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
02/14/1996

ENFORCEMENT REPORT FOR 02/14/96

February 14, 1996 96-07

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Smoked Sockeye Salmon, sliced, in 1 kg
unlabeled packages. Recall #F-291-6.
CODE Lot #LW9511.
MANUFACTURER Smoki Foods, Inc., SeaTac, Washington.
RECALLED BY Manufacturer, by telephone and by letter on
January 12, 1996. FDA-initiated recall
complete.
DISTRIBUTION Japan.
QUANTITY 1,388 pounds (43 cases of 15 1-kg packages)
were distributed.
REASON Product is contaminated with Listeria
monocytogenes.

_______________
UPDATE Safeway Select Light Rocky Road Ice Cream, in
half gallon containers, Recall #F-268-6, which
appeared in the January 31, 1996 Enforcement
Report should read:
RECALLED BY: Jerseymaid Dairies, Commerce
California.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Mead Johnson Sustacal Nutritional Powder, add
skim milk or water, in 1 pound containers.
Recall #F-271-6.
CODE Lot numbers: BFD61, BJD62, BAJ63, BAJ64.
MANUFACTURER Mead Johnson Nutritional Group, Evansville,
Indiana.
RECALLED BY Manufacturer, by letter April 21, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide, Dominican Republic, Panama.
QUANTITY 9,563 cases were distributed.
REASON Product label declares the product as lactose
free when it actually contains lactose.

_______________
PRODUCT Sumthin Sweet Peppermint Starlights, red,
white, and green candy mints packaged in 2-3/4
and 10 ounce plastic bags. Recall #F-275-6.
CODE None.
MANUFACTURER CenDee Confectionery & Nut Products, Inc.,
Plainview, New York.
RECALLED BY Manufacturer, by letters mailed on December
29, 1995. Firm-initiated recall complete.
DISTRIBUTION New York and New Jersey.
QUANTITY 100 40-pound cases were distributed; firm
estimates none remains on the market.
REASON The product contains undeclared FD&C Yellow
No. 5.

_______________
PRODUCT Land O'Lakes Sweet Cream Salted Butter, in 1
pound cartons, 4 quarters per carton. Recall
#F-281-6.
CODE Pull dates: Feb 10 96T and Mar 01 96T.
MANUFACTURER California Milk Producers, Tipton, California.
RECALLED BY Land O' Lakes, Inc., Arden Hills, Minnesota,
by electronic mail message sent on January 12,
1996. Firm-initiated recall complete.
DISTRIBUTIOn Eastern United States.
QUANTITY 1,569 cases of 36 1-pound packages per case
were distributed.
REASON Product contains pieces of metal.

_______________
PRODUCT Cheerios Toasted Whole Grain Oat Cereal, in 2
pound 3 ounce boxes. Recall #F-282-6.
CODE Better If Used By date of 03MAY96UYB10.
MANUFACTURER General Mills, Inc. Plants, Toledo, Ohio, and
Buffalo, New York.
RECALLED BY General Mills, Inc., Minneapolis, Minnesota,
by letter sent December 20, 1995 and January
4, 1996, and by press release on December 22,
1995 and January 5, 1996. Firm-initiated
recall complete.
DISTRIBUTION Eastern United States.

-2-QUANTITY 4,752 retail boxes were distributed.
REASON Product contains undeclared almonds.

_______________
PRODUCT Various toaster pastries individually wrapped
in laminated pouches 6 per carton (Net wt. 11
oz.) unless otherwise stated, 12 cartons per
case: (a) Frosted Strawberry Toaster
Pastries, under the following labels:
Baker's Treat, distributed by Aldi Inc.,
Weis Quality, packed for Weis Markets, Inc.,
Hy-Vee, distributed by Hy-Vee Food Stores,
Inc.,
Mega, distributed by Topco Associates, Inc.,
DeMoulas Market Basket, distributed by
DeMoulas & Market Basket Stores,
Kroger Toaster Treats, distributed by The
Kroger Co.,
Food Club, distributed by Topco Associates,
Inc.,
Food Lion, distributed by Food Lion Inc.,
Janet Lee, distributed by Albertson's Inc.,
Nabisco Toastettes Tarts, distributed by
Nabisco, East, two-packs per carton (8 tarts
total), Net Wt. 13 oz.;
(b) Frosted Brown Sugar Cinnamon Toaster
Pastries under the following labels:
Baker's Treat, distributed by Aldi Inc.,
Weis Quality, packed for Weis Markets, Inc.,
Hy-Vee, distributed by Hy-Vee Food Stores,
Inc.,
Mega, distributed by Topco Associates, Inc.,
DeMoulas Market Basket, distributed by
DeMoulas & Market Basket Stores,
Kroger Toaster Treats, distributed by The
Kroger Co.,
Food Club, distributed by Topco Associates,
Inc.,
Food Lion, distributed by Food Lion Inc.,
Flavor Kist Toast'em Pastries, Schulze and
Burch Biscuit Co.;
(c) Strawberry Toaster Pastries, under the
following labels:
Weis Quality, packed for Weis Markets, Inc.,
Hy-Vee, distributed by Hy-Vee Food Stores,
Inc.,
DeMoulas Market Basket, distributed by
DeMoulas & Market Basket Stores,
Kroger Toaster Treats, distributed by The
Kroger Co.,
Food Club, distributed by Topco Associates,
Inc.,

-3- Food Lion, distributed by Food Lion Inc.,
America's Choice, distributed by Compass
Foods,
Stop & Shop Toaster Tarts, distributed by the
Stop & Shop Supermarket Company,
Janet Lee, distributed by Albertson's Inc.;
(d) Frosted Cherry Toaster Pastries under the
following labels: Hy-Vee, distributed by
Hy-Vee Food Stores, Inc.,
Kroger Toaster Treats, distributed by The
Kroger Co.,
Food Club, distributed by Topco Associates,
Inc., Food Lion, distributed by Food Lion
Inc.,
Janet Lee, distributed by Albertson's Inc.,
Nabisco Toastettes Tarts, distributed by
Nabisco, 4 two-packs per carton (8 tarts
total), Net Wt. 13 oz.;
(e) Frosted Blueberry Toaster Pastries, under
the following labels: (i) Hy-Vee, distributed
by Hy-Vee Food Stores, Inc.,
DeMoulas Market Basket, distributed by
DeMoulas & Market Basket Stores,
Food Club, distributed by Topco Associates,
Inc.,
Food Lion, distributed by Food Lion Inc.,
Janet Lee, distributed by Albertson's Inc.,
(f) Apple Cinnamon Toaster Pastries, under the
following labels: Hy-Vee, distributed by
Hy-Vee Food Stores, Inc.,
DeMoulas Market Basket, distributed by
DeMoulas & Market Basket Stores,
Kroger Toaster Treats, distributed by The
Kroger Co.,
Flavor Kist Toast'em Pastries, Schulze and
Burch Biscuit Co.,
(g) Blueberry Toaster Pastries, under the
following labels: DeMoulas Market Basket,
distributed by DeMoulas & Market Basket
Stores,
Food Lion, distributed by Food Lion Inc.,
(h) Frosted Fudge Toaster Pastries, under the
following labels: Nabisco Toastettes Tarts,
Distributed by Nabisco, 4 two-packs per carton
(8 tarts total), Net Wt. 13 oz.
Recall #F-283-290-6.
CODE All product produced on 8/28/95 through
9/1/95.
MANUFACTURER Schulze & Burch Biscuit Company, Chicago,
Illinois.
RECALLED BY Manufacturer, by telephone, followed by letter
on December 20, 1995. Firm-initiated recall
ongoing.
-4-DISTRIBUTION Nationwide.
QUANTITY 161,065 cases were distributed; firm estimated
that little if any product remained on market
at time of recall initiation.
REASON Products contain pieces of metal screen wire.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Red Blood Cells; (b) Frozen Plasma.
Recall #B-184/185-6.
CODE Unit #04H44843.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
RECALLED BY Manufacturer, by letters dated February 28,
1991 and March 6, 1991. Firm-initiated recall
complete.
DISTRIBUTION Massachusetts, California.
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 repeatedly
reactive for anti-HIV-1, Western Blot
indeterminate, were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-189-6.
CODE Unit #141805.
MANUFACTURER Saint Joseph Hospital Blood Bank, Denver,
Colorado.
RECALLED BY Manufacturer, telephone on March 15, 1995.
Firm-initiated recall complete.
DISTRIBUTION Colorado.
QUANTITY 1 unit.
REASON Blood product, which tested negative for the
antibody to the Human T-Lymphotropic Virus I
(anti-HTLV-1), but was collected from a donor
who previously tested repeatedly reactive for
anti-HTLV-1, Western Blot/RIPA indeterminate,
was distributed.

_______________
PRODUCT Platelets. Recall #B-190-6.
CODE Unit #39-79208.
MANUFACTURER Michigan Community Blood Center, Grand Rapids,
Michigan.
RECALLED BY Manufacturer, by telephone April 13, 1995.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASON Blood product not processed according to GMP's
(unvalidated centrifuge), was distributed.

-5-_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Cryoprecipitated AHF; (e)
Recovered Plasma. Recall #B-193/197-6.
CODE Unit numbers: (a) 24LG83891, 24LG81191.
24LJ03991, 24LY24371, 24LE67714, 24LJ91924,
24LE61252, 24LY09214, 24LQ45265, 24LS48629,
24LE47720, 4LS45854, 24LS42474; (b) 24LY24371,
24LJ91924, 24LE61252, 24LY09214, 24LS48629,
24LS45854, 24LS42474; (c) 24LE61252,
24LY09214; (d) 24LE67714; (e) 24LG83891,
24LG81191, 24LY24371, 24LE67714, 24LJ91924,
24LQ45265, 24LS48629, 24LE47720, 24LS45854,
24LS42474.
MANUFACTURER American Red Cross Blood Services, Louisville,
Kentucky.
RECALLED BY Manufacturer, by letters dated February 23,
1995, April 3, 1995, and January 17, 1996.
Firm-recall ongoing.
DISTRIBUTION Kentucky, Indiana, California, Switzerland.
QUANTITY (a) 13 units; (b) 7 units; (c) 2 units; (d) 1
unit; (e) 10 units.
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 repeatedly
reactive for anti-HIV-1 and was improperly
reentered, were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-208-6.
CODE Unit #56G59596.
MANUFACTURER American Red Cross Blood Services, Syracuse,
New York.
RECALLED BY Manufacturer, by letter dated June 1, 1995.
Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly
reactive for antibody to the hepatitis B core
antigen (anti-HBc), was distributed.

_______________
PRODUCT Platelets Pheresis. Recall #B-215-6.
CODE Unit #30164-4086.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, Bismark, North Dakota.
RECALLED BY Manufacturer, by telephone on February 3,
1995. Firm-initiated recall complete.
DISTRIBUTION North Dakota.
QUANTITY 1 unit.

-6-REASON Blood product, which was labeled with an
extended expiration date, was distributed.

_______________
PRODUCT Platelets; Platelets, Pooled.
Recall #B-222-6.
CODE Platelets - Units 4615041, 4615045, 4618609,
4618611, 4618616, 4618618, 4618621, 4618622,
4618625, 4622714, 4622719, 4622720, 4622721,
4622722, 4624148, 4624150, 4624152, 4624153,
4624157, 4624160, 4624164, 4624167, 4626849,
4626850, 4626852, 4626853, 4626856, 4626857;
Pooled Platelets, Unit 4554745.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by telephone on September 12,
1995, followed by letter dated October 6,
1995. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 28 platelets units and 1 pooled platelets
unit.
REASON Blood products, labeled with an extended
expiration date, were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-191-6.
CODE Unit #T77889.
MANUFACTURER Topeka Blood Bank, Inc., Topeka, Kansas.
RECALLED BY Manufacturer, by telephone February 16, 1995,
and by letter dated February 22, 1995. Firm-
initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit.
REASON Blood product, labeled with an incorrect
ABO/Rh group label and unit number, was
distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-198-6.
CODE Unit #38-07976.
MANUFACTURER Michigan Community Blood Center, Grand Rapids,
Michigan.
RECALLED BY Manufacturer, by fax on September 8, 1994.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
REASON Unlicensed blood product was distributed
interstate.

-7-_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells.
Recall #B-199/200-6.
CODE Unit numbers: (a) 25-04739, 25-04734, 25-
04731, 25-04728; (b) 25-04736, 25-04732, 25-
04733, 25-04730.
MANUFACTURER Michigan Community Blood Center, Grand Rapids,
Michigan.
RECALLED BY Manufacturer, notified consignees on June 9,
1993. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 4 units of each component.
REASON Blood products, which were labeled with an
extended expiration date, were distributed.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-203-6.
CODE Unit #0470918.
MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo,
Texas.
RECALLED BY Manufacturer, retrieved from hospital
inventory on September 23, 1994. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Fresh Frozen Plasma, which was not frozen
within eight hours of phlebotomy, was
distributed.

_______________
PRODUCT Red Blood Cells, Irradiated. Recall #B-216-6.
CODE Unit #30034-4822.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, Bismark, North Dakota.
RECALLED BY Manufacturer, by visit on March 11, 1994.
Firm-initiated recall complete.
DISTRIBUTION North Dakota.
QUANTITY 1 unit.
REASON Blood product, which was labeled with an
extended expiration date, was distributed.

_______________
PRODUCT Autologous Red Blood Cells. Recall #B-217-6.
CODE Unit #30035-2935.
MANUFACTURER Blood Systems, Inc., doing business as United
Blood Services, Bismark, North Dakota.
RECALLED BY Manufacturer, by letter dated August 25, 1994,
and by telephone on August 26, 1994. Firm-
initiated recall complete.
DISTRIBUTION North Dakota.
QUANTITY 1 unit.

-8-REASON Autologous blood product, which tested
positive for syphilis, was distributed without
a "Biohazard" label.

_______________
PRODUCT Platelets, Pheresis. Recall #B-218-6.
CODE Unit numbers: 1175000, 1175001, 1175002,
1175003, 1175004, 1175006.
MANUFACTURER Houchin Community Blood Bank, Bakersfield,
California.
RECALLED BY Manufacturer. Firm-initiated recall ongoing.
DISTRIBUTION California.
QUANTITY 6 units.
REASON Blood product untested for syphilis, was
distributed.

_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c)
Platelets, Pheresis. Recall #B-219/221-6.
CODE Unit numbers: (a) J00247, J01555, J03749;
(b) 310221894, GM11719, 55C74984, J01393,
J01401, J01427, J02792, J03517, J03981,
J04821, J05277, J05278, N63781, N78099,
R00593, R01304, W35379, W36880, W36881,
X13791, X15076, KC79395, KC80786, KC98793,
KC98794, KM05347, KM05553, KM05554, KM05555,
LY04749, LY06336, LY06355, LY06360, LY06580,
LY08806, LY08808;
(c) P06556, P07080, P10410, LP00015, LP00022,
LP00033, LP00034, LP00038, LP00043, LP00048,
LP00049, LP00071, LP00089, LP00096, LP00130,
LP00143, LP00144, LP00188, LP00199, LP00341,
LP00344, LP00411, LP00426, LP00442, LP00497,
LP00523, LP00524, LP00535, LP00587, LP00633,
LP00975, LP01322, LP01439, LP01616, LP01700,
LP01719, LP01737, LP01830.
MANUFACTURER Lifeblood/Mid-South Regional Blood Center,
Memphis, Tennessee.
RECALLED BY Manufacturer, by letter dated October 19,
1994. Firm-initiated recall complete.
DISTRIBUTION Mississippi, Arkansas, Missouri, Colorado.
QUANTITY (a) 3 units; (b) 36 units; (c) 38 units.
REASON Unlicensed blood products were shipped
interstate.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Gibeck brand 3 Liter Latex Breathing Bags,
Part #8311-130. Recall #Z-201-6.
CODE Lot numbers: S503023, S504023, S504027,
S505003, S505011, S505020, S506006.

-9-MANUFACTURER Precision Latex, Inc., Ashland, Ohio
(assembler).
RECALLED BY Gibeck, Inc., Indianapolis, Indiana, by letter
dated August 14, 1995. Firm-initiated recall
complete.
DISTRIBUTION Nationwide, Spain, Canada.
QUANTITY 114,493 bags were distributed.
REASON The adhesive-backed vinyl label applied over
the neck of the bag to restrain the neck of
the bag from stretching may not be adequately
securing the bag to the bushing.

_______________
PRODUCT Kinematic II Instrument Intramedullary
Alignment Rod, used in femoral preparation to
determine the correct angle of the femoral cut
prior to the insertion of the Kinemax Knee:
(a) Catalog #6784-8-110 (left knee); (
(b) Catalog #6784-8-120 (right knee).
Recall #Z-342/343-6.
CODE Package date code: (a) 95025; (b) 95096.
MANUFACTURER Howmedica, Inc., Rutherford, New Jersey.
RECALLED BY Manufacturer, by Inter-Company Correspondence
dated July 12, 1995. Firm-initiated recall
complete.
DISTRIBUTION International.
QUANTITY (a) 22 units; (b) 12 units were distributed;
firm estimated that (a) 7 units; (b) 3 units
remained on market at time of recall
initiation.
REASON The alignment rod for the right knee is
labeled as "left", and vice versa.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Acrysof Intraocular Lenses, Model MA60BM,
Recall #Z-359-6.
CODE Lot Number 367744 with a July 31, 2000
expiration date, serial Numbers 367744.001
through 367744.093.
MANUFACTURER Alcon Laboratories, Inc./CILCO, Huntington,
West Virginia.
RECALLED BY Alcon Laboratories, Inc., Fort Worth, Texas
(Corporate offices) by verbal instructions on
October 25, 26, 27, 1995 followed by letter
dated November 11, 1995. Firm-initiated
recall completed.
DISTRIBUTION Alabama, California, Connecticut, Delaware,
Iowa, Indiana Kentucky, Michigan, North
Carolina, North Dakota, New Jersey, New York,
Pennsylvania, South Carolina, Texas, Utah,
Washington, international.
-10-QUANTITY Recall resulted in the retrieval of 55
unimplanted lenses distributed between
approximately August 8 and October 25, 1995.
Thirty (30) lenses were implanted prior to
initiation of the recall.
REASON Granular haze was observed in some lenses
from this lot after the lenses had been
implanted.

_______________
PRODUCT Diagnostic Ultrasound Imaging Systems, used
for diagnostic examinations of patients:
(a) Model No. 5200A (B&W);
(b) Model No. 5200B (renamed "PERFORMA") - B&W
with Doppler Option);
(c) Model No. 5200S (color).
Recall #Z-382/384-6.
CODE 342 units with unique unsequential serial
numbers.
MANUFACTURER Texas Instruments, Inc., Dallas, Texas
(component (PAL)).
RECALLED BY Acoustic Imaging Technologies Corporation,
Phoenix, Arizona, by letter August 24, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 342 units were distributed.
REASON The programmable array logic (PAL) circuitry
is defective, causing overheating of the
transducer, which might cause patient burns.

_______________
PRODUCT Diagnostic Ultrasound Imaging Systems:
(a) Model No. 5200A (B&W);
(b) Model No. 5200B (renamed "PERFORMA" - B&W
with Doppler Option). Recall #Z-387/388-6.
CODE 444 systems with unique, non-sequential serial
numbers.
MANUFACTURER Acoustic Imaging Technologies Corporation,
Phoenix, Arizona.
RECALLED BY Manufacturer, by letters of September 28,
1995, and October 27, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 444 units were distributed.
REASON Devices contain a flammable air filter which
may ignite if a capacitor overheats and melts
on the printed circuit board located above the
air filter which might result in patient or
operator burns or smoke inhalation injury.

-11-_______________
PRODUCT Beam Limiting Devices: (a) Model BLF-75A;
(b) Model BLA-150A; (c) Model BLA-550A;
(d) Model BLA-151A; (e) Model TF-UA-2L;
(f) Model TF-10ML-2; (g) Model TF-35S;
(h) Model No. TF-63SA. Recall #Z-394/401-6.
CODE Non-sequential serial numbers.
MANUFACTURER Toshiba America Medical Systems, Inc., Tustin,
California.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan February 5, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 305 units.
REASON The diagnostic x-ray devices were found to be
in noncompliance with the Federal Performance
Standard for Diagnostic X-Ray Systems and
Their Major Components, in that the glass
utilized in the rear surface mirror becomes
tinted and deteriorated due to the cumulative
effects of radiation exposure. The result is
that they may not meet the average illuminance
requirement (as stated in 21 CFR
1020.31(d)(2)(ii)) of 160 lux at 100
centimeters after sustained exposure to
radiation.

_______________
PRODUCT Trojan Ultra Texture Latex Condoms
"lubricated" for Mutual Pleasure with Special
Receptacle End, in 12 unit cartons.
Recall #Z-403-6.
CODE Lot #MFD112993N.
MANUFACTURER Carter-Wallace, Inc., Trenton, New Jersey.
RECALLED BY Carter-Wallace, Inc., Cranbury, New Jersey, by
visit between August 23 and 25, 1995. Firm-
initiated recall complete.
DISTRIBUTION Alabama, Connecticut, Florida, Georgia,
Illinois, Maine, Michigan, New Hampshire, New
Jersey, New York, North Carolina, Ohio,
Pennsylvania, Rhode Island, Tennessee,
Virginia.
QUANTITY 630 cases (12 boxes per case, 12 units per
box) were distributed; firm estimates none
remains on the market.
REASON The condoms failed the ASTM water leak test.

_______________
PRODUCT (a) Surgical Irrigators, Models SI1000 and
SI2000; (b) Pressure Infusers, Models AD50,
AD1000, AD1500, AD2000, Blood infusion
devices. Recall #Z-404/405-6.

-12-CODE Devices manufactured or repaired between
02/20/94 and 04/30/94.
MANUFACTURER Alton Dean Medical, Inc., Woods Cross, Utah.
RECALLED BY Manufacturer, by letter January 3, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 892 devices were distributed.
REASON Two of the pressure relieving safe-guards
(diaphragm and pressure relieving valve) were
not included in the devices.

_______________
PRODUCT Ortho Brain Thromboplastin, used for
deficiencies of clotting factor activity:
(a) Product Code #732470; (b) Product Code
#732400. Recall #Z-406/407-6.
CODE Lot numbers: (a) OBT194; (b) OBT196, OBT197,
OBT201.
MANUFACTURER Ortho Diagnostic Systems, Inc., Raritan, New
Jersey.
RECALLED BY Manufacturer, by letter December 16 or 17,
1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and International.
QUANTITY 454 kits were distributed.
REASON The wrong International Sensitivity Index
(ISI) was assigned to the above lots.

_______________
PRODUCT Optical Trigger Probe, used for quality
control measurements in a
laboratory/inspection room environment.
Recall #Z-431-6.
CODE Model #OTS5-LD.
MANUFACTURER Surface Measurement, Inc., Burnsville,
Minnesota.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan January 15, 1996.
Firm-initiated field correction ongoing.
DISTRIBUTION Minnesota.
QUANTITY 1 unit.
REASON The laser product failed to comply with 21 CFR
1040.10(f)(1) in that it exceeded the Class I
accessible emission limits.

_______________
PRODUCT Class IIIb Laser Profiler, used to test miles
transmitters and target vests.
Recall #Z-432-6.
CODE Model LR 2000.
MANUFACTURER ROC Associates, Inc., Worthington, Ohio.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan November 9, 1995.
Firm-initiated field correction complete.
-13-DISTRIBUTION Nationwide.
QUANTITY 4 units.
REASON The laser product failed to comply with the
Federal laser product performance standard
protective housing requirements, 21 CFR
1040.10(f)(1), beam attenuator requirement 21
CFR 1040.10(f)(6), the user information 21 CFR
1040.10(h).

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Gemini Blood/Solution Non-Vented IV
Administration Sets, used with the Gemini PC-
2TX Volumetric Infusion Pump.
Recall #Z-370-6.
CODE Lot #95F284.
MANUFACTURER Arplamed, S.A. D.E.C.V., Tijuana, B.C.,
Mexico.
RECALLED BY IMED Corporation, San Diego, California, by
telephone on October 25, 1995, followed by
letter dated November 1, 1995. Firm-initiated
recall complete.
DISTRIBUTION Arizona, California, Colorado, Idaho, Kansas,
Louisiana, Nevada, New York, Oregon,
Pennsylvania, Tennessee, Texas, Virginia,
Washington state, Wisconsin, Wyoming, Mexico.
QUANTITY 224 cases (10 sets per case) were distributed.
REASON The non-vented IV sets are mislabeled as
vented IV sets.

_______________
PRODUCT Zoll AC Power Charger used with Zoll
defibrillators/pacemakers, Model numbers
PD1400, D1400, D2000 and 1600.
Recall #Z-402-6.
CODE Serial numbers: 1000-3920
(domestic/international); S1001-S1104
(German).
MANUFACTURER Zoll Medical Corporation, Burlington,
Massachusetts.
RECALLED BY Manufacturer, by letter dated December 21,
1995, and by providing a notification and
modification kit part #7777-015. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 2,535 units were distributed.

-14-REASON The external case of the AC Power Charger may
exhibit localized melting, typical of
excessive heat which has been attributed to a
short circuit between the power etch of the
circuit board and the conductive coated
internal case surface.

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III
========
_______________
PRODUCT Vitamin B12 1000 mcg/ml (500 ml).
Recall #V-009-6.
CODE Lot numbers: 3282, 3602, 3607.
MANUFACTURER GEN/Rx, Fort Collins, Colorado.
RECALLED BY Manufacturer, by January 22, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Missouri.
QUANTITY 8,722 500-ml units were distributed.
REASON Product is degrading and has fallen out of
specifications for pH.

_______________
PRODUCT ALPO Premium Cat Food, in 5.5 ounce cans.
Recall #V-010-6.
CODE Variety: Can Code(s):
Flounder, Cod, Sole 25241514
Poultry Dinner 25229517, 25241517
Beef and Seafood 25229518
Beef Banquet 25229550, 25236550,
25250550
Whitefish and Tuna 25236551
Turkey and Bacon 25235552, 25250552
Salmon and Shrimp 25235553, 25242553,
25250553
Beef and Liver 25236554, 25250554
Savory Grill 25230555, 25236555,
25250555
Turkey and Giblets 25235556, 25241556
Captains Table 25229557, 25235557,
25241557
Liver and Chicken 25236558, 25242558
Robust Stew 25242559
Sliced Beef and Cheddar 25243560
Ocean Whitefish 25229562, 25241562
Sliced Beef 25243563
Sliced Turkey 25242564
Tuna and Chicken 25235566, 25249566
Chicken/Cheese 25235568
Liver, Bacon, Egg 25242569
MANUFACTURER Friskies Petcare Company, Division. Nestle
Food Company, Crete, Nebraska.

-15-
RECALLED BY Nestle USA, Inc., Glendale, California, by
Sales Department Bulletin sent on September
19, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 139,000 cases (24 cans per case) were
distributed.
REASON Product was contained in cans with defective
can seams, which may lead to spoilage.

-16-

END OF ENFORCEMENT REPORT FOR FEBRUARY 14, 1996. BLANK PAGES MAY
FOLLOW.

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