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
12/22/1992
RECALLS AND FIELD CORRECTIONS: December 23, 1992
FOODS -- CLASS II
92-52
PRODUCT Healthy Choice Nonfat Pasteurized Process Cheese Product, 2
pound loaves, all flavors, regular and Mexican.
Recall #F-132-3.
CODE All lots.
MANUFACTURER Beatrice Cheese, Inc., Waukesha, Wisconsin.
RECALLED BY Manufacturer, by telephone November 2, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 200,000 loaves were distributed.
REASON The product has a remote potential for supporting the growth of
Clostridium Botulinum and toxin production.
PRODUCT Shucks Buttered Popcorn, packed in 28 ounce clear cellophane
bags. Recall #F-133-3.
CODE None.
MANUFACTURER Golden Harvest Popcorn Company, Overland Park, Kansas.
RECALLED BY Manufacturer, by telephone November 3, 1992. Firm-initiated
recall complete.
DISTRIBUTION Local distribution.
QUANTITY Approximately 288 bags were distributed.
REASON Product contains undeclared FD&C Yellow #2.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Platelets, Pheresis. Recall #B-092-3.
CODE Units Q15485 and Q18718BB.
MANUFACTURER Carolina-Georgia Blood Center, Greenville, South Carolina.
RECALLED BY Consignees notified firm by telephone April 30, 1992, and July
20, 1992. Firm-initiated recall complete.
DISTRIBUTION South Carolina and Missouri.
QUANTITY 2 units.
REASON Products labeled with incorrect expiration dates were
distributed.
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-093/094-3.
CODE Unit #N41937.
MANUFACTURER Peninsula Blood Bank, Burlingame, California.
RECALLED BY Manufacturer, by telephone May 26, 1992. Firm-initiated recall
complete.
DISTRIBUTION California.
QUANTITY 1 unit of each component.
REASON Blood products which tested repeatedly reactive for the
antibody to the hepatitis C virus (anti-HCV) were distributed.
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-095/096-3.
CODE Unit #M34154.
MANUFACTURER Milton S. Hershey Medical Center, University Hospital Blood
Bank, Hershey, Pennsylvania.
RECALLED BY Manufacturer, by letter October 2, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit of each component.
REASON Blood products, which tested negative for the antibody to 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 Recovered Plasma. Recall #B-097-3.
CODE Unit #147619.
MANUFACTURER York Hospital Blood Bank, York, Pennsylvania.
RECALLED BY Manufacturer, by letter October 22, 1992. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
-2-
REASON Blood product, which tested negative for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), but was collected
from a donor who previously tested repeatedly reactive for
anti-HIV-1, was distributed.
PRODUCT Recovered Plasma. Recall #B-098-3.
CODE Unit numbers: 9201530, 9201533, 9201535, 9201536, 9201537,
9201539, 9201543.
MANUFACTURER Children's Hospital, Washington, D.C.
RECALLED BY Manufacturer, by letters dated October 16, 1992, and November
30, 1992. Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 7 units.
REASON Blood products, incorrectly tested for the antibodies to human
immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), were
distributed for further manufacture into in-vitro products.
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma. Recall #B-099/100-3.
CODE Unit numbers: 40GL46148, 40GL46150, 40GL46151, 40GL46152,
40GL46153, 40GL46154, 40GL46155, 40GL46157.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY Manufacturer, by telephone October 23, 1992, followed by letter
November 4, 1992. Firm-initiated recall complete.
DISTRIBUTION (a) Illinois, Iowa, Washington, D.C., Missouri, Puerto Rico;
(b) California.
QUANTITY 8 units of each component.
REASON Blood products, incorrectly tested for hepatitis B surface
antigen (HBsAg), were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT Recovered Plasma. Recall #B-088-3.
CODE Unit numbers: C81448, C81466, C81473
C81476, C81479, C81484, C81494, C81505, C81510,
C81512, C81524, C81540, C81541, C81549, C81550,
C81595, C81596, C81598, C81632, C81634, C81635,
C81648, C81674, C81685, C81686, C81687, C81688,
C81692, C81693, C81704, C81713, C81714, C81716,
C81717, C81718, C81722, C81723, C81748, C81749,
C81769, C81776, C81777, C81778, C81781, C81782,
C81795, C81796, C81797, C81803, C81806, C81808,
C81809, C81821, C81829, C81831, C81833, C81856,
C81863, C81864, C81867, C81870, C81875, C81876
C81879, C81880, C81888, C81890, C81898, C81900,
C81912, C81916, C81922, C81930, C81931, C81934,
C81935, C81938, C81940, C81966, C81969, C81979,
C81989, C81990, C81991, C81993, C81996, C81997,
C82002, C82005, C82007, C82009, C82013, C82014,
-3-
C82018, C82028, C82030, C82039, C82044, C82048,
C82057, C82058, C82059, C82060, C82064, C82066,
C82067, C82068, C82069, C82071, C82075, C82103,
C82109, C82111, C82116, C82121, C82127, C82137,
C82140, C82142, C82149, C82163, C82164, C82165,
C82179, C82182, C82185, C82187, C82189, C82192,
C82195, C82196, C82202, C82213, C82238, C82239,
C82240, C82242, C82245, C82252, C82254, C82257,
C82260, C82261, C82263, C82266, C82271, C82276,
C82287, C82289, C82290, C82291, C82292, C82293,
C82296, C82299, C82308, C82309, C82315, C82320,
C82321, C82322, C82327, C82329, C82330, C82331,
C82338, C82342, C82344, C82345, C82349, C82350,
C82362, C82365, C82367, C82373, C82375, C82376,
C82379, C82381, C82395, C82398, C82402, C82429,
C82430, C82473, C82479, C82485, C82487, C82495
C82496, C82516, C82520, C82534, C82539, C82549,
C82577, C82579, C82586, C82603, C82604, C82613,
C82615, C82627, C82628, C82629, C82672, C82673,
C82708, C82717, C82753, C82754, C82781, C82784,
C82786, C82788, C82799, C82803, C82804, C82805,
C82809, C82812, C82818, C82829, C82831, C82834,
C82842, C82872, C82889, C82891, C82892, C82899,
C82904, C82905, C82908, C82911, C82924, C82929,
C82931, C82933, C82936, C82942, C82951, C82955,
C82956, C82957, C82958, C82965, C82970, C82971,
C82972, C82977, C82992, C82994, C83009, C83013,
C83014, C83023, C83028, C83032, C83034, C83035,
C83036, C83042, C83052, C83078, C83096, C83099,
C83100, C83108, C83112, C83114, C83120, C83130,
C83145, C83177, C83184, C83186, C83187, C83188,
C83189, C83195, C83199, C83200, C83202, C83203,
C83204, C83208, C83210, C83218, C83224, C83226,
C83231, C83233, C83249, C83257, C83259, C83263,
C83267, C83268, C83271, C83275, C83276, C83277,
C83280, C83282, C83284, C83285, C83286, C83290,
C83293, C83295, C83298, C83301, C83307, C83310,
C83324, C83335, C83337, C83339, C83341, C83343,
C83344, C83345, C83346, C83351, C83352, C83358,
C83362, C83364, C83366, C83368, C83369, C83374,
C83375, C83380, C83385, C83389, C83399, C83400,
C83404, C83405, C83406, C83411, C83412, C83413,
C83421, C83422, C83426, C83427, C83439, C83442,
C83455, C83456, C83463, C83476, C83480, C83482,
C83484, C83485, C83494, C83496, C83497, C83499.
MANUFACTURER Nueces County Medical Society Community Blood Bank, Corpus
Christi, Texas.
RECALLED BY Manufacturer, by letter October 22, 1992. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 363 units.
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REASON Blood products, which were unsuitable for use in the
manufacture of injectable products but were labeled as if
suitable for the manufacture of injectable products, were
distributed.
PRODUCT (a) Cryoprecipitated AHF; (b) Recovered Plasma.
Recall #B-089/090-3.
CODE Unit #25GZ21838.
MANUFACTURER American Red Cross Blood Services, Greater Upstate New York
Region, Syracuse, New York.
RECALLED BY Manufacturer, by telephone September 3, 1992. Firm-initiated
recall complete.
DISTRIBUTION New York, Switzerland.
QUANTITY 1 unit of each component.
REASON Blood products, which tested repeatedly reactive for hepatitis
B surface antigen (HBsAg), were distributed.
PRODUCT Coombs Control Reagent Red Blood Cells. Recall #B-091-3.
CODE Lot #K129.
MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan, New Jersey.
RECALLED BY Manufacturer, by letter July 13, 1992. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 1,795 packages were distributed.
REASON Reagent Red Blood Cells which were found to be hemolyzed were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Pediatric Sample Cups, used to hold pediatric samples which are
used with the 550 Express or the Fast 4 Clinical Analyzers.
Recall #Z-151-3.
CODE Catalog #751063. All cartons with manufacturing date codes of
9-10-91 through 10-21-91.
MANUFACTURER Elyria Plastics, Elyria, Ohio.
RECALLED BY Manufacturer, by telephone October 23, 1992, followed by
letter. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 158 cartons (1,000 cups per carton) were distributed.
REASON The cups may leak.
PRODUCT Lyphomed Empty Sterilized Vial, 10 ml and 30 ml. Recall
#Z-154-3.
CODE Product #SV10, lot #300939, and Product #SV30, lot #310984.
MANUFACTURER Fujisawa USA, Inc., Grand Island, New York.
RECALLED BY Fujisawa USA, Inc., Melrose Park, Illinois, by FAX October 23,
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Italy.
-5-
QUANTITY 183,700 vials were distributed; firm estimates 27,555 vials
remain on the market.
REASON An improper crimp on the vial seal may result in a lack of
assurance of sterility of the product.
PRODUCT Scanlan Taheri Assurance Valvulotome, used to excise valves in
veins to facilitate in-situ by-pass procedures.
Recall #Z-159-3.
CODE Catalog #1001-771. All Lots.
MANUFACTURER Scanlan International, St. Paul, Minnesota.
RECALLED BY Manufacturer, by letter November 6, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Austria.
QUANTITY 199 units were distributed.
REASON The device does not function as intended which could result in
injury to the vessel.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Sagittal Blade, Thick, No Offset, Part Number 2108-118, a
cutting accessory for orthopedic bone saw. Recall #Z-130-3.
CODE Lot #92080341.
MANUFACTURER Stryker Corporation Instruments Division, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter September 21, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 120 boxes were distributed.
REASON Mislabeled. Part #2108-105, Sagittal Deep Cutting Blade may be
in the package instead of Part #2108-118.
PRODUCT Sagittal Blade, Wide, Thick, Part #2108-110, a cutting
accessory for orthopedic bone saw. Recall #Z-131-3.
CODE Lot #92060231.
MANUFACTURER Stryker Corporation Instrument Division, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter September 21, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Virginia, Washington state.
QUANTITY 6 boxes (3 blades per box) were distributed.
REASON Mislabeled. Part #277-88-10 may be in the package instead of
Part #2108-110.
PRODUCT ALT (IFCC) Reagent in single vials, used on the Ciba Corning
400E Chemistry Analyzer. Recall #Z-150-3.
CODE Lot #G64MK.
MANUFACTURER Ciba Corning Diagnostics Corporation, Oberlin, Ohio.
RECALLED BY Manufacturer, by telephone October 9 and 11, 1991, and by
letter October 17, 1991. Firm-initiated recall complete.
DISTRIBUTION Texas, Illinois.
QUANTITY 130 vials were distributed.
REASON Some of the vials were filled with an excess of ALT reagent.
-6-
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
PRODUCT Neomycin products:
(a) Bulk Neomycin Sulfite USP Powder; (b) Neomycin Unfinished;
(c) Neomycin Agricultural; (d) Neomycin Technical.
Recall #V-053-2.
CODE Lot numbers: (a) 430HR, 073HT, 177FU, 178F7; (b) 889DP;
(c) 501FX, 502FX, 503FX, 504FX, 505FX, 508FX, 509FX, 865HB,
866HB, 867HB, 887HB, 888HB, 038HP; (d) 358FU.
MANUFACTURER The Upjohn Company, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter August 18, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION New Jersey, Florida, Nebraska, Belgium, Germany, India, Mexico,
Argentina, Taiwan, Hong Kong, Canada.
QUANTITY Undetermined amount.
REASON Product contains elevated levels of sodium fluoride.
MEDICAL DEVICE SAFETY ALERTS:
PRODUCT Hurst and Maloney Mercury-Filled Bougies, esophageal dilators.
Safety Alert #M-002-3.
CODE All product marked "Don't Use After 4-30-95" which appears
directly on the product, not on the label.
MANUFACTURER Pilling Company, Fort Washington, Pennsylvania.
ALERTED BY Manufacturer, by letter August 22, 1992.
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 12,000 units were distributed.
REASON A design change in which the tapered tip was made shorter,
which could possibly contribute to complaints of esophageal
perforation, puncturing or tearing.
PRODUCT Renalin Cold Sterilant for dialysis use in 1 liter bottles and
2-1/2 gallon bottles. Safety Alert #M-003-3.
CODE All lots.
MANUFACTURER Minntech Corporation, Minneapolis, Minnesota.
ALERTED BY Manufacturer issued an Urgent: Important Safety Alert dated
October 10, 1992.
DISTRIBUTION Nationwide.
QUANTITY 37,000 cases of 2-1/2 gallon bottles (2 bottles per case) and
7,000 cases of 12 one-liter bottles per case were distributed.
REASON Preliminary findings showed a statistical increase in the
relative risk of death for both manual and automated Renalin
reuse and for all glutaraldehyde reuse over the control (no
reuse); and showed a statistical increase in the risk of death
with manual Renalin reuse procedures compared to the control.
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END OF ENFORCEMENT REPORT FOR DECEMBER 23, 1992. BLANK PAGES MAY
FOLLOW.
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