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
10/13/1993
Recalls and Field Corrections: Foods -- Class II -- 10/13/1993
October 13, 1993 93-41
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Cooked Shrimp: (a) Neptune brand Cooked Shell-on Shrimp,
51/60 count, approximately 3 pounds; (b) Neptune Brand X
Shrimp Pieces Medium Cooked Shrimp, 51/60 count, in 48
ounce clear plastic bags. Recall #F-629/630-3.
CODE Case code: 31623. The individual bags are not coded.
MANUFACTURER Neptune Fisheries, Inc., Newport News, Virginia.
RECALLED BY Manufacturer, by letter, July 2, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Massachusetts, Maryland, Vermont, Pennsylvania, Texas,
Canada.
QUANTITY 729 cases: 400 cases (3 3-pound bags) and 190 cases (6 3-
pound bags).
REASON Product is contaminated with Salmonella.
_______________
PRODUCT Pecan Spinners (baked goods). Recall #F-661-3.
CODE Lot #554210.
MANUFACTURER Continental Baking Company, Inc., Ogden, Utah.
RECALLED BY Continental Baking Company, St. Louis, Missouri, by
facsimile August 11, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Utah, Washington state, California.
QUANTITY 15,301 packages.
REASON Product is contaminated with metal shavings.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Pepsi Cola, in 16 ounce glass bottles. Recall #F-662-3.
CODE G153A through H313A followed by 4 numerals.
MANUFACTURER Seltzer & Rydholm, Inc., Auburn, Maine.
RECALLED BY Manufacturer, by visit beginning September 1, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Maine.
QUANTITY 10,458 cases (24 bottles per case) were distributed.
REASON Product is contaminated with insects.
_______________
PRODUCT Solopol EF Hand Cleanser for industrial dirt with
biodegradable scrubber, in 2,000 ml bottles.
Recall #F-663-3.
CODE Catalog #83134, lot numbers: 9211722, 9208763, 9211724.
MANUFACTURER Stockhausen, Inc., Greensboro, North Carolina.
RECALLED BY Manufacturer, by letter, March 16, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Product was contaminated with salmonella.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Cromolyn Sodium Inhalation, USP, in 2 ml plastic tubes, Rx
aqueous solution for nebulization for the management of
patients with bronchial asthma. Recall #D-002-4.
CODE Lot #A001 through A037, all expiration dates.
MANUFACTURER Xactdose, Inc., South Beloit, Illinois (repacker).
RECALLED BY Repacker, by letter September 24, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,387 cases (120 tubes per case) were distributed; firm
estimates little product, if any, remains on the market.
REASON Current good manufacturing practice and labeling
deficiencies.
_______________
PRODUCT Esgic Tablets, in 100 tablet and 500 tablet bottles, Rx for
the temporary relief of the symptom complex of tension
headache. Recall #D-003-4.
CODE Lot numbers: 9912 EXP 10/93 (100-tablet), 10917 EXP 11/93
(500-tablet).
MANUFACTURER Forest Pharmaceuticals, Inc., Cincinnati, Ohio.
RECALLED BY Forest Pharmaceuticals, Inc., St. Louis, Missouri, by
letter September 1, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 14,625 bottles of lot 9912 and 2,888 bottles of lot 10917
were distributed.
REASON Unreliable data in the Abbreviated New Drug Application.
-2- _______________
UPDATE Epi Pen, 0.3 mg Epinephrine Auto-Injector, Recall #D-332-3,
which appeared in the September 8, 1993, Enforcement Report
as a Class III should have appeared as a Class II recall.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Bisacodyl Laxative Suppositories, in boxes of 12, each
labeled to contain 10 mg Bisacodyl USP. Recall #D-001-4.
CODE Lot #90921 EXP 11/95.
MANUFACTURER Great Southern Laboratories (GSL), Houston, Texas.
RECALLED BY Manufacturer, by letter December 29, 1992. Firm-initiated
recall complete.
DISTRIBUTION Alabama, California, Florida, Iowa, Illinois, Louisiana,
Maryland, Michigan, Mississippi, New Jersey, New York,
Texas.
QUANTITY 11,325 boxes (12 units per box).
REASON Subpotency.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets, Pheresis;
(c) Cryoprecipitated AHF; (d) Recovered Plasma.
Recall #B-382\385-3.
CODE Unit numbers: (a) F89011, M12342, M13156, W04959, X59630;
(b) Q00542; (c) F88900; (d) M13156.
MANUFACTURER Central California Blood Bank, Fresno, California.
RECALLED BY Manufacturer, by (a) telephone and by letters from March
26, 1992, through November 2, 1992; (b) by letter November
7, 1992; (c) by letter January 27, 1993; (d) by letters
November 6, 1992 to February 4, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION California.
QUANTITY (a) 5 units; (b) 1 unit; (c) 1 unit; (d) 1 unit.
REASON Blood products, which: 1) were collected from recently
tattooed donors; 2) tested repeatedly reactive for the
antibody to the hepatitis B core antigen (anti-HBc); 3)
were collected from a donor with a history of cancer; 4)
were untested for syphilis; 5) were mislabeled with the
incorrect expiration dates, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma; (c)
Platelets.
Recall #B-430\432-3.
CODE (a) Units 21361, 30161, 30168, 30177, 30318, 30477, 30507,
30668, 31526, 31537, 31806, 32360, 32585, 33992, 34055,
34057, 34096, 34159, 34171, 34182, 34219, 34258, 34275,
34323, 34326, 34797, 34849, 34894, 34931, 35079, 35088,
35320, 35325, 35472, 35735, 35915, 35975, 35979, 36379,
36638, 36665, 36666, 37002, 37092, 37093, 37103, 37112,
-3- 37113, 37114, 37116, 37124, 37126, 37142, 37158, 37174,
37179, 37249, 37388, 37390, 37391, 38126, 38185, 38503,
38772, 38877, 38878, 39688, 39696, 39785, 39806, 39808,
39814, 39821, 39823, 39826, 39828, 39833, 39837, 39843,
39845, 39849, 39855, 40217, 40364, 40460, 41167, 41171,
41178, 41191, 41313, 41513, 41525, 41631, 41632, 41660,
41799, 41884, 42675, 42991, 43012, 43158, 43761, 43891,
44956, 45325, 45364, 45366, 45372, 45373, 45377, 45584,
45600, 45658, 45949, 46116, 46117, 46393, 46395, 46441,
46493, 46496, 46550, 46806, 46852, 46854, 46900, 46901,
46977, 47022, 47088, 48147, 48150, 47152, 47155, 47156,
47159, 47166, 47169, 47170, 47246, 47290, 47306, 47436,
47438, 47452, 47466, 47469, 47507, 47602, 47622, 47675,
47712, 47721, 47724, 47731, 47755, 47784, 47791, 47795,
47796, 47801, 47807, 47809, 47812, 47814, 47840, 48181,
48567, 48568, 48570, 48621, 48622, 48624, 48625, 48722,
49071, 49092, 49155, 49299, 49345, 49709, 49859, 49948,
49989, 49996, 50662, 50739, 50768, 50791, 51278, 51428,
52063, 52314, 52558, 52583, 52609, 52612, 52613, 52614,
52615, 52634, 52636, 52645, 52662, 52663, 52751, 52978,
53778, 54022, 54086, 54094, 54200, 54202, 54203, 54205,
54206, 54209, 54210, 54211, 54213, 54246, 54247, 54248,
54250, 54252, 54253, 54255, 54257, 54379, 55089, 55654,
56004, 57036, 57252, 57253, 57254, 57550, 57671, 57769,
57791, 57844, 57862, 58890, 58961, 59230, 61279, 62542,
62638, 63381, 64737, 65972, 66155, 66166, 67097, 67774,
68171, 68210, 70203, 70474, 71046, 71117, 71311;
(b) Units 21361, 30168, 30318, 30477, 30507, 30930, 31363,
31537, 31806, 32585, 33992, 34055, 34171, 34182, 34185,
34219, 34258, 34275, 34326, 34894, 34931, 35088, 35320,
35472, 35735, 35915, 35979, 36379, 36638, 37092, 37103,
37112, 37113, 37116, 37124, 37126, 37142, 37158, 37174,
37179, 37249, 37391, 38185, 38468, 38503, 38704, 38772,
38878, 39855, 40460, 40985, 41313, 41513, 41525, 41632,
41660, 41884, 42675, 43012, 43158, 43891, 44956, 45325,
45364, 45366, 45372, 45373, 45377, 45584, 45600, 45658,
45949, 46116, 46117, 46393, 46395, 46441, 46493, 46496,
46550, 46806, 46852, 46854, 46900, 46901, 46977, 47022,
47088, 47147, 47150, 47152, 47155, 47156, 47159, 47166,
47169, 47170, 47246, 47290, 47306, 47436, 47438, 47452,
47466, 47469, 47507, 47602, 47622, 47675, 47712, 47721,
47724, 47731, 47755, 47784, 47791, 47795, 47796, 47801,
47807, 47809, 47812, 47814, 47840, 48181, 48567, 48568,
48570, 48621, 48622, 48624, 48625, 48722, 49092, 49155,
49299, 49345, 49709, 49859, 49948, 49989, 49996, 50739,
50768, 50791, 51278, 51428, 52063, 52314, 52558, 52583,
52609, 52612, 52613, 52614, 52615, 52634, 52636, 52645,
52663, 52751, 53778, 54022, 54086, 54094, 54200, 54202,
54205, 54206, 54209, 54210, 54211, 54213, 54246, 54248,
54250, 54252, 54253, 54257, 54379, 55089, 55654, 56004,
57036, 57252, 57769, 57791, 58890, 58961, 59230, 61279,
-4- 62401, 62461, 62542, 62638, 63381, 64737, 65972, 66032,
66155, 66166, 67097, 67774, 68171, 68210, 68234, 70203;
(c) Units 21361, 30161, 31363, 32585, 34931, 37391, 38185,
38503, 39828, 40985, 41191, 41799, 41884, 42675, 43012,
43891, 44956, 45373, 45377, 45584, 45600, 45949, 46116,
46117, 46393, 46395, 46441, 46493, 46496, 46550, 46806,
46852, 46854, 46900, 46901, 46977, 47022, 47088, 48147,
47152, 47155, 47156, 47159, 47169, 47246, 47247, 47290,
47306, 47436, 47438, 47452, 47466, 47469, 47507, 47602,
47712, 47721, 47724, 47755, 47784, 47791, 47795, 47796,
47801, 47809, 47812, 47814, 47840, 48181, 48567, 48568,
48570, 48621, 48622, 48624, 48625, 48722, 49155, 49299,
49345, 49709, 49859, 49948, 49989, 49996, 50739, 50768,
50791, 51428, 52063, 52558, 52583, 52609, 52612, 52613,
52614, 52615, 52634, 52636, 52645, 52662, 52663, 52751,
52978, 54022, 54086, 54094, 54200, 54202, 54203, 54205,
54206, 54209, 54210, 54211, 54213, 54246, 54247, 54248,
54250, 54255, 54257, 54379, 55654, 58890, 56004, 57036,
57252, 57253, 57769, 57791, 57844, 57862, 59230, 62542,
64737, 65972, 66032, 67097, 67774, 68234, 70203, 71117.
MANUFACTURER Metropolitan Washington Blood Bank, Silver Spring,
Maryland.
RECALLED BY Manufacturer, by letters in June, July, August 1992. Firm-
initiated recall ongoing.
DISTRIBUTION Maryland, District of Columbia, Virginia.
QUANTITY (a) 262 units; (b) 206 units; (c) 130 units.
REASON Blood products which 1) were tested improperly for the
Hepatitis B surface Antigen (HBsAg), the antibody to the
Human Immunodeficiency Virus Type 1 (anti-HIV-1), or the
antibody to the Human T-Lymphotrophic Virus Type I (anti-
HTLV-I), or 2) tested repeatedly reactive for HBsAg or
anti-HIV-1 but were collected from donors who previously
tested repeatedly reactive for HBsAg or anti-HIV, were
distributed; or 3) tested nonreactive for HBsAg or anti-
HIV-1 but were collected from donors who previously tested
repeatedly reactive for HBsAg or anti-HIV, were
distributed.
_______________
PRODUCT (a) Red Blood Cells; Recovered Plasma. Recall #B-433/434-3.
CODE Unit #12LV11364.
MANUFACTURER American Red Cross, Charlotte, North Carolina.
RECALLED BY Manufacturer, by telephone and by letter May 5, 1993.
Firm-initiated recall complete.
DISTRIBUTION North Carolina, California.
QUANTITY 1 unit of each component.
REASON Blood products, which tested repeatedly reactive for
Hepatitis B Surface antigen (HBsAg), were distributed.
________________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Platelets Expired;
(d) Cryoprecipitated AHF (e) Recovered Plasma.
Recall #B-442\446-3.
-5- CODE Unit numbers: (a) 39F37363, 39G11052, 39J20276;
(b) 39J20276; (c) 39F37363; (d) 39F37363; (e) 39F37363,
39G11052, 39J20276.
MANUFACTURER American National Red Cross, Huntington, West Virginia.
RECALLED BY Manufacturer, (a) by letters January 29, 1992, and April 7,
1993; (b&c) by letter January 29, 1992 and by telephone and
letter of April 7, 1993; (d) by letter January 27, 1992;
(e) by letter February 13, 1992 and April 7, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION West Virginia, California, Kentucky, Switzerland.
QUANTITY (a) 3 units; (b) 1 unit; (c) 1 unit; (d) 1 unit; (e) 3
units.
REASON Blood products, collected from a donor immigrated from sub-
Saharan Africa and was not tested for the human
immunodeficiency virus type 2 (anti-HIV-2), were
distributed.
_______________
PRODUCT Recovered Plasma. Recall #B-447-3.
CODE Unit #CH-5910.
MANUFACTURER Columbia Hospital, Columbia, Pennsylvania.
RECALLED BY Manufacturer, by telephone June 4, 1993, followed by letter
June 7, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Maryland.
QUANTITY 1 unit.
REASON A blood product, collected from a donor in which donor
suitability was not determined, was distributed.
_______________
PRODUCT Platelets. Recall #B-458-3
CODE Unit #31GF14907.
MANUFACTURER American Red Cross Blood Services, Buffalo, New York.
RECALLED BY Manufacturer, by letter October 2, 1992. Firm-initiated
recall complete.
DISTRIBUTION South Carolina.
QUANTITY 1 unit.
REASON A Blood product, which was collected from a donor who had
visited an area designated as endemic for malaria, was
distributed.
_______________
PRODUCT Platelets. Recall #B-459-3.
CODE Unit #FM60593.
MANUFACTURER Fairfax Hospital Blood Donor Services, Annandale, Virginia.
RECALLED BY Manufacturer, by telephone on or about November 6, 1991.
Firm-initiated recall complete.
DISTRIBUTION Washington, D.C.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for the
antibody to the Hepatitis B Core antigen (anti-HBc), was
distributed.
-6- _______________
PRODUCT Red Blood Cells. Recall #B-461-3.
CODE Unit #2677109.
MANUFACTURER Greater New York Blood Program, Valhalla, New York.
RECALLED BY Manufacturer, by facsimile September 16, 1992. Firm-
initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Blood product, corresponding to a unit of Platelets which
was pooled and possibly contaminated with Staphylococcus
epidermidis and diptheroids, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-462\463-3.
CODE Unit #01F43224.
MANUFACTURER Leon County Blood Bank, Tallahassee, Florida.
RECALLED BY Manufacturer, by telephone September 28, 1992, followed by
(a) letter dated September 30, 1992; (b) by letter June 24,
1993. Firm-initiated recall complete.
DISTRIBUTION Massachusetts, Florida.
QUANTITY 1 unit of each component.
REASON Blood products, collected from an ineligible donor due to
ear piercing by a non-sterile method less than twelve
months prior to donation, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Recovered Plasma. Recall #B-386-3.
CODE Unit numbers F88900 and X59630.
MANUFACTURER Central California Blood Bank, Fresno, California.
RECALLED BY Manufacturer, by letters dated from November 6, 1992 to
February 4, 1993. Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY 2 units.
REASON Blood product untested for syphilis was distributed.
_______________
PRODUCT Blood Grouping Reagent/Anti-P1, Saline Tube Test.
Recall #B-425-3.
CODE Lot numbers: 6140 EXP 6/26/93; 6141 EXP 1/22/94; 6142 EXP
6/24/94; 6143 EXP 9/18/94.
MANUFACTURER Organon Teknika Corporation, West Chester, Pennsylvania.
RECALLED BY Manufacturer, by letter May 17, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, Australia, Canada, Ireland, Mexico, Costa Rica,
Taiwan, Japan.
QUANTITY 1,719 units were distributed.
REASON Anti-P1 blood grouping reagents, contaminated with a rare
antibody that interfered with the test results of Group A
red blood cells, were distributed.
-7- _______________
PRODUCT (a) Red Blood Cells; (b) Platelets, Pheresis.
Recall #B-435/436-3.
CODE Unit numbers: (a) 12R37224; (b) 12LT10288, 12FY17609,
12FT27620, 12FT27623, 12FT27625.
MANUFACTURER American Red Cross, Charlotte, North Carolina.
RECALLED BY Manufacturer, by telephone and by letter May 5, 1993.
Firm-initiated recall complete.
DISTRIBUTION North Carolina, California.
QUANTITY (a) 1 unit; (b) 5 units.
REASON Blood products which tested initially reactive for
Hepatitis B Surface Antigen HBsAg and non-reactive by a
single repeat test, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT LSM - Lymphocyte Separation Medium, an in-vitro test
intended to be used to isolate lymphocytes from peripheral
blood. Recall #Z-629-3.
CODE Product #36427, lot #102889.
MANUFACTURER Organon Teknika Corporation, Durham, North Carolina.
RECALLED BY Manufacturer, by letter April 22, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide, Hong Kong, Netherlands, Switzerland, Japan.
QUANTITY 1,125 unit packages were distributed.
REASON Device is contaminated with Pseudomonas Pickettii.
_______________
PRODUCT Sterile equipment covers, under Cover Ups label, used to
cover a wide variety of O.R. equipment in hospitals:
(a) Product #CU-3628; (b) Product #CU-3620; (c) Product
#CU-3020. Recall #Z-670/672-3.
CODE Lot numbers: (a) 1695, shipped prior to 3/16/93, 1200-000,
all product shipped; (b) 1740, shipped prior to 3/16/93;
(c) 1650, all product shipped.
MANUFACTURER American Medical Products, Cartersville, Georgia.
RECALLED BY Manufacturer, by letter March 24, 1993. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 240 units of lot #1650; 80 units of lot 1740; 720 units of
lot 1695; and 80 units of lot 1200-0000.
REASON The devices were distributed non-sterile.
_______________
PRODUCT DPX-L Bone Densitometers and DPX Bone Densitometers with
Body Composition Output Function. Recall Z-726\727-3.
CODE All units.
MANUFACTURER Lunar Corporation, Madison, Wisconsin.
RECALLED BY Manufacturer, by letter August 2, 1993. Firm-initiated
field correction ongoing.
DISTRIBUTION Nationwide and international.
-8- QUANTITY Approximately 950 units were distributed.
REASON Devices are Class III devices and do not have approved
applications for premarket approval (PMA's).
_______________
PRODUCT "Vamp" (Venous Arterial Blood Management Protection
System), an accessory to the Vamp Blood Sampling System, a
medical device used to collect blood: (a) Vamp Needle Less
Shielded Cannula with Luer Lock, Model No. 48-VMP400;
(b) Vamp Direct Draw Blood Transfer Unit, Model #48-VMP700.
Recall #Z-731/732-3.
CODE (a) Model number: 48-VMP400
Lot numbers: 2G0954-SJ2F3788, 2H1030-SJ2G3891,
2G0955-SJ2F3789, 2H1030-SJ2G3892, 2G1100-SJ2G3998
2I1198-SJ2H4104, 2H1028-SJ2G3876, 2I1199-SJ2H4106,
2H1029-SJ2G3878;
(b) Model number 48-VMP700
Lot numbers: 2G0954-SJ2F3791, 2H1030-SJ2G3893,
2G0955-SJ2F3792, 2H1030-SJ2G3894, 2G1100-SJ2G3997,
2I1198-SJ2H4105, 2H1028-SJ2G3877, 2I1199-SJ2H4107,
2H1029-SJ2G3879.
MANUFACTURER Baxter Healthcare Corporation, Edwards Critical Care
Division, Irvine, California.
RECALLED BY Manufacturer, by letter October 13, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 1,112 cases; (b) 856 cases, (50 units per case) were
distributed.
REASON Individual plastic pouches were torn during manufacture.
The tears may compromise the sterility of the device.
_______________
PRODUCT Lasermedics Microlight 830, Model 101VS, for veterinary
laser therapy. Recall #Z-784-3.
CODE None.
MANUFACTURER Lasermedics, Inc., Stafford, Texas.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan August 31, 1993. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide
QUANTITY 5 units.
REASON Noncompliance with performance standard for laser products.
_______________
PRODUCT Iolab Posterior Chamber Intraocular Lens:
(a) Model #4141S, 22.5 diopter, 6.5 mm Optic, PMMA loops;
(b) Model #4240S, 12.0 Diopter, 6.0 mm optic, Prolene
loops.
Recall #Z-818/819-3.
CODE Lot numbers: (a) 4141S 100391 2024 through 4141S 100391
2047; (b) 4240S 100391 2000 through 4240S 100391 2023.
MANUFACTURER Iolab Corporation, Claremont, California.
-9- RECALLED BY Manufacturer, by telephone December 26, 1991 and March 10,
1992. Firm-initiated recall complete.
DISTRIBUTION California, Florida, Georgia, Illinois, Michigan,
Pennsylvania, Texas.
QUANTITY (a) 15 lenses; (b) 3 lenses were distributed. Firm
estimates none remains on the market.
REASON Lenses were labeled with the incorrect diopter power.
_______________
PRODUCT Dextrolyte II Peritoneal Dialysis Cycler Set XXX Prong:
(a) Catalog #48-1002-4, 5 Prong Cycler Set;
(b) Catalog #48-1003-2, 5 Prong Cycler Set;
(c) Catalog #48-1007-3, 12 Prong Cycler Set;
(d) Catalog #48-1033-9, 3 Prong Cycler Set;
(e) Catalog #48-1038-8, 8 Prong Cycler Set;
(f) Catalog #48-1111-3, 2 Liter LBO Cycler Set.
Recall #Z-821/826-3.
CODE Lot numbers: (a) M1S507, M1S510, M2A505, B2B512, M2B513,
M2B514, M2B516, M2B520, M2B522, M2D502, M2D503, M2D504,
M2D513, M2E505, M2E506, M2H502, M2H503, M2H504, M2H505,
M2H506, M2H507, M2H508, M2H515, M2H516, M2J502, M2J505,
M2J510, M2K501, M2K502, M2K504, M2K505, M2K506, M2K507,
M2K508, M2K509, M2L502, M2L503, M2L506, M2L507, M2L510,
M2L512, M2L514, M2L515, M2L516, M2N501, M2N506, M2N508,
M2N509, M2P504, M2P505, M2P508, M2P509, M2P510, M2P511,
M2P512, M2S501, M2S502, M2S505, M3A508, M3A509, M3A511,
M3A512, M3A513, M3A514, M3A515, M3B507, M3B508, M3B512,
M3C505, M3C506, M3C510, M3C514, M3C516, M3D501, M3E501;
(b) M2H523; (c) M2C505, M2J511; (d) M2L505, M3B506; (e)
M2A506, M2B523, M2E501, M2J506, M2J512, M2L509, M2L511,
M2N507, M2P502, M2S503, M3A518, M3B516; (f) M2N505.
MANUFACTURER National Medical Product, Medical Product Division,
McAllen, Texas.
RECALLED BY National Medical Care, Medical Product Division, Rockleigh,
New Jersey, by letter June 17, 1993. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 20,215 cases (10 sets per case).
REASON Leakage of heater and weigh arm bags. The firm changed
component specifications for the thickness of the film used
in the manufacture of peritoneal dialysis heater and weigh
bags from 10 mil to 15 mil while not adequately controlling
the sealing operation.
_______________
PRODUCT Arterial and Venous Bloodlines under the Baxter Healthcare
label: (a) Arterial Blood Tubing Set for Hemodialysis,
Catalog 96-4262; (b) Venous Blood Tubing Set for
Hemodialysis, Catalog #96-4491. Recall #Z-842/843-3.
CODE Lot numbers: (a) R1L619; (b) R1K618.
-10- MANUFACTURER National Medical Care, Medical Product Division, Reynosa,
Mexico; National Medical Care, Medical Product Division,
McAllen, Texas.
RECALLED BY National Medical Care, Medical Product Division, Rockleigh,
New Jersey, by letter March 29, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION Undetermined.
QUANTITY (a) 6,036 units; (b) 12,024 units were distributed; firm
estimates (a) 14 units; (b) 26 units remain on the market.
REASON The devices were yellow and were found to contain the
herbicide Treflan.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT SickleQuick Test Kit, an in-vitro diagnostic test intended
to be used as a differential solubility test for hemoglobin
S: (a) Product Code #33375; (b) Product Code #33376.
Recall #Z-626/627-3.
CODE Lot #L20083 and L20084.
MANUFACTURER BHP Diagnostics Corporation, Westchester, Pennsylvania.
RECALLED BY Organon Teknika, Durham, North Carolina, by letter on or
about March 23, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Canada, Japan.
QUANTITY Firm shipped 400 packages of lot L20083 retaining 1 package
as a reserve sample 188 packages of lot L20084.
REASON Vial caps did not provide proper seals resulting in product
leakage.
_______________
PRODUCT Turbiquant RF Test Kit, in-vitro diagnostic.
Recall #Z-660-3.
CODE Lot Numbers: 985411 and 123106. Kit lot 24510 EXP2/23/93.
MANUFACTURER Behringwerke AC, Marburg, Germany.
RECALLED BY Behring Diagnostics, Inc., Somerville, New Jersey, by
letters January 25-26, 1993. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 199 test kits.
REASON The RF reagent results in assay values which were
artificially low and do not conform to manufacturer's
specifications. This could cause a potential for
inaccurate test results.
_______________
PRODUCT Schiapparelli Biosystems AST-LTS (GOT) Reagent for the
determination of Serum Aspartate Aminotransferase:
(a) Catalog No. R2-61; (b) Catalog No. RG-1-61.
Recall #Z-690/691-3.
CODE (a) Lot No. Expiration Date
930307 01/95
921010 03/94
-11- 920607 03/94
920606 09/93
920207 09/93
(b) 930412 01/95
920912 03/94
920412 09/93
911205 09/93
MANUFACTURER Schiapparelli Biosystems, Inc., Columbia, Maryland.
RECALLED BY Schiapparelli Biosystems, Inc., ENI Diagnostics Division,
Fairfield, New Jersey, by letter March 25, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 5,353 units; (b) 2,524 units.
REASON Some vials do not meet the initial reagent absorbance
requirements for 1.0 after storage at 2-8 degrees C for 12
days following reconstitution.
_______________
PRODUCT Reaads Anti-Cardiolipin Semi-Quantitative Test Kit, an
enzyme-linked immunosorbent assay (ELISA) for the semi-
quantitative determination of IgG and IgM anti-cardiolipin
antibodies in human serum or plasma. Recall #Z-735-3.
CODE Lot numbers: CL-168, CL169, CL170.
MANUFACTURER Reaads Medical Products, Inc., Westminister, Colorado.
RECALLED BY Manufacturer, by telephone July 15 and 19, 1993. Firm-
initiated recall ongoing.
DISTRIBUTION Rhode Island, Maryland, Michigan, North Carolina,
Washington state, Tennessee, Pennsylvania, New Jersey.
QUANTITY 29 kits.
REASON There were too many IgG and IgMs anti-cardiolipin positive
samples and that the reagent blanks may be too high causing
false positive results.
_______________
PRODUCT (a) Criterion Ultra Dailyware Natural Tint (polymacon)
Contact Lenses: (1) Color: Aqua, Sag I, Power -5.00
(2) Color: Aqua, Sag I, Power -6.00
(3) Color: Aqua, Sag II, Power -4.00
(4) Color: Aqua, Sag II, Power -3.00
(5) Color: Blue, Sag I, Power -5.00
(6) Color: Green, Sag I, Power -1.50
(7) Color: Green, Sag II, Power +.25
(b) Criterion Ultra Flexiware Natural Tint (polymacon)
Contact Lenses: (1) Color: Blue, Power -2.75;
(2) Color: Blue, Power -5.50. All products were assigned a
May 1988 expiration date. Recall #Z-816/817-3.
CODE Lot numbers: (a) (1) 420003 and 420004; (2) 420005 and
420006; (3) 420007 and 420008; (4) 420009; (5) 419994; (6)
419995; (7) 420001 and 420002;
(b) (1) 410010 and 420011; (2) 420012 and 420013.
MANUFACTURER Manufactured in Ireland.
-12- RECALLED BY Bausch & Lomb, Inc., Rochester, New York (relabeler), by
telephone June 11, 1993. Firm-initiated recall complete.
DISTRIBUTION Tennessee.
QUANTITY 484 lenses were distributed; firm estimates none remains on
the market.
REASON Lenses were relabeled with the wrong expiration date.
MEDICAL DEVICE SAFETY ALERTS:
============================================
_______________
PRODUCT Theratronics teletherapy, accelerator and simulator
radiation devices for cancer therapy with Theratronics'
treatment tables: (a) Theratron Teletherapy Models T80,
T765, T780C; (b) Linear Accelerator Models T6, T20, T25;
(c) Simulator Models T720, T750. Safety Alert #N-077/079-
3.
CODE (a) Theratron teletherapy models (User Bulletin
CUB 93-03)
Theratron 80 (T80) - Serial Numbers 007, 012, 016, 019,
024, 031, 032, 036, 038, 040, 043, 044, 051, 060, 066, 071,
078, 079, 080, 085, 086, 088, 089, 093, 095, 099, 108, 118,
120, 125, 128, 133, 139, 140, 145, 149, 150, 157, 161, 162,
163, 164, 165, 166, 167, 168, 169, 176, 177, 178, 180, 181,
185, 187, 188, 190, 194, 198, 200, 201, 204, 206, 207, 208,
209, 212, 218, 219, 222, 227, 231, 233, 234, 239, 242, 246,
247, 251, 255, 257, 258, 261, 264, 265, 267, 268, 271, 272,
274, 282, 283, 284, 285, 288, 291, 292, 293, 294, 295, 297,
301, 306, 311, 316, 321, 325, 328, 329, 332, 333, 339, 343,
345, 349, 353, 364, 376, 378, 379, 382, 384, 394, 505, 507,
514, 518, 523, 526, 529, 530, 532, 534, 539
Theratron 765 (T765) - Serial Numbers 007, 008
Theratron 780 (T780) - Serial Numbers 003, 004, 005, 007,
008, 010, 011, 016, 017, 020, 021, 024, 026, 027, 028, 033,
037, 040, 042, 049, 051, 052, 055, 056, 057, 058, 059, 060,
062, 064, 073, 074, 075, 082, 083, 086, 089, 097, 098, 101,
113, 114, 116, 121, 127, 128, 129, 133, 136, 137, 149, 150,
160, 161, 177, 178, 179, 182, 201, 215, 221, 226, 230, 232,
233, 234, 235, 236, 241, 249, 251, 252, 253, 262, 266, 275,
278, 280, 284, 288, 293, 296, 298, 299, 302, 306, 307, 308,
311, 314, 315, 318, 322, 323, 326, 333, 334, 335, 336, 341,
343, 351, 358, 359, 366, 367, 369, 377, 381, 386, 388, 395,
398, 399, 401, 402, 415, 417, 426, 428, 431, 433
Theratron 780C (T780C) - Serial Numbers 002, 009, 014, 016,
020, 022, 024, 030, 032, 035, 036, 038, 043, 058, 072, 073,
074, 078, 082, 103
Theratron 1000 - Serial Numbers 001, 002, 004, 005, 007,
008, 010, 011, 012
Phoenix Model - Serial Numbers 001, 003, 005, 008, 010,
012, 014, 017, 018, 020, 023, 032, 036;
(b) Linear accelerator models (User Bulletin AUB 93-02)
Therac 6 (T6) - Serial Numbers 010, 015, 018, 020, 021,
024, 025, 027, 030, 031, 035, 036, 037, 038, 039, 563
-13- Therac 20 (T20 - Serial Numbers 041, 043, 058, 064, 065,
067, 077, 412, 512, 711, 813;
Therac 25 (T25) - Serial Numbers 022, 024, 025
(c) Simulator models (User Bulletin SUB 93-01)
Therasim 720 (T720) - Serial Numbers 036, 038, 044, 048,
055, 070, 600 and one unit with unknown serial number
Therasim 750 (T750) - Serial Numbers 005, 006, 008, 012,
015, 016, 022, 023, 024, 031, 034, 036, 037, 038, 040,
044, 046, 047, 048, 049, 050, 051, 052, 055, 057, 060,
062, 063, 064, 066, 072, 076, 077, 078, 080, 082, 083,
084, 085, 087, 088, 089, 091, 092, 093, 097, 098, 099,
101, 102, 103, 104, 105, 106, 107, 108, 110, 113, 114,
115, 116, 117, 119, 120, 121, 122, 123, 125, 126, 127,
128, 129, 130, 131, 132, 135, 137, 138, 140
SIM - Serial Numbers 008, 010, 014, 016, 025
[Clarification is being obtained for this model as firm's
consignee lists provides "SIM" only for the name of the
model.]
MANUFACTURER Theratronics International, Ltd. [formerly Atomic Energy of
Canada, Ltd. (AECL Medical)], Kanata, Ontario, Canada;
Theratronics International, Ltd., 2833 Trinity Mills Road,
Carrollton, Texas.
ALERTED BY Theratroncis International, Ltd., Kanata, Canada, by User
Bulletins CUB93-03, AUB 93-02 and SUB 93-01 dated May 5,
1993.
DISTRIBUTION Nationwide and international.
QUANTITY 421 units.
REASON Potential for injury to operator's and patient's fingers if
hands are not kept clear of the treatment table mechanisms
while table movement is in progress.
_______________
PRODUCT MicroSelectron High Dose Rate Treatment Tube used with
Nucletron Micro Selectron-HDR Remote Afterloading Systems,
used for connecting needles and flexible implants.
Safety Alert #N-080-3.
CODE All units.
MANUFACTURER Nucletron BV, Waardgelder 1, The Netherlands.
RECALLED BY Nucletron Corporation, Columbia, Maryland, by sending
technical notes to users on June 10, 1991.
DISTRIBUTION Nationwide, Argentina, Brazil, Canada, Columbia, Mexico,
Venezuela, West Indies.
QUANTITY 242 high dose rate units.
-14- REASON Under certain conditions, less than accurate performance
could prevail. Prior to using the Source Position
Simulator for depth measurements of the x-ray catheter for
radiographs of the implant area, users should insure that
the treatment tubes and implant applicators are draped in a
curved rather than straight fashion in order to achieve
appropriate connection to the microSelectron-HRD. This
method will insure the highest accuracy of the system and
the ability to accurately position the source.
-15-
END OF ENFORCEMENT REPORT FOR OCTOBER 13, 1993. BLANK PAGES MAY
FOLLOW.
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