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.


February 3, 1999                                 99-05

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________
PRODUCT
Caramel Apple Kisses, individually wrapped caramel/taffy candy sold in bulk 21.5 pound cartons. Recall #F-148-9.

CODE
Case codes A8177 and A8190.

MANUFACTURER
Primrose Candy Company, Chicago, Illinois.

RECALLED BY
Manufacturer, by telephone on October 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
Oregon and Washington state.

QUANTITY
16 cases were distributed.

REASON
Product contained undeclared peanuts.

________
PRODUCT
Egg Roll Wrappers, in 40 pound boxes. Recall #F-150-9.

CODE
All product produced before December 5, 1998.

MANUFACTURER
Wan-Gee Foods, Inc., doing business as Hanson Foods Manufacturing Company, St. Louis, Missouri.

RECALLED BY
Manufacturer, by telephone and by letter dated December 17, 1998. Firm-initiated recall complete.

DISTRIBUTION
Minnesota, Texas, Illinois, Missouri, Nebraska, Indiana, Oklahoma, Ohio.

QUANTITY
Undetermined.

REASON
Product may contain undeclared eggs.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II

________
PRODUCT
Nog brand Chocolate Variegate, product #201. Recall #F-147-9.

CODE
Lot numbers: 14821, 14822, 14824.

MANUFACTURER
Nog, Inc., Dunkirk, New York.

RECALLED BY
Manufacturer, by telephone and letter on January 30, 1998. Completed recall resulted from sample analysis and follow-up by the New York State Department of Agriculture and Markets.

DISTRIBUTION
North Carolina.

QUANTITY
6 Totes (3000 lbs. each) were distributed.

REASON
Product was a low-acid canned food that was manufactured without adherence to Federal canned food regulations.

________
PRODUCT
Poultry Stuffing, 10 pound and 20 ounce size packages. Recall #F-149-9.

CODE
Lot #'s 371, 372, 373, 374, 375, 377, 378, 381, 383,385, 386, 389, 390, 391, 392.

MANUFACTURER
Winter Gardens Quality Food, Inc., New Oxford, Pennsylvania.

RECALLED BY
Manufacturer, by visit beginning on December 11, 1998, and by letter mailed December 16, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Mid-Atlantic states.

QUANTITY
Approximately 1000 pounds were distributed.

REASON
Product contains undeclared FD&C Yellow No. 5, FD&C Yellow No. 6, and FD&C Red No. 40.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

________
PRODUCT
Oxygen, USP, compressed, in the following sizes of cylinders: OXUSP200 (equivalent to H), OXUSP150 (equivalent to S), OXUSP125 (equivalent to M), OXUSPE00, OXUSPD00, and OXUSPB00. Recall #D-096-9.

CODE

Lot #Q00J341A, EXP 12-07-98     Lot #Q00J341B, EXP 12-07-98
Lot #Q00J342A, EXP 12-08-98     Lot #Q00J343A, EXP 12-09-98
Lot #Q00J343B, EXP 12-09-98     Lot #Q01J344A, EXP 12-10-98
Lot #Q01J345A, EXP 12-11-98     Lot #Q01J348A, EXP 12-14-98
Lot #Q01J348B, EXP 12-14-98     Lot #Q01J349A, EXP 12-15-98
Lot #Q01J350A, EXP 12-16-98     Lot #Q01J351A, EXP 12-17-98
Lot #Q01J352A, EXP 12-18-98     Lot #Q01J355A, EXP 12-21-98
Lot #Q01J356A, EXP 12-22-98     Lot #Q01J357A, EXP 12-23-98
Lot #Q01J357B, EXP 12-23-98.

MANUFACTURER
Airgas - North Central, Inc., Spencer, Iowa.

RECALLED BY
Airgas - North Central, Inc., Waterloo, Iowa, by telephone on December 28, 1998, and by letter dated January 5,1999. Firm-initiated recall ongoing.

DISTRIBUTION
Iowa, South Dakota, Minnesota.

QUANTITY
687 cylinders were distributed.

REASON
Mislabeling - Product given incorrect expiration date.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ________
PRODUCT
Platelets, Pheresis. Recall #B-115-9.

CODE
Unit #3358036.

MANUFACTURER
Gulf Coast Regional Blood Center, Houston, Texas.

RECALLED BY
Manufacturer, by fax dated July 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product had an unacceptable platelet count.

________
PRODUCT
Source Leukocytes. Recall #B-180-9.

CODE
Unit #53GN11855.MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letters dated February 3, 1998 and April 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Jersey and Switzerland.

QUANTITY
1 unit was distributed.

REASON
Blood product tested negative for HBsAg, but was collected from a donor who previously tested reactive for Hepatitis B.

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-392/393-9.

CODE
Unit #12433-1955.

MANUFACTURER
United Blood Services, Albuquerque, New Mexico.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on December 2, 1998, and by letter dated December 17, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Mexico and Colorado.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor taking the drug Methotrexate.

________
PRODUCT
a) Plasma; b) Red Blood Cells for Further Manufacture. Recall #B-394/395-9.CODE
Unit #53GL86233.

MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter dated June 23, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois and Maryland.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who gave a history of having tested positive for hepatitis.

________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-398/399-9.

CODE
Unit #3373411.

MANUFACTURER
Gulf Coast Regional Blood Center, Houston, Texas.

RECALLED BY
Manufacturer, by fax dated July 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas and New Jersey.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor whose suitability was not adequately determined.

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-406/407-9.

CODE
Unit #8003752.

MANUFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED BY
Manufacturer, by letter dated November 18, 1998, and by telephone on November 17, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

________
PRODUCT
a) Red Blood Cells; b) Plasma. Recall #B-408/409-9.

CODE
Unit #53L05240.

MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter dated November 16, 1998, or by telephone on November 4, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maryland and District of Columbia.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of having tested positive for hepatitis.

________
PRODUCT
Red Blood Cells. Recall #B-410-9.

CODE
Unit numbers: 10013837, 10013847, 10013849.

MANUFACTURER
W.E. & Lela I. Stewart Regional Blood Center, Tyler, Texas.

RECALLED BY
Manufacturer, by letter dated August 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
3 units were distributed.

REASON
Blood products were collected in a manner that compromised the sterility of the units.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitated AHF; e) Recovered Plasma. Recall #B-411/415-9.

CODE
Unit numbers: a) 4620321, 4734241, 4774365, 4933063, 4980277, 5019749, 5064112; b) 4933063, 4980277; c) 4933063, 4980277, 5064112; d) 5019749; e) 4620321, 4734241, 4774365.

MANUFACTURER
BloodCare, Dallas, Texas.

RECALLED BY
BloodCare, doing business as Carter BloodCare, Bedford, Texas, by telephone on August 14, 1998, and by letter dated August 25, 1998. Firm-initiated recall complete.

DISTRIBUTION
Louisiana, Texas, California, Switzerland.

QUANTITY
a) 7 units; b) 2 units; c) 3 units; d) 1 unit; e) 3 units were distributed.

REASON
Blood products tested negative for the antibody to the human T-lymphotropic virus type I (anti-HTLV-I), but were collected from a donor who previously tested repeatedly reactive for anti-HTLV-1.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Plasma; d) Recovered Plasma. Recall #B-418/421-9.

CODE
unit numbers: a) 53M74012, 53FC58478; b) 53M74012; c) 53M74012; d) 53FC58478.

MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.

RECALLED BY
Manufacturer, by letter dated May 27, 1998, or by telephone on May 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
Maryland.

QUANTITY
a) 2 units; b-d) 1 unit of each component was distributed.

REASON
Blood products were collected from a donor who had previously been deferred for having engaged in high risk behavior.

________
PRODUCT
Red Blood Cells. Recall #B-422-9.

CODE
Unit numbers: 42M95167 and 42FM22637.

MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.

RECALLED BY
Manufacturer, by letter dated December 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
2 units were distributed.

REASON
Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

________
PRODUCT
a) Platelets; b) Fresh Frozen Plasma. Recall #B-424/425-9.

CODE
Unit #3440490.

MANUFACTURER
Gulf Coast Regional Blood Center, Houston, Texas.

RECALLED BY
Manufacturer, by telephone on August 13, 1998, and by fax dated either July 17, 1998, or August 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor taking the drug Proscar.

________
PRODUCT
Platelets, Pheresis. Recall #B-426-9.

CODE
Unit #10012571.

MANUFACTURER
W.E. & Lela I. Stewart Regional Blood Center, Tyler, Texas.

RECALLED BY
Manufacturer, by letter dated October 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected in a manner that compromised the sterility of the unit.

________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall #B-427-9.

CODE
Unit numbers: 17182-3791-02, 17184-0091-01, 17184-2192.

MANUFACTURER
United Blood Services, McAllen, Texas.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated October 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas.

QUANTITY
3 units were distributed.

REASON
Blood products had unacceptable platelet counts.

________
PRODUCT
Platelets. Recall #B-428-9.

CODE
Unit #H38714.

MANUFACTURER
Northern Illinois Blood Bank, Rockford, Illinois.

RECALLED BY
Manufacturer, by telephone on June 22, 1998, and by letter dated July 10, 1998. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

QUANTITY
1 unit was distributed.

REASON
Blood product was mislabeled as CMV antibody negative.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma. Recall #B-396/397-9.

CODE
Unit #KH88698.

MANUFACTURER
Virginia Blood Services, Richmond, Virginia.

RECALLED BY
Manufacturer, by letters dated December 8, 1998, and September 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Virginia and Switzerland.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were colleted from a donor whose donor history screening was incomplete.

________
PRODUCT
Fresh Frozen Plasma. Recall #B-400-9.

CODE
Unit #26156-0453.

MANUFACTURER
United Blood Services, Hot Springs, Arkansas.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on November 16, 1998, and by letter dated November 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arkansas.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from a whole blood unit that had discrepant start and end times documented.

________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall #B-401-9.

CODE
Unit #11320-6658.

MANUFACTURER
United Blood Services, El Paso, Texas.

RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on November 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Mexico.

QUANTITY
1 unit was distributed.

REASON
Blood product was stored at unacceptable temperatures.

________
PRODUCT
Allergenic Extract - GS Rhizopus Mix. Recall #B-402-9.

CODE
Lot MO12-143-1G1.

MANUFACTURER
Greer Laboratories, Inc., Lenoir, North Carolina.

RECALLED BY
Manufacturer, by telephone on December 11, 1998 and December 14, 1998. Firm-initialed recall complete.

DISTRIBUTION
Florida and Wisconsin.

QUANTITY
2 vials.

REASON
Allergenic extract was labeled with an incorrect lot number.

________
PRODUCT
Red Blood Cells, Washed. Recall #B-416-9.

CODE
Unit #07FJ31030.

MANUFACTURER
American Red Cross, Tucson, Arizona.

RECALLED BY
Manufacturer, by letter dated November 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Arizona.

QUANTITY
1 unit was distributed.

REASON
Red blood cells failed red cell recovery ratio.

________
PRODUCT
Red Blood Cells. Recall #B-417-9.

CODE
Unit #49X64859.

MANUFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.

RECALLED BY
Manufacturer, by telephone on December 4, 1998. Firm-initiated recall complete.

DISTRIBUTION
Oklahoma.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who exceeded the donation acceptance criteria for body temperature.

________
PRODUCT
Platelets. Recall #B-423-9.

CODE
Unit #39F67614.

MANUFACTURER
American Red Cross, Huntington, West Virginia.

RECALLED BY
Manufacturer, by letter dated October 7, 1998. Firm-initiated recall complete.

DISTRIBUTION
West Virginia.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a unit of whole blood with a discrepant collection time.

________
PRODUCT
Red Blood Cells, Irradiated. Recall #B-430-9.

CODE
Unit #04S87117.

MANUFACTURER
American Red Cross, Dedham, Massachusetts.

RECALLED BY
Manufacturer, by telephone on January 14, 1997. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts.

QUANTITY
1 unit was distributed.

REASON
Blood product was stored at unacceptable temperatures.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

_______
PRODUCT
Intraocular Lens, Model MA60BM. Recall #Z-373-9.

CODE
Lot 481577, Various serial numbers.

MANUFACTURER
Alcon Laboratories, Huntington, West Virginia.

RECALLED BY
Manufacturer, by letter on or about November 15, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Japan.

QUANTITY
7 lenses were distributed.

REASON
Mislabeling - The dioptric power on the primary label (17.0D) did not match that on the secondary label (17.5D). The actual power for all units measured 17.0D.

________
PRODUCT
Simulix-HP, radiation therapy simulation system. Recall #Z-374-9.

CODE
Product manufactured between 1994 and 1995.

MANUFACTURER
Nucletron BV, The Netherlands.

RECALLED BY
Nucletron Corporation, Columbia, Maryland, by correcting units beginning on August 11, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Ohio, Indiana, Missouri, Canada.

QUANTITY
7 units were distributed.

REASON
Oil leaking from AFD motor and dripping onto the brake assembly of the opposing FAD motor causing the brake to slip, potentially permitting involuntary and unwanted movement of the gantry.

_______
PRODUCT

2 Fr. Nutriline Neonatal Catheter and 2 Fr. Nutriline 
Catheter Tray:
a) 2 Fr. Nutriline Neonatal Catheter, Product No. 1262.30,
Expiration Date 12/02, and 06/03;
b) 2 Fr. Nutriline Neonatal Catheter and Tray, Product No.
1262.03K, EXP Date 12/00 and 03/01. Recall #Z-516/517-9.

CODE
Lot numbers: a) G07.A41, H03.A22, H91.A23; b) 9788, 9788A, 108333.

MANUFACTURER
Vygon GmBH & Company KG, Aacheln, Germany.

RECALLED BY
Vygon Corporation, East Rutherford, New Jersey, by letter dated June 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts, Connecticut, New York, Pennsylvania, Maryland, Georgia, Florida, Ohio, Minnesota, Illinois, Missouri, Louisiana, Oklahoma, Texas, Colorado, Arizona, California, Hawaii, Washington state, Puerto Rico, Canada.

QUANTITY
a) 75 trays; b) 758 trays were distributed.

REASON
Devices exhibited cracking at the catheter hub during use due to a change in the product hub dimensions and a change in material.

________
PRODUCT

Wound Closure Instrument Trays and Incision and Drainage Trays:
a) Baxter Wound Closure Instrument Trays (Catalogue Nos.
25004-010, 25004-020, 25004-040, 24004-010, 24004-020,
24004-040);
b) Baxter Incision and Drainage Trays (Catalogue Nos. 25006-010,
25006-040, 24006-010); 
c) Ni-Med Incision and Drainage Trays (Catalogue No. 15-1220. 
Recall #Z-521/523-9.

CODE

a)  BAXTER - Wound Closure Instrument Trays
    Cat. #25004-010 (stainless instruments), lot #719, #765
    Cat. #25004-020 (stainless instruments), lot #722, #765
    Cat. #25004-040 (stainless instruments), lot #716, #719,
         #722, #763, #766
    Cat. #24004-010 (wire instruments), lot #716, #764
    Cat. #24004-020 (wire instruments), lot #716, #719
    Cat. #24004-040 (wire instruments), lot #716;
b)  BAXTER  - Incision and Drainage Trays 
    Cat. #25006-010 (stainless instruments), lot #762
    Cat. #25006-040 (stainless instruments), lot #716, #764, #765
    Cat. #24006-010 (wire instruments), lot #716, #719, #765;
c)  NI-MED - Incision and Drainage Trays
    Cat. #15-1220, lot #687.

MANUFACTURER
Ni-Med, Inc., Farmington, Missouri.

RECALLED BY
Manufacturer, by telephone on October 20, 1998, and by letters dated November 5, 1998, and December 8, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
a&b) Approximately 1,086 cases were distributed; c) 2 cases were distributed.

REASON
The sterility of some packages may be breached.

________
PRODUCT
I-125 SEEDS, Model 6711. Recall #Z-524-9.

CODE
Sales order 559202.

MANUFACTURER
Medi-Physics, Inc., Arlington Heights, Illinois.

RECALLED BY
Nycomed Amersham Imaging, Princeton, New Jersey, by telephone on January 6, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama.

QUANTITY
111 seeds were distributed.

REASON
Out of radioactive range seed present in shipment.

________
PRODUCT
DFS Dimension Distal Radius Fixator, Product No. 04300, a unilateral external fixator designed for the treatment of upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies and soft tissue deformities. Recall #Z-525-9.

CODE
Lot Numbers (Etched on unit) 029333, 031503, 031993, 038346, 038484, Packing Lot Nos. 029522, 033559, 032998, 038443 or 038444, 038533 or 038733.

MANUFACTURER
EBI Medical Systems, Inc., Parsippany, New Jersey, by letters dated October 14, 1998, and November 5, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York, Maryland, Texas, California, Illinois, Virginia, Pennsylvania, South Dakota, Iowa.

QUANTITY
126 units were distributed.

REASON
The binding that locks the distal rail in place could prevent the ball from locking properly at the time of operation.

________
PRODUCT
BioGran/Bioactive glass Syringe Bone Graft Material 750 mg 300-355 mm (50-45 mesh): a) Part No. 2100-0001 (2 pk); b) Part No. 2100-0002 (7 pk). Recall #Z-526/527-9.

CODE
Lot numbers: a) 802017; b) 803015, 803024, 803025, 803032, 804018, 805016, 805017, 806019, 806020.

MANUFACTURER
Ethox Corporation, Buffalo, New York.

RECALLED BY
Orthovita, Malvern, Pennsylvania, by letters dated October 1998, and October 9, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Texas, Georgia, Kentucky, Michigan, international.

QUANTITY
24,757 syringes were distributed.

REASON
The BioGran material cannot be dispensed from the syringes without greater than normal force resulting in potential breakage of syringes and possible injury to users and patient.

________
PRODUCT

Unipolar Endoscopic Coagulator-Cutter Electrodes:
Tip style, electrode size, Endovnt cat, Vital cat, Dexide cat, Smith & Nephew
a) Spatula 
w/o suction 5mm x 33cm:    custom,      n/a,       n/a,         n/a
w/o suction 4mm x 32cm:    custom,      n/a,       n/a,         n/a
w/o suction 5mm x 32cm:    15-1123,     n/a,       n/a,         n/a
w/suction   5mm x 33cm:    15-1124,     56300,     200-43,    7205708
w/suction   5mm x 45cm:    n/a,         n/a,       200-53,      n/a
b) J-Hook
w/o suction 3mm x 30cm:    23-5017,     n/a,       n/a,         n/a
w/o suction 4mm x 33cm:    custom,      n/a,       n/a,         n/a
w/o suction 5mm x 32cm:    15-1112,     n/a,       n/a,         n/a
w/o suction 5mm x 33cm:    custom,      n/a,       n/a,         n/a
w/suction   5mm x 33cm:    custom,      56301,     200-45,    7205709
w/suction   5mm x 45cm:    n/a,         n/a,       200-55,      n/a
c) L-Hook
w/o suction 4mm x 33cm:    custom,      n/a,       n/a,         n/a
w/o suction 5mm x 33cm:    15-1110,     n/a,       n/a,         n/a
w/suction   5mm x 33cm:    custom,      56302,     200-44,    7205710
w/suction   5mm x 45cm:    n/a,         n/a,       200-54,      n/a
d) Needle
w/o suction 4mm x 33cm:    custom,      n/a,       n/a,         n/a
w/o suction 5mm x 45cm:    custom,      n/a,       200-56,    7205711
w/o suction 5mm x 33cm:    n/a,         n/a,       200-46,      n/a
w/suction   5mm x 33cm:    custom,      n/a,       n/a,         n/a
w/suction   5mm x 45cm:    custom,      n/a,       n/a,         n/a
e) Knife
w/o suction 5mm x 33cm:    n/a,         n/a,       200-47,      n/a
w/o suction 5mm x 45cm:    n/a,         n/a,       200-57,      n/a
f) Button
w/o suction 5mm x 33cm:    n/a,         n/a,       200-48,      n/a   w/o
suction 5mm x 45cm:        n/a,         n/a,       200-58,      n/a
Recall #Z-529/552-9.

CODE
There are no lot numbers for the Endoventions or Vital Concepts catalog numbers. Lot numbers for electrodes sold under the Dexide catalog numbers are any lot number that starts with "065".

MANUFACTURER
U.S. Endo, Inc., Bensenville, Illinois.

RECALLED BY
Manufacturer, by telephone on December 11 and 18, 1998, and by letter on January 11, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Illinois, Michigan, California, Missouri, Washington state, Ohio, Texas, Massachusetts.

QUANTITY
1,095 electrodes were distributed.

REASON
The electrodes were marketed without an approved 510(k) and failed insulation testing.

_______
UPDATE



Haemotronic Arterial - Venous Blood Tubing Sets, used in
conjunction with dialyzers during hemodialysis:
a) Product No. TS 505/H2,;
b) Product No. TS 508/H2.  Recall #Z-505/506-9, which appeared in
the January 27, 1999 Enforcement report should read:
CODE

Lot numbers:  a) B97-6263; b) B98-67.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________
PRODUCT
Auto Suture disposable Stapling Instrument: a) Signet 35W, Sterile; b) Signet 35W, Non-Sterile, bulk. Recall #Z-180/181-9.

CODE
a) Product #054006; b) Product #054016.

MANUFACTURER
United States Surgical Corporation, North Haven, Connecticut.

RECALLED BY
Manufacturer, by telephone on October 9, 1998. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
a) 177,971 units; b) 2,143 bulk were distributed.

REASON
Staple may not release after firing.

________
PRODUCT
Human Aortic Heart Valve for Transplantation, Model No. AV00. Recall #Z-479-9.

CODE
Serial No. 998521 (Donor ID No. 95-209).

MANUFACTURER
Upstate New York Transplant Services, Inc. (UNYTS), Buffalo, New York.

RECALLED BY
Manufacturer, by letter dated October 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
Georgia and New York.

QUANTITY
1 valve.

REASON
The testing firm inappropriately released the heart valve based on negative confirmatory test results, even though the HBSAG test results were reported by the contract laboratory as "weak positive".

________
PRODUCT
Roche Reagent for Creatinine, in-vitro diagnostic reagent intended for use in the quantitative determination of Creatinine in serum, plasma, and urine: a) Roche Reagent for Creatinine, Order No. 47002; b) Roche Reagent for Creatinine, Order No. 47003. Recall #Z-518/519-9.

CODE
a) Lot Nos. P2237 (Exp. 7/99), 02147 (Exp. 4/22/99), 02137 (Exp. 12/11/98), 02127 (Exp. 12/11/98), 02106 (Exp. 6/18/98), 00296 (Exp. 6/18/98), and 00286 (Exp. 6/18/98); b)Lot Nos. P2237 (Exp. 7/99), 00367 (Exp. 4/22/99).

MANUFACTURER
Roche Diagnostic Systems, Kaiseraugst, Switzerland.

RECALLED BY
Roche Diagnostic Systems, Inc., Somerville, New Jersey, by letter dated May 28, 1998. Firm-initiated field correction complete.

DISTRIBUTION
Nationwide.

QUANTITY
a) 2,146 of lot P2237, 2,030 of lot 02147, 1,499 of lot 02137, 1,493 of lot 02127, 999 of lot 02106, 268 of lot 00296, 1,124 of lot 00286; b) 2,331 of lot P2237, 2,945 of lot 00367 were distributed.

REASON
The Working Reagent when held in a disposable boat or in the rack compatible COBAS MIRA bottle has on-board stability of 6 hours rather than 24 hours as state in the package insert.

________
PRODUCT
Human Heart Valves for Transplantation: Donor ID Numbers: 97-081, 96-303, 96-010, 98-068. Recall #Z-520-9.

MANUFACTURER
Erie County Medical Center (ECMC), Buffalo, New York (testing laboratory).

RECALLED BY
Upstate New York Transplant Services, Inc. (UNYTS), Buffalo, New York, by telephone followed by letters dated September 29, 1998, and October 13, 1998. Firm-initiated recall complete.

DISTRIBUTION
Georgia.

QUANTITY
4 valves are involved.

REASON
The testing firm was not following test kit manufacturer's instructions for interpreting tests for HBsAg, HCV, HIV-1,2. Test results were not properly interpreted and results were reported as negative when they should have been reported as positive.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS I

________
PRODUCT
Multiple brands and formulas of dog food with corn as the primary ingredient:

1  Formula 100  
   Dura Life 21%
   Feedin Time Premium Chunk Style
   Golden Boy Chunk Style
   Retriever Chunk Style 
2. Formula 102
   Ol' Roy Premium
   Sportsman Choice Original
3. Formula 103
   Country Acres 21%
   Wendland Chunk Style
4. Formula 104
   Dura Life Puppy
   Ol' Roy Puppy
5. Formula 106
   Country Acres Hi Pro 27%
   Feedin Times Premium Hi Protein for Dogs
   Golden Boy Hi Pro
   Grand Paw High Protein
   Remarkable Menu for Dogs
   Retriever Hi Pro
   Wendland High Protein
   Winchester Hi Pro  
6. Formula 107
   PMI Nutrition Puppy
   Feedin Time Premium Puppy for Dogs
   Hill Country Fare Puppy
   Remarkable Menu for Dogs
   Retriever Puppy
   Wendland Puppy
   Winchester Puppy
7. Formula 110  -   Winner Chunk Style
8. Formula 111  - Ol' Roy Lean
9. Formula 116  - Slick 
10. Formula 123
    Feedin Time Krunchy Bites and Bones for Dogs
    Hill Country Fare Small Crunchy Bites & Bones
    Ol' Roy Krunchy Bites & Bones
    Remarkable Menu for Dogs - Bites & Bones
11. Formula 136 - PMI Nutrition Hi Protein Performance
12. Formula 137
    PMI Nutrition Adult 
    Country Acres
    Winchester Adult
13. Formula 138  - PMI Nutrition Canine
14. Formula 139 - PMI Nutrition Premium 22
15. Formula 150
    Hill Country Fare Bite Size Dog Food
    Remarkable Menu for Dogs - Chunk Style 
16. Formula 151 - Hill Country Fare Hi-Protein Dog Food
17. Formula 171
    Exceed Professional
    Maxximum - Performance
18. Formula 177
    Maxximum - Performance
    Ol' Roy Performance
    Sportsman Choice Performance
19. Formula 180 - Wendland Meat Base
20. Formula 181 - PMI Nutrition Prime 26
21. Formula 207
    Dura Life Gravy
    Feedin Time Premium Gravy Style for Dogs
    Hilly Country Fare Gravy Style Dog Food
    Retriever Gravy
22. Formula 261 - PMI Nutrition Exclusive Adult Growth.
Recall #V-005/026-9.

CODE
Sell by dates JUL 01 99E through AUG 31 99E -- All lots manufactured July 1 through August 31, 1998.

MANUFACTURER
Doane Pet Care, Temple, Texas.

RECALLED BY
Manufacturer, by telephone and press release on November 2, 1998, followed by fax and express mail letters. Firm-initiated recall ongoing.

DISTRIBUTION
Texas and Louisiana.

QUANTITY
1,362,516 bags were distributed.

REASON
Aflatoxin contamination.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II

________
PRODUCT
Diethylstilbestrol (DES) 1 mg capsules in 100 capsule bottles Human drug Rx label. Recall #V-032-9.

CODE
Lot Numbers: 980906A, 981205A, 981206B, 981307A, 981704A, 982904A, 982906H.

MANUFACTURER
Red Oak Drug, Red Oak, Texas.

RECALLED BY
Manufacturer, by letter dated November 10, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
New York and Pennsylvania.

QUANTITY
1,395 bottles were distributed.

REASON
Product is an unapproved new animal drug.

________
PRODUCT
a) Milk Fever 23% (for the treatment of milk fever in cattle and as a nutritional supplement for bovine) 500 ml. Per bottle, under the following brands: Radix Labs; River Valley Veterinary Clinic, Plain, WI; Perry Veterinary Clinic, Perry, NY; AgriLabs Calcium Gluconate 23% Solution, Sterile, St Joseph, MO; Sun Animal Health Products, Calcium 23%, Clear Lake, WI; b) Radix Labs Cal-Phos 17 (aid in treatment of hypocalcemia and other conditions associated with calcium, phosphorus, magnesium deficiencies in cattle, sheep and swine. Recall #V-033/034-9.

CODE

Lot numbers : R7J014, R7K020 -  Milk Fever 23%
R7H007, R7J014, R7K020 -Agri Labs 
R7H015 - Sun Animal Health
R7J015 - Radix Labs Cal-Phos 17.

MANUFACTURER
Radix Laboratories, Inc., Eau Claire, Wisconsin.

RECALLED BY
Manufacturer, by letter dated January 5, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Georgia, Illinois, Iowa, Michigan, Minnesota, Missouri, New York, Pennsylvania, Wisconsin, Canada.

QUANTITY
a) 34,854 500-ml bottles; b) 758 500 ml-bottles were distributed.

REASON
Precipitate found in the injectable product at 18 month check (product has 2 year expiration dating).

END OF ENFORCEMENT REPORT FOR FEBRUARY 3, 1999.

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