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 contain
s
information
on actions taken in connection with agency regulatory activities.
ENFORCE
09/03/1996
ENFORCEMENT REPORT FOR 09/04/96
September 4, 1996 96-36
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I =========================
_______________
PRODUCT: (a) Vanilla Cookie Dough Fudge packaged in 5 ounce and 9 ounce
packages; (b) Double Chocolate Brownie Fudge & Vanilla Cookie
Dough Fudge multi package under the Hebert Candies label.
Recall #F-679/680-6.
CODE: Product manufactured on June 26, 1996 and distributed between
June 26, 1996 through July 10, 1996.
MANUFACTURER: Home of Hebert Candies, Inc., Shrewsbury, Massachusetts.
RECALLED BY: Manufacturer by telephone July 10, 1996. Firm-initiated
recall complete.
DISTRIBUTION: Massachusetts, Maine, New Hampshire.
QUANTITY: Approximately 153 pounds were distributed.
REASON: The product contain undeclared liquid pasteurized eggs.
_______________
PRODUCT: Smoked trout, Recall #F-682-6.
CODE: "4510".
MANUFACTURER: Shuckman's Food Company, Louisville, Kentucky.
RECALLED BY: Manufacturer by telephone on July 18, 1991. Firm-initiated
recall complete.
DISTRIBUTION: Kentucky.
QUANTITY: 30 pounds were distributed.
REASON: The product is contaminated with Listeria monocytogenes.
_______________
PRODUCT: Mercer's brand Cookie Dough Ice Cream in half gallon and 2 1/2
gallon tubs, Recall #F-683-6.
CODE: Not coded.
MANUFACTURER: Mercer's Dairy Inc., Booneville, New York.
RECALLED BY: Manufacturer by letter on or about July 31, 1996. Firm-
initiated recall complete.
DISTRIBUTION: New York.
QUANTITY: 1,930 half gallons were distributed.
REASON: The product contains undeclared eggs.
_______________
PRODUCT: Chocolate Chip Cookie Dough Ice Cream in half gallons and
square pints, Recall #F-684-6.
CODE: 5A17, 5K07, 6D11, 6D24, 6E23, 6P17, 6P27 (1/2 gallon); 5A16,
6D12, 6E01, 6P01, 6017, 6S10.
MANUFACTURER: Hersey Creamery Company, Harrisburg, Pennsylvania.
RECALLED BY: Manufacturer by telephone June 27, 1996, and press release on
June 28, 1996. Firm-initiated recall ongoing.
DISTRIBUTION: Midwest and Eastern United States.
QUANTITY: 42,834/half gallon; 51,184 pints were distributed.
REASON: The product contains undeclared eggs.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II =========================
_______________
PRODUCT: Strawberry Cheese Cake Ice Cream, bulk 3 gallon containers,
1/2 gallon containers, quarts and pints, Recall #F-681-6.
CODE: E23, F17, G5.
MANUFACTURER: University of Wisconsin-Madison, Madison, Wisconsin.
RECALLED BY: Manufacturer by letter July 30, 1996. Firm-initiated recall
complete.
DISTRIBUTION: Wisconsin.
QUANTITY: 141/3 gallon containers; 70/half gallon containers; 115
quarts; 40 pints were distributed.
REASON: The product does not list a complete ingredient statement and
contains undeclare wheat flour, an allergen.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ========================
_______________
PRODUCT: Cecelia brand Quick Blanched Mushrooms, Pieces and Stems in 62
ounce white plastic containers. Recall #F-677-6.
CODE: 'JAN 09 1996' on outside label.
MANUFACTURER: Prima Foods, Inc., Rehrersburg, New Jersey.
RECALLED BY: Destefano Foods, Inc., Edison, New Jersey by telephone on or
about October 16, 1995 with follow-up letter. Firm-initiated
recall complete.
DISTRIBUTION: New Jersey.
QUANTITY: 93 cases were distributed.
REASON: The mushrooms are unfit for food due to off taste and off
odor.
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_______________
PRODUCT: Preferred Selections brand Cheese Salsa in 10.75 ounce jars.
Recall #F-678-6.
CODE: 6 BG 103.
MANUFACTURER: Sauces Unlimited, Inc., San Antonio, Texas.
RECALLED BY: Manufacturer by telephone June 6, 1996. Firm-initiated recall
complete.
DISTRIBUTION: Pennsylvania, Florida, Wisconsin.
QUANTITY: 339 cases were distributed.
REASON: The product is unfit for food due to lid seal failure and
spoilage.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II =========================
_______________
PRODUCT: Delflex brand and custom manufactured NMC (National Medical
Care) Rx peritoneal dialysis solution for home dialysis use.
53 lots packaged in 2, 3 and 5 liter bags,
Recall #D-231/252-
CODE:
Fresenius product code Product Lot #
044-50501 1.5% Dextrose, Low Mg, 5 Liter 07-008-6F
07-162-6F
07-175-6F
07-048-6G
07-100-6G
044-50502 2.5% Dextrose, Low Mg, 5 Liter 07-094-6F
07-148-6F
07-183-6F
07-203-6F
07-042-6G
044-50511 1.5% Dextrose, Std Mg, 5 Liter 07-174-6F
07-099-6G
044-20201 1.5% Dextrose, Low Mg, 2 Liter 07-190-6F
044-20322 2.5% Dextrose, Low Mg, Low Ca, 2L/3L 07-193-6F
044-50512 2.5% Dextrose, Std Mg, 5 Liter 07-196-6F
07-055-6G
07-098-6G
07-121-6G
044-20211 1.5% Dextrose, Std Mg, 2 Liter 07-204-6F
044-50524 4.25% Dextrose, Low Mg,Low Ca, 5Liter 07-079-6G
044-50522 2.5% Dextrose, Low Mg,Low Ca, 5 Liter 07-002-6G
07-041-6G
07-062-6G
-3- 07-063-6G 07-086-6G
07-178-6G
044-50521 1.5% Dextrose, Low Mg, Low Ca, 5 Liter07-009-6G
044-50504 4.25% Dextrose, Low Mg, 5 Liter 07-010-6G
07-064-6G
07-069-6G
044-30321 1.5% Dextrose, Low Mg, Low Ca, 3 Liter07-038-6G
044-25321 1.5% Dextrose, Low Mg, Low Ca, 2.5L/3L07-052-6G
044-20202 2.5% Dextrose, Low Mg, 2 Liter 07-074-6G
044-25311 1.5% Dextrose, Std Mg, 2.5L/3L 07-087-6G
044-25314 4.25% Dextrose, Std Mg, 2.5L/3L 07-089-6G
044-15211 1.5% Dextrose,Std Mg, 1.5L/2L 07-147-6G
044-20221 2.5% Dextrose, Std Mg, 2 Liter 07-154-6G
NMC Product Code:
65-2204-9 4.25% Dextrose, Low Mg, 2 Liter 07-121-6F
65-2202-3 2.5% Dextrose, Low Mg, 2 Liter 07-189-6F
65-2221-3 1.5% Dextrose, Low Mg, Low Ca, 2Liter 07-197-6F
65-5502-3 2.5% Dextrose, Low Mg, 5 Liter 07-017-6G
07-034-6G
65-5521-3 1.5% Dextrose, Low Mg, Low Ca, 5Liter 07-018-6G
07-078-6G
65-5504-9 4.25% Dextrose, Low Mg, 5 Liter 07-049-6G
65-2322-9 2.5% Dextrose, Low Mg, Low Ca, 2L/3L 07-051-6G
65-5501-5 1.5% Dextrose, Low Mg, 5 Liter 07-056-6G
07-120-6G
65-4302-9 2.5% Dextrose, Low Mg, 3 Liter 07-075-6G
65-5522-1 2.5% Dextrose, Low Mg, Low Ca, 5Liter 07-085-6G
65-3302-0 2.5% Dextrose, Low Mg, 2.5L/3L 07-088-6G
65-1214-9 4.25% Dextrose, Std Mg, 1.5L/2L 07-162-6G
65-3314-5 4.25% Dextrose, Std Mg, 2.5L/3L 07-163-6G
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MANUFACTURER: Fresenius USA, Inc., Ogden, UT 84404
RECALLED BY: Manufacturer by telephone August 15, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION: Nationwide and Canada.
QUANTITY: 672,000 liters were distributed.
REASON: Excessive endotoxin levels.
_______________
PRODUCT: Empire Airgas labeled as "Oxygen Compressed USP" packaged in
aluminum and steel high pressure cylinder sizes 300, 200, 125,
E and D, Recall #D-253-6.
CODE: All lots with 001 thru 214.
MANUFACTURER: Empire Airgas, Inc., Syracuse, New York.
RECALLED BY: Empire Airgas, Inc., Elmira, New York by letter August 16,
1996. Firm-initiated recall ongoing.
DISTRIBUTION: New York.
QUANTITY: 31,000 units were distributed.
REASON: GMP deficiencies.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =====================
_______________
PRODUCT: (a) Red Blood Cells; (b) Cryoprecipitated AHF; (c) Recovered
Plasma, Recall #B-593/595-6.
CODE: Unit number (a-c) 30H81550.
MANUFACTURER: American Red Cross Blood Services, Ashley, Pennsylvania.
RECALLED BY: Manufacturer by letter December 6, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION: Pennsylvania, New York.
QUANTITY: 1 unit was distributed.
REASON: Blood products, which tested negative for the antibody to the
human immunodeficiency virus type 1 (anti-HIV-1), but were
collected from a donor who previously tested repeatedly
reactive for anti-HIV-1, were distributed.
_______________
PRODUCT: (a) Red Blood Cells; (b) Platelets, Recall #B-596/597-6.
CODE: Unit numbers: (a) LH37443, KE12275, (b) KE1275.
MANUFACTURER: Central Blood Bank, Pittsburgh, Pennsylvania.
RECALLED BY: Manufacturer by telephone May 22 and May 31, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION: Pennsylvania
QUANTITY 3 units were distributed.
REASON: Blood products, collected from donors who traveled to areas
considered endemic for malaria, were distributed.
_______________
PRODUCT: (a) Red Blood Cells; (b) Recovered Plasma,
Recall #B-598/599-6.
CODE: Unit number FF37663.
MANUFACTURER: Blood Bank of the Redwoods, Santa Rosa, California.
-5- RECALLED BY: Manufacturer by telephone and letter September 9, 1995. Firm-
initiated recall complete.
DISTRIBUTION: California.
QUANTITY: 2 unit was distributed.
REASON: Blood products, which tested negative for antibody to the
hepatitis C virus encoded antigen (anti-HCV), but were
collected from a donor who previously tested repeatedly
reactive for anti-HBC, were distributed.
_______________
PRODUCT: Recovered Plasma, Recall #B-600-6.
CODE: Unit number J32232.
MANUFACTURER: San Diego Blood Bank, San Diego, California.
RECALLED BY: Manufacturer by fax July 31, 1995. Firm-initiated recall
complete.
DISTRIBUTION: North Carolina.
QUANTITY: 1 unit was distributed.
REASON: Blood product, collected from a donor who reported a history
of body piercing, was distributed.
_______________
PRODUCT: Red Blood Cells. Recall #B-602-6.
CODE: Unit numbers 9309726, 9309818.
MANUFACTURER: LifeSource Blood Services, Glenview, Illinois.
RECALLED BY: Manufacturer by telephone December 18, 1995. Firm-initiated
recall complete
DISTRIBUTION: Illinois.
QUANTITY: 2 units were distributed.
REASON: Blood products, which were exposed to unacceptable storage
temperatures, were distributed.
_______________
PRODUCT: (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma,
Recall #B-603/605-6.
CODE: Unit number (a-c) 3D2745.
MANUFACTURER: Puget Sound Blood Center, Seattle, Washington.
RECALLED BY: Manufacturer by letter July 13, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION: Washington, California.
QUANTITY: 3 units were distributed.
REASON: Blood products, collected from a donor whose spouse was
diagnosed with hepatitis B, were distributed.
_______________
PRODUCT: (a) Cryoprecipitated AHF; (b) Recovered Plasma, Recall #B-
610/611-6.
CODE: Unit number: (a & b) 38FN90184.
MANUFACTURER: American Red Cross, Fort Wayne, Indiana.
RECALLED BY: Manufacturer by letters March 27 and 29, 1995. Firm-initiated
recall complete.
DISTRIBUTION: Wisconsin, California.
-6- QUANTITY: 2 units were distributed.
REASON: Blood products, corresponding to a unit of Red Blood Cells
which were contaminated with a gram positive cocci suspected
to be Serratia Marcescens, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ====================
_______________
PRODUCT: Recovered Plasma, Recall #B-586-6.
CODE: Unit number 40GR43997.
MANUFACTURER: American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY: Manufacturer by questionable plasma inquiry dated April 18,
1996. Firm-initiated recall complete.
DISTRIBUTION: California.
QUANTITY: 1 unit was distributed.
REASON: Blood product, which tested initially reactive for the
hepatitis B surface antigen (HBsAg), and was not retested as
required, was distributed.
_______________
PRODUCT: Irradiated Red Blood Cells, Recall #B-601-6.
CODE: Unit numbers 30FG09793, 30FH18877.
MANUFACTURER: American Red Cross Blood Services, Ashley, Pennsylvania.
RECALLED BY: Manufacturer by telephone on February 13, 1995. Firm-
initiated recall complete.
DISTRIBUTION: Pennsylvania
QUANTITY: 2 units were distributed.
REASON: Blood products, labeled with an extended expiration date, were
distributed.
_______________
PRODUCT: Red Blood Cells, Recall #B-609-6.
CODE: Unit numbers 013L72772, 013T72528.
MANUFACTURER: American Red Cross, Detroit, Michigan
RECALLED BY: Manufacturer by letter July 19, 1995. Firm-initiated recall
complete.
DISTRIBUTION: Michigan.
QUANTITY: 2 units were distributed.
REASON: Blood products, mislabeled with the incorrect expiration date
were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ======================
_______________
PRODUCT: Becton Dickinson Control Syringe, a device that consists of a
10cc calibrated hollow plastic barrel and a movable plunger,
Recall #Z-983-6
CODE: Catalog number 304134, Lot #6C428, 6C429.
MANUFACTURER: Becton Dickinson Division, North Canaan, Connecticut.
-7- RECALLED BY: Becton Dickinson, Franklin Lakes, New Jersey by telephone
April 18, 1996, with follow-up letter of April 23, 1996.
Firm-intiated recall complete.
DISTRIBUTION: Connecticut
QUANTITY: 40,900 units were distributed.
REASON: A molding problem could result in cracked thumbring.
_______________
PRODUCT: Biological Microroughins Latex Examination Gloves, Powder-Free
in all sizes, Recall #Z-1054-6.
CODE: "CM 1054 M 9403".
MANUFACTURER: Tekmedic (M) SDN. BHD., Taman Tun Drismai, Mali.
RECALLED BY: Intax Inc. (d/b/a Calderwood Rubber & Plastic), Santa Barbara,
California by letter and telephone August 4, 1994. Firm-
initiated recall complete.
DISTRIBUTION: California.
QUANTITY: 655 cases were distributed.
REASON: The gloves failed the water leak test.
_______________
PRODUCT: Haemotronic Arterial Venous Blood Tubing Set for Hemodialysis
Model 5M 4208, Recall #Z-1096-6.
CODE: Lot #B942538.
MANUFACTURER: Haemotronic S.p.A., Modena, Italy.
RECALLED BY: Haemotronic Inc., Fairfield, New Jersey by fax on April 3,
1996. Firm-initiated recall ongoing.
DISTRIBUTION: Tennessee.
QUANTITY: 9,984 sets were distributed.
REASON: The device is subject to blood leakage.
_______________
PRODUCT: ICON Software Versions Less Than 6.0.2 used on the ICON A, AP,
P, V, and MacICON Workstations and the Integrated Gamma Camera
Systems Diacam, Orbiter, Multispect 2 and Multispect 3, Recall
#Z-1097/1100-6.
CODE: None.
MANUFACTURER: Siemens Medical Systems, Inc., Hoffman Estates, Illinois.
RECALLED BY: Manufacturer by letters February 1996, March 1996 and June
1996. Firm-initiated recall ongoing.
DISTRIBUTION: Nationwide and international.
QUANTITY: 2,240 units were distributed.
REASON: The ICON software versions less than 6.0.2 contained bugs
which effect the acquisition of patient data, caused the loss
of patient data, and require the re-injection of patient with
radioactive isotopes in some instances.
-8-
_______________
PRODUCT: SIRECUST 960/961/1260/1261/1280/1281 MULTI I/O; Pressure
Waveform Triggering of External Devices, Software Versions up
to and including VA4, Recall #Z-1103/1107-6
CODE: Part number Description
28 74 506 E2501 S/W UPG VA2-XMS MIOP 9+12
28 74 514 E2501 S/W UPG VA2-AXX Multi I/O 9+12
33 60 760 E2501 S/W UPG VBO-BXX Multi I/O 9+12
43 27 008 E2501 S/W UPG VA4-XXX MIOP 12/9
47 13 637 E2501 S/W UPG VBO/VA4 Multi I/O 9+12
MANUFACTURER: Siemens Medical Systems, Inc., Danvers, Massachusetts.
RECALLED BY: Manufacturer issued a device safety alert dated May 6, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION: Nationwide, international.
QUANTITY: Undetermined amount distributed.
REASON: Misbranded. The user manual does not address the possible
potential for the loss trigger and for the balloon pump to
remain in a deflated state which will produce an audible alarm
when it occurs.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ======================
_______________
PRODUCT: Linvatec brand, SPIKED WASHER, Catalog Number 8631S, 17mm X
2.5, Sterile, Single used in conjunction with Linvatec soft
tissue anchoring screws to attach ligaments, tendons and other
soft tissues to long bone, Recall #Z-1095-6
CODE: Lot Number 33747
MANUFACTURER: Linvatec, Largo, FL 34643
RECALLED BY: Manufacturer, by letter July 12, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION: Nationwide.
QUANTITY: 26 devices were distributed.
REASON: Both the package and etching on the washer was labeled as 17mm
x 2.5 instead of the correct dimension of 17mm x 1.3.
______________
END OF ENFORCEMENT REPORT FOR September 4, 1996. BLANK PAGES MAY FOLLOW.
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