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
11/27/1991
Recalls and Field Corrections: November 27, 1991
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
Product: (a) Van Camp's Pork and Beans in 16 ounce cans labeled in
part, "Great with Hot Dogs & Hamburgers" (previous label);
"High Fiber, Low Fat & Cholesterol" (current label),
packed in 48 6-packs (24 cans) and "Pallet" store display
cases containing 24 16-ounce cans;
(b) Van Camp's Premium Baked Beans seasoned with bacon
and brown sugar in 16 ounce cans, packed 24 cans per case;
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(c) Van Camp's Dark Red Kidney Beans in 15 ounce cans,
packed 24 cans per case;
(d) Van Camp's New Orleans Style Red Kidney Beans in
15 ounce cans, packed 24 cans per case;
(e) Van Camp's Brown Sugar beans in 16 ounce cans packed
24 cans per case. Recall #F-016/020-2.
Code: (a-d) All lots bearing a product code beginning with the
letters "D" and "O";
(e) DSG (top line) over 09H0 (bottom line) - 09H0
indicates the lot was manufactured 8/9/90.
DSG (top line) over 17K9 (bottom line) - 17K9 indicates
the lot was manufactured 11/17/89.
Manufacturer: The Quaker Oats Company, Dallas, Texas.
Recalled by: Stokley-Van Camp, Inc., a subsidiary of The Quaker Oats
Company, Chicago, Illinois, by press release October 11,
1991, and by letter dated October 14, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 1,663,613 cases (12 to 24 cans per case) were distributed.
Reason: Under processing.
----
Product: Progresso and La Sierra brand New England Clam Chowder,
in 10.5 ounce and 18.5 ounce cans. Recall #F-021-2.
Code: All product which does not bear the sulfite declaration
in the ingredient statement.
Manufacturer: Progresso Quality Foods, Vineland, New Jersey.
Recalled by: Pet Inc., St. Louis, Missouri, by letter October 18, 1991,
and by press release covering the Progresso brand product
October 11, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 72,000 cans were distributed.
Reason: Product contains undeclared sulfites.
----
Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
Product: Dried fruits and nuts:
(a) Ann's House of Nuts brand California Mix, in 12
and 16 ounce plastic packages;
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(b) Dried Papaya, Ann's House of Nuts brand, in 16 ounce
packages, and Continental brand, in 8 ounce plastic packages.
Recall #F-047/048-2.
Code: (a) Julian date of manufacture codes - 156, 171, 189, 190,
210, and 211 with pull dates in 1992;
(b) Julian date of manufacture code - 155 (i.e. June 4th
Continental and Ann's House of Nuts brand) and 189
(i.e. July 8, Ann's House of Nuts brand) both brands with
pull dates in 1992.
Manufacturer: Ann's House of Nuts, Inc., Rockville, Maryland.
Recalled by: Manufacturer, by visit. Firm-initiated
field correction (relabeling) ongoing.
Distribution: (a) Washington, D.C., Maryland, Virginia, West Virginia,
New Jersey, Pennsylvania, New York, Ohio, Michigan;
(b) Maryland, Virginia, Michigan.
Quantity: (a) 592 cases (24 16-ounce packages), 2,836 (12 12-ounce
packages), and 111 cases 25 pounds were distributed;
(b) 77 cases (24 16-ounce packages) and 100 cases
(24 8-ounce packages) were distributed.
Reason: Product contains undeclared FD&C Yellow No. 6.
----
Product: Nutri-Lene Complete Nutrition Supplement, Chocolate Flavor,
in 27.3 ounce cans. Recall #F-050-2.
Code: Lot #910101.
Manufacturer: Quality Formulation Laboratories, West Paterson,
New Jersey.
Recalled by: Medical Weight Management, West Paterson, New Jersey,
by letter June 4, 1991. Firm-initiated recall complete.
Distribution: New Jersey.
Quantity: 1,039 cans were distributed; firm estimates none remains
on the market.
Reason: Product is subpotent in niacin and potassium content.
----
Product: Food Lion brand Assorted Frozen Ice Pops, Cherry, Grape,
and Orange flavored, 2 ounces each, packed 24 units
per box. Recall #F-052-2.
Code: Lot #F2491, indicates production on June 24, 1991.
Manufacturer: Land-O-Sun Dairies, Atlanta, Georgia.
Recalled by: Manufacturer, by telephone July 25, 1991. Firm-
initiated recall complete.
Distribution: Southeastern United States.
Quantity: 1,734 cases (6 boxes per case) were distributed;
firm estimates none remains on the market.
Reason: Product is contaminated with calcium chloride.
----
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CORRECTION: Recall #F-025-2, which appeared in the November 6, 1991
Enforcement Report should have read:
Product: Framesi brand Oxina 20, hydrogen peroxide.
Manufacturer: Fort Pitt Acquisition, P.B.A. Framesi, USA,
Inc., Coraopolis, Pennsylvania.
----
COSMETICS
Class I -
NONE
Class II -
NONE
Class III -
Product: Feminine Wash, in 8 ounce bottles. Recall #F-049-2.
Code: All lots.
Manufacturer: Pennex Products Company, Inc., Verona, Pennsylvania.
Recalled by: Manufacturer, by telephone September 24, 1991. Firm-
initiated recall ongoing.
Distribution: Nationwide.
Quantity: 36,648 bottles were distributed.
Reason: Product is contaminated with mold.
----
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: (a) Robitussin (Guaifenesin Syrup, USP), Expectorant,
8 ounces, unit cartons in open shelf stock;
(b) Robitussin DM, Cough Suppressant - Expectorant, 8 ounces,
sealed in shipping cases only. Products are OTC cough
formulas. Recall #D-089/090-2.
Code: Lot numbers: (a) 91 182-2, 91 183-2, 91-184-2, 91-185-2,
91-193-2; (b) 182, 183, 184, 193.
Manufacturer: Consumer Products Division, A.H. Robins Company,
Richmond, Virginia.
Recalled by: Manufacturer, by letter October 29, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 302,400 cartons were distributed.
Reason: Some bottles of Robitussin DM were packaged in unit
cartons labeled Robitussin.
----
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Product: Adriamycin, PFS (Doxorubicin Hydrochloride Injection),
20 mg (2mg/ml), in 10 ml vials, a Rx drug used to treat
cancer patients. Recall #D-092-2.
Code: Lot #DXB001 on vials. Additionally #55001TY on shipping
cartons and shrink wrap for products distributed by Abbott
Laboratories.
Manufacturer: Adria - SP, Inc., Albuquerque, New Mexico.
Recalled by: Adria Laboratories, Division of Erbamont, Inc., Dublin,
Ohio, by telephone November 4, 1991, followed by letter
November 6, 1991, and visit. Firm-initiated field
correction complete.
Distribution: Nationwide.
Quantity: 1,270 vials were distributed.
Reason: Vials of the 20 mg strength were packaged in unit cartons
labeled 10 mg.
----
Product: Meprobamate/Aspirin Tablets 200 mg/325 mg, in 100 and 500
tablet bottles, a Rx sedative, under the following labels:
Par Pharmaceutical, Parmed, Goldline, Rugby, Qualitest,
Quad, Martec, Best Generics, H.L. Moore Drug Exchange,
Major Pharmaceuticals. Recall #D-093-2.
Code: Lot numbers: 111590 EXP 4/92, 213790 EXP 5/92,
214190 EXP 5/92, 228890 EXP 10/92, 131690 EXP 10/92,
133090 EXP 11/92, 135290 EXP 12/92, 234789 EXP 12/91,
402391 EXP 1/93, 105791 EXP 2/93.
Manufacturer: Par Pharmaceutical, Inc., Spring Valley, New York.
Recalled by: Manufacturer, by letter November 6, 1991. Firm-
initiated recall ongoing.
Distribution: Nationwide and Puerto Rico
Quantity: Lot # Bottles Tablets
111590 775 500's
10,384 100's
213790 604 500's
11,395 100's
214190 599 500's
10,510 100's
228890 921 500's
9,543 100's
131690 900 500's
9,899 100's
133090 840 500's
9,972 100's
135290 1,053 500's
9,314 100's
234789 710 500's
10,804 100's
402391 880 500's
9,955 100's
105791 402 500's
9,955 100's were distributed.
-5-
Reason: Lack of assurance of bioequivalency and Abbreviated
New Drug Approval discrepancies.
----
Product: Meclofenamate Sodium Capsules, 50 mg, and 100 mg,,
in bottles of 100 and 500 capsules, a Rx drug indicated
for the treatment of signs and symptoms of acute and
chronic rheumatoid arthritis and osteoarthritis, under
the following labels: Par, Martec, Major, Goldline,
Genetco, Best Generic. Recall #D-094/095-2.
Code: Lot numbers and EXP dates: 126990 09/92, 623290 08/92
124090 08/92, 231690 11/92, 124390 08/92, 229690 10/92
133490 11/92, 326790 09/92, 104291 02/93, 223490 08/92
406791 03/93.
Manufacturer: Par Pharmaceutical, Inc., Spring Valley, New York.
Recalled by: Manufacturer, by letter November 4 and 5, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 38,001 100-capsule bottles and 1,911 500-capsule bottles
were distributed.
Reason: Lack of assurance of bioequivalency and Abbreviated New
Drug Approval discrepancies.
----
Product: Platelets, Pheresis. Recall #B-042-2.
Code: Unit #Z05664.
Manufacturer: Regional Health Resource Center, Champaign County Blood
Bank, Urbana, Illinois.
Recalled by: Manufacturer, by telephone September 11, 1991.
Firm-initiated recall complete.
Distribution: Illinois.
Quantity: 1 unit.
Reason: Blood product, labeled with incorrect expiration date,
was distributed.
----
Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-046/047-2.
Code: Unit numbers: (a) 5602850, 5602890, 5602905, 5602952;
(b) 5602850, 5602890, 5602905.
Manufacturer: Department of the Navy, Naval Hospital, Pensacola, Florida.
Recalled by: Manufacturer, by letter dated March 5, 1991. Firm-initiated
recall ongoing.
Distribution: Florida.
Quantity: (a) 4 units; (b) 3 units.
Reason: Blood components, which tested initially reactive
for hepatitis B surface antigen (HBsAg) and non-reactive
by a single repeat test, were distributed.
----
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Product: (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-052/053-2.
Code: Unit numbers: (a) 0082365; (b) 0082365, 0084009.
Manufacturer: Cape Fear Valley Medical Center Blood Bank, Fayetteville,
North Carolina.
Recalled by: Manufacturer, by telephone September 13, 1991. Firm-
initiated recall ongoing.
Distribution: North Carolina, Florida, Massachusetts.
Quantity: (a) 1 unit; (b) 2 units.
Reason: Blood products, which tested non-reactive for the
antibody to the human immunodeficiency virus type
1 (anti-HIV-1) but were drawn from a donor who
previously tested repeatably reactive for anti-HIV-1,
were distributed.
----
Class III -
Product: Osco brand Stool Softener with Laxative, 100 softgels,
product is taken for treatment of temporary constipation.
Recall #D-091-2.
Code: C6118E EXP 3 93.
Manufacturer: Pennex Products Company, Inc., Verona, Pennsylvania.
Recalled by: Manufacturer, by letter dated October 29, 1991. Firm-
initiated recall ongoing.
Distribution: Illinois.
Quantity: 269 dozen cases (24 bottles per case) were distributed;
firm estimates 175 cases remain on the market.
Reason: Some cartons of stool softener with laxative product
contain bottles of plain stool softener without laxative.
----
DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: Lifecare PLV-102 Portable Volume Ventilator.
Recall #Z-070-2.
Code: All serial numbers up to and including 910840.
Manufacturer: Lifecare, Lafayette, Colorado.
Recalled by: Manufacturer, by letter October 14, 1991. Firm-intiated
recall ongoing.
Distribution: Nationwide and international.
Quantity: Approximately 1,250 units were distributed.
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Reason: Should either the NOVRAM or EPROM (internal electronic
components) fail to operate fully to specificaton,
the ventilator could stop with no audible alarm sound,
however, a visual alarm will appear in the volume
display window.
----
Product: Fisher Imaging Omni 325 Mobile C-Arm X-Ray Units:
(a) Model 55507G; (b) Model 55508G; (c) Model 55509G;
(d) Model 55509G-2; (e) Model 55515G; (f) 59700G;
(h) 59700G-2. Recall #Z-071/077-2.
Code: Serial numbers: AA2202, BB6698, 0054-0988-001,
0054-0489-001, 0054-0989-001, 0054-0789-001, 0054-0989-002,
0054-0290-001, 0096-0590-001, 0054-0191-001, 0054-0990-001,
0054-1190-001, 0056-0890-001, 0056-1290-001, 0056-0190-001,
0056-1089-002, 0056-0889-001, 0056-0998-001, 0056-1288-001,
1028-0589-1LN, 0056-0190-001, 0056-0489-001, 0056-0589-001,
0056-0490-001, 0056-0588-001, BB6709, BB6629, BB6603,
0056-0188-002, 0035-0391-001, 0056-0391-001, 0035-0790-001,
0035-0190-001, 0035-0190-002, 0035-0690-001, 0054-0590-001,
0035-0789-001, 0054-0889-002, 0034-0889-001, 0035-0989-001,
0035-0989-002, 0035-1189-003, 0035-1189-002, 0035-1289-001,
0035-0189-001, 0035-0189-002, 0054-0688-001, 0035-0289-001,
0054-0189-002, 0035-0289-001, 0035-0389-001, 0035-0490-001,
0096-0988-001, 0035-0988-001, 0054-1188-002, 0054-1188-003,
0054-1188-001, 0054-1288-001, 0035-0188-001, 0035-0288-001,
0057-0388-001, 0054-0488-001, 0054-0488-002, 0054-0588-001,
0054-0688-001, 0035-0788-001, BB6605, BB6621, BB6636,
BB6648, AA2129, AA2088, AA2023, AA2097, Z2202, AA2029,
0054-0189-002.
Manufacturer: Fisher Imaging Corporation, Denver, Colorado.
Recalled by: Manufacturer, by visit March 13, 1991 and by Service
Bulletin #91005. Firm-initiated field correction ongoing.
Distribution: Nationwide, El Salvador, Hong Kong, Japan, Soviet Union,
Australia.
Quantity: 77 units were distributed.
Reason: Product can cause an electrical shock hazard to the
operator.
----
Product: Surface Coils for use in Signa brand Magnetic Resonance
Diagnostic Imaging System, used to produce cross-sectional
images of the body for detection of various irregular
pathologies. Recall #Z-084-2.
Code: All Signa Spectro Coils, model numbers 46-265101G1,
46-265201G2, 46-265202G1, 46-26520G2G2, 46-265203G1,
46-265203G2, 46-265204G1, 46-265204G2 and GE Medical
Advances, Inc surface coils installed into and
accompanying the Signa Magnetic Resonance System
Operator Console, Model #46-243445G1. All coils were
manufactured prior to 6/30/91.
-8-
Manufacturer: Medical Advances, Inc.,Milwaukee, Wisconsin, and
G.E. Medical Systems, Waukesha, Wisconsin.
Recalled by: G.E. Medical Systems, Waukesha, Wisconsin, by letter
September 27, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and interntaional.
Quantity: 1,018 units were distributed.
Reason: During scanning, induced currents can be generated in
surface coil cables causing heating of the cables which may
result in burns to patients.
----
Product: Exhalation Valve Manifold (non-dispoaable), for use
with ventilators. Recall #Z-089-2.
Code: Lot numbers 2526, 2687, 3292.
Manufacturer: Instrumentation Industries, Inc., Bethel Park,
Pennsylvania.
Recalled by: Manufacturer, by letter August 14, 1991. Firm-initiated
recall ongoing.
Distribution: Connecticut, Kentucky, Minnesota, California, Maryland,
Colorado, New Jersey, Georgia, Texas, West Virginia,
Canada, Japan.
Quantity: 232 units were distributed.
Reason: The wrong component was used as part of the device.
This mistake may cause the balloon diaphragm to sit too
closely to the valve seat resulting in increased
resistance to exhalation and difficulty in breathing.
----
Product: Computerized Tomographic Series 9800 X-Ray Systems:
(a) All CT9800 Quick Systems with 46-278373G1,
46-278373G2, 46-237745G1, 46-237745G3, 46-237745G4
single bay computer systems manufactured prior to
March 15, 1991, using software version SE (and above),
W-series and also Non-Quick Systems 46-218710G1,
46-218710G2, 46-218710G801;
(b) 46-229674G801, 46-218710G805 Single Bay Computer
Systems with software versions QE (and above);
(c) All CT9800 Quick Systems with 46-237745G1 Single bay
Computer Systems manufactured prior to December 30, 1988;
using 9A, 9B, SA, SB, SC, SF or SFA software; and applying
to customers who have not signed an operating and basic
service limited license agreement. Recall #Z-090/092-2.
Code: All serial numbers of units identified above.
Manufacturer: G.E. Medical Systems, New Berlin, Wisconsin.
Recalled by: G.E. Medical Systems, Waukesha, Wisconsin, by letter
October 1, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 2,115 units were distributed.
-9-
Reason: If manual controls (table side push-buttons) for moving the
table out of the gantry or tilting the gantry are operated
during the auto-positioning of scanning, releasing the
manual control button sometimes results in the unexpected
movement of the table or gantry back into the auto-position.
----
Product: Brake Rod Assembly (part of DADC '500') unit, push/pull
system mounted on steering wheel column and operated by
hand by physically handicapped people to accelerate or
brake automobile. Recall #Z-095-2.
Code: Serial numbers 500286 through 500291, 500300 through
500304, 500307 through 500310, 500386 through 500395,
500418 through 500427.
Manufacturer: Driving Aids Development Corporation, Vienna, Virginia.
Recalled by: Manufacturer, by letters of May 11, 1990 and March 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 23 units remain on the market.
Reason: If the control lever is held while the brake pedal is
depressed by applying force with the foot, the result is
the same as pulling on the control lever - the vehicle will
accelerate instead of stopping.
----
Product: Cine-fluoroscopic Systems used for angiography.
Recall #Z-121-2.
Code: All serial numbers that incorporate dual scan capability.
Manufacturer: Toshiba America Medical Systems, Inc., Tustin, California.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan October 31, 1991. Firm-initiated field correction
ongoing.
Distribution: Nationwide.
Quantity: 58 units were distributed.
Reason: Noncompliance with performance standard for fluoroscopic
equipment in that the x-ray field was not limited to the
size of the visible area.
----
Product: Bard PTA Balloon Dilatation Catheter, 5 French.
Recall #Z-122-2.
Code: Lot numbers: 07BBA045, 07BBA046, 07CB6623, 07CB5784,
07BB6428, 07CB5786, 07CB5787, 07CB3322, 07CB5788,
07AB6390.
Manufacturer: C.R. Bard, Inc., Billerica, Massachusetts.
Recalled by: C.R. Bard, Inc., Covington, Georgia, by telephone
August 19, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
-10-
Quantity: 458 units were distributed.
Reason: Product is non-sterile.
----
Product: Accu-Chek Easy Blood Glucose Monitor, Model 788, a hand
held monitor that measures blood glucose levels using
paper reagent strips. Recall #Z-100-2.
Code: All product since manufacture/distribution began on
March 3, 1991.
Manufacturer: United Medical Manufacturing Company, Indianapolis,
Indiana.
Recalled by: Boehringer Mannheim Corporation, Indianapolis,
Indiana, by letter September 10, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 86,560 units were distributed; firm estimated 40,000
units remain on the market.
Reason: Potential for elevated results in low glucose range.
----
Class III -
Product: Nonsterile fiber diverters with accessories and
corresponding replacement tubes, used in surgery
with the laserscope KTP/YAG surgical lasers for
placement of laser fiber optics:
(a) Model #10-0481, 4.8 mm diameter Single Channel
Fiber Diverter;
(b) Model #10-0482, 9.6 mm diameter Triple Channel
Fiber Diverter w/2 stopcock;
(c) Model #10-0483, 9.6 mm diameter Triple Channel Fiber
Diverter w/2 trumpet valves;
(d) Model #10-0484, Replacement tubes for Triple Channel
Diverters. Recall #Z-066/069-2.
Code: Lot numbers from #8246 through 8829.
Manufacturer: G.M. Engineering, Inc., La Verne, California.
Recalled by: Laserscope, San Jose, California, by letters of
December 26, 1990 and February 26, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide, Japan, Korea.
Quantity: (a) 99 units; (b) 12 units; (c) 20 units; (d) 3 units
were distributed; frim estimates 59 units remain on
the market.
Reason: A design flaw in the fiber diverters could allow the
fibers or tips to break off inside the patient during
surgery.
----
-11-
Product: IDEIA Chlamydia Test Kit, an amplified enzyme-linked
immunoassay for the detection of Chlamydia Trachomatis in
human clinical specimens, for in-vitro diagnostic use.
Recall #Z-082-2.
Code: Lot #108411, Catalog #8886-590093.
Manufacturer: API Analytab Products, Division of Sherwood Medical
Plainview, New York.
Recalled by: Manufacturer, by telephone from June 7 through June 11,
1991, followed by letter June 12, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide and Canada.
Quantity: 143 kits were distributed.
Reason: There is a misprint on the outer box label indicating
incorrectly that the product should be stored at
room temperature, 15-30 dgrees C. Proper storage
temperature for the test kit is 2-8 degrees C.
----
Product: Clearplan Easy One-Step Ovulation Predictor, for
detecting the increase of luteinizing hormone (LH) in
urine. Recall #Z-083-2.
Code: Lot numbers: 8141, 8145B, 8146, 8747, 8148, 8149,
8151, 8152C, 8153, 8154, 8156C.
Manufacturer: Unipath Ltd., Bedford, England.
Recalled by: Whitehall Laboratories, Division of American Home
Products, New York, New York, by letter October 4, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 47,500 units were distributed.
Reason: The resin used in the absorbant tip does not dry properly.
The resin has to stay on the absorbant tip during the
performance of the test.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II-
NONE
Class III -
Product: Penicillin G Procaine, USP 250 ml (injectable).
Recall #V-008-2.
Code: Lot numbers: 1293-01, 1294-01, 1295-01, 1302-01,
1295-02, 1295-03, 1301-03. EXP 9/93.
Manufacturer: Norbrook Laboratories Ltd., Newry, Northern Ireland.
Recalled by: Glasgow Pharmaceuticals, Inc., doing business as
Sussex Vale Biotech, Inc., Glasgow, Kentucky, by
issuing a distribution stop September 9, 1991.
Firm-initiated field correction (relabeling) ongoing.
-12-
Distribution: Nebraska, California.
Quantity: 60,000 vials were distributed; firm estimates 2,471
vials remain on the market.
Reason: Labeling states a 48 hour discard time instead of the
approved 72 hour discard time.
----
Medical Device Safety Alert:
Product: FoCus Hollow Fiber Dialyzer and the FoCus Hemophan Hollow
Fiber Dialyzer, artificial kidneys used in conjunction with
various dialysis machines:
(a) FoCus Cuprophan Hollow Fiber Dialyzer, Models
70, 90 and 120;
(b) FoCus Hemophan Hollow Fiber Dialyzer, Models
70H, 90H, and 120H. Safety Alert #M-003/004-2.
Code: Lot numbers beginning with F7, F8 and F9A through F9L,
for both FoCus Dialyzer product groups.
Catalog numbers: (a) 01-9851-5 (FoCus 70), 01-9852-3
(FoCus 90), 01-9853-1 (FoCus 120);
(b) 01-9856-4 (FoCus 70H), 01-9854-9 (FoCus 90H),
01-9855-6 (FoCus 120H).
Manufacturer: Erika, doing business as National Medical Care,
Dublin, Ireland.
Alerted by: National Medical Care, Rockleigh, New Jersey, by
letter June 1991.
Distribution: Nationwide, Puerto Rico, Canada, Taiwan.
Quantity: 890,426 units were distributed.
Reason: The inner fibers used in the manufacture of dialyzer prior
to October 1, 1989, have an excess number of small inner
diameter fibers that could result in poor reuse, clotting,
leaking and ultrafiltration problems.
----
Product: CPI Delta Dual Chamber Pulse Generator (implantable
pacemaker) Type DDD, 3.2 mm Low Profile Connector, Model 925,
catalog #600925. Safety Alert #M-005-2.
Code: All serial numbers.
Manufacturer: Cardiac Pacemakers, Inc., St. Paul, Minnesota.
Alerted by: Manufacturer, by letter October 23, 1991.
Distribution: Nationwide and international.
Quantity: 3,036 units were distributed.
Reason: Post-ERI replacement time is less than stated in the
Physician's Manual. With the previous indicator (85 ppm),
patients may be at risk due to the shortened time from ERI
to end-of-life (no output).
----
-13-
Disposition of Injunction:
Defendant: Marshall Warehouses, Inc., Charles P. Marshall,
President, Jerome, Idaho.
Product: Dried beans and Wheat (91-534-870 et al.)
Nature of Products consisted in whole or in part of a filthy
Charges: substance, and were held under insanitary conditions
whereby they may have become contaminated with filth.
Disposition: On October 22, 1991, the Court granted a permanent
injunction against the defendants which prohibits them
from introducing or delivering for introduction into
interstate commerce foods held at their facility unless and
until they establish and implement adequate methods and
controls to prevnt food from being held under insanitary
conditions; U.S. District Court for the Western District
of Washington. INJ #1250.
-14-
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