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
08/31/1994
Recalls and Field Corrections: Foods -- Class II -- 08/31/1994
August 31, 1994 94-35
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=======================
_______________
PRODUCT Oxygen USP in size D & E Cylinders. Recall #D-352-4.
CODE Lot numbers: 032894-25, 032994-29, 032994-30, 032994-30,
032994-31, 032994-32, 032994-33, 053194-2.
MANUFACTURER Medical Park Pharmacy, Morehead, North Carolina.
RECALLED BY Manufacturer, by telephone June 17, 1994. Firm-initiated
recall complete.
DISTRIBUTION Undetermined.
QUANTITY Undetermined.
REASON Current good manufacturing practice deficiencies.
_______________
PRODUCT Risperdal (Risperidone) Tablets, labeled as containing 2 mg
tablets, an oral anti-psychotic drug, in bottles of 60.
Recall #D-373-4.
CODE Lot #93L425E EXP 6/95.
MANUFACTURER Johnson and Johnson Pharmaceutical Partners, Gurabo, Puerto
Rico.
RECALLED BY Janssen Pharmaceutica, Titusville, New Jersey, by letter
July 15, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 16,536 bottles were distributed; firm estimated that 1000
bottles remained on market at time of recall.
REASON A bottle labeled as 2 mg tablets contained 1 mg tablets.
_______________
PRODUCT Prednisone Tablets, USP, (a) 5 mg; (b) 10 mg, in unit dose
blister packs in cartons of 100 tablets, Rx oral
glucocorticoid anti-inflammatory. Recall #D-374/375-4.
CODE Lot numbers: (a) 2P425, 3A822, 3F173, 3K572, 4B244, 4I681,;
(b) 2P394, 2V694, 3C002, 3J413, 3P738, 4B207.
MANUFACTURER Purepac Pharmaceutical Company, Division of Kalipharma,
Inc., Elizabeth, New Jersey.
RECALLED BY UDL Laboratories, Inc., Rockford, Illinois (repacker), by
letter August 12, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 20,215 cartons of 100 unit dose; (b) 13,199 cartons of
100 unit dose tablets were distributed. Firm estimates 35%
of product remains on market.
REASON Product may not meet dissolution specifications through
expiration dates.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Bulk pharmaceuticals:
1. Activated Charcoal Powder, USP, (125 grams & 500 grams)
2. Ammonium Carbonate, Chips, NF, (125 grams, 500 grams &
x 500 grams); Ammonium Carbonate, Powder, NF (500
grams, 12 x 500 grams & 300 pounds)
3. Benzyl Alcohol, NF, (475 pounds)
4. Butylparaben, NF (2.5 kilograms)
5. Calcium Chloride, Dihydrate, Granular, USP, (pyrogen
tested - 12 kilograms, 70 pounds & 100 pounds) (not
pyrogen tested - 500 grams, 100 pounds & 300 pounds)
6. Edetate Disodium, USP, (500 grams & 12 kilograms)
7. Hydrogen Peroxide, Topical Solution, 2.5% - 3.5%, USP,
(500 milliliters & 4 liters)
8. Iodine Tincture, 2%, USP, (500 milliliters)
9. Lanolin, Hydrous (lanolin, modified), USP, (454 grams)
10. Magnesium Chloride, Hexahydrate, USP, (12 kilograms &
90 pounds)
11. Potassium Iodide, Granular, USP, (125 grams, 500 grams,
2.5 kilograms, 12 kilograms & 100 pounds)
12. Potassium Phosphate, monobasic, crystal, pyrogen
tested, USP (12 kilograms & 100 pounds)
13. Salicylic Acid, fine crystal, USP (125 grams, 500 grams
& 4 x 500 grams); and, salicylic acid, powder, USP,
(125 grams, 12 x 125 grams, 500 grams & 4 x 500 grams)
14. Silver Nitrate, crystal, USP, (30 grams, 125 grams &
500 grams)
15. Sodium Bicarbonate, powder, pyrogen tested, USP, (12
kilograms & 100 pounds); Sodium Bicarbonate, powder,
[not pyrogen tested], USP, (500 grams, 12 x 500 grams,
2.5 kilograms, 4 x 2.5 kilograms, 12 kilograms & 100
pounds)
16. Sodium Carbonate, anhydrous, granular, NF, (500 grams,
100 pounds & 200 pounds)
-2-
17. Sodium Iodide, Crystal, USP, (125 grams & 500 grams)
18. Sodium Phosphate, dibasic, pyrogen tested, USP (12
kilograms & 200 pounds), sodium phosphate, dibasic,
[not pyrogen tested], USP, (500 grams, 2.5 kilograms,
25 pounds, 100 pounds & 300 pounds)
19. Sodium Thiosulphate, pentahydrate, USP, (500 grams,
12 x 500 grams, 2.5 kilograms, 4 x 2.5 kilograms & 110
pounds)
20. Sucrose, Crystal, NF, (12 kilograms).
Recall #D-353/372-4.
CODE All lots bearing lot numbers C26001 (July 1989) through
H26001 (July 1994).
MANUFACTURER J.T. Baker, Inc., Jackson, Tennessee.
RECALLED BY J.T. Baker, Inc., Phillipsburg, New Jersey, by letter July
13, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Approximately 1.2 million pounds of the powder/crystal
products and approximately 1,500 liters of the liquid
products were distributed.
REASON Insufficient stability data to support expiration dates.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
====================
______________
PRODUCT LifeTec Community Blood Center Systems Software Revision
1.60. Recall #B-423-4.
CODE Version 1.60 only.
MANUFACTURER SysTec Computer Associates, Inc., Smithtown, New York.
RECALLED BY Manufacturer, by letter February 24, 1993, followed by the
program revisions on March 1, 1993. Firm-initiated field
correction complete.
DISTRIBUTION South Carolina, Tennessee, Louisiana, Georgia, Mississippi.
QUANTITY 7 pieces.
REASON Computer software, containing design defects which resulted
in the release of unsuitable blood products, was distributed
for use in blood banks.
______________
PRODUCT Source Plasma. Recall #B-428-4.
CODE Unit numbers: XE02549, XE02592, XE02710, XE03245, XE03327,
XE03363, XE03809, XE03877, XE03948, XE04015, XE04349,
XE04374, XE04570, XE04761, XE05103, XE05133, XE05211,
XE05266, XE05325, XE05404, XE05675, XE05715, XE05788,
XE05853, XE05916, XE06077, XE06120, XE06178, XE06221,
XE09195, XE09264, XE09308, XE09394, XE09896, XE09959,
XE10180, XE10243, XE10314, XE10665, XE10742, XE10838,
XE10879, XE12010, XE12114, XE12239, XE12324, XE12460,
XE12545, XE12741, XE12928, XE12999, XE13110, XE13181,
XE13301, XE13371, XE13669, XE13743, XE02569, XE02794,
XE05556, XE06025, XE06422, XE06869, XE07256, XE15802,
XE16171, XE16259, XE16425, XE16647, XE16715, XE16918,
XE17338, XE18641, XE20609, XE20933, XE20952, XE21054,
XE21118, XE21140, XE21569, XE21650, XE21777, XE21846,
XE23240, XE23240, XE23522, XE23522, XE24333, XE24333,
-3-
XE22183, XE22292, XE22393, XE22431, XE22673, XE23168,
XE24415, XE24415, XE24789, XE24961, XE25363, XE25790,
XE26404, XE26607, XE26718, XE27407, XE27537, XE28433,
XE29031, XE29074, XE29182, XE29226, XE29540, XE29769,
XE29853, XE29952, XE30159, XE30513, XE30672, XE30827,
XE31663, XE31746, XE32311, XE32428, XE32713, XE32824,
XE32952, XE33406, XE33471, XE33703, XE34045, XE34149,
XE34339, XE35034, XE38347, XE39043, XE39945, XE40240,
XE40924, XE41655, XE41968, XE42054, XE42342, XE42595,
XE42903, XE43058, XE43282, XE43292, XE43654, XE44164,
XE44400, XE45115, XE45372, XE45700, XE46012, XE48467,
XE70185, XE86637.
MANUFACTURER Plasma Products of Virginia, Inc., Richmond, Virginia;
Community Bio Resources, Inc., Richmond, Virginia.
RECALLED BY Community Bio Resources, Inc., Birmingham, Alabama, by fax
April 14, 1994, and by letter April 29, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Michigan, Austria.
QUANTITY 157 units.
REASON Blood products which were non-reactive for hepatitis B
surface antigen (HBsAg), but collected from donors who
previously tested repeatedly reactive for HBsAg were
distributed.
_______________
PRODUCT Source Plasma. Recall #B-429-4.
CODE Unit numbers: PE48018, PE48121, PE48430, PE49639, PE48927,
PE49121, PE49407, PE49568, PE49867, PE50032, PE50297,
PE50444, PE50732, PE50930, PE51220, PE51395, PE51707,
PE51979, PE52164, PE52381, PE53840, PE52935, PE53272,
PE53612, PE54029, PE54467, PE55826.
MANUFACTURER Community Bio Resources, Inc., Richmond, Virginia.
RECALLED BY Community Bio Resources, Inc., Birmingham, Alabama, by
letter April 26, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Austria.
QUANTITY 27 units.
REASON Blood products collected from a donor who reported a history
of behavior known to increase the risk for transmission of
human immunodeficiency virus (HIV) were distributed.
_______________
PRODUCT Source Plasma. Recall #B-430-4.
CODE Unit numbers: XC92459, XC92922, XC93387, XC93965, XC94382.
MANUFACTURER Community Bio Resources, Inc., Richmond, Virginia.
RECALLED BY Community Bio Resources, Inc., Birmingham, Alabama, by
letter April 26, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Austria.
QUANTITY 5 units.
REASON Blood products collected from a donor who had previously
been deferred for suspected intravenous drug use were
distributed.
-4-
_______________
PRODUCT Red Blood Cells. Recall #B-435-4.
CODE Unit #6730953.
MANUFACTURER Blood Center of Southeast Texas, Beaumont, Texas.
RECALLED BY Manufacturer, by telephone January 20, 1994. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product collected from an ineligible donor due to ear
piercing by a non-sterile method less than twelve months
prior to donation was distributed.
_______________
PRODUCT Platelets, Pheresis. Recall #B-434-4.
CODE Unit #90-48037.
MANUFACTURER Medic, Inc., Knoxville, Tennessee.
RECALLED BY Manufacturer, by telephone October 21, 1993 with follow-up
letter November 12, 1993. Firm-initiated recall complete.
DISTRIBUTION Tennessee.
QUANTITY 1 unit.
REASON Blood product that tested negative for the antibody to
hepatitis B core antigen (anti-HBc) was collected from a
donor who previously tested reactive for anti-HBc on two
separate occasions was distributed.
_______________
PRODUCT Source Plasma. Recall #B-436-4.
CODE Unit numbers: PE2466, PE2631, PE2759, PE2935, PE3078,
PE3237, PE3401, PE3544, PE3658, PE3809, PE3929, PE4088,
PE4209, PE4350, PE4445, PE4612, PE4704, PE4819, PE5204,
PE5297, PE5352, PE5521, PE5619, PE5771, PE5913, PE6042,
PE6192, PE6299, PE6458, PE6602, PE6715, PE7101, PE7245,
PE7364, PE7647, PE7987, PE8133, PE8458, PE8607, PE9066,
PE9301, PE11073, PE11157, PE11263, 0300145, 0300369,
E4036443, E4036772, E4037104, E4039829, E4039992, E4040210,
E4040401, E4040596, E4040751, E4040997, E4041174, E4041427,
E4041610, E4041843, E4042007, E4042242, E4042390, E4042640,
E4042815, E4043093, E4043265, E4043517, E4043668, E4044015,
E4044259, E4044693, E4044913, E4045489, E4045619, E4045880,
E4046047, E4046158, E4046407, E4046541, E4046779, E4046968,
E4047201, E4047456, E4047666, E4047849, E4048099, E4048333,
E4048623, E4048851, E4049419, E4049616, E4049805, E4050047,
E4050267, E4050520, E4050735, E4050945.
MANUFACTURER Plasma Products of Virginia, Inc., Richmond, Virginia.
RECALLED BY Community Bio Resources, Inc., Birmingham, Alabama by letter
April 26, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Austria.
QUANTITY 98 units.
REASON Blood products collected from a donor who had previously
been deferred for intravenous drug use were distributed.
-5- _______________
PRODUCT Red Blood Cells. Recall #B-437-4.
CODE Unit #128654.
MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, Alaska.
RECALLED BY Manufacturer, by letter April 6, 1994. Firm-initiated
recall complete.
DISTRIBUTION Alaska.
QUANTITY 1 unit.
REASON Blood product which tested repeatedly reactive for hepatitis
B surface antigen (HBsAg) was distributed.
_______________
PRODUCT Source Plasma. Recall #B-438-4.
CODE Unit numbers: 0045247, 0045460, 0045725, 0045819, 0047192,
0047474, 0052807, 0053105, 0064462, 0064917, 0064945,
0065281, 0065282, 0065306, 0065622, 0066338, 0066339.
MANUFACTURER Stillwater Plasma Center, Inc., Stillwater, Oklahoma.
RECALLED BY Manufacturer, by letter December 7, 1993. Firm-initiated
recall ongoing.
DISTRIBUTION New York and international.
QUANTITY 17 units.
REASON Blood products, which either 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; or were collected from a
donor who tested negative for anti-HIV-1, but who reported
behavior that increased the risk of HIV infection, were
distributed.
_______________
PRODUCT Source Plasma. Recall #B-448-4.
CODE Unit numbers: XF79127, XF79391.
MANUFACTURER Community Bio-Resources, Inc., New Orleans.
RECALLED BY Manufacturer, by letter January 17, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Austria.
QUANTITY 2 units.
REASON Blood product which was collected from a donor who had a
history of intravenous drug (IV) use was distributed.
_______________
PRODUCT Anti-Fyb Blood Grouping Reagent. Recall #B-451-4.
CODE Lot numbers FYB25A3 and FYB25B EXP 10/8/94.
MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan, New Jersey.
RECALLED BY Manufacturer, by letter April 14, 1994, and by fax April 15,
1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 517 packages of lot FYB25A3 and 183 packages of lot FYB25B.
REASON Anti-Fyb blood grouping reagent, exhibiting decreased
reactivity with Fyb positive red blood cells was
distributed.
-6-
_______________
PRODUCT Red Blood Cells. Recall #B-452-4.
CODE Unit #FR00467.
MANUFACTURER Central Pennsylvania Blood Bank, Ephrata, Pennsylvania.
RECALLED BY Central Pennsylvania Blood Bank, Hummelstown, Pennsylvania,
by telephone January 25, 1994, followed by letter January
26, 1994. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
REASON Blood product, that tested negative for the antibodies to
human immunodeficiency virus types 1 and 2 (anti-HIV-1/2),
but was collected from a donor who previously tested
repeatedly reactive for anti-HIV-1/2, was distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT LifeTec Community Blood Center Systems Software Version 2.0.
Recall #B-424-4.
CODE Version 2.0.
MANUFACTURER SysTec Computer Associates, Inc., Smithtown, New York.
RECALLED BY Manufacturer, by letter February 24, 1993, followed by the
program revisions on March 1, 1993. Firm-initiated field
correction complete.
DISTRIBUTION Iowa.
QUANTITY 1 piece.
REASON Computer software requiring subsequent modifications, was
distributed for use in blood banks.
_______________
PRODUCT Platelets. Recall #B-439-4.
CODE Unit #6180941.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone April 27, 1994, followed by
letter. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Blood product corresponding to Red Blood Cells possibly
contaminated with Propionibacterium acnes, was distributed.
_______________
PRODUCT Platelets, Pheresis. Recall #B-442-4.
CODE Unit numbers: 42FR25628, 42FR25636, 42FR25644.
MANUFACTURER American Red Cross, Cleveland, Ohio.
RECALLED BY American Red Cross, Charlotte, North Carolina, by telephone
February 21, 1994, and letters dated February 22 and 24,
1994. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 3 units.
REASON Blood products shipped under unacceptable temperature were
distributed.
-7-
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Vas-Cath Soft-Cell Catheters, used for hemodialysis,
apheresis, hemofiltratio and hemoperfusion access via the
subclavian, jugular or femoral vein: (a) Soft-Cell Lumen
Catheters (straight): (b) Soft-Cell Dual Lumen Catheters
(Curved); (c) Peritoneal Dialysis Catheters (Curved); (d)
Peritoneal Dialysis Catheters (Straight).
Recall #Z-1243/1246-4.
CODE (a) Catalog Numbers: (a) PDLC-5512, PDLC-5519, PDLC-5523,
lot numbers: All lots below lot 152-### or with a sterility
date earlier than 9/13/91.
(b) Catalog numbers: PDLC-5519PC, PDLC-5523PC; Lot numbers:
All lots below lot 246-### or with a sterility date earlier
than 5/12/92.
(c) Catalog numbers: CCPD-11060, CCPD-11056, CCPD-12056,
CCPD-12062; Lot numbers: All lots below 210-## or with a
sterility date earlier than 1/27/92;
(d) Catalog numbers: CPD-11031, CPD-11037, CPD-11042, CPD-
11046, CPD-11541, CPD-11546, CPD-12031, CPD-12032, CPD-
12037, CPD-12042, CPD-12047; Lot numbers: All lots below
lot 179-### or with a sterility date earlier than 11/19/91.
MANUFACTURER Vas-Cath, Inc., Mississauga, Ontario, Canada.
RECALLED BY Manufacturer, by telephone December 7, 1993, and by fax
December 9, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Indiana, Texas, New Jersey, Kansas, Alabama, Illinois,
Michigan, Nebraska, Utah, Washington state, California,
Minnesota, Arizona.
QUANTITY Soft-Cell Dual Lumen Catheters:
PDLC-5512 - 400 units PDLC-5519 - 4,290 units
PDLC-5523 - 3,270 units PDLC-5519PC - 2,740 units
PDLC-5523PC - 1,745 units
Peritoneal Dialysis Catheters:
CCPD-11060 - 30 units CCPD-11056 - 30 units
CCPD-12056 - 95 units CCPD-12062 - 30 units
CPD-11031 - 5 units CPD-11037 - 20 units
CPD-11042 - 5 units CPD-11046 - 5 units
CPD-11541 - 30 units CPD-11546 - 20 units
CPD-12032 - 10 units CPD-12037 - 15 units
CPD-12042 - 50 units CPD-12047 - 70 units.
REASON The cuff may detach due to the breakdown of adhesive bonding
after long term implantation.
_______________
PRODUCT Multiple Arterial and Venous Bloodlines, Rx medical device
products used in hemodialysis treatment:
(a) Catalog #03-9252-2 - Arterial Bloodline;
(b) Catalog #03-9253-0 - Arterial Bloodline;
(c) Catalog #03-9254-8 - Arterial Bloodline;
(d) Catalog #03-9265-4 - Arterial Bloodline;
(e) Catalog #03-9452-8 - Venous Bloodline;
(f) Catalog #03-9460-1 - Venous Bloodline;
(g) Catalog #03-9463-5 - Venous Bloodline;
-8-
(h) Catalog #03-9464-3 - Venous Bloodline;
(i) Catalog #03-9483-3 - Venous Bloodline.
Recall #Z-1249/1257-4.
CODE Catalog Numbers Lot Numbers
03-9252-2 M2C002, M2D001, M2D002
03-9252-2 M2D003, M2L003
03-9253-0 M2N002, M2N003
03-9254-8 M2L004, M2L005
03-9265-4 M2N005
03-9452-8 M2K001, M2K002, M2K003
03-9452-8 M2K004, M2K005, M2K006
03-9452-8 M2K007, M2K008, M2K009
03-9452-8 M2K010
03-9460-1 M2S004
03-9463-5 M3A004
03-9464-3 M3A005, M3D003
03-9483-3 M2L001, M2L002.
MANUFACTURER National Medical Care, Medical Products Division, McAllen,
Texas, and satellite plant at Reynosa, Mexico.
RECALLED BY National Medical Care, Medical Products Division, Rockleigh,
New Jersey (responsible firm), by letter December 8, 1993.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and Ireland.
QUANTITY 285,564 devices were distributed; firm estimates that little
product remains on the market.
REASON Certain bloodlines were manufactured without sufficient
documentation to assure compliance with device
specifications and also exhibit a tendency to cause
microbubbles.
_______________
PRODUCT Ohmeda Vaporizers: (a) Ohmeda Tec 6 (desflurane) Vaporizers
for use with Ohmeda Anesthesia Systems; (b) Ohmeda Tec 6
(desflurane) Vaporizers for use with North American Drager
Anesthesia Systems (also known as the Tec 6 NAD Variant.
Recall #Z-1261/1262-4.
CODE Serial numbers: ACTV32001 to ACTV 51502, ACTW01001 to
ACTW30093; (b) ACWW14001 to ACWW30288, ACWW31001 to
ACWW51200, ACWX01001 to ACW19010.
MANUFACTURER Ohmeda Medical Systems Division, Steeton, West Yorkshire,
England.
RECALLED BY Ohmeda Medical Systems Division, Madison, Wisconsin, by
letters dated July 8, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 12,700 units were distributed.
REASON Devices delivered higher concentrations of the anesthetic
agent than indicated by the vaporizer setting. In addition,
the Tec 6 NAD Variant Vaporizer has developed a significant
fresh gas leak when the vaporizer was turned off after use.
_______________
PRODUCT Neonatal Monitoring System and Central Display Unit.
Recall #Z-1273-4.
-9-
CODE All serial numbers.
MANUFACTURER S&W Medico Teknik, Abyro, Denmark (responsible firm).
RECALLED BY Air Shields, Inc., Hatboro, Pennsylvania, by letter June 2,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico
QUANTITY Approximately 40 units.
REASON The 105 degree centigrade capacitor, when exposed to
temperatures higher than it is rated, will dry out and lose
its electrical capacity prematurely. The capacitor failure
will cause an interruption of the monitor network
communication and loss of display functions.
_______________
PRODUCT Hardware Trigger Board, Catalog #0005-1030, a component of
the Abiomed BVS 5000 Bi-Ventricular Support System, which is
an automated bi-ventricular support device intended to
provide complete short term support of the left and/or right
sides of the heart. Recall #Z-1274-4.
CODE 1149, 1160, 1162, 1163, 1164, 1165, 1166, 1167, 1168, 1169,
1170, 1171, 1172, 1173, 1174, 1175, 1176, 1177, 1178, 1179,
1180, 1182, 1183, 1184, 1185, 1186, 1187, 1188, 1189, 1190,
1191, 1192, 1193, 1194, 1195, 1196, 1197, 1198 (consoles
located at the manufacturer at time of recall);
1121, 1129, 1146, 1147, 1148, 1150, 1151, 1152, 1153, 1154,
1155, 1156, 1157, 1158, 1161, 1181, 1159 (consoles in
distribution).
MANUFACTURER Electronic Associates, Inc., (EAI), West Long Branch, New
Jersey.
RECALLED BY Abiomed, Inc., Danvers, Massachusetts, by letter January 28,
1994. Firm-initiated recall complete.
DISTRIBUTION California, Wisconsin, Arizona, New York, Texas, Minnesota,
Virginia, Louisiana., Kuwait.
QUANTITY 65 units.
REASON When power to the unit is interrupted, the emergency system
(battery backup) may not engage in the specified time. The
likely result of such an event would be temporary impairment
of circulation.
_______________
PRODUCT Digital I/O Board, part #0005-1050, a component of the
Abiomed BVS 5000 Bi-Ventricular Support System Consoles.
The BVS 5000 Bi-Ventricular Support System is an automated
bi-ventricular support device intended to provide complete
short term support of the left and/or right sides of the
heart. Recall #Z-1275-4.
CODE Serial numbers: 1144, 1149, 1162, 1163, 1169, 1171, 1172,
1173, 1175, 1176, 1177, 1178, 1179, 1180, 1182, 1183, 1184,
1185, 1186, 1187, 1188, 1189, 1190, 1191, 1192, 1193, 1195,
1196 (units at manufacturer at time of recall);
1139, 1140, 1141, 1142, 1143, 1145, 1146, 1147, 1148, 1150.
1151, 1152, 1153, 1154, 1155, 1157, 1158, 1160, 1161, 1164,
1165, 1166, 1167, 1168, 1170, 1181, 1159, 1174 (units
distributed).
-10-
MANUFACTURER Electronic Associates Inc., (EAI), West Long Branch, New
Jersey.
RECALLED BY Abiomed, Inc., Danvers, Massachusetts, by letter February
18, 1994. Firm-initiated recall complete.
DISTRIBUTION Illinois, Georgia, Louisiana, Massachusetts, Minnesota, New
Jersey, Ohio, Pennsylvania, Arkansas, California, New York,
Texas, Virginia, Wisconsin, Liechtenstein, The Netherlands.
QUANTITY 57 units.
REASON The potential exists for a capacitor at C3 on the Digital
I/O board to be damaged by coming in contact with the
circuit board. If this occurred, there would be a shorting
of the capacitor, an insulation split, and an eventual
shutdown of the unit.
_______________
PRODUCT Howmedica Luhr Fixation Systems Micro/Pan Screwdriver, used
to attach plates and screws to the crainofacial area during
surgery. Recall #Z-1276-4.
CODE Catalog #6518-2-410.
MANUFACTURER Howmedica GMBH, Kiel, Germany.
RECALLED BY Howmedica, Inc., Rutherford, New Jersey (responsible firm),
by letter June 15, 1994, followed by telephone on or about
July 15, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide
QUANTITY 286 units were distributed; firm estimates 276 units remain
on the market.
REASON The device contains gold electroplating which has been found
to peel and flake under normal conditions of use.
_______________
PRODUCT Custom Cataract Trays containing Laparotomy Sponges used to
absorb blood and other body fluids during cataract eye
surgery: (a) 12" x 12" Lap Sponges, Catalog numbers
CCESC01LAC, TSS01SL; (b) 18" x 18" Lap Sponges, Catalog
numbers AVMC06LC, CCESC01LAC, GNWMH01LH, TRH01TT, TEC01TO.
Recall #Z-1280/1281-4.
CODE All lots.
MANUFACTURER Sterile Design, Inc., Tampa, Florida.
RECALLED BY Iolab, Inc., Claremont, California, by telephone November
12, 1993. Firm-initiated recall complete.
DISTRIBUTION California, Hawaii, Texas, Louisiana, South Carolina,
Oklahoma.
QUANTITY 8,698 trays were distributed; firm estimates none remains on
the market.
REASON The lap sponges were found to be non-sterile.
_______________
PRODUCT Various single use custom sterile procedure kits and trays
packaged and sterilized by Sterling Medical Products:
1. Laceration Trays - Catalog Nos. 661, STD-670, 675, 679,
786, 823-FH, 828, 923, 949, 956, 966;
2. Suture Removal Trays - Reorder Nos. 101L, 116, 117;
Catalog Nos. STD-702, STD-706L, STD-713, STD-718,
-11-
STD-736, STD-741;
3. Dressing Trays - Catalog Nos. 538, 755, 758, 779, 889A,
5091;
4. Suture Trays - Catalog Nos. STD-621, STD-690, 985;
5. Circumcision Trays - Catalog Nos. 901, 904;
6. Towel Clamps, 2-1/2" - Catalog No. 526;
7. Raytec Sponge Kit - Catalog No. 762;
8. CVL Tubing Change Tray - Catalog No. 890;
9. Renal Acute Care Cath Tray - Catalog No. 1573;
10. Scissors, Sharp/Blunt - Catalog No. SS30;
11. Hemostat, Kelly Curved - Catalog No. SS41;
12. Baxter Sharp/Blunt Scissors, 5-1/2" - Catalog No.
35048-150 (distributed by Baxter Healthcare Corp.,
Hospital Supply Div.);
13. Baxter Iris Scissors, Straight - Catalog No. 35048-045
(distributed by Baxter Healthcare Corp., Hospital
Supply Div.). Recall #Z-1301/1313-4.
CODE Sterilization/production lot 478.
MANUFACTURER Sterling Medical Products, Prophetstown, Illinois.
RECALLED BY Manufacturer, by telephone August 9, 1994, followed by
letter. Firm-initiated recall ongoing.
DISTRIBUTION Illinois, Pennsylvania, New York, Massachusetts, Alabama,
Virginia, Wisconsin, Texas, Arkansas.
QUANTITY 430 cases were distributed; firm estimates 50 percent
remains on the market.
REASON Sterility testing indicated the presence of mold in some of
the devices.
_______________
PRODUCT Portable Medical Oxygen Cylinders with Thermo Oxygen Valves.
Recall #Z-1315-4.
CODE Lot numbers 5304 1/92 or 5304 4/92 embossed on the side of
the valve.
MANUFACTURER Thermo Valves, Inc., Santa Rosa, California (responsible
firm).
RECALLED BY Contemporary Products, Inc., Irvine, California, by letter
May 11, 1994. Firm-initiated recall ongoing.
DISTRIBUTION California, Illinois, Michigan, Wyoming.
QUANTITY 1,147 valves mated to cylinders and 35 valves were
distributed.
REASON The post valves have defective seating, resulting in leakage
of the oxygen.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Triglycerides Reagent, used along with patient samples and
controls to determine the triglyceride level in the blood
using a spectrophotometer. Recall #Z-1192-4.
CODE Lot numbers: J14NK (kit), GIN (14 ml fill bottle).
MANUFACTURER Ciba Corning Diagnostics Corporation, Oberlin, Ohio.
RECALLED BY Manufacturer, by letter January 11, 1993. Firm-initiated
recall ongoing.
-12-
DISTRIBUTION Nationwide and international.
QUANTITY 410 kits (20 14-ml bottles per kit) were distributed.
REASON The wrong stopper was used with the bottle of reagent
causing the reagent to become unstable.
_______________
PRODUCT Probes used with Diagnostic Ultrasound BladderScan BVI 2500,
used to scan a patient's bladder using ultrasound and to
calculate the amount of urine in the bladder.
Recall #Z-1242-4.
CODE Probe serial numbers: 04154, 10471, 10513, 10564.
MANUFACTURER Diagnostic Ultrasound Corporation, Redmond, Washington.
RECALLED BY Manufacturer, by telephone June 21, 1994, followed by letter
June 23, 1994. Firm-initiated recall complete.
DISTRIBUTION New Jersey, California.
QUANTITY 4 probes were distributed.
REASON Probes do not meet in-process test limits.
_______________
PRODUCT Steinman Pin, Plain, Single Diamond Point, Plain End - 3/16"
x 9", Catalog #5009115S, an orthopedic implant.
Recall #Z-1314-4.
CODE Lot #024307.
MANUFACTURER Kirschner Medical Corporation, Fair Lawn, New Jersey.
RECALLED BY Manufacturer, by telephone between April 11, 1994 and June
22, 1994, and by letters April 18, 1994, May 2, 1994, and
May 17, 1994. Firm-initiated recall complete.
DISTRIBUTION Virginia, North Carolina.
QUANTITY 80 pins were distributed; firm estimates none remains on
market.
REASON The product is incorrectly labeled as plain when, in fact,
the Steinman Pin is threaded.
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END OF ENFORCEMENT REPORT FOR AUGUST 31, 1994. BLANK PAGES MAY
FOLLOW.