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
09/06/1995
ENFORCEMENT REPORT FOR 09/06/95
September 6, 1995
RECALLS AND FIELD CORRECTION: DRUGS -- CLASS III
=======================
_______________
PRODUCT Nitrostat Sublingual Tablets (Nitroglycerin tablets) 0.4 mg
bottles, used for the treatment and management of patients
with angina pectoris, Recall #D-243-5.
CODE Lot #002D2F4, exp. date 12/95.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis (division of Warner Lambert Co.), Morris Plain,
New Jersey, by certified mail August 10, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 22,427 bottles were distributed.
REASON Product may not meet assay specifications through expiration
date.
CORRECTION: Recall #D-235-5, which appeared in the August 23, 1995,
Enforcement Report should read: Recalled by, Manufacturer,
by letter August 1, 1994 and telephone July 29, 1994 instead
of July 29, 1995.
CORRECTION: Recall #F-768-5, which appeared in the August 30, 1995,
Enforcement Report should read: Product: Ground Nutmeg
packaged in 16 ounce and .70 ounce packages instead of 70
ounce packages.
RECALLS AND FIELD CORRECTION: BIOLOGICS -- CLASS II
======================
_______________
PRODUCT Red Blood Cells, Recall #B-555-5.
CODE Unit #10R05825
MANUFACTURER American National Red Cross, Springfield, Missouri.
RECALLED BY Manufacturer, by letter July 28, 1994. Firm-initiated
recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit.
REASON Blood product, which tested negative for the antibody to the
human T-lymphotropic virus type I (anti-HTLV-I) but was
collected from a donor who previously tested repeatedly
reactive for anti-HTLV-I, was distributed.
_______________
PRODUCT (a) Whole Blood CPDA-1; (b) Red Blood Cells, Recall #B-
556/557-5.
CODE Unit #'s (a) 42FK50236; (b) 42FK35726.
MANUFACTURER American National Red Cross, Cleveland, Ohio.
RECALLED BY Manufacturer, by letter September 7, 1994. Firm-initiated
recall complete.
DISTRIBUTION Ohio.
QUANTITY 2 units.
REASON Blood products, which were collected from a donor with a
medical history of cancer were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma,
Recall #B-558/560-5.
CODE Unit #16T39672.
MANUFACTURER American National Red Cross, Columbus, Ohio.
RECALLED BY Manufacturer, by letter February 20, 1995. Firm-initiated
recall complete.
DISTRIBUTION Ohio.
QUANTITY 3 units.
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; (c) Recovered Plasma,
Recall #B-561/563-5.
CODE Unit #42L60374.
-2-
MANUFACTURER American National Red Cross, Cleveland, Ohio.
RECALLED BY Manufacturer, by letter June 22, 1994 and by facsimile on
June 29, 1994. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 3 units.
REASON Blood products, which tested negative for the hepatitis B
surface antigen (HBsAg) but were collected from a donor who
previously tested repeatedly reactive for HBsAg, were
distributed.
______________
PRODUCT (a) Red Blood Cells; (b) Platelet Concentrate; (c)
Cryoprecipitated AHF; (d) Fresh Frozen Plasma; (e) Recovered
Plasma; (f) Platelets, for further manufacture; Recall #B-
564/569-5.
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, Rochester, New York.
RECALLED BY Manufacturer, by letters dated September 1994 to January
1995. Firm-initiated recall complete.
DISTRIBUTION California, Florida, New York, Pennsylvania, Puerto Rico,
Switzerland.
QUANTITY 109 units.
REASON Blood products which: 1) tested repeatedly reactive for
antibody to human immunodeficiency virus type 1 (anti-HIV-
1); 2) tested negative for anti-HIV-1, but were collected
from donors who previously tested repeatedly reactive for
anti-HIV-1; or 3) tested negative for anti-HIV-1, but were
collected from a donor who previously tested initially
reactive for anti-HIV-1 and was not retested in duplicate,
were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma,
Recall #B-570/572-5.
CODE Unit #s (a & b) 42L66542; (c) 42L66542, 42Y77970, 42N83022.
MANUFACTURER American National Red Cross, Cleveland, Ohio.
RECALLED BY Manufacturer, by letter and facsimile on or about September
7, or 8, 1994. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 5 units.
REASON Blood products, which were collected from a donor who was at
increased risk for infectious diseases, were distributed.
-3-
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma, Recall #B-
574/575-5.
CODE Unit #s (a) 42FW18422, 42T25023, 42T25025, 42FY58361,
42K59498, 42T25009; (b) 42FW18422.
MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY Manufacturer, by letters between January 9, 1995 and July
11, 1995. Firm-initiated recall complete.
DISTRIBUTION Ohio, California, Missouri.
QUANTITY 7 units.
REASON Blood products, associated with a unit of pooled platelets
which was contaminated with Staphylococcus epidermidis, were
distributed.
_______________
PRODUCT (a) Whole Blood CPDA-1; (b) Red Blood Cells; (c) Red Blood
Cells Leukocytes Removed; (d) Platelets; (e) Platelets,
Pheresis; (f) Cryoprecipitated AHF; (g) Single Donor Plasma;
Recall #B-578/584-5.
CODE Contact FDA, Center for Biologics Evaluation and Research,
Office of Compliance, (301) 594-1070, for individual unit
numbers recalled.
MANUFACTURER American National Red Cross, Baltimore, Maryland.
RECALLED BY Manufacturer, by facsimile and letter dated May 25, 1994 and
June 7, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Maryland, Virginia, Pennsylvania, California, Massachusetts,
Washington, D.C.
QUANTITY 970 units.
REASON Blood products, which were improperly tested for syphilis,
were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma, Recall #B-
552/553-5.
CODE Unit #47J32890.
MANUFACTURER American National Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by letter May 3, 1995. Firm initiated recall
complete.
DISTRIBUTION Iowa.
QUANTITY 2 units.
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.
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_______________
PRODUCT Red Blood Cells, Recall #B-554-5.
CODE Unit #10F76830.
MANUFACTURER American National Red Cross, Springfield, Missouri.
RECALLED BY Manufacturer, by telephone October 3, 1994. Firm-initiated
recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit.
REASON Blood product, which was labeled with an incorrect
expiration date, was distributed.
_______________
PRODUCT Recovered Plasma, Recall #B-573-5.
CODE Unit #42M62528.
MANUFACTURER American National Red Cross, Cleveland, Ohio.
RECALLED BY Manufacturer, by facsimile on April 21, 1994. Firm-
initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, corresponding to Red Blood Cells which were
contaminated with Staphlyococcus epidermidis, was
distributed.
_______________
PRODUCT Red Blood Cells, Recall #B-577-5.
CODE Unit #s 36FM03719, 36FM03720, 36FM03751, 36FM03753.
MANUFACTURER American Red Cross Blood Services, Columbia, South Carolina.
RECALLED BY Manufacturer, by telephone and letter June 16, 1994. Firm-
initiated recall complete.
DISTRIBUTION South Carolina.
QUANTITY 4 units.
REASON Blood products, which were collected in outdated blood
collection bags, were distributed.
_______________
PRODUCT (a) Whole Blood For Research; (b) Recovered Plasma; (c)
Platelets For Further Manufacture, Recall #B-585/587-5.
CODE Contact FDA, Center for Biologics Evaluation and Research,
Office of Compliance, (301) 594-1070, for individual unit
numbers recalled.
MANUFACTURER American National Red Cross, Baltimore, Maryland.
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RECALLED BY Manufacturer, by facsimile and letter dated June 7, 1994.
Firm-initiated recall complete.
DISTRIBUTION Maryland, Virginia, Pennsylvania, California, Massachusetts,
Washington, D.C.
QUANTITY 282 units.
REASON Blood products, which were improperly tested for syphilis,
were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
======================
_______________
PRODUCT Trophy Intraoral X-ray, Recall #Z-1099/1101-5.
CODE 70-X; IRIX 70-C; IRIX 70-E.
MANUFACTURER Trophy Radiology, France.
RECALLED BY Trophy Radiology, Marietta, Georgia, by letter on or about
July 7, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates 2,500 units were distributed and remain on
market.
REASON The X-ray unit's arm can become detached and fall to the
floor.
_______________
PRODUCT Mobil Plus Mobile X-ray System, Recall #Z-1102-5.
CODE None
MANUFACTURER International Medical Systems, Inc., Riverside, California.
RECALLED BY Manufacturer, by letter July 14, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 38 units
REASON The diagnostic x-ray devices failed to meet Federal
Performance Standard for Diagnostic x-ray systems and their
major components, in that the illuminance of the light
localizer did not meet the requirements of 21 CFR
1020.31(d)(2) (ii).
_______________
PRODUCT Site CD II Phacoemulsification Handpiece, used primarily in
cataract removal surgeries, Recall #Z-1116-5.
CODE All units.
MANUFACTURER Site Microsurgical Systems, Inc., Horsham, Pennsylvania.
RECALLED BY Iolab Corporation, Claremont, California, by telephone and
letter dated December 8, 1994. Firm-initiated recall
ongoing.
-6-
DISTRIBUTION Nationwide, France, Australia, United Kingdom.
QUANTITY 79 units were shipped.
REASON Metal particles may flake off the device into the eye.
_______________
PRODUCT (a) Low Profile Plastic Port/Introducer Kit, Catalog #6022;
(b) Low Profile Plastic Port, Catalog #1012, used for long-
term vascular access, generally for chemotherapy, Recall #Z-
1117/1118-5.
CODE Lot #s (a) 9501; (b) 9452.
MANUFACTURER Therex Corporation, Walpole, Massachusetts.
RECALLED BY Manufacturer, by telephone and follow-up letter February 2,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Vermont, Canada.
QUANTITY 1,100 units were distributed.
REASON Fluid from o-rings may leak into subcutaneous tissue causing
tissue damage around the port.
_______________
PRODUCT TowerSpore Biological Indicator Strips, Catalog numbers
T40020, 40020, A9360-20, Recall #Z-1119/1121-5.
CODE Lot #s X686, X687, X688, X689, X692, X693, X694, X695, X697.
MANUFACTURER North American Science Associates, Northwood, Ohio.
RECALLED BY Baxter Healthcare Corporation, McGaw Park, Illinois by
telephone August 3, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 1,559 cases were distributed.
REASON The product is labeled for ambient or refrigerated storage,
but stability data does not support the expiration dates
assigned when the product is stored at room temperature.
_______________
PRODUCT Hall Surgical Osteon Bur, Recall #Z-1122-5.
CODE Lot #s 09660200, 08728300.
MANUFACTURER Linvatec Corporation, Largo, Florida.
RECALLED BY Manufacturer, by letter February 3, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, South Africa, Australia, Japan, France.
QUANTITY 186 devices were distributed.
REASON Mislabeled bur size.
-7-
_______________
PRODUCT Classic Tip Trocar, Product code OMS-T10NR, OMS-T11NR, OMS-
T12NR, Recall #Z-1123/1125-5.
CODE Lot #s 0106951, 0606951, 0806951, 0906951, 1206951, 1306951,
1505951, 1506951, 1805951, 2106951, 2305951, 2606951,
2806951, 3005951, 3105951, 1270051095, 1280051195.
MANUFACTURER Origin Medsystems, Inc., Menlo Park, California.
RECALLED BY Manufacturer, by letter July 27, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Argentina, Canada, Cyprus, France, Greece, The
Netherlands, Republic of China (Taiwan).
QUANTITY 2,200 units were distributed.
REASON The trocer's metal tip may separate from the plastic
obturator.
_______________
PRODUCT Sterile CarraGauze Strips 1"x 5 yards, packaged in high
dentisy polyethylene bottles, Recall #Z-1126-5.
CODE Lot #023, Order #101012.
MANUFACTURER DuoTek, Division of STS DuoTek, Inc., Fairport, New York.
RECALLED BY Carrington Laboratories, Inc., Irving, Texas, by letter
August 11, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,293 units were distributed.
REASON The product does not meet the sterility assurance level
specification.
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______________
PRODUCT Neonatal Transport System (TI 100), Recall #z-1127/1129-5
CODE Serial numbers:
1001901 1010920 1020974 1021033 1041900 1050955 2000170 2000234
1001904 1020921 1020975 1021039 1043900 1050956 2000171 2000235
1002900 1020922 1020976 1021040 1044900 1050957 2000173 2000236
1002901 1020923 1020977 1021041 1050900 1050959 2000176 2000238
1003900 1020924 1020978 1021042 1050903 1050960 20001578 2000240
1003901 1020925 1020979 1021043 1050905 1050961 2000181 2000240
1004901 1020926 1020980 1021044 1050905 1050962 2000183 2000241
1005900 1020927 1029091 1021045 1050906 1050963 2000184 2000242
1006900 1020928 1020982 1021046 1050907 1050964 2000185 2000243
1006901 1020929 1020983 1021047 1050908 1050965* 2000186 2000244
1007900 1020930 1020984 1021048 1050909 1050966 2000187 2000245
1007901 1020931 1020985 1021049 1059010 1050967 2000188 2000246
1008900 1020932 1020986 1021050 1050911 1050968* 2000189 2000247
1008901 1020933 1020987 1021051* 1050912 10509718 2000190 2000248
1009900 1020934 1020988 1021052 1050913 1050972* 2000191 2000249
1009901 1020935 1020989* 1021053 1050914 2000104 2000192 2000250
1010900 1020936 1020990 1021054* 1050915 2000105 2000193 2000251
1010901 1020937 1020991 1021055 1050917 2000106 2000194 2000252
1011900 1020938 1020992 1021056 1050919 2000109 2000195 2000253
1011901 1020939 1020993* 1021057 1050921 2000111 2000196 2000254
1012900 1020940 1020994 1021058 1050922 2000112 2000198 2000257
1012901 1020941 1020995 1021059* 1050923 2000113 2000199 2000258
1013900 1020942 1020996 1021060* 1050925 2000115 2000200 2000259
1013901 1020943 1020997 1021061 1050926 2000119* 2000201 2000260
1014900 1020944 1020999 1021062 1050927 2000121 2000202 2000261
1014901 1020945* 1021000 1021063 1050928 2000127* 2000203 2000262
1015900 1020946 1021001 1021064* 1050929 2000128 2000204 2000263
1015901 1020947 1021002 1021065 1050930 2000129 2000205 2000264
1016900 1020948* 1021003 1021066 1050931* 2000130 2000206 2000265
1017900 1020950 1021004 1021067 1050933 2000131 2000207 2000267
1018900 1020952 1021007 1021900 1050934 2000136 2000208 TB220-1
1019900 1020963 1021008* 1021936 1050935 2000137* 2000209 TB220-2
1020900 1020955 1021009 1022900 1050936 2000138 2000210
1020901 1020956 1021010 1023900 1050937 2000139 2000213
1020902 1020957 1021011 1024900 1050938 2000140 2000214
1020903 1020958 1021012 1025900 1050939 2000143* 2000216
1020904 1020959 1021013 1026900 1050940 2000145* 2000217
1020905 1020960 1021014 1027900 1050941 2000146* 2000218
1020906 1020961 1021015 1028900 1050942 2000147 2000220
1020907 1020962 1021016* 1029900 1050943 2000148* 2000221
1020908 1020963 1021017 1030900 1050944 2000155* 2000222
1020909 1020964 1021018 1032900 1050945 2000156 2000223
1020911 1020965 1021019 1032900 1050946 2000157 2000225
1020912 1020966 1021020 1033900 103097 2000159 2000226
-9-
1020913 1020967 1021022 1034900 1050948 2000160 2000227
1020914 1020968 1021025 1035900 1050949 2000161 2000228
1020915 1020969 1021026 1036900 1050950 2000162 2000229
1020916 1020970 1021027* 1037900 1050951 2000163 2000230
1020917 1020971 1021030 1038900 1050952 2000165 2000231
1020918 1020972 1021031 1039900 1050953 2000167 2000232
1020919 1020973 1021032 1040900 1050954 2000168* 2000233
MANUFACTURER K-1 Medical Products Inc., El Cajon, California
RECALLED BY Air Shields Inc., Hatboro, Pennsylvania, by letter July 5,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, international.
QUANTITY 389 units were distributed.
REASON The high pressure check valves in the mechanical ventilator
contained in the "frame" of a newborn incubator system may
fail permanently.
_______________
PRODUCT Dash Latex Examination Gloves, Recall #Z-1133/1134-5.
CODE Lot #1552, 5163.
MANUFACTURER Dash Medical, Malaysia.
RECALLED BY Dash Medical Gloves Inc., Franklin, Wisconsin, by routine
inspection July 31, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide
QUANTITY 250 cases were distributed.
REASON The gloves failed the Food and Drug Administration water
leak testing for patient examination.
_______________
PRODUCT (a) DispoMed Latex Examination Gloves, Powder-Free (All
Sizes); (b) Proctor Latex, Powder-Free, Examination Gloves,
All Sizes, Recall #Z-1135/1136-5.
CODE Lot #FXS, FXM, FXL.
MANUFACTURER Unknown.
RECALLED BY Baxter Healthcare Corporation, McGaw Park, Illinois, by
letter August 15, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 1,307 cases; (b) 8 boxes were distributed.
REASON The gloves exhibited signs of deterioration, including
sticking together, and discoloration, they have the
potential for spontaneous combustion, demonstrated by signs
of heat and possibly smoldering.
-10-
_______________
PRODUCT Protec-Top Vinyl Examination Gloves, Pre Powdered, 100
gloves per box/10 boxes per carton in sizes small, medium,
and large, Recall #Z-1137/1139-5.
CODE 318-5000, lot number 140601 (small); 318-5005, lot number
140602 (medium); 318-5010, lot number 140603 (large).
MANUFACTURER JH Gloves Company, Ltd., Taiwan.
RECALLED BY Carl Parker Associates, Inc., Hauppauge, New York, by
letters dated June 16 and June 20, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION New York.
QUANTITY 690 gloves were distributed.
REASON The gloves failed FDA water leak testing.
RECALLS AND FIELD CORRECTION: DEVICES -- CLASS III
=======================
_______________
PRODUCT Site CD Phacoemulsification Handpiece, Revision B Labeling,
used in corneal removal surgery, Recall #Z-1130-5.
CODE Not coded.
MANUFACTURER Fibra Sonics, Inc., Chicago Illinois
RECALLED BY Site Microsurgical Systems, Inc., Horsham, Pennsylvania, by
letter April 21, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Japan, England, Australia.
QUANTITY 39 units were distributed.
REASON "Flash" sterilization techniques could lead to cracks in the
tubes due to thermal shock.
_______________
PRODUCT Site CD II Phacoemulsification Handpiece, Recall #Z-1131-5.
CODE All product manufactured between June 1992 and July 1993.
MANUFACTURER Fibra Sonics, Inc., Chicago, Illinois.
RECALLED BY Site Microsurgical Systems Inc., Horsham, Pennsylvania, by
letter May 9, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Bangkok, France, Japan, United Arab Emirates,
Canada, England.
QUANTITY 820 handpieces were distributed.
REASON "Flash" sterilization techniques could lead to cracks in the
tubes due to thermal shock.
-11-
SEIZURES:
=================================================================
_______________
PRODUCT Frozen Shrimp (95-711-532 et al).
CHARGE Adulterated - One lot contains Salmonella, a poisonous or
deleterious substance which may render it injurious to
health; and, all lots except the lot contaminated with
Salmonella, consist in whole or in part of a decomposed
substance by reason of the presence therein of decomposed
shrimp.
LOCATION Mercury Cold Storage, Inc., Dover, Florida.
FILED August 25, 1995; U.S. District Court for the Middle District
of Florida, Tampa Division; Civil #95-1412-CIV-T-17A; FDC
#67103.
SEIZED August 29, 1995 - goods valued at approximately $500,000.
_______________
PRODUCT Dried, Sliced Betel Nut (95-741-549).
CHARGE Adulterated - The article contains a poisonous and
deleterious substance which may ordinarily render it
injurious to health.
LOCATION Lien Hoa Food Corporation, Chicago, Illinois.
FILED August 25, 1995; U.S. District Court for the Northern
District of Illinois, Eastern Division; Civil #95-C-4903;
FDC #67100.
SEIZED August 28, 1995 - goods valued at approximately $7,000.
END OF ENFORCEMENT REPORT FOR SEPTEMBER 6, 1995. BLANK PAGES MAY
FOLLOW.
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