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.

June 11, 1997 97-24

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============

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PRODUCT Pasteurized, Homogenized Frozen Egg Product.
Recall #F-446-7.
CODE 101-7.
MANUFACTURER Willamette Egg Farms, Inc., Canby, Oregon.
RECALLED BY Manufacturer, by telephone April 22-23, 1997.
Firm-initiated recall complete.
DISTRIBUTION California and Idaho.
QUANTITY Firm estimates none remains on the market.
REASON Product is contaminated with salmonella.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ===========
_______________
PRODUCT Apricot Spreadable Fruit in 10 ounce (248g)
glass bottles. Recall #F-447-7.
CODE Date code or lot number printed on side of the
cap read in part"***JUN 19, 1998***".
MANUFACTURER Allied Old English Inc., Port Reading, New
Jersey.
RECALLED BY Trader Joe's Company, S. Pasadena, California,
by letter on March 3, 1997. Firm-initiated
recall complete.
DISTRIBUTION California, Arizona, Nevada, New York,
Connecticut, Massachusetts.
QUANTITY 807 cases (36 jars per case) were distributed.
REASON Product contained undeclared sulfites.

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PRODUCT Kraft "Off the Block" random weight cheeses:
a) Swiss Cheese
b) Extra Sharp Cheddar Cheese
c) Sharp Cheddar Cheese
d) Medium Cheddar Cheese
e) Mild Cheddar Cheese
f) Monterey Jack Cheese
g) Low-Moisture Part-Skim Mozzarella Cheese
h) Longhorn Style Colby Cheese
I) Longhorn Style Mild Cheddar Cheese
j) Longhorn Style Colby Monterey Jack Cheeses
Recall #F-448/457-7.
CODE All sizes and varieties with Sell By codes
prior to and including 10-11-97 and "E1" to
the left of the bar code.
MANUFACTURER Central Valley Dairy Products, Tulare,
California.
RECALLED BY Kraft Foods, Inc., Northfield, Illinois, by
memorandum dated April 18, 1997. Completed
recall resulted from sample analysis and
followup by the California State Department of
Weights and Measures.
DISTRIBUTION California, Montana, Utah, Idaho, Washington
state, Oregon, Nevada, Hawaii.
QUANTITY Approximately 880,000 pounds was distributed;
firm estimated that 30% remained on market at
time of recall initiation.
REASON The products are short weight.

RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II ========
_______________
PRODUCT Basis Face the Day Lotion, in 4 fluid ounce
(118 ml) plastic bottles. Recall #F-445-7.
CODE UPC: 72140 85737, Batch #6340R1 EXP 12/98.
MANUFACTURER Beiersdorf, Inc., Norwalk, Connecticut.
RECALLED BY Manufacturer, by letter on March 31, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Arkansas, Ohio.
QUANTITY 289 cases (3,648 pieces) were distributed.
REASON Product is adulterated due to the presence of
Pseudomonas aeruginosa.

-2-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
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PRODUCT Platelets. Recall #B-860-7.
CODE Unit #42KJ14461.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated May 22, 1996.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a whole blood
unit with an extended collection time.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-863/864-7.
CODE Unit #15033-9913.
MANUFACTURER United Blood Services, Lubbock, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated March 19, 1997. Firm-initiated
recall complete.
DISTRIBUTION Texas and North Carolina.
QUANTITY 1 unit of each component was distributed.
REASON Blood products 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
negative.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-869/871-7.
CODE Unit #28026-8571.
MANUFACTURER United Blood Services, San Angelo, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letters dated February 18, 1997, and May 2,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Texas and North Carolina.
QUANTITY 1 unit of each component was distributed.
REASON Blood products 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
negative.

_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c)
Recovered Plasma. Recall #B-872/874-7.
CODE Unit numbers: a) 12057-9116, 11034-1955; (b)
12057-9116; c) 11034-1955.
-3-MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letters dated February 24, 1997, and April 28,
1997. Firm-initiated recall complete.
DISTRIBUTION Texas, New Mexico, Switzerland.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit was
distributed.
REASON Blood products were collected from a donor who
had been deferred for a history of liver
disease or hepatitis.

_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Plasma.
Recall #B-886/888-7.
CODE Unit #2642763.
MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone and letter on July
18, 1996. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
reported high risk behavior.

_______________
PRODUCT Red Blood Cells. Recall #B-892-7.
CODE Unit #42X80670, 42FX32157, 42L41058.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated March 11, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 3 units were distributed.
REASON Blood products were collected from a donor
taking the drug Zovirax.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT Red Blood Cells. Recall #B-865-7.
CODE Unit #29444-3665.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on April 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was stored at room temperature
for an unacceptable length of time.

-4-_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered
Plasma. Recall #B-866/868-7.
CODE Unit #11031-5584.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letters dated February 24, 1997, and April 28,
1997. Firm-initiated recall complete.
DISTRIBUTION Texas and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products 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
negative.

_______________
PRODUCT Platelets and Recovered Plasma.
Recall #B-890/891-7.
CODE Unit #42FY82786.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio
RECALLED BY Manufacturer, by letter dated April 1, 1997
and March 24, 1997. Firm-initiated recall
complete.
DISTRIBUTION Ohio and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products corresponded to a unit of Red
Blood Cells which was positive for
Propionibacterium sp.

_______________
PRODUCT Fresh Frozen Plasma, Pheresis.
Recall #B-893-7.
CODE Unit #81-09684.
MANUFACTURER Michigan Community Blood Center, Traverse
City, Michigan.
RECALLED BY Manufacturer, by telephone on January 29,
1997. Firm-initiated recall complete.
DISTRIBUTION Connecticut.
QUANTITY 1 unit was distributed.
REASON Blood product was not frozen within eight
hours of collection .

RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II ==========
_______________
PRODUCT Diagnostic X-Ray System - SuperStand, for
general purpose radiography:

-5- a) Model No. WWT0100 XRT Table;
b) Model No. WWT0101 XRT Table;
c) Model No. WWT0200 XRT Table;
d) Model No. WWT0201 XRT Table;
e) Model No. WWT0300 XRT Table.
Recall #Z-634/638-7.
CODE None.
MANUFACTURER Wuestec Medical, Inc., Mobile, Alabama.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan on June 2, 1997. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON The diagnostic x-ray devices were found
noncompliant with 21 CFR 1020.30(n) of the
Federal Performance Standard for Diagnostic
X-Ray System and Their Major Components.

_______________
PRODUCT Stryker Instruments brand 1.1 mm drill bits,
used during surgical procedures to drill
bones:
a) Short Part #5110-100-10; b) Medium Part
#5120-100-10. Recall #Z-640/641-7.
CODE Lot #97032115.
MANUFACTURER Stryker Instruments, Division of Stryker
Corporation, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter on April 30, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma and Pennsylvania.
QUANTITY 11 drill bits were distributed.
REASON The drill bits may break during use at maximum
speed, resulting in injury to the patient or
user.

_______________
UPDATE Recall #Z-565-7, ADAC Laboratories Pinnacle
Radiation Therapy Planning Software Version
2.1f which appeared in the May 28, 1997
Enforcement is a Class II Recall. The REASON
should read: The wedge scatter fields will be
calculated incorrectly if the wedge filter is
not square. A monitor unit miscalculation of
up to 12.25% is possible.

-6-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III =========
_______________
PRODUCT ACTtrac-100 Electronic Control Device, Model
#313-35, instrument verification cartridge
used to provide a separate means for quality
control of the instruments in the clinical
testing environment. Recall #Z-643-7.
CODE Lot #9704001300.
MANUFACTURER Medtronic Blood Management, Parker, Colorado.
RECALLED BY Manufacturer, by telephone on May 15, 1997,
followed by letter on May 16, 1997. Firm-initiated recall ongoing.
DISTRIBUTION California, Florida, Missouri, Oklahoma,
Pennsylvania, Washington state.
QUANTITY 8 units were distributed.
REASON The device overlay incorrectly labels this
device as "ACTtrac-10 with ACTtrac-10 time
ranges instead of "ACTtrac-100" with
ACTtrac-100 time ranges.

SEIZURES: ===================================================
_______________
PRODUCT Bread Crumbs, Rice, Dry Pasta, Dehydrated
Potatoes (97-722-306).
CHARGE Adulterated -- Rodents.
LOCATION Merchants White Line Warehousing, Inc., Des
Moines, Iowa.
FILED April 28, 1997 ; U.S. District Court for the
Southern District of Iowa, Central Division;
Civil #4-97-CV-80301, FDC #67183.
SEIZED May 20, 1997 - goods valued at approximately
$29,367.

_______________
PRODUCT Glow in the Dark Cream Makeup (96-753-347)
CHARGE Adulterated -- Product contains unapproved
color additive.
LOCATION Zauder Brothers, Inc., Freeport, New York.
FILED April 2, 1997 - U.S. District Court for the
Eastern District of New York; Civil #CV 97-1596; FDC # 67169.
SEIZED April 21, 1997 - goods valued at approximately
$4,000.

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END OF ENFORCEMENT REPORT FOR JUNE 11, 1997. BLANK PAGES MAY FOLLOW

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