intermediate packages were mislabeled as
North O/H Cold-A-Rest Nasal Decongestant, Pain
Reliever Tablets.

_______________
PRODUCT Amphojel Suspension, aluminum hydroxide gel,
without flavor, OTC antacid, in 12 fluid ounce
bottles. Recall #D-106-6.
CODE Lot #3941126 EXP 12/96.
MANUFACTURER Wyeth-Ayerst Laboratories, Rouses Point, New
York.
RECALLED BY Whitehall Robbins, Richmond, Virginia, by
letter dated March 22, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 31,668 units were distributed.
REASON Product does not meet potency specifications.

-5-_______________
UPDATE Cyproheptadine HCl 2mg/5ml Syrup, Recall #D-
096-6, manufactured by Halsey Drug Company,
Brooklyn, New York, which appeared in the
March 27, 1996 Enforcement Report has been
extended to include the following lot numbers:
4K10 (9/96), 4K19C (10/96), 4K19D (10/96),
4K28F (11/96), 4K28G (12/96), 5A12C (12/96),
5B16B (3/97), 5B16C (5/97), 5F08B (6/97),
5H08C (8/97), 5J07C (9/97), 5J07D (9/97) and
5L06 (10/97).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Platelets. Recall #B-327-6.
CODE Unit #39KX10113.
MANUFACTURER American Red Cross Blood Services, Huntington,
West Virginia.
RECALLED BY Manufacturer, by letter dated September 6,
1994. Firm-initiated recall complete.
DISTRIBUTION West Virginia.
QUANTITY 1 unit.
REASON Blood products, corresponding to a unit of Red
Blood Cells from which micrococcus sp. was
cultured, were distributed.

_______________
PRODUCT Platelets. Recall #B-329-6.
CODE Unit #39KX10791.
MANUFACTURER American Red Cross Blood Services, Huntington,
West Virginia.
RECALLED BY Manufacturer, by letter dated October 14,
1994. Firm-initiated recall complete.
DISTRIBUTION West Virginia.
QUANTITY 1 unit.
REASON Blood products, corresponding to a unit of Red
Blood cells contaminated with Staphylococcus
aureus, were distributed.

_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells;
(c) Platelets; (d) Platelets, Pheresis; (e)
Fresh Frozen Plasma. Recall #B-336/340-6.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 594-
1070 for individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Lansing,
Michigan.
RECALLED BY Manufacturer, by letter on May 10, 1994.
Firm-initiated recall complete.
DISTRIBUTION Michigan, California, Puerto Rico.

-6-QUANTITY (a) 7 units; (b) 613 units; (c) 406 units;
(d) 14 units; (e) 16 units.
REASON Blood products, which were incorrectly tested
for the antibody to the hepatitis C virus
encoded antigen (anti-HCV), were distributed.

_______________
PRODUCT (a) Red Blood Cells: (b) Platelets.
Recall #B-344/345-6.
CODE Unit #12415-0565.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, Albuquerque, New Mexico.
RECALLED BY Manufacturer, by telephone on January 23,
1996. Firm-initiated recall complete.
DISTRIBUTION New Mexico.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor who
received a tattoo within twelve months of
donation.

_______________
PRODUCT Autologous Red Blood Cells. Recall #B-346-6.
CODE Unit #N29989.
MANUFACTURER Mississippi Valley Regional Blood Center,
Davenport, Iowa.
RECALLED BY Manufacturer, by telephone on July 13, 1995.
Firm-initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit.
REASON Autologous blood product, not correctly
labeled "For Autologous Use Only," was
distributed.

_______________
PRODUCT Platelets, Pheresis. Recall #B-351-6.
CODE Unit numbers: 36242-8173-1, 36242-8173-2,
36243-4376, 36244-2882.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, Ventura, California.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated January 23, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION California, Illinois, Missouri.
QUANTITY 4 units.
REASON Blood products, collected from a donor whose
spouse tested positive for the hepatitis B
surface antigen (HBsAg), were distributed.

_______________
PRODUCT Platelets. Recall #B-357-6.
CODE Unit #11313 1029.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, El Paso, Texas.
-7-RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated February 21, 1996. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product, which was collected from a
donor who exceeded the donation collection
time, was distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Recovered Plasma. Recall #B-328-6.
CODE Unit #39KX10113.
MANUFACTURER American Red Cross Blood Services, Huntington,
West Virginia.
RECALLED BY Manufacturer, by letter on August 31, 1994.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood products, corresponding to a unit of Red
Blood Cells from which micrococcus sp. was
cultured, were distributed.

_______________
PRODUCT Recovered Plasma. Recall #B-330-6.
CODE Unit #39KX10791.
MANUFACTURER American Red Cross Blood Services, Huntington,
West Virginia.
RECALLED BY Manufacturer, by letter on October 14, 1994.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood products, corresponding to a unit of Red
Blood Cells contaminated with Staphylococcus
aureus, were distributed.

_______________
PRODUCT (a) Red Blood Cells, for further manufacture;
(b) Platelets, for further manufacture; (c)
Recovered Plasma. Recall #B-341/343-6.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 594-
1070 for individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Lansing,
Michigan.
RECALLED BY Manufacturer, by letter on May 10, 1994.
Firm-initiated recall complete.
DISTRIBUTION Michigan, California, Puerto Rico.
QUANTITY (a) 1 unit; (b) 78 units; (c) 631 units.

-8-REASON Blood products, which were incorrectly tested
for the antibody to the hepatitis C virus
encoded antigen (anti-HCV), were distributed.

_______________
PRODUCT Recovered Plasma. Recall #B-347-6.
CODE Unit #N29989.
MANUFACTURER Mississippi Valley Regional Blood Center,
Davenport, Iowa.
RECALLED BY Manufacturer, by telephone on July 14, 1995.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Autologous blood product, not correctly
labeled "For Autologous Use Only," was
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-348/350-6.
CODE Unit numbers: (a) 10213-5598
10201-6825 10193-6705 10231-4988
01198-6632 10206-5924 10210-6553
10210-1919 10241-4203 10229-0618
10152-6999 10493-5336
(b) 10206-5924 10213-5598 10231-4988
(c) 10198-6632 10210-1919 10201-6825
10152-6999 10493-5336 10241-4203
10229-0618 10220-6553 10213-5598
10206-5924 10193-6705 10231-4988.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated December 28, 1995. Firm-
initiated recall complete.
DISTRIBUTION Florida, Massachusetts, Virginia, Texas, North
Carolina, Arizona, Switzerland.
QUANTITY (a) 12 units; (b) 3 units; (c) 12 units.
REASON Blood products, which tested negative for the
hepatitis B surface antigen (HBsAg), and the
antibody to the hepatitis B core antigen
(anti-HBc), but were collected from a donor
who previously tested positive for HBsAg, were
distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Latex Free Outlet Hoses for use with Ohmeda
Anesthesia Systems:
(a) Latex Free Outlet Hoses for Part No.
0236-0042-800;

-9- (b) Latex Free Outlet Hoses for Part No.
0236-0042-801;
(c) Latex Free Outlet Hoses for Part No.
1010-8057-000;
(d) Latex Free Outlet Hoses for Part No.
1010-7064-000. Recall Z-538/541-6.
CODE Hoses manufactured since September 22, 1995.
MANUFACTURER Ohmeda Medical Systems Division, Madison,
Wisconsin.
RECALLED BY Manufacturer, by letter dated March 1, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 1,661 hoses were distributed.
REASON The inner wall of this hose may be cut during
insertion of the hose connectors during
manufacturing which results in restricted gas
flow during the oxygen flush.

_______________
PRODUCT Biad 89 and Triad 88 Whole body Spect Nuclear
Imaging Systems, used by technologists for
diagnostic and research purposes.
Recall #Z-546/547-6.
CODE Biad 89 with serial numbers 102 - 190;
Triad 88 with serial numbers 101 - 197.
MANUFACTURER Trionix Research Laboratory, Inc., Twinsburg,
Ohio.
RECALLED BY Manufacturer, by letter May 6, 1995. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 133 units were distributed.
REASON Due to a gantry code software error in
calculating the collimator thickness, the
device's detector head may move closer to the
patient than necessary and may even touch the
patient, which could result in potential
injury to patients.

_______________
PRODUCT One-Step Armboard Surgical Table Accessory,
Part #426637-542, Model numbers F-ABSA-A1, F-
ABSA-A2, F-ABSA-A3, designed for use on the
AMSCO 1080, AMSCO 2080 and AMSCO QUANTUM 3080
Surgical Tables. Recall #Z-551-6.
CODE Serial numbers 29724 through 40852.
MANUFACTURER AMATECH Corporation, Acton, Massachusetts
(armboard); AMSCO, American Sterilizer
Company, Montgomery, Alabama (tables).
RECALLED BY AMSCO, American Sterilizer Company, Erie,
Pennsylvania, by memorandum issued on December
18, 1995, January 20, 1996, and February 21,
1996. Firm-initiated recall ongoing.

-10-DISTRIBUTION Nationwide and international.
QUANTITY 4,498 units were distributed.
REASON The armboard may detach from the surgical
table, and possibly injure the patient.

_______________
PRODUCT Midmark Model 7100 General Surgical Tables.
Recall #Z-552-6.
CODE Serial Numbers: TDW-1081 through TDW-1092,
TDW-1094 through TDW-1115.
MANUFACTURER M. Schaerer AG, Moosseedorf, Switzerland.
RECALLED BY Midmark Corporation, Versailles, Ohio, by
telephone on September 27, 1995. Firm-
initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 2 units were distributed.
REASON There is a potential for the surgical table
become unstable due to faulty weld of the
table column.

_______________
PRODUCT SYNERGYTM Anterior Spinal System Implants:
(a) Part No. 4105 Implant Sterilization Case
and SYNERGYTM Anterior Spinal System Implants
including hex nuts, integral screws, closed
screws, rods, anterior washers, and crosslink
assemblies
(b) Part No. 4106 Instrument Sterilization
Case # 1
(c) Part No. 4107 Instrument Sterilization
Case # 2. Recall #Z-553/555-6.
CODE All code.
MANUFACTURER Cross Medical Products, Inc., Columbus, Ohio.
RECALLED BY Manufacturer, by letter dated March 10, 1995.
Firm-initiated field correction complete.
DISTRIBUTION Kentucky, Utah, Alabama, Georgia, Indiana,
Minnesota, North Carolina, Florida, Italy,
Japan, Turkey, Korea, Singapore, Belgium.
QUANTITY 5,726 implantable devices were distributed.
REASON The package insert, Part No. EXP003-1,
specifies an inadequate sterilization time
that does not ensure that the required
sterility assurance level is achieved.

_______________
PRODUCT First-Medic 710 Semi-Automatic Defibrillator.
Recall #Z-556-6.
CODE Serial Numbers 560-00032 to 560-000857 (non-
continuous).
MANUFACTURER Physio Control Corporation, Redmond,
Washington.

-11-RECALLED BY Manufacturer, by visit beginning on February
2, 1996 and hand delivered letter. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 109 units were distributed.
REASON The units may inadvertently switch from the
semi-automatic mode to the manual mode during
operation of the device, due to defective
software.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT IL Testtm PT-Fibrinogen for the ACL System,
used for the simultaneous determination of
Prothrombin Time and Fibrinogenon the ACl (tm)
System. Recall #Z-532-6.
CODE Catalog #97567-10, lot numbers NO342966 and
N0443403.
MANUFACTURER Instrumentation Laboratory Company,
Orangeburg, New York.
RECALLED BY Instrumentation Laboratory Company (ILC),
Lexington, Massachusetts, by letter dated
September 15, 1994 and by telephone December
1995. Firm-initiated recall complete.
DISTRIBUTION Michigan, Missouri, Florida, Arkansas,
Louisiana, Vermont, Arizona, Iowa, Texas,
Virginia, New York, Oregon, California.
QUANTITY 4200 kits were distributed.
REASON The recovery values were not in the expected
range.

_______________
PRODUCT ReferrILtm 3/C Calibrator for the IL Genesis
Analyzer, and the IL Monarch and Multistat
Systems, for in-vitro diagnostic use.
Recall #Z-533-6.
CODE Catalog #35222-12, lot #N1132194.
MANUFACTURER Instrumentation Laboratory Company,
Orangeburg, New York.
RECALLED BY Instrumentation Laboratory Company (ILC),
Lexington, Massachusetts, by letter dated May
15, 1995, followed by telephone during mid-
December 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 1,745 packages were distributed.
REASON The T. Bilirubin recoveries were high.

-12-_______________
PRODUCT IL Testtm ISE Reference and Buffer Solution
for the Monarch and Phoenix Chemistry Systems,
for in-vitro diagnostic use: (a) ISE Reference
Catalog numbers: 3337204; (b) ISE Buffer
Catalog #3337404. Recall #Z-534/535-6.
CODE Lot Numbers: (a) N0642924, N0732923, N0532065,
N0432064; (b) N1142995, N0142072, N1232071,
N1133554, N0732070, N0632089, N0432068,
N1121692.
MANUFACTURER Instrumentation Laboratory Company,
Orangeburg, New York.
RECALLED BY Instrumentation Laboratory Company (ILC),
Lexington, Massachusetts, by letters dated
April 11, 1995 and September 29, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide, Puerto Rico, Antigua, British West
Indies.
QUANTITY Lot No. Quantity Released
(a) N0842824 3000
N0732923 2541
N0532085 2549
N0432084 2547
(b) N0142072 5182
N1232071 5088
N1133554 5162
N0732070 3078
N0632089 3839
N0432068 2048
N1121692 811.
REASON The bacteriostat/fungistat potency may
decrease after one year which is short of the
expiration date.
_______________
PRODUCT (a) IL Testtm APTT (Activated Partial
Thromboplastin Time), for in-vitro diagnostic
use; (b) IL Testtm Pt-Fibrinogen reagents for
the ACO System, for in-vitro diagnostic use.
Recall #Z-536/537-6.
CODE (a) Catalog No. 200060,
Kit Lot Nos. APPT Reagent Lot Nos.
N0242975 (5/95) N0242974 (5/95)
N0543374 (11/96) N0543369 (11/96)
N0742946 (12/95) N0543340 (12/95)
N0742947 (1/96) N0743371 (1/96)
N0742948 (1/96) N0743244 (1/96)
N1043312 (3/96) N1043245 (3/96
(b) Catalog No. 97567-10, Lot Nos. N0543405
(5/97), N01143411 (11/97), N01043409 (10/97),
N0743406 (7/97).
MANUFACTURER Instrumentation Laboratory Company,
Orangeburg, New York.
-13-RECALLED BY Instrumentation Laboratory Company (ILC),
Lexington, Massachusetts, by letter dated
January 25, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY (a) Kit Lot #N0242975 = 817 kits
Kit Lot #N0543374 = 4643
Kit Lot #N0742946 = 5045
Kit Lot #N0742947 = 5374
Kit Lot #N0742948 = 7851
Kit Lot #N1043312 = 8712
(b) PT-FIB: Lot #N0543405 = 3864
Lot #N1143411 = 3831
Lot #N1043409 = 3733
Lot #N0743406 = 3791.
REASON The normal range values may have an upward
shift of 0.5 to 1.0 seconds for the IL TEST
PT-FIB and 2 to 4 seconds for the APTT. The
APTT may also have an increased sensitivity to
lupus-like inhibitors.

_______________
PRODUCT Victory series Orthodontic 2nd Bicuspid
Brackets:
(a) Miniature Metal Wing, Part# 017-433;
(b) Mini Mesh Alexander Rx, Part# 2017-433;
(c) APC Miniature Metal Single, Part# 017-460.
Recall #Z-557/559-6.
CODE None. Recall limited to specific shipments of
product to specific customers who were sent
the recall notification letter.
MANUFACTURER 3M Unitek, 3M Dental Products Division,
Monrovia, California.
RECALLED BY Manufacturer, by letter dated November 17,
1995. Firm-initiated recall ongoing.
DISTRIBUTION California, Colorado, Indiana, Missouri, Ohio,
Oklahoma, South Dakota, Tennessee, Texas,
Utah, and international.
QUANTITY 3,162 brackets subject to recall.
REASON The packaging labels were labeled with a -17°
bracket torque when the packages actually
contained products with a -11° bracket torque.

_______________
PRODUCT Bacto Streptolysin O Reagent, desiccated
streptolysin O, in vials labeled 10 ml, an in-
vitro diagnostic used for determining the
amount of antistreptolysin O titers in sera.
Recall #Z-563-6.
CODE Lot #69762JA.
MANUFACTURER Difco Laboratories, Livonia, Michigan.
RECALLED BY Manufacturer, by letter sent on November 20,
1995. Firm-initiated recall complete.
-14-DISTRIBUTION California, Delaware, Illinois, Kansas,
Kentucky, Mississippi, Missouri, Ohio, Puerto
Rico, Texas, Canada, England, Finland
Honduras, Turkey.
QUANTITY 135 packages were distributed.
REASON The 25 ml vials containing reagent were
incorrectly labeled to rehydrate with 10 ml of
distilled water.

_______________
PRODUCT Dade Actin Activated Cephaloplastin Reagent,
an in-vitro diagnostic, under the following
private labels: Baxter Healthcare, Baxter
Diagnostics, Baxter S.A., Baxter S.p.A.,
Baxter NV/S, Baxter S.A. BP 56, Baxter
Deutschland GmbH, Baxter Healthcare Ltd,
Baxter Medical AB, Baxter Dade A.G.
Recall #Z-566-6.
CODE Lot numbers: APAC-611 A, B, C, D, E and F;
APAC-614 A, B, C, D and E; APAC-618 A, B, C,
and D.
MANUFACTURER Dade International of Puerto Rico, Aguada,
Puerto Rico.
RECALLED BY Manufacturer, by letter dated December 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 52,217 packages were distributed.
REASON The Activated Cephaloplastin Reagent gave a
prolonged activated partial thromboplastin
times with normal and abnormal controls and
normal patient samples.

INFORMATION: ================================================

AGAINST Roger Ferris and Anthony Ferris, Utica, New
York.
CHARGED August 17, 1995 - One-Count Criminal
Misdemeanor Information; Cr. #95-CR-369(DNH),
U.S. District Court for the Northern District
of New York. On or about August 16, 1995, in
the Northern District of New York, the
defendants did forcibly assault, resist,
oppose, impede, intimidate, and interfere with
a government investigator while engaged in or
on account of the performance of official
duties, namely as an Investigator of the U.S.
Food and Drug Administration conducting a
routine sanitary inspection of R. Ferris &
Sons, Inc., a wholesale produce distributor,
in Utica, New York. October 17, 1995 - Plea
Agreement Under Rule 11 of the Federal Rules
of Criminal Procedure; Cr. #95-CR-369(DNH);

-15- U.S. District Court for the Northern District
of New York. The defendants each plead guilty
to a One-Count Misdemeanor Information, as
charged.
SENTENCE The defendants were fined $1,500 each and
sentenced to serve 100 hours of community
service, and placed on probation for one year.

-16-

END OF ENFORCEMENT REPORT FOR APRIL 3, 1996.
BLANK PAGES MAY FOLLOW.

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