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
06/17/1992
RECALLS AND FIELD CORRECTIONS: June 17, 1992
DRUGS -- CLASS II
92-25
PRODUCT Clindamycin Phosphate Injection, USP, 150 mg/ml, equivalent to
150 mg Clindamycin, in 2 ml, 4 ml, and 6 ml single dose vials,
a Rx IM or IV injectable antibiotic. Recall #D-378-2.
CODE Lot numbers: 911009, 911029, 911006, 911032, all of which have
EXP 4/93.
MANUFACTURER Smith & Nephew SoloPak, Elk Grove Village, Illinois.
RECALLED BY Manufacturer, by letter May 29, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 97,575 vials were distributed; firm estimates 30 percent
remains on the market.
REASON Potency of product not assured through expiration date.
PRODUCT Cephradine Capsules, USP, 250 mg and 500 mg, prompt release
capsules, packed 24 and 100 capsules/bottle as well as 100
capsules/blister, a Rx semisynthetic cephalosporin antibiotic,
oral dosage form, in capsules containing 250 mg or 500 mg
cephradine. The products were packaged and distributed by
Biocraft Laboratories, Inc., under the following labels, sizes,
and strengths:
250 mg, 100's: 500 mg, 100's: 250 mg, 24's:
Biocraft Biocraft Biocraft
-1-
Qualitest UDL Lab Schein
Rugby Warner-Chilcott
Geneva Drug Guild 500 mg, 24's:
H.L. Moore Qualitest Biocraft
United Research Major Schein
Best Generic Bioline Geneva
Bioline H.L. Moore Goldline
Goldline Goldline
Warner-Chilcott Rugby
Schein Geneva
Harber. Recall #D-381/382-2.
CODE Lot number Potency Package Sizes EXP dates
51129 500 mg 24's, 100's, Blister Packs 3/1/93
51152 250 mg 24's, 100's 3/1/93
51189 500 mg 100's 4/1/93
51190 500 mg 100's 4/1/93
51210 500 mg 100's 5/1/93
51212 250 mg 100's 5/1/93
51213 250 mg 24's, 100's 5/1/93
51223 250 mg 100's 5/1/93
51224 500 mg 24's, 100's 3/1/93
MANUFACTURER Biocraft Laboratories, Inc., Fairfield, New Jersey.
RECALLED BY Manufacturer, by telephone February 24-28, 1992, followed by
letter March 11, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 10,220,360 tablets were distributed; firm
estimates 15 percent remains on the market.
REASON Potency not assured through expiration date.
PRODUCT Proloid (Thyroglobulin Tablets, USP), a Rx preparation used as
a replacement or supplemental therapy in patients with
hypothyroidism: 0.5 grain (32 mg) 100's; 1.0 grain (65 mg)
100's/1000's; 1.5 grain (100 mg) 100's; 2.0 grain (130 mg)
100's; 3.0 grain (200 mg) 100's. Recall #D-383/387-2.
CODE All lots.
MANUFACTURER Parke-Davis Division of Warner-Lambert Company, Vega Baja,
Puerto Rico.
RECALLED BY Parke-Davis Division of Warner-Lambert Company, Morris Plains,
New Jersey, by letter December 27, 1991. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,363,249 bottles were distributed; firm estimated that 6,000
bottles remained on the market as of January 1992.
REASON Potency not assured through expiration date.
PRODUCT Various Rx injectable drug products:
(a) M.V.C. 9+4 (Pediatric) Multivitamin Concentrate for
Infusion, a Rx sterile, lyophilized product for reconstitution
and dilution, in 10 ml amber single dose vials, 25 vials per
case; (b&c) Nalbuphine Hydrochloride Injection; a Rx sterile
-2-
analgesic for IM, IV and SC use for the relief of moderate to
severe pain, 10 mg/ml, in 1 ml single dose vials, 10 vials per
tray; 10 ml multiple dose vials; 20 mg/ml, in 1 ml single dose
vials, 10 vials per tray, 10 ml multiple dose vials;
(d) Haloperidol Injection, USP, 5 mg/ml, an Rx sterile
psychopharmacologic agent for intramuscular use, in 1 ml vials,
and in 10 ml multiple dose vials;
(e&f) Ritodrine Hydrochloride Injection, USP, a Rx sterile
smooth muscle relaxant: 10 mg/ml, in 5 ml vials, 10 vials per
tray; 15 mg/ml, in 10 ml vials, 10 vials per tray;
(g) Zinc Sulfate Injection, USP, 1 mg/ml; a Rx trace element
additive, 10 ml, a single dose vial, and in 30 ml multiple dose
vials. Recall #D-389/395-2.
CODE All lots within expiration date.
MANUFACTURER Lyphomed, Division of Fujisawa USA, Inc., Melrose Park,
Illinois.
RECALLED BY Manufacturer, by letter June 1, 1992.. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 300,500 vials were distributed; firm estimates none remains
on the market; (b&c) 366,649 vials were distributed, with the
firm estimating that 91,000 vials remain on the market; (d)
262,181 vials were distributed, with the firm estimating that
122,000 vials remain on the market; (e&f) 34,840 vials were
distributed, with the firm estimating that 13,000 vials remain
on the market; (g) 190,150 vials were distributed, with the firm
estimating that 40,000 vials remain on the market.
REASON Lack of assurance of bioequivalence and ANDA discrepancies.
RECALLS AND FIELD CORRECTIONS: DRUGS -- Class III
PRODUCT Liquipharm Senna-Relief Syrup, in 2 fluid ounce brown glass
bottles, an OTC combination liquid cathartic. Recall #D-379-2.
CODE OC2 EXP 3/92, OL2 EXP 10/92.
MANUFACTURER Liquidpharm Inc., Los Angeles, California.
RECALLED BY Manufacturer, by undated letter February 28, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Arizona, California, Colorado, Illinois, Kentucky, Wyoming,
Puerto Rico, Belgium.
QUANTITY 350 bottles were distributed.
REASON Label lacks alcohol content statement.
PRODUCT Dipyridamole Tablets, USP, 50 mg, in 1000 tablet bottles, a Rx
vasodilator. Recall #D-380-2.
CODE Lot #1002033 EXP 12/92.
MANUFACTURER Sidmak Laboratories, Inc., East Hanover, New Jersey.
RECALLED BY Manufacturer, by letter mailed March 12, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico.
-3-
QUANTITY 1,879 1,000-bottles were distributed; firm estimates little, if
any product remains on the market.
REASON Product does not meet dissolution specifications.
PRODUCT Nylidrin Tablets, USP, 6 mg, in 100 and 1000 tablet bottles, a
Rx vasodilator, under the following labels: Zenith, Goldline,
Major, Bioline, H.L. Moore. Recall #D-388-2.
CODE Lot #2348-070 EXP 6/92.
MANUFACTURER Zenith Laboratories, Inc., Northvale, New Jersey.
RECALLED BY Manufacturer, by letter mailed November 8, 1991.
Firm-initiated recall ongoing.
DISTRIBUTION Arizona, California, Florida, Kentucky, Illinois, Michigan,
Louisiana, Pennsylvania, Ohio, Tennessee, New York, South
Carolina, Massachusetts, Connecticut, Puerto Rico.
QUANTITY 950,000 tablets were distributed.
REASON Potency not assured through expiration date.
UPDATE Americaine Hemorrhoidal Ointment (benzocaine 20%) in 1/4 ounce
(physician's smaple), in ounce and 1-1/3 ounce tubes, Recall
#D-356-2 which appeared in the June 10, 1992 Enforcement Report
includes only material distributed on or after August 1, 1991.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT Platelets, Pheresis (Washed). Recall #B-298-2.
CODE Unit #17GS48287.
MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota.
RECALLED BY Manufacturer, by telephone February 25, 1992, followed by
letter February 28, 1992. Firm-initiated recall complete.
DISTRIBUTION Minnesota.
QUANTITY 1 unit.
REASON Blood product, labeled with the incorrect expiration date and
time, was distributed.
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated AHF;
(d) Fresh Frozen Plasma; (e) Recovered Plasma.
Recall #B-299/303-2.
CODE Unit numbers: (a) 16G32767, 16G80833, 16H10862, 16H20665,
16H45448, 16J25233, 16J29029, 16K66473;
(b) 16G80883, 16H45448, 16J25233, 16K66473;
(c) 16J29029; (d) 16H45448;
(e) 16G32767, 16G80833, 16H10862, 16H20665, 16J25233, 16J29029,
16K66473.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY Manufacturer, by letters of September 5, 1991 and November 13,
1991. Firm-initiated recall complete.
DISTRIBUTION Ohio, New York, California, North Carolina, Michigan.
-4-
QUANTITY (a) 8 units; (b) 4 units; (c) 1 unit; (d) 1 unit; (e) 7 units.
REASON Blood products, which tested negative for 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) Recovered Plasma. Recall #B-305/306-2.
CODE Unit #39G69808.
MANUFACTURER American Red Cross Blood Services, Huntington, West Virginia.
RECALLED BY Manufacturer, by letter August 14, 1991. Firm-initiated recall
ongoing.
DISTRIBUTION West Virginia.
QUANTITY 1 unit of each component.
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 anti-HIV-1
repeatedly reactive, were distributed.
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Platelets, Pheresis;
(d) Recovered Plasma. Recall #B-307/310-2.
CODE Unit numbers: (a) 8253328, 8278438, 8290279; (b) 8253328;
(c) 7008599; (d) 8253328, 8278438, 8290279.
MANUFACTURER Southwest Florida Blood Bank, Tampa, Florida.
RECALLED BY Manufacturer, by letter January 2, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Florida, Texas, Pennsylvania, New Jersey.
QUANTITY (a) 3 units; (b) 1 unit; (c) 1 unit; (d) 3 units.
REASON Blood products, which tested negative for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), but were collected
from donors who previously tested repeatedly reactive for
anti-HIV-1, were distributed.
PRODUCT Recombigen HIV-1 EIA Test Kit. Recall #B-311-2.
CODE Lot #A6856 EXP 1/93.
MANUFACTURER Cambridge Biotech Corporation, Worcester, Massachusetts.
RECALLED BY Manufacturer, by letter December 27, 1991. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 121 kits.
REASON Antibody to human immunodeficiency virus type 1 (anti-HIV-1)
test kits, exhibiting decreased sensitivity during the dating
period, were distributed.
PRODUCT Red Blood Cells. Recall #B-312-2.
CODE Unit #7241784.
MANUFACTURER Department of the Air Force, USAF Medical Center Scott (MAC),
Scott Air Force Base, Illinois.
RECALLED BY Manufacturer, by letter April 10, 1991. Firm-initiated recall
complete.
-5-
DISTRIBUTION Missouri.
QUANTITY 1 unit.
REASON Blood product which tested repeatedly reactive for hepatitis B
surface antigen (HBsAg), was distributed.
PRODUCT Source Plasma. Recall #B-313-2.
CODE Unit numbers: 250997, 251101, 251114, 251129, 251136, 251139,
251146, 251154, 251160, 251176, 251179, 251180, 251212, 251219,
251235, 251239, 251243, 251246, 251253, 251261, 251262, 251276,
251292, 251293, 251295, 251300, 251307, 251309, 251319, 251320,
251334, 251336, 251339, 251352, 251358, 251372, 251386, 251395,
251401, 251411, 251416, 251418, 251451, 251461, 251475, 251477,
251480, 251489, 251490, 251512, 251528, 251603, 251604, 251615,
251620, 251624, 251625, 251626, 251633, 251634, 251635, 251636,
251643, 251650, 251651, 251655, 251668, 251669, 251671, 251674,
395309, 395678, 396027, 396033, 396111, 396261, 396537, 396848,
535175, 536175, 536321, 536707, 537372, 537408, 670692, 842058,
842261, 842263, 842387, 842604, 842685, 842708.
MANUFACTURER Plasma Services of San Antonio, San Antonio, Texas (testing
facility/responsible firm).
RECALLED BY Plasma Services, Scottsdale, Arizona, by letters on October 11,
17, and 30, 1991. Firm-initiated recall ongoing.
DISTRIBUTION North Carolina, Michigan, Florida, Germany.
QUANTITY 91 units.
REASON Blood product incorrectly tested for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), was distributed.
PRODUCT Recovered Plasma. Recall #B-316-2.
CODE Unit #16F46817.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY Manufacturer, by letter August 20, 1991. Firm-initiated recall
ongoing.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Recovered Plasma, collected from a donor who had received a
transfusion 2-3 months prior to donation, was distributed.
PRODUCT Granulocytes, Pheresis. Recall #B-317-2.
CODE Unit #26J20677.
MANUFACTURER American Red Cross Blood Services, Mobile, Alabama.
RECALLED BY Manufacturer, by telephone November 15, 1991. Firm-initiated
recall complete.
DISTRIBUTION Alabama.
QUANTITY 1 unit.
REASON A unit of Granulocytes, Pheresis labeled with the incorrect
expiration date, was distributed.
-6-
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT Cryoprecipitated AHF. Recall #B-304-2.
CODE Unit #50F71951.
MANUFACTURER American Red Cross Blood Services, Toledo, Ohio.
RECALLED BY Manufacturer, by telephone December 12, 1991, followed by
letter dated January 9, 1992. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Cryoprecipitated AHF, labeled with the incorrect expiration
date was distributed.
PRODUCT Source Plasma. Recall #B-314-2.
CODE All units except those units listed in the Class II Recall
#B-313-2.
MANUFACTURER Plasma Services of San Antonio, San Antonio, Texas (testing
facility/responsible firm).
RECALLED BY Plasma Services, Scottsdale, Arizona, by letters via facsimile
on October 11, 17, and 30, 1991. Firm-initiated recall
complete.
DISTRIBUTION North Carolina.
QUANTITY 16,231 units were distributed.
REASON Blood products, incorrectly tested for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), were distributed.
PRODUCT Red Blood Cells. Recall #B-315-2.
CODE Unit #50L03579.
MANUFACTURER American Red Cross Blood Services, Toledo, Ohio.
RECALLED BY Consignee notified firm by letter November 15, 1991. Recall
complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit.
REASON Blood product labeled with incorrect expiration dates was
distributed.
PRODUCT Source Plasma. Recall #B-318-2.
CODE Bleed Date Unit Numbers
12/23/91 N-22020-047 thru N-22024-047, N-22026-047
N-22027-047, G-10517-047 thru G10529-047
G-10531-047 thru G-10586-047
12/24/92 N-22028-047 thru N-22030-047
G-10587-047 thru G-10627-047
G-10629-047 thru G-10631-047
G-10633-047 thru G-10641-047
G-10643-047 thru G-10649-047
G-10651-047 thru G-10660-047
12/26/91 N-22031-047 thru N-22037-047
N-22039-047
N-22041-047
-7-
G-10661-047 thru G-10706-047
G-10708-047 thru G-10714-047
G-10716-047 thru G-10744-047
12/27/91 N-22042-047 thru N-22045-047
G-10745-057 thru G-10823-047
G-10825-047 thru G-10837-047
G-10839-047
12/30/91 N-22046-047 thru N-22051-047
N-22053-047 thru N-22054-047
N-22056-047
G-10840-047 thru G-10859-047
G-10861-047 thru G-10883-047
G-10885-047 thru G-10891-047
G-10893-047 thru G-10950-047
12/31/91 N-22057-057
N-22059-047
N-22060-047
N-22061-047
G-10951-047 thru G-10988-047
G-10990-047 thru G-11029-047
1/2/92 N-22062-047 thru N-22064-047
N-22066-047 thru N-22069-047
G-11030-047 thru G-11053-047
G-11055-047 thru G-11059-047
G-11061-047 thru G-11078-047
G-11080-047 thru G-11097-047
G-11099-047 thru G-11105-047
G-11107-047 thru G-11114-047
1/3/92 N-22070-047 thru N-22074-047
G-11115-047 thru G-11207-047
1/6/92 N-22076-047 thru N-22080-047
G-11209-047 thru G-11230-047
G-11232-047 thru G-11259-047
G-11261-047 thru G-11301-047
1/7/92 N-22081-047
N-22083-047
N-22088-047
N-22090-047
G-11302-047 thru G-11323-047
G-11325-047 thru G-11334-047
G-11336-047
G-11337-047
G-11339-047 thru G-11342-047
G-11344-047 thru G-11366-047
G-11368-047 thru G-11382-047
G-11384-047 thru G-11390-047
1/8/92 N-22091-047 thru N-22094-047
G-11392-047 thru G-11426-047
G-11428-047 thru G-11439-047
1/9/92 N-22097-047 thru N-22109-047
G-11440-047 thru G-11484-047
G-11486-047 thru G-11489-047
-8-
G-11491-047 thru G-11514-047
1/10/92 N-22110-047 thru N-22112-047
N-22115-057 thru N-22119-047
G-11515-047 thru G-11541-047
G-11543-047 thru G-11544-047
G-11546-047 thru G-11572-047
G-11574-047 thru G-11596-047
G-11598-047 thru G-11617-047
1/13/92 N-22121-047 thru N-22132-047
G-11618-047 thru G-11696-047
1/14/92 N-22134-047
N-22135-047
N-22137-047 thru N-22141-047
N-22143-047 thru N-22146-047
G-11697-047 thru G-11740-047
G-11742-047 thru G-11746-047
G-11748-047 thru G-11752-047
G-11754-047 thru G-11780-047
1/15/92 N-22147-047 thru N-22153-047
N-22156-047
G-11781-047 thru G-11784-047
G-11786-047 thru G-11824-047
G-11826-047 thru G-11832-047
1/16/92 N-22157-047 thru N-22162-047
G-11833-047 thru G-11868-047
G-11870-047 thru G-11902-047
1/17/92 N-22165-047 thru N-22171-047
N-22174-047 thru N-22177-047
G-11903-047 thru G-11960-047
G-11962-047 thru G-11965-047
G-11967-047 thru G-11989-047
G-11991-047 thru G-11997-047
G-11999-047 thru G-12002-047
G-12004-047 thru G-12015-047
G-12017-047 thru G-12023-047
1/20/92 N-22178-047, N-22180-047, N-22181-047
N-22183-047, N-22184-047
G-12024-047 thru G-12072-047
G-12074-047 thru G-12096-047
1/21/92 N-22185-047 thru N-22190-047
G-12097-047 thru G-12139-047
G-12141-047 thru G-12164-047
G-12166-047 thru G-12170-047
G-12172-047 thru G-12188-047
1/22/92 N-22191-047 thru N-22205-047
N-22207-047
G-12189-047 thru G-12194-047
G-12196-047 thru G-12223-047
G-12225-047 thru G-12243-047
G-12245-047 thru G-12257-047
1/23/92 N-22208-047 thru N-22210-047
N-22212-047 thru N-22214-047
G-12258-047
-9-
G-12260-047 thru G-12263-047
G-12265-047 thru G-12317-047
G-12319-047 thru G-12334-047
1/24/92 N-22215-047
N-22217-047 thru N-22220-047
G-12335-047 thru G-12346-047
G-12348-047 thru G-12436-047
G-12438-047 thru G-12454-047
MANUFACTURER Plasma-Tec, Ltd., Erie, Pennsylvania.
RECALLED BY Manufacturer, by telephone May 5, 1992, followed by letters
dated May 11, and 12, 1992. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 2,052 units.
REASON Source Plasma, exposed to unacceptably elevated storage
temperatures and not properly relabeled as Source Plasma,
Salvaged, was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Model Optilase 1000 Laser, used for cardiovascular and other
surgery. Recall #Z-686-2.
CODE Serial numbers: None.
MANUFACTURER Trimedyne, Inc., Irvine, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan
May 19, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 366 units were distributed.
REASON Noncompliance with the performance standard for laser products
in that the beam attenuators (safety shutters) were inadequate
to prevent human access to laser radiation.
PRODUCT Laser Diodes: (a) Model HLG711G; (b) Model HL6712G;
(c) Model HL7836G, used primarily as components in electronic
manufacturing. Recall #Z-687/689-2.
CODE Serial numbers: None.
Manufacturer Hitachi America, Ltd., San Jose, California (Bellsey and Baker,
San Francisco, California.
RECALLED BY Manufacturer. FDA approved the firm corrective action plan May
19, 1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 38,149 units were distributed.
REASON Noncompliance with the performance standards for laser products
in that they lacked warning logotype labeling, laser aperture
labeling, and proper user safety instructions.
PRODUCT Sun Jet Tanning Beds. Recall #Z-690-2.
CODE None.
-10-
MANUFACTURER McGuire's Sun & Fitness Tanning Center, Charlotte, North
Carolina.
RECALLED BY Manufacturer. Firm-initiated field correction ongoing.
DISTRIBUTION North Carolina, Ohio, South Carolina, Virginia.
QUANTITY 4 units were distributed.
REASON Noncompliance with the performance standards for sunlamp
products in that the beds lacked adequate labeling, as well as
the required manufacturer information.
PRODUCT C02 Cartridge Holder for the Metromat, used for dilating the
uterine cavity by means of C02 gas during hysteroscopy:
(a) C02 Cartridge Holder, Catalog #2121.00;
(b) C02 Cartridge Holder, Catalog #2129.009.
Recall #Z-695/696-2.
CODE All serial numbers of both models.
MANUFACTURER Richard Wolf Medical Instruments Corporation, Rosemont,
Illinois.
RECALLED BY Richard Wolf Medical Instruments Corporation, Vernon Hills,
Illinois, by letter January 10, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 998 units were distributed.
REASON The product could allow rapid gas pressure build-up which if
not exhausted through the pressure relief system, could cause
an explosion.
PRODUCT Software program for Sonoline Clor Flow SI-1200 Ultra Sound
Scanner, Software Revision 5.02. Recall #Z-697-2.
CODE Product #1393334, software disc serial numbers 271 thru 280.
MANUFACTURER Siemens Ultrasound, Inc., San Ramon, California.
RECALLED BY Manufacturer, by letter and telephone October 22, 1991.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 17 units were distributed.
REASON Defective software may lead to a miscalculation of mitral valve
oriface size. This could lead to a delay in proper diagnosis
and treatment for mitral valve stenosis.
PRODUCT PRN Port Infusion Sets with Injection Site and NonCor Needle:
(a) Product No. PIS191;
(b) Product No. PIS193;
(c) Product No. PIS1915;
(d) Product No. PIS201;
(e) Product No. PIS203;
(f) Product No. PIS2015;
(g) Product No. PIS221;
(h) Product No. PIS223;
(i) Product No. PIS2215;
(j) Product No. IS191;
-11-
(k) Product No. IS193;
(l) Product No. IS1915;
(m) Product No. IS201;
(n) Product No. IS203;
(o) Product No. IS2015;
(p) Product No. IS221;
(q) Product No. IS223;
(r) Product No. IS2215. Recall #Z-743/760-2.
CODE All units.
MANUFACTURER Nipro Medical Industries, Ltd., Nissho Corporation,
Tatebayashi, Gumma, Japan.
RECALLED BY PRN Services, Inc., Madison Heights, Michigan, by letter March
20, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 182,341 units were distributed.
REASON Cannula separation can occur.
PRODUCT Resume Model 3586 Lead Kit for Spinal Cord Stimulation, used to
alleviate pain. Recall #Z-761-2.
CODE LW0010503N - LW0010512N.
MANUFACTURER Medtronic, Inc., Minneapolis, Minnesota.
RECALLED BY Manufacturer, by telephone April 16, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION Georgia, Massachusetts, Minnesota, Pennsylvania, Texas,
Virginia.
QUANTITY 10 leads.
REASON Firm was unable to verify that it had successfully completed a
critical step in the manufacturing process.
PRODUCT Operator's Manual for Sarns 9000 Perfusion Systems, Part
#34-9998-9812-4, May 1991 Revision. Recall #Z-762-2.
CODE Not coded. Systems with manuals which were distributed between
9/23/91 and 12/20/91. All manuals are copies of the May 1991
revision.
MANUFACTURER Sarns, Inc., 3M Health Care, Ann Arbor, Michigan.
RECALLED BY Manufacturer, by letters of February 25, 1992, March 2 and 3,
1992. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 220 manuals were distributed.
REASON Pages in the manual may be duplicated and/or omitted. These
pages may concern emergency procedures.
PRODUCT Silicone Rubber Catheter/Connector Kit, a sterile device
intended for single use only. Recall #Z-764-2.
CODE Catalog #37958, lot #LCN 191 EXP 8/13/96.
MANUFACTURER Infusaid, Inc., a Pfizer Company, Norwood, Massachusetts.
RECALLED BY Manufacturer, by telephone April 16, 1992 followed by letter.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Germany, France, Australia.
QUANTITY 109 units were distributed.
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REASON The device was not sterilized prior to being released into
commercial distribution.
PRODUCT Vascutek Dacron Vascular Grafts:
(a) Product Code 380008 , 8 mm x 100 cm;
(b) Product Code 380010, 10 mm x 100 cm. Recall #Z-765/766-2.
CODE All lots.
MANUFACTURER Vascutek, Ltd., Renfrewshire, Scotland.
RECALLED BY Impra, Inc., Phoenix, Arizona, by telephone February 7, 1992.
Firm-initiated recall complete.
DISTRIBUTION Alabama, New York.
QUANTITY 16 units.
REASON The devices were labeled as 75 mm long, when they were actually
100 cm long.
UPDATE American Sterilizer 3080RL Surgical Table, Recall #Z-742-2
which appeared in the June 10, 1992 Enforcement Report should
read: Firm-initiated field correction complete.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Endo-V Intravaginal Needle Guides:
(a) Model 89 90 251; (b) Model 89 90 145;
(c) Model 89 90 269; (d) Model 89 90 277;
(e) Model 89 90 137. Recall #Z-767/771-2.
CODE None.
MANUFACTURER Siemens Ultrasound, Inc., San Ramon, California.
RECALLED BY Manufacturer, by letter March 18, 1991. Firm-initiated recall
complete.
DISTRIBUTION California, Hawaii.
QUANTITY 32 units were distributed.
REASON The needle guides will not allow the biopsy needle to pass
through.
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
PRODUCT Chloramphenicol Capsules (a) 100 mg; (b) 250 mg; (c) 500 mg, a
Rx veterinary product, under the following labels, Veterinary
Pharmaceuticals, Henry Schein, Vedco, The Butler Company, Tech
America Group, and Burns Veterinary. Recall #V-041/043-2.
CODE lot numbers: 0A390GG, 0A390GQ, 9C390EU, 9C390EV, 81390EL,
81390EM, 8D390DL, 8C390CO, 7K390DN, 0B386GL, OA387GF, 7K387BZ,
9H386BT, 81386DC, 8C386CN, 7L386AS, 78386BY, 7G386EA, 7N3865O,
0A387GE, 9C387BK, 9C387CZ, 7L387AQ, 7L387AR, 7K387CA, 7L387AP,
7G387EC, 7G387EB, 7N38752, 7N38751, 0A387GP, 7K387CB.
MANUFACTURER Barr Laboratories, Inc., Northvale, New Jersey.
RECALLED BY Nylos Trading Company, Inc., Pomona, New York, by letter April
20, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
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QUANTITY (a) 5,500,000 capsules; (b) 16,000,000 capsules; (c) 36,000,000
capsules were distributed.
REASON Product failed dissolution testing; changes were made to the
manufacturing process without an approved supplemental NADA;
and, Barr laboratories is unable to provide batch records for
one of the lots.
MEDICAL DEVICE SAFETY ALERTS
PRODUCT COBE CentrySystem 3 Dialysis Control Unit, performs the
necessary control functions for hemodialysis therapy. Safety
Alert #M-060-2.
CODE All serial numbers
MANUFACTURER CGH Medical, Inc., Lakewood, Colorado.
ALERTED BY Manufacturer, by letter May 18, 1992.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 4,000 units were distributed.
REASON Very small microbubbles, which are smaller than 10 microliters,
may not be detectable by the device's ultrasonic air bubble
detector system. As a result, air has been observed in the
venous line downstream of the venous clamp which could result
in air reaching the patient.
SEIZURES:
PRODUCT Chunk Light Tuna in Water (92-607-533, et al).
CHARGE Adulterated - The product consists in part of decomposed tuna
fish, and it is a pet food which has been relabeled as human
food, thus concealing its inferiority. Misbranded - The
product is offered for sale under the name of another food.
FIRM Greater Pittsburgh Community Food Bank, McKeesport,
Pennsylvania.
FILED April 30v:, 1992 - U.S. District Court for the Western District
of Pennsylvania; Civil #92-1161, FDC #66406.
SEIZED May 13, 1992 - goods valued at approximately $15,000.
PRODUCT Various articles of drug (91-645-201, et al).
CHARGE New drug - One product has no approved new drug application in
effect. Misbranded - One product is in package form and fails
to bear a label containing the name and address of the
manufacturer, packer, or distributor as required by regulation;
another product fails to bear a label containing all required
words, statements, and other information in the English
language, as required by regulation; some of the products are
fabricated from two or more ingredients and their labels fail
to bear the established name and quantity of each active
ingredient; and the products are prescription drugs and their
label fails to bear the prescription legend.
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FIRM International Wholesale Corporation, N.E., Washington, D.C.
FILED May 1, 1992 - U.S. District Court for the District of Columbia;
Civil #92-1039, FDC #66372.
SEIZED May 11, 1992 - goods valued at approximately $17,000.
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END OF ENFORCEMENT REPORT FOR JUNE 17, 1992. BLANK PAGES MAY FOLLOW.
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