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
06/22/1994

Recalls and Field Corrections: Foods -- Class II -- 06/22/1994

June 22, 1994 94-25

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Vallone's Assorted Butter Style Cookies, in 1 pound, 2
pound, and 5 pound boxes. Recall #F-421-4.
CODE Products with expiration dates from 12/93 through 5/94.
MANUFACTURER Vallone's, Inc., Carteret, New Jersey.
RECALLED BY Manufacturer, by letters in mid-November 1993. Firm-
initiated recall complete.
DISTRIBUTION New Jersey, Florida.
QUANTITY 4,000 pounds.
REASON Product contains undeclared FD&C Yellow No. 5.

_______________
PRODUCT Wheaties Honey Gold Wholesome, Sweetened Whole Wheat & Corn
Cereal With Honey, 21.25 ounces. Recall #F-426-4.
CODE Better If Used By date of 21FEB95QQ____.
MANUFACTURER General Mills, Inc., Covington, Georgia.
RECALLED BY General Mills, Inc., Minneapolis, Minnesota, by electronic
mail May 23, 1994, by press release May 20, 1994, and by
issuing a notice to the Food Allergy Network May 23, 1994.
Firm-initiated recall ongoing.
DISTRIBUTION Alaska, California, Idaho, Montana, Oregon, Washington
state.
QUANTITY 1,128 cases (14 boxes per case).
REASON Product contains undeclared almonds._______________
PRODUCT Ice Cream in 3 gallon bulk containers: (a) Rocky Road; (b)
Heavenly Hash. Recall #F-427/428-4.
CODE None other than the flavor of the ice cream written or
stamped on container.
MANUFACTURER Taylor Milk Company, Ambridge, Pennsylvania.
RECALLED BY Tri-Point Ice Cream Sales Company, Ambridge, Pennsylvania,
by letter March 25, 1994. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, West Virginia, Ohio.
QUANTITY Undetermined.
REASON Products contained undeclared almonds.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Ice Cream in 3 gallon bulk containers: (a) Butter Pecan;
(b) Praline Pecan. Recall #F-424/425-4.
CODE None other than the flavor of the ice cream written or
stamped on container.
MANUFACTURER Taylor Milk Company, Ambridge, Pennsylvania.
RECALLED BY Tri-Point Ice Cream Sales Company, Ambridge, Pennsylvania,
by letter dated March 25, 1994. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania, West Virginia, Ohio.
QUANTITY Undetermined.
REASON Products contain undeclared pecans.

_______________
PRODUCT Pasta products: (a) Luigi Vitelli #9 Thin Spaghetti;
(b) Luigi Vitelli #17 Linguine, unit weight 16 ounces.
Recall #F-422/423-4.
CODE Lot numbers: (a) 466352; (b) 466395.
MANUFACTURER Maktas Makarnacilik, Izmir, Turkey.
RECALLED BY Vitelli-Elvea Company, Inc., Hawthorne, New Jersey, by
letter issued mid-December 1993. Firm-initiated recall
complete.
DISTRIBUTION New Jersey, New York.
QUANTITY Firm estimates none remains on the market.
REASON Products are substandard for declared iron.

_______________
PRODUCT Toasted Almond Fudge Ice Cream in 3 gallon containers.
Recall #F-429-4.
CODE None other than the flavor of the contents written or
stamped on the container.
MANUFACTURER Taylor Milk Company, Ambridge, Pennsylvania.
RECALLED BY Tri-Point Ice Cream Sales Company, Ambridge, Pennsylvania,
by letter dated March 24, 1994. Firm-initiated recall
complete.
DISTRIBUTION Pennsylvania, West Virginia, Ohio.
QUANTITY Undetermined.
REASON Product contained undeclared almonds.

-2-_______________
PRODUCT Pistachio Almond Ice Cream, in 3 gallon bulk containers.
Recall #F-430-4.
CODE None other than the flavor of the ice cream written or
stamped on container.
MANUFACTURER Taylor Milk Company, Ambridge, Pennsylvania.
RECALLED BY Tri-Point Ice Cream Sales Company, Ambridge, Pennsylvania,
by letter dated March 25, 1994. Firm-Initiated recall
complete.
DISTRIBUTION Pennsylvania, West Virginia, Ohio.
QUANTITY Undetermined.
REASON Product contained undeclared Pistachios.

_______________
PRODUCT Kern's Real Fruit Sodas, packed in 12 fluid ounce cans: (a)
Apricot Soda; (b) Guava Soda; (c) Mango-Orange Soda; (d)
Peach-Passion Fruit Soda; (e) Strawberry-Kiwi Soda; (f)
Tropical Soda. Recall #F-431/436-4.
CODE Although the contaminated cans were only noted in the codes
indicated by an *, all of the following codes were recalled:
Apricot Soda (Item 28500): 4035 LA, 4082 NA, 4083 NA, 4088
NA, 4102 NA*, and 4107 NA*;
Mango-Orange Soda (Item 28530): 4035 LA, 4085 NA, 4104 NA*,
and 4105 NA*;
Guava Soda (Item 28520): 4035 LA, 4084 NA, 4085 NA, 4099
NA*, 4100 NA*, and 4101 NA*;
Strawberry-Kiwi Soda (Item 28550): 4035 LA, 4084 NA, 4087
NA, 4088 NA, and 4106 NA*;
Peach-Passion Fruit (Item 28510): 4035 LA, 4083 NA, 4103 NA,
and 4107 NA;
Tropical Soda (Item 28560): 4035 LA, 4086 NA, and 4105 NA.
MANUFACTURER Arrowhead Mountain Spring Water Company, Ontario,
California.
RECALLED BY Nestle Beverage Company, San Francisco, California, by
letter April 21, 1994. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY Approximately 15,145 cans were distributed; firm estimates
none remains on the market.
REASON Product was contaminated with mold.

_______________
PRODUCT Plochman's Mild Yellow Mustard in 10.5 ounce yellow plastic
squeeze bottles. Recall #F-437-4.
CODE Lot numbers 216C3 and 242C3.
MANUFACTURER Plochman, Inc., Chicago, Illinois.
RECALLED BY Manufacturer, by telephone April 15, 1994. Firm-initiated
recall complete.
DISTRIBUTION Massachusetts, Georgia, Illinois, South Carolina, Missouri,
Michigan, Wisconsin, New York.
QUANTITY 3,566 cases (24 bottles per case) were distributed; firm
estimates none remains on the market.
REASON Product contained mold.

-3-RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Various drug products: (a) Acetic Acid (2%) & Aluminum
Acetate Otic Solution, 60 ml, under the following labels:
Bausch & Lomb, H.L. Moore, Mayor, Rugby; (b) Neomycin &
Polymyxin B Sulfates and Hydrocortisone Otic Solution, 10
ml, under the following labels: Bausch & Lomb, Akorn, Best,
Butler, Clinical, Equipharm, Goldline, Harber, J.J. Balan,
Major, OcuSoft, Parmed, Pedinol, Qualitest, Rugby, Teral,
URL; (c) Neomycin Polymyxin B Sulfates and Gramicidin
Ophthalmic Solution, 2 ml, and 10 ml, under the following
labels: Bausch & Lomb, Akorn, Best, Butler, Equipharm,
Genetic, Goldline, Harber, H.L. Moore, J.J. Balan, Major,
Medical Ophthalmics, OcuSoft, Parmed, Phoenix, Qualitest,
Rugby, Schein, Spectrum, URL, Vedco; (d) Erythromycin
Ethylsuccinate Oral Suspension, 200 mg/5 ml, 100 ml, under
the following labels: Bausch & Lomb, Major, Qualitest,
Rugby, Schein, URL. Recall #D-300/303-4.
CODE All lots with four digit lot numbers.
MANUFACTURER Pharmafair, Inc., Hauppauge, New York.
RECALLED BY Pharmafair, Inc., c/o BLP, (Bausch & Lomb Pharmaceuticals),
Tampa, Florida, by letters of April 22, 1994 and May 25,
1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,335,745 total units were distributed; firm estimated that
50% of this number remained on market at time of recall.
REASON Products were marketed with inadequate documentation to
support Abbreviated New Drug Applications.

_______________
PRODUCT Liqui-Prep Bowel Evacuant Kit with Magnesium Citrate Oral
Solution, USP, in 10 fluid ounce containers,
nonprescription, for use in preparation of the patient for
surgery, or for preparation of the colon for x-ray and
endoscopic examination. Recall #D-304-4.
CODE Catalog #3066, lot numbers: 08243066A, 08743066, 08743066A,
08843066, 08943066, 08143066A.
MANUFACTURER Cumberland-Swan, Inc., Smyrna, Tennessee (Magnesium Citrate
Oral Solution); E-Z-EM, Inc., Westbury, New York (kit).
RECALLED BY E-Z-EM, Inc., Westbury, New York (repacker), by letter April
20, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 500 cases (24 bottles per case) were distributed.
REASON Some bottles of the Magnesium Citrate Solution Kit component
contained glass particles.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Dog Fennel Allergenic Extract (Eupatorium capillifolium), in
10 ml, 30 ml, and 50 ml vials. Recall #B-312-4.
CODE Lot #F13083193 EXP 8/30/99.

-4-MANUFACTURER Antigen Laboratories, Inc., Liberty, Missouri.
RECALLED BY Manufacturer, by telephone January 7, 1994. Firm-initiated
recall complete.
DISTRIBUTION Georgia, South Carolina, Florida, Washington state.
QUANTITY 2 10-ml vials, 1 30-ml vial, and 2 50-ml vials.
REASON Allergenic extracts which were labeled with incorrect
species name were distributed.

_______________
PRODUCT Source Plasma. Recall #B-318-4.
CODE Unit numbers 82297744 and 82298208.
MANUFACTURER North American Biologicals, Inc., doing business as Grand
River Donor Center, Detroit, Michigan.
RECALLED BY North American Biologicals, Inc., Miami Florida, by letter
September 28, 1992. Firm-initiated recall complete.
DISTRIBUTION Puerto Rico.
QUANTITY 2 units.
REASON Blood products, which tested negative for the antibodies to
human, immunodeficiency virus types 1 and 2 (anti-HIV-1/2),
but were collected from a donor who previously tested
repeatedly reactive for anti-HIV-1/2, were distributed.

_______________
PRODUCT (a) Red Blood Cells for Further Manufacturer; (b) Recovered
Plasma. Recall #B-319/320-4.
CODE Unit #03R69097.
MANUFACTURER The American National Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by letters of November 5 and 15, 1993. Firm-
initiated recall complete.
DISTRIBUTION Illinois, Switzerland.
QUANTITY 1 unit of each component.
REASON Blood products, that 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) Platelets; (c) Fresh Frozen Plasma;
(d) Platelets for Further Manufacture. Recall #B-321/324-4.
CODE Unit numbers: (a) 03C53984, 03G47125; (b) 03G47125; (c)
03C53984; (d) 03C53984.
MANUFACTURER The American National Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by letter December 22, 1993. Firm-initiated
recall complete.
DISTRIBUTION Georgia, Florida.
QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit; (d) 1 unit.
REASON Blood products collected from a donor who reported a history
of hepatitis were distributed.

_______________
PRODUCT Recovered Plasma. Recall #B-325-4.
CODE Unit 158427.

-5-MANUFACTURER Beth Israel Hospital, Boston, Massachusetts.
RECALLED BY Manufacturer, by telephone, fax, and letter April 14, 1994.
Firm-initiated recall complete.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit.
REASON Blood product, which tested negative for the antibody to
hepatitis C virus encoded antigen (anti-HCV), but was
collected from a donor who previously tested repeatedly
reactive for anti-HCV, was distributed.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-326-4.
CODE Unit #22GG51332.
MANUFACTURER The American National Red Cross, Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by telephone January 14, 1993, followed by
letter January 26, 1993. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
REASON Blood product, containing anti-D (Rho) antibodies, but
labeled as negative for unexpected antibodies, was
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma.
Recall #B-330/332-4.
CODE Unit numbers: (a&b) 03FR02035, 03G25343, 03LM18668,
03R81193; (c) 03LM18668.
MANUFACTURER The American National Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by letter August 6, 1993. Firm-initiated
recall complete.
DISTRIBUTION Georgia.
QUANTITY (a) 4 units; (b) 4 units; (c) 1 unit.
REASON Blood products, that 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, were distributed.

_______________
PRODUCT Source Plasma. Recall #B-333-4.
CODE Unit #11471935.
MANUFACTURER North American Biologicals, Inc., Kansas City, Missouri.
RECALLED BY Manufacturer, by telephone January 7, 1993, followed by
letter January 12, 1993. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Source Plasma, that tested repeatedly reactive for the
antibody to hepatitis C virus encoded antigen (anti-HCV),
was distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-334-4.
CODE Unit #11N75587.

-6-MANUFACTURER The American National Red Cross, St. Louis, Missouri.
RECALLED BY Manufacturer, by telephone December 2, 1992, followed by
letter December 3, 1992. Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 1 unit.
REASON Blood product, that tested negative for the antibody to
hepatitis B core antigen (anti-HBc), but was collected from
a donor who previously tested repeatedly reactive for anti-
HBc on more than one occasion, was distributed.

_______________
PRODUCT Source Plasma. Recall #B-335-4.
CODE C-10176-691 C-10232-691 C-10432-691 C-10561-691
C-10653-691 C-10777-691 C-10867-691 C-11007-691
C-11143-691 C-11333-691 C-11411-691 C-11600-691
C-11691-691 C-11808-691 C-11893-691 C-12064-691
C-12161-691 C-12392-691 C-12514-691 C-12762-691
C-12866-691 C-13093-691 C-13095-691 C-13189-691
C-13309-691 C-13341-691 C-13403-691 C-13447-691.
MANUFACTURER Premier Bio Resources, Inc., Gulfport, Mississippi.
RECALLED BY Premier BioResources, Inc., Fort Worth, Texas, by letters
dated March 4 and 7, 1994. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 28 units.
REASON Source Plasma, that either tested negative for the
antibodies to human immunodeficiency virus types 1 and 2
(anti-HIV-1/2), but were collected from a donor who
previously tested repeatedly reactive for anti-HIV-1/2; or
tested negative for hepatitis B surface antigen (HBsAg) and
the antibody to hepatitis C virus encoded antigen (anti-
HCV), but were collected from a donor who previously
reported a history of hepatitis, were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Cryoprecipitated AHF (Human). Recall #B-315-4.
CODE Unit numbers: 22GL96498, 22GL96511, 22GT51314, 22GT51316,
22GX11292, 22GY43319, 22LV14533, 22LV14540, 22LQ26362.
MANUFACTURER American Red Cross, Philadelphia, Pennsylvania.
RECALLED BY Manufacturer, by telephone May 13, 1993, followed by letter
May 21, 1993. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, New Jersey.
QUANTITY 9 units.
REASON Units of Cryoprecipitated AHF (Human), exposed to
unacceptable temperature and allowed to thaw, were
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-327/328-4.
CODE Unit numbers: (a) 03FF21084; (b) 03FF21084.
MANUFACTURER The American National Red Cross, Atlanta, Georgia.

-7-RECALLED BY Manufacturer, by telephone July 2, 1993, followed by letter
July 30, 1993. Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit of each component.
REASON Blood products, untested for hepatitis B surface antigen
(HBsAg), were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-329-4.
CODE Unit #03K11304.
MANUFACTURER The American National Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone December 4, 1993. Firm-initiated
recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit.
REASON Blood product, labeled with the incorrect expiration date,
was distributed.

_______________
PRODUCT Recovered Plasma. Recall #B-336-4.
CODE Unit #03K01387.
MANUFACTURER American Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by letter January 14, 1993. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Recovered Plasma, corresponding to a unit of Red Blood Cells
contaminated with Alpha Streptococcus, was distributed.

_______________
PRODUCT Cryoprecipitated AHF. Recall #B-337-4.
CODE Unit numbers: 11K64979, 11K65346, 11F86180.
MANUFACTURER The American National Red Cross, St. Louis, Missouri.
RECALLED BY Manufacturer, telephone December 2, 1992, followed by letter
January 4, 1993. Firm-initiated recall complete.
DISTRIBUTION Missouri.
QUANTITY 3 units.
REASON Blood product, which was exposed to unacceptable storage
temperatures and allowed to thaw, was distributed.

_______________
PRODUCT Recovered Plasma. Recall #B-340-4.
CODE Unit #03FT11965.
MANUFACTURER The American National Red Cross, Atlanta, Georgia.
RECALLED BY Manufacturer, by letter March 3, 1994. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product collected from a donor who reported a history
of cancer was distributed.

-8-
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Glucose Test Strips for use with Glucometer 3, for in-vitro
(external) diagnostic use, under the following labels:
Family Pharmacy, Health Mart, Full Value, Good Neighbor
Pharmacy, Valu Rite, Relief Plus, Quick Check 3, Perry
Healthcare, and Longs. Recall #Z-930-4.
CODE Lot Numbers: 30152, 30173, 30187, 30190B, 30193, 30216,
30228, 30238, 30242, 30244, 30251A, 30251B, 30259, 30263,
30264, 30266, 30270, 30272, 30276, 30278, 30280, 30284,
30285, 30293, 30294, 30300, 30301A, 30301B, 30303, 30310,
30313, 30314, 30319, 30320, 30324, 30333, 30336, and 30356;
MANUFACTURER Diagnostic Solutions, Inc., Irvine, California.
RECALLED BY Manufacturer, by letter April 4, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 37,458 bottles were distributed from 7/7/93 to 1/14/94.
REASON The product does not meet its labeling claims. The device
also gives results which are significantly higher than those
obtained by the reference method.

_______________
PRODUCT Radiofocus Introducer B Kit, intended to be inserted
percutaneously into a vein or artery to facilitate the
insertion of angiographic, electrode, balloon or similar
catheters. Recall #Z-962-4.
CODE 8893I20A, 8893I20, 8893I23, 8893I25, 8893I25A.
MANUFACTURER Terumo Corporation, Toyko, Japan.
RECALLED BY Terumo Medical Corporation, Elkton, Maryland, by letters
sent March 11, 1994, and April 6, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Massachusetts, Canada.
QUANTITY 16,600 kits were distributed.
REASON The hemostasis valve within the introducer device may leak,
depending upon the orientation (positioning) of the valve.

_______________
PRODUCT Model 3000LE Ophthalmic Laser System, for use in ophthalmic
surgery - posterior capsulotomies. Recall #Z-966-4.
CODE Model 3000LE.
MANUFACTURER Alcon Surgical Inc., Irvine, California.
RECALLED BY Manufacturer. FDA approved the firm's corrective action
plan May 20, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 56 units.
REASON Joystick aiming control was poorly seated causing internal
electrical wires to become prematurely worn and broken.

-9-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Simmons Plating System Locking Nut, Catalog #SP-1003, non-
sterile, intended for sterilization by hospital, used in
lumbar spinal fusions. Recall #Z-940-4.
CODE All lots.
MANUFACTURER Smith & Nephew Richards, Inc., Memphis, Tennessee.
RECALLED BY Manufacturer, by voice mail message March 2, 1994, followed
by letter March 8, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 20,534 locking nuts were distributed from October 1990 until
January 1994.
REASON The nuts were manufactured from a type of 300 stainless
steel other than type 316LVM (ASTM F138).

_______________
PRODUCT Automated Chemiluminiscene System (ACS):Cuvette Part
#672002, used with the ACS:180. A cuvette is a tall plastic
container which carries a patient sample and to which test
reagents are dispensed where a test reaction takes place.
Recall #Z-943-4.
CODE Lot numbers D01600 - D02175.
MANUFACTURER Carrera Corporation, Export, Pennsylvania.
RECALLED BY Ciba Corning Diagnostics Corporation, Norwood,
Massachusetts, by letter March 28, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON The ASC:180 system had a track jam caused by a deformity in
the neck of the cuvette.

_______________
PRODUCT Automated Chemiluminiscene System (ACS) Multicalibrator A
Lot CA27 and CA31 the Low and High Calibrators contained in
the ACS Calibrator A are for calibrating the ACS
immunoassays: (a) Part #672170000;
(b) Part #672180000. Recall #Z-944/945-4.
CODE Lot numbers CA27 and CA31, EXP 27 Jul 94 packaged in ACS
Multicalibrator kit lot numbers:
(a) 22911, 22951, 23027, 23591, 23611, 23779, 23824;
(b) 22913, 22952, 23592, 23610, 23655.
MANUFACTURER Ciba Corning Diagnostics Corporation, East Walpole,
Massachusetts.
RECALLED BY Manufacturer, by telephone February 10, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 741 kits; (b) 249 kits were distributed.
REASON The theoretical concentrations of master curve standards
were incorrectly assigned by quality control. The values
were not obtained via referenced standard values used in
testing.

-10-_______________
PRODUCT Automated Chemiluminiscene System (ACS):180 SPT (System
Performance Tests) Reagent, Part #672196 SPT used to
evaluate the performance of the ACS:180 subassemblies at
installation, after repair procedures, and as a
troubleshooting aid. Recall #Z-946-4.
CODE Reagent Lot 2773 packaged in kit lot numbers 1506, 4005,
4007, 4308, 4309, 4310, 6006, 01113; Wash Solid Phase lot
LOP 2993 in kit lot numbers 14007, 16003, 16809; Reagent
Dispense Check lot LOL 0604 in kit lot #182302.
MANUFACTURER Ciba Corning Diagnostics Corporation, East Walpole,
Massachusetts.
RECALLED BY Manufacturer, by telephone April 14, 1993, and by recall
notice July 21, 1993. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 480 units of lot 2773, 270 units of lot 2993, and 42 units
of lot 0604.
REASON The lot of reagent 2773 was contaminated with lactobacillus
Coryniformis. The (SPT) reagents have degraded in their
performance specifications resulting in check problems in
the ACS operations.

_______________
PRODUCT Automated Chemiluminiscene System (ACS) T4 Master Curve Card
used with ACS T4/50 test and 300 test kits, intended for the
quantitative determination of Thyroxine (T4) in serum using
the ACS:180 system: (a) Catalog #672200; (b) Catalog
#672201. Recall #Z-947/948-4.
CODE Lot numbers: (a) 02003; (b) 02004.
MANUFACTURER Ciba Corning Diagnostics Corporation, East Walpole,
Massachusetts.
RECALLED BY Manufacturer, by telephone February 5, 1993, and by fax to
international account January 3, 1993. Firm-initiated
recall complete.
DISTRIBUTION New York, Michigan, Pennsylvania, Massachusetts, Ohio,
California, Rhode Island, Oklahoma, Japan.
QUANTITY (a) 350 kits; (b) 39 kits.
REASON The standard value printed on the master curve card was
incorrect.

_______________
PRODUCT Cell Culture Tube and Drams, Catalog #71-217 D, used for
isolation of virus in clinical specimens. Recall #Z-949-4.
CODE Lot numbers: 1C2818 (tubes), 1C2804 (drams).
MANUFACTURER Whittaker Bioproducts, Inc., Walkersville, Maryland.
RECALLED BY Manufacturer, by telephone October 18, 1991. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 670 units of lot 1C2804 and 3,755 units of 1C2818 were
distributed.
REASON Device was contaminated with IBR bovine herpes virus.

-11-_______________
PRODUCT EMEM Cell Culture Medium, in 100 ml bottles, used for the
growth and maintenance of cells in culture.
Recall #Z-952-4.
CODE Catalog #12-125A, Lot 1M0865.
MANUFACTURER Whittaker Bioproducts, Inc., Walkersville, Maryland.
RECALLED BY Manufacturer, by telephone on or about October 9, 1992.
Firm-initiated recall complete.
DISTRIBUTION Nationwide, Germany, Spain, France, Japan.
QUANTITY 1,226 units were distributed.
REASON The device had a pH of 7.6 which is higher that the firm's
established specification of 6.7 to 7.3.

_______________
PRODUCT Rubecap-M Test Kit, an enzyme-linked antibody capture assay
for Rubella Virus IgM antibody in human serum.
Recall #Z-953-4.
CODE Catalog #31-002U, lot 1E2241.
MANUFACTURER Mercia Diagnostics supplies the kit format and Whittaker
Bioproducts labels and packages the kits.
RECALLED BY Whittaker Bioproducts, Inc., Walkersville, Maryland, by
telephone October 31, 1991, followed by letter November 30,
1991. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Austria, Germany, France, England, Italy.
QUANTITY 70 kits were distributed.
REASON Device had a pH of 7.6 which is higher than the firm's
established specification of 6.7 to 7.3. The control ranges
for positive and negative controls included in the kit are
incorrectly stated on the component label.

_______________
PRODUCT QuinEvac IIa Smoke Evacuator, Model #SE-11111-E, used in
hospital operating rooms where there is a large volume of
smoke plume generated during laser surgery or electrosurgery
products. Recall #Z-967-4.
CODE Serial numbers: 155300, 155302, 155309-18.
MANUFACTURER Linemaster Switch Corporation, Woodstock, Connecticut.
RECALLED BY Recto Molded Products, Inc., (doing business as Quinn
Healthcare Products), Cincinnati, Ohio, by telephone and fax
March 29, 1993. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 20 units.
REASON The footswitch may stick in the open or closed position.

_______________
PRODUCT Triage brand Drugs of Abuse in-Vitro Diagnostic Test Kits, a
urine test for screening seven classes of drugs: (a) Catalog
#95000 (25 determinations); (b) 95004 (10 determinations).
Recall #Z-970/971-4.
CODE Lot numbers: (a) W4095 through W4377 EXP 11/29/94 through
2/5/95; (b) W4467 through W4598 EXP 2/15/95 through 3/28/95.
MANUFACTURER Biosite Diagnostics, Inc., San Diego, California.

-12-RECALLED BY Manufacturer, by letter April 22, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, Canada, Japan, Singapore, China, Malaysia.
QUANTITY (a) 11,462 kits; (b) 387 kits were distributed between
December 1993 and April 1994.
REASON The test results may indicate false positive for the THC
(marijuana) portion of the panel. The performance of the
THC assay in the Triage Panel degrades at a faster rate than
indicated by the expiration date on the product labeling.

MEDICAL DEVICE SAFETY ALERTS:
============================================
_______________
PRODUCT Kangaroo Enteral Feeding Pumps Model 224, Reorder #8884-
322408, and Model 324, Reorder #8884-322407.
Safety Alert #N-050/051-4.
CODE All serial numbers.
MANUFACTURER Sherwood Medical Watertown, New York.
ALERTED BY Sherwood Medical Company, St. Louis, Missouri, by letter
February 10, 1994.
DISTRIBUTION Nationwide and international.
QUANTITY 35,048 Model 224 pumps and 71,588 Model 324 pumps since
1988.
REASON Arcing may occur between electrical components leading to
electrical fires.

-13-

END OF ENFORCEMENT REPORT FOR JUNE 22, 1994. BLANK PAGES MAY FOLLOW.
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