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
03/27/1996
ENFORCEMENT REPORT FOR 03/27/96
March 27, 1996 96-13
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Bulk Toleron Food Grade (brand of Ferrous
Fumarate USP), in 110 pound drums, for use as
a nutrient and vitamin supplement.
Recall #F-345-6.
CODE Lot #SPK334.
MANUFACTURER Nitrokemia Company, Hungary.
RECALLED BY Mallinckrodt Chemical, Inc., St. Louis,
Missouri, by letters dated December 21, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION New Jersey, Michigan, California, Missouri,
Minnesota.
QUANTITY 320 drums were distributed.
REASON Product contains foreign material.
_______________
PRODUCT Dietary supplement labeled in part,
Performance Plus/KSA Inc. Tone and Shape Your
Body All Natural Fat and Cellulite Burning
Formula, in 120 capsule bottles.
Recall #F-346-6.
CODE Lot numbers: 7306, 7479, 1690.
MANUFACTURER Magno-Humphries Laboratories, Inc., Tigard,
Oregon.
RECALLED BY Manufacturer, by telephone on February 20,
1996. Firm-initiated recall complete.
DISTRIBUTION Washington state, Oregon.
QUANTITY 2,272 bottles were distributed.
REASON The product's label declares 60 mg of iron
when the product is formulated to contain 6 mg
of iron.
_______________
PRODUCT Minute Maid fruit juice products containing
apple juice: (a) Apple Juice in 8.45 fluid
ounce tetrapak packages; (b) Grape Juice in
8.45 fluid ounce tetrapak packages; (c)
Variety Pak containing Apple Juice and Grape
Juice in 8.45 fluid ounce tetrapak packages.
Recall #F-347/349-6.
CODE Lot numbers: (a) D21999A, D21999B, H12948C,
H12948D, H13055B, H13055C, H13055D;
(b) D21981E, H13235A, H13235B;
(c) H13125B, H13220C, H13304B, H13359B,
H13502E, H13502D, H13576E.
MANUFACTURER Coca-Cola Foods, in Aburndale, Florida and
Hightstown, New Jersey.
RECALLED BY Coca-Cola Foods, Houston, Texas, by visit on
March 7, 1996. Firm-initiated recall ongoing.
See also FDA talk paper T96-14, dated February
26, 1996.
DISTRIBUTION Nationwide.
QUANTITY 57,230 cases (27 units per case) were
distributed; firm estimated that less than 10
percent remained on market at time of recall
initiation.
REASON Hydrolyzed inulin syrup has been substituted
in part for apple juice in these products.
_______________
PRODUCT Minute Maid and Minute Maid Orchard's Best
fruit juice products containing apple juice as
follows:
(a) Minute Maid Apple Juice in 8.45 fluid
ounce tetrapak packages;
(b) Minute Maid Grape Juice in 8.45 fluid
ounce tetrapak packages;
(c) Minute Maid Orchard's Best Country Apple
Blackberry juice in 46 fluid ounce plastic
containers;
(d) Minute Maid Orchard's Best Country Apple
Cranberry Raspberry juice in 12 ounce frozen
cans;
(e) Minute Maid Orchard's Best Ripe Apple
Raspberry juice in 12 ounce frozen cans;
-2- (f) Minute Maid Orchard's Best Country Ripe
Apple Raspberry juice in 64 fluid ounce paper
cartons, chilled;
(g) Minute Maid Orchard's Best Country
Raspberry Peach juice in 46 fluid ounce
plastic containers;
(h) Minute Maid Orchard's Best Country Sweet
Strawberry Peach juice in 12 ounce frozen
cans;
(i) Minute Maid Orchard's Best Country Sweet
Strawberry Peach juice in 64 fluid ounce paper
cartons, chilled;
(j) Minute Maid Orchard's Best Country Wild
Mountain Grape in juice 12 ounce frozen cans;
(k) Minute Maid Variety Pack containing in
part Apple Juice in 8.45 ounce tetrapak
packages and Grape Juice in 8.45 ounce
tetrapak packages. Recall #F-350/360-6.
CODE Lot numbers: (a) T28036C, T28521A; (b)
G13470A, G14084C; (c) D28376D, T27806C,
T28376D, T29060E, T29061A (d) D23409B; (e)
D22254A, D22254B, D22254G, D23408A, D23408B,
D23408C, D23409C; (f) H14610F, H14905D; (g)
T26217A, T272930, T27810E, T27956B, T29061A;
(h) D22256A, D22256B, D23410C, D23675B; (i)
H15008A, H14609F, H14905D, H14917A; (j)
D23421C; (k) Lots G13413A, G13479B, G13481A,
G13483B, G13485D, G13560A, G13598A, G13642C,
G13689C, G13691D, G14015C, G14019D, G14084D,
G14118B, G14122E, G14259A, G14261E, T28009B,
T28049E, T28256A, T28341E.
MANUFACTURER Coca-Cola Foods, Auburndale, Florida;
Coca-Cola Foods, Geneva, Ohio;
Coca-Cola Foods, Paw Paw, Michigan;
Coca-Cola Foods, Hightstown, New Jersey.
RECALLED BY Coca-Cola Foods, Houston, Texas, by visit on
February 23, 1996. Firm-initiated recall
ongoing. See also FDA talk paper T96-14,
dated February 26, 1996.
DISTRIBUTION Nationwide.
QUANTITY 236,000 cases (27 units per case) were
distributed; firm estimated that 122,000 cases
remained on market at time of recall
initiation.
REASON Hydrolyzed inulin syrup has been substituted
in part for apple juice in these products.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Dilantin Kapseals, 100 mg, Extended Phenytoin
Sodium Capsules, in bottles of 100 and 1,000.
Recall #D-095-6.
-3- CODE Lot numbers: 06365F EXP 6/9 and 02975F EXP
7/97.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY The Parke-Davis Division of Warner Lambert
Company, Morris Plains, New Jersey, by letter
on February 22, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 39,393 bottles of lot 06365F, and 3,952
bottles of lot 02975F.
REASON Product does not meet dissolution
specifications.
_______________
PRODUCT Metoclopramide Tablets USP, 5 mg, under either
the Vangard Labs label, packaged 10 tablets
per card, 10 cards per box, or the Glasgow
Pharmaceutical label, packaged 25 tablets per
card, 30 cards per box, for use with patients
with symptomatic, documented gastroesophageal
reflux. Recall #D-097-6.
CODE Lot numbers: 3456-005 EXP 3/97 (Vangard),
121-002 EXP 3/97 (Glasgow).
MANUFACTURER Biocraft Laboratories, Inc., Fair Lawn, New
Jersey.
RECALLED BY Vangard Labs, Inc., Glasgow, Kentucky, by
letters on January 30, 1996 and March 13,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 288 boxes (28,800 tablets) Vangard label and
102 boxes (76,500 tablet) Glasgow label were
distributed.
REASON Product does not meet content uniformity
specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Cyproheptadine HCl 2 mg/5 ml Syrup, packaged
in 16 ounce and in 1 gallon plastic
containers, Rx antihistaminic/antiserotonergic
agent, under the following labels: Halsey,
Qualitest, Schein, Aligen, Goldline.
Recall #D-096-6.
CODE Lot numbers: 45959 EXP 2/96, 45977 EXP 4/96,
46008 EXP 7/96, 4H31 EXP 8/96, 4H31D 8/96,
4K19B EXP 9/96, 5H08B EXP 6/97.
MANUFACTURER Halsey Drug Company, Inc., Brooklyn, New York.
RECALLED BY Manufacturer, by letter sent on March 12,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Puerto Rico.
-4- QUANTITY 37,414 16-ounce containers and 4,624 gallon
containers were distributed.
REASON Assay and pH stability results are below
specification.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Platelets, Pheresis. Recall #B-278-6.
CODE Unit #KZ24581.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on or about
September 26, 1995. Firm-initiated recall
complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit split into two portions.
REASON Blood product, collected from a donor who had
traveled to an area designated as endemic for
malaria, was distributed.
_______________
PRODUCT Platelets, Pheresis. Recall #B-293-6.
CODE Unit numbers KZ28403 and KZ28418.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on or about August
14, 1995. Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 2 units.
REASON Blood products, which were collected from
donors whose health history screening was
inadequately performed, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-331/332-6.
CODE Unit numbers: (a) 10494-5704, 10497-6601,
10500-4510; (b) 10494-5704, 10500-4510.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated December 26, 1995. Firm-
initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY (a) 3 units; (b) 2 units.
REASON Blood products, collected from a donor who
lived in an area designated as endemic for
malaria, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-333-6.
CODE Unit numbers: 10496-7357 and 10499-2885.
-5- MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated December 21, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Arizona, Texas.
QUANTITY 2 units.
REASON Blood products, collected from a donor who
lived in an area designated as endemic for
malaria, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Recovered Plasma. Recall #B-294-6.
CODE Unit #KN27273.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by fax on or about July 19,
1995. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, collected from a donor whose
health history screening was inadequately
performed, was distributed.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-334-6.
CODE Unit #10500-9485.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Scottsdale, Arizona, by
telephone on November 27, 1995. Firm-
initiated recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit.
REASON Blood product which was not frozen within
eight hours of collection was distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Servo 300 Ventilator, Product #6079391 E338E.
Recall #Z-499-6.
CODE Serial numbers up to and including 6087.
MANUFACTURER Siemens-Elema AB, Solna, Sweden.
RECALLED BY Siemens Medical Systems (SMS), Inc., Danvers,
Massachusetts, by letter dated October 17,
1995. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 240 units were distributed.
-6- REASON The internal batteries of the device are
subject to short circuits.
_______________
PRODUCT Medi-Trace 530 Series Electrodes (also known
as ECL 530 Medi-Trace Foam), ECG Conductive
Adhesive Monitoring Electrodes.
Recall #Z-500-6.
CODE All lots.
MANUFACTURER Graphic Controls Corporation, Gananoque,
Ontario, Canada.
RECALLED BY Graphic Controls Corporation, Buffalo, New
York, by "product advisory" letter issued on
February 6, 1996. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 10,264,680 electrodes were distributed; firm
estimated that 1,362,000 units remained on
market at time of recall initiation.
REASON The product's labeling does not provide
adequate directions for use and does not
include all necessary precaution statements.
_______________
PRODUCT Medi-Trace 533 AMR Foam ECG Conductive
Adhesive Electrodes. Recall #Z-505-6.
CODE All lots.
MANUFACTURER Graphic Controls Corporation, Gananoque,
Ontario, Canada.
RECALLED BY Graphic Controls Corporation, Buffalo, New
York, by letter dated February 9, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION California, Illinois, Kansas, Missouri,
Louisiana, Oregon, South Carolina, Washington
state.
QUANTITY 221,760 electrodes were distributed; firm
estimated that 65,520 electrodes remained on
market at time of recall initiation.
REASON The product's labeling does not provide
adequate directions for use and does not
include all necessary precaution statements.
_______________
PRODUCT Medi-Trace 530 Series Conductive Adhesive
Electrodes used in telemetry kits:
(a) Medi-Trace MPK-MOD2 (formerly MPK-MEM5),
Reorder/Part No. 31027983;
(b) Medi-Trace MPK-MOD3 (formerly MPK-MEMSW),
Reorder/Part No. 31027942;
(c) Medi-Trace MPK-MOD4, Reorder No. 31098448.
Recall #Z-506/508-6.
CODE All lots.
-7- MANUFACTURER Graphic Controls Corporation, Gananoque,
Ontario, Canada.
RECALLED BY Graphic Controls Corporation, Buffalo, New
York, by letter dated February 9, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Texas, Arkansas, Alabama.
QUANTITY 9,244 kits were distributed.
REASON The product's labeling does not provide
adequate directions for use and does not
include all necessary precaution statements.
Also kits MPK-MOD2 (MPK-MEM5) and MPK-MOD3
(MPK-MEMSW) may contain LT4 Wishard Electrodes
which conflicts with product literature that
states the kits contain Medi-Trace 530 series
electrodes.
_______________
PRODUCT Electrosurgical generators:
(a) Force FX; (b) Force 300, (c) NS2000.
Recall #Z-509/511-6.
CODE Serial numbers: (a) F5G101A - F6B657A; (b)
F5I101B - F6A284B; (c) N5D101S - N5L178S.
MANUFACTURER Valleylab, Inc., Boulder, Colorado.
RECALLED BY Manufacturer, by letter on February 21, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 559 generators.
REASON Software logic error. A potential exists for
allowing the output of the generator to remain
active ("latch on") after the surgeon releases
the button or footswitch to deactivate the
generator.
_______________
PRODUCT Force 10, 20, 30, and 40 Electrosurgical
Generators. Recall #Z-512/515-6.
CODE All model numbers within the following serial
number ranges except those which have been
previously subjected to the calibration
verification test per 10/93 Service Bulletin.
R2L1559S - R2L1673S R4A4044S - R4A4213S
R3A1674S - R3A1843S R4B4214S - R4B4388S
R3B1844S - R3B2018S R4C4389S - R4C4658S
R3C2019S - R3C2288S R4D4659S - R4D4883S
R3D2289S - R3D2448S R4E4884S - R4E5093S
R3E2449S - R3E2608S R4F5094S - R4F5298S
R3F2609S - R3F2683S R4G5299S - R4G5432S
R3G2684S - R3G2873S R4H5433S - R4H5554S
R3H2874S - R3H3143S R4I5555S - R4I5726S
R3I3144S - R3I3463S R4J5727S - R4J5924S
R3J3464S - R3J3573S R4K5925S - R4K6116S
R3K3574S - R3K3733S R4L6117S - R4L6230S
-8- R3L3734S - R3L4043S R5A6231S - R5A6374S
R5B6375S - R5B6480S.
MANUFACTURER Valleylab, Inc., Boulder, Colorado.
RECALLED BY Manufacturer, by letter January 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 4,921 generators.
REASON A REM transformer component defect. A
potential exists that may allow the REM alarm
indicator light to remain green, indicating
proper attachment of the return electrode,
when incomplete patient contact actually
exists. When this occurs, the REM system will
not alarm or disable the generator.
_______________
PRODUCT Maxima Oxygenator product line of hollow fiber
oxygenators, intended for use in procedures
requiring the extracorporeal oxygenation of
and carbondioxide removal from blood during
cardiopulmonary bypass:
(a) Model No. 1380, Maxima;
(b) Model No. CB1380, Carmeda Maxima;
(c) Model No. 1300, Maxima with Filtered
Reservoir;
(d) Model No. 3380, Maxima Plus;
(e) Model No. CB3380, Carmeda Maxima Plus;
(f) Model No. 3300, Maxima Plus with Filtered
Reservoir;
(g) Model No. 3310, Maxima Plus with
non-filtered Reservoir;
(h) Model No. MAX-PRF, Maxima Plus PRF;
(i) Model No. CBMAX-PRF, Carmeda Maxima Plus
PRF;
(j) Model No. MAX-PRFB, Maxima Plus PRF with
filtered Reservoir;
(k) Model No. MAX-PRFT, Maxima Plus PRF with
filtered Reservoir;
(l) Model No. MAX-PRFN, Maxima Plus PRF with
non-filtered Reservoir;
(m) Model No. 3311, Maxima Plus with Hardshell
Venous Reservoir. Recall #Z-516/528-6.
CODE All lot numbers.
MANUFACTURER United For Excellence, Inc. (UFE), Riverfalls,
Wisconsin (Hex housing component).
RECALLED BY Medtronic Inc., Cardiopulmonary Division,
Anaheim, California, by sending inter-office
memorandum on October 24, 1995, followed by
letter January 19, 1996. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 56,125 units were distributed.
-9- REASON The venous inlet port is subject to leakage
due to defective molding.
_______________
PRODUCT Programalith III Pulse Generators:
(a) Model 241, unipolar with a lead connector
size of 5 mm
(b) Model 242, bipolar and accepts a
bifurcated lead
(c) Model 249, unipolar with a lead connector
size of 6 mm. Recall #Z-529/531-6.
CODE Serial numbers 86900 to 87949, 107800 to
107899, and 108000 to 108866.
MANUFACTURER Pacesetter, Inc., Sylmar, California.
RECALLED BY Manufacturer, by letter February 15, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Japan, Latin America.
QUANTITY 1,290 units were distributed.
REASON Devices may fail due to output loss.
_______________
PRODUCT Force 10, 30, and 40 Electrosurgical
Generators. Recall #Z-548/550-6.
CODE All of the following serial numbers:
R5L8276S R5L8199S R5L8164S R6B8282S
R5L8280S R5L8200S R5L8165S R6B8283S
R5J8016S R5L8201S R5L8168S R6B8291S
R5J8017S R5L8204S R5L8170S R6B8293S
R5J8018S R5L8248S R5L8171S R6B8294S
R5J8019S R5L8253S R5L8172S R6B8295S
R5J8021S R5L8254S R5L8173S R6B8297S
R5J8023S R5L8255S R5L8174S R6B8298S
R5J8024S R5L8256S R5L8175S R6B8300S
R5J8025S R5L8257S R5L8176S R6B8301S
R5K8050S R5L8258S R5L8177S R6B8302S
R5K8067S R5L8259S R5L8178S R6B8343S
R5K8068S R6B8303S R5L8179S R6B8344S
R5K8069S R6B8304S R5L8180S R6B8345S
R5K8070S R6B8305S R5L8184S R6B8346S
R5L8260S R6B8306S R5L8185S R6B8350S
R5L8261S R6B8307S R5L8190S R6B8352S
R5K8149S R6B8308S R5L8191S R6B8353S
R5K8150S R6B8371S R5L8192S R6B8354S
R5K8151S R6B8372S R5L8193S R6B8355S
R5K8152S R5L8161S R5L8194S R6B8359S
R5K8153S R5L8162S R5L8195S R6B8360S
R5L8198S R5L8163S R5L8196S R6B8361S.
MANUFACTURER Valleylab, Inc., Boulder, Colorado.
RECALLED BY Manufacturer, by letter dated March 7, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 93 generators.
-10- REASON Some of the generators contain a defective
component that has the potential for
initiating self-activation, which could result
in burns to the patient or surgical personnel.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT High Definition Imaging Ultrasound System HDI
3000 Part #8500-0030-01, projects ultrasound
energy from a transducer in direct contact
with the body for the purpose of detecting
abnormalities in soft tissue structures and
vessels. Recall #Z-428-6.
CODE Domestic serial numbers:
003GC1 003GBT 003GBQ 003GGN
003GDJ 003GG8 003GFV 003GC5
003GC0 003GCR 003GC4 003GGK
003GG7 003GFZ 003GG4 003GBP
003GDH 003GBR 003GC2 003GCT
003GFW 003GDC
International serial numbers:
003GF1 003GDM 003GBX 003GCC
003GF5 003GBY 003GCB 003GDL
003GGV 003GGW 003GCD 003GCF
003GDW 003GF9 003GGY 003GDT
003GCJ.
MANUFACTURER Advanced Technology Laboratories, Bothell,
Washington.
RECALLED BY Manufacturer, by letters dated August 14 and
23, 1995. Firm-initiated field correction
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 39 units were distributed
REASON A software coding error causes a calculation
error that affects the accuracy of the color
M-Mode time measurements.
_______________
PRODUCT High Definition Imaging Ultrasound System HDI
3000 Part No. 8500-0030-01 with 8.2.2 and
8.2.3 Software Versions, projects ultrasound
energy from a transducer in direct contact
with the body for the purpose of detecting
abnormalities in soft tissue structures and
vessels. Recall #Z-501-6.
CODE HDI 3000 systems and 8.2.2 and 8.2.3 upgrades.
MANUFACTURER Advanced Technology Laboratories (ATL),
Bothell, Washington.
RECALLED BY Manufacturer, by letter dated January 22,
1996. Firm-initiated field correction
complete.
-11- DISTRIBUTION Nationwide and international.
QUANTITY 344 units subject to field correction.
REASON An error in the software which caused the
Doppler history buffer to become discontinuous
and out of synch with time.
-12-
END OF ENFORCEMENT REPORT FOR MARCH 27, 1996. BLANK PAGES MAY
FOLLOW.
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