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 contain
s
information
on actions taken in connection with agency regulatory activities.
ENFORCE
08/14/1996
ENFORCEMENT REPORT FOR 08/14/96
August 14, 1996 96-33
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Vlasic Sweet Relish, in 10 fluid ounce glass
jars. Recall #F-641-6.
CODE Lot numbers: Jun 97 6T5 printed on side edge
of cap, Lot #Jun 97 6T5 VC3 ---- (followed by
hour code; Packing flat coded 20JUN97C.
MANUFACTURER Vlasic Foods, Inc., Imlay City, Michigan.
RECALLED BY Vlasic Foods, Inc., a subsidiary of Campbell
Soup, Inc., Camden, New Jersey, by letter and
telephone on April 12, 1996. Firm-initiated
recall complete.
DISTRIBUTION Illinois, Indiana, Kentucky, Michigan,
Mississippi, New York, Ohio, Pennsylvania,
Tennessee, Texas, Virginia.
QUANTITY 1,728 cases (12 jars per case) were
distributed; firm estimated that less than 100
cases remained on market at time of recall
initiation.
REASON Product is adulterated due to the presence of
glass pieces.
_______________
PRODUCT Baladna Lupini Beans, in 8 ounce, 16 ounce and
1 quart Ball Mason glass jars, distributed by
Eden International. Recall #F-643-6.
CODE None. All Baladna labeled product, all sizes.
Labels were preprinted with "Expiry Date:
12/1996."
MANUFACTURER R.B. Gourmet Products, Inc., Blue Island,
Illinois.
RECALLED BY Eden International, Inc., Blue Island,
Illinois, by telephone after May 23, 1996, and
by letter sent on May 28, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Illinois, Michigan, Minnesota, Missouri, New
Jersey, New York, Ohio, Oklahoma,
Pennsylvania, Tennessee, Virginia, Colombia.
QUANTITY 85 cases were distributed.
REASON The Baladna Lupini Beans were prepared, packed
or held under conditions whereby it may have
been rendered injurious to health because FDA
analysis of the product indicates that the pH,
salt content, water activity, and processing
method of the product is insufficient to
protect the public health. Additionally, the
product is unfit for food because the food is
contained in swollen containers.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Pepsi-Cola in 2 liter bottles and 12 ounce
cans. Recall #F-640-6.
CODE 2 liter bottles - expiration date "APR 15 96"
- product lot code range from 06:00HJ01156
through 06:00HJ01226 / 12 ounce cans -
expiration date "OCT 21 96" product lot codes
range from 23:00HJ01186 through 11:00HJ1196.
MANUFACTURER Pepsi Cola and National Brand Beverages Ltd.,
Pennsauken, New Jersey.
RECALLED BY Manufacturer, by telephone on January 27,
1996, followed by visit, by press release on
January 26, 1996, and by letter dated February
2, 1996. Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY Approximately 25,100 cases (8 2-liter bottles
per case) and 2,500 cases (24 12-ounce cans
per case) were distributed.
REASON The product has an off-odor and taste.
_______________
PRODUCT Welch's Sparkling Grape Soda, in 2 liter clear
plastic bottles with white cap.
Recall #F-642-6.
CODE Date of production "019-6" - product lot code
"HJ01196".
MANUFACTURER Pepsi Cola and National Brand Beverages Ltd.,
Pennsauken, New Jersey.
-2- RECALLED BY Canada Dry Delaware Valley Bottling Company,
Pennsauken, New Jersey, by visit on February
1-2, 1996. Firm-initiated recall complete.
DISTRIBUTION New Jersey, Pennsylvania, Delaware.
QUANTITY Approximately 2,426 cases (8 2-liter bottles
per case) were distributed.
REASON The product has an off-odor and taste.
_______________
PRODUCT Various canned food products put up in 8 oz.,
16 oz. and 1 qt. Ball Mason glass jars, 12
jars per case (Note: the pickled turnips were
also shipped in 18 lb. pails):
(a) Baladna Hot Vegetable Mix
(b) Baladna Pickled Hot Peppers & Carrots
(c) Baladna Eggplant (Stuffed) [also known as
Magdoose]
(d) Baladna Pickled Turnips
(e) Baladna Pickled Beets
(f) Baladna Shatta (crushed peppers)
(g) Baladna Lebni
(h) Baladna Lebni with Shatta
(i) Baladna Lebni with Mint
(j) Baladna Pure Butter. Recall #F-644/653-6.
CODE All Baladna labeled product, all sizes. There
are no lot numbers on the jars. The labels
were preprinted with "Expiry Date: 12/1996".
MANUFACTURER R.B. Gourmet Products, Inc., Blue Island,
Illinois.
RECALLED BY Eden International, Blue Island, Illinois
(distributor), by telephone after may 23, 1996
followed by letter dated May 28, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Illinois, Michigan, Minnesota, Missouri, New
Jersey, Pennsylvania, Tennessee, Virginia, New
York, Ohio, Oklahoma, Colombia.
QUANTITY 170 cases of Hot Vegetables Mixed, 82 cases of
Lebni, 1 case of Lebni with Shatta, 113 cases
of Eggplant (Magdoose), 167 cases and 94 pails
of Pickled Turnips, 36 cases of Shatta, and 20
cases of Pure Butter were distributed between
October, 1995 and May, 1996, with the firm
estimating that very little remains on the
market. An unknown small amount of Pickled
Hot Peppers & Carrots, Lebni with Mint and
Pickled Beets were distributed and the firm
believes none to remain on the market.
-3- REASON Products (a) (b) (c) (d) (e) and (f) are
acidified foods that were manufactured under
no manufacturing controls or scheduled
processes. In addition, products (a) (b) and
(d) were found to be unfit for food because
these foods were contained in swollen
containers. Products (g) (h) (i) and (j) are
misbranded in that they fail to bear
nutritional labeling and the firm has not
filed for an exemption. In addition, the
butter product is labeled "Pure Butter" when
it in fact has added spices and preservatives.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma; (d) Recovered Plasma.
Recall #B-578/581-6.
CODE Unit numbers: 962051, 974308, 984120; (b)
962051; (c) 962051; (d) 984120.
MANUFACTURER Central Kentucky Blood Center, Lexington,
Kentucky.
RECALLED BY Manufacturer, by letters dated April 26, 1995.
Firm-initiated recall complete.
DISTRIBUTION Kentucky, Massachusetts, Maryland.
QUANTITY (a) 3 units; (b) 1 unit; (c) 1 unit; (d) 1
unit.
REASON Blood products were collected from a donor
with a history of jaundice.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-582/583-6.
CODE Unit #40GL08359.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letter dated April 19, 1996.
Firm-initiated recall complete.
DISTRIBUTION Illinois, California.
QUANTITY 1 unit of each component.
REASON Blood products, tested repeatedly reactive for
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), and were subjected to
additional retesting, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-591/592-6.
CODE Unit #FY58361.
MANUFACTURER INOVA Health Systems, Annandale, Virginia.
-4- RECALLED BY Manufacturer, by letter dated June 17, 1996.
Firm-initiated recall complete.
DISTRIBUTION Virginia, New Jersey.
QUANTITY 1 unit of each component.
REASON Blood products, from a donor who had an
accidental needlestick within the previous 12
months, were distributed.
_______________
UPDATE Recall numbers B-467-6 Red Blood Cells; B-468-
6 Recovered Plasma; B-470-6 Red Blood Cells;
B-471-6 Platelets, Expired; B-472-6 Recovered
Plasma; B-495-6 Red Blood Cells; B-496-6
Platelets; B-497-6 Platelets, Expired; and B-
498-6 Recovered Plasma, which appeared in the
July 10, 1996 Enforcement Report were
manufactured and recalled by Permian Basin
Regional Blood Center, Midland, Texas, and NOT
by Permian Basin Blood Institute.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT 3/8" Proximal Barb T-Connector, Part #20688
found in the following Fem-Flex Femoral
Arterial Cannulae. Catalog numbers:
TF-A-020-25, TF-A-022-25, TF-A-024-25,
TF-A-024-25-H, FEM II-016-A, FEM II-018-A, FEM
II-020-A, DII-FEM II-020-A, ARL-2011-90TA,
ARL-2211-90TA, ARL-2411-90TA, AL-2011-90TA,
AL-2211-90TA, AL-2411-90TA, ARL-2011-STA,
ARL-2211-STA, ARL-2411-STA, AA-020-TFTA,
AA-022-TFTA, AA-024-TFTA, ARS-020-CSTA,
ARS-022-CSTA, ARS-024-CSTA, DII-AL-2211-90TA,
SPC1023-24, SPC1037 SPC2008-24, SPC2067-22,
SPC2086-22, SPC2099, SPC653, SPC675,
SPC732-22, SPC732-24, SPC946, SPC2145, FEM
II-1618 KIT, FEM II-1820 KIT, FEM II-2020 KIT,
FEM II-2024 KIT, FEM II-2028 KIT, KIT-036.
Devices are used to provide access for surgeon
during cardiopulmonary procedures.
Recall #Z-988-6.
CODE All products contain part #20688, 3/8"
Proximal Barb T-Connector, Lot #9509152.
MANUFACTURER Research Medical, Inc., Midvale, Utah.
RECALLED BY Manufacturer, by fax on July 3-5, 1996, and by
letter on July 8, 1996. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 19,428 units were distributed.
REASON The t-connectors are leaking and cracking.
-5- _______________
PRODUCT Prolog Cardiac Pulse Generator, Model 688,
indicated for sensing/pacing in the ventricle
and atrium. Recall #Z-1004-6.
CODE Serial numbers: 628884967, 628887028,
638805002, 68805010.
MANUFACTURER Pacesetter, AB (formerly Siemens-Elema),
Solna, Sweden.
RECALLED BY Pacesetter, Inc., Sylmar, California, by
letter on June 21, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION California, Pennsylvania, New York.
QUANTITY 4 units were distributed.
REASON The pacemaker may exhibit a sudden loss of
output due to a corrosion bridge that forms
across the feedthrough inside the
battery.
_______________
PRODUCT DMS-250 Dual Monitor Chemical Indicator Strip,
for use in steam or EO gas sterilization.
Recall #Z-1013-6.
CODE Lot numbers: 9402 and 9403.
MANUFACTURER SPS Medical Supply Corporation, Rush, New York
(device); Tempil Division, Air Liquide America
Corporation, South Plainfield, New Jersey
(ink).
RECALLED BY SPS Medical Supply Corporation, Rush, New
York, by telephone on or about April 29, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 380 cases of lot 9403 and 96 cases of lot 9402
were distributed.
REASON The indicator turns yellow (instead of orange)
when processed in EO gas.
_______________
PRODUCT Ni-Med Suction Catheter Kits:
(a) 6 Fr., Catalog #19-6000
(b) 6 Fr., Catalog #SAM02019605-19C
(c) 8 Fr., Catalog #19-8000
(d) 8 Fr., Catalog #SAM02019604-19C
(e) 10 Fr., Catalog #19-1000
(f) 14 Fr., Catalog #19-1400.
Recall #Z-1014/1019-6.
CODES Lot #168-V, Exp. 3/98, Lot #273-C, Exp. 12/97
Lot #218-C, Exp. 5/97, Lot #278-C, Exp. 1/98
Lot #258-C, Exp. 10/97, Lot #279-C, Exp. 1/98
Lot #259-C, Exp. 10/97, Lot #285-C, Exp. 1/98
Lot #260-C, Exp. 10/97, Lot #297-C, Exp. 3/98
Lot #266-C, Exp. 11/97, Lot #299-C, Exp. 3/98
Lot #272-C, Exp. 12/97.
-6- MANUFACTURER Ni-Med, Inc., Park Hills, Missouri.
RECALLED BY Manufacturer, by telephone on April 8, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Missouri, Illinois.
QUANTITY The following amounts were distributed:
6 Fr. - 8,600 units distributed, 1,811 units
recovered
8 Fr. - 39,800 units distributed, 15,325 units
recovered
10 Fr. - 10,900 units distributed, 2,708 units
recovered
14 Fr. - 2,250 units distributed, 544 units
recovered.
REASON Products were marketed without an approved
510(k).
_______________
PRODUCT Percutaneous Stoma Measuring Device (PSMD)
Tray, used to measure the stoma or opening
created for direct patient feeding.
Recall #Z-1020-6.
CODE All codes manufactured since 1993.
MANUFACTURER Plastofilm Industries, Inc., Wheaton,
Illinois.
RECALLED BY Applied Medical Technology, Independence,
Ohio, by letters dated June 27, 1996 and July
1, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Massachusetts, Wisconsin, Japan, France,
Israel, England, Portugal, Sweden, Belgium.
QUANTITY 6,200 kits were distributed; firm estimated
that approximately 4,199 kits may still have
been in use at time of recall initiation.
REASON A rough spot or burr in the PSMD tray could
potentially cause a hole in the tray, thus
compromising the sterility of the device.
_______________
PRODUCT Manuals for VAX-D Therapeutic Table.
Recall #Z-1021-6.
CODE All tables from US sales (sales started 1991
to 4/96) are included in the recall. The
VAX-D Therapeutic Tables consist of a table
and console unit. Each console and table have
a unique serial number.
MANUFACTURER VAT-TECH Inc., Palm Harbor, Florida.
RECALLED BY Manufacturer, by letter mailed beginning on
May 15, 1996. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
-7- REASON The firm marketed the device without an
approved 510(k) for the new intended use of
decompression of the intervertebral disc
identified in the device users manual.
_______________
UPDATE Graham Field White Finger Cots,
Recall #Z-1006/1009-6 which appeared in the
August 7, 1996 Enforcement Report listed an
incorrect catalog number for item (b). The
correct number is 88-3910L.
MEDICAL DEVICE SAFETY ALERTS: ==============================
_______________
PRODUCT Monoplace Hyperbaric System, Model 2500B, used
for hyperbaric oxygen therapy to treat
ailments caused by insufficient oxygen supply.
Safety Alert #N-024-6.
CODE 2500B-002 through 2500B-663.
MANUFACTURER Sechrist Industries, Inc., Anaheim,
California.
ALERTED BY Manufacturer, by letters of February 22 and
26, 1996.
DISTRIBUTION Nationwide and international.
QUANTITY 662 chambers were distributed.
REASON Failure to follow labeled safety procedures
resulted in an explosion with fatalities.
Letters urged users to review the safety and
emergency procedures outlined in the
operations manual.
-8-
END OF ENFORCEMENT REPORT FOR AUGUST 14, 1996. BLANK PAGES MAY FOLLOW.
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