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
07/12/1995
ENFORCEMENT REPORT FOR 07 12 95
July 12, 1995 95-28
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
==========================
_______________
PRODUCT Yoder's brand Regular Style Potato Salad, in 2 pound
containers. Recall #F-686-5.
CODE MAY 31A.
MANUFACTURER I & K Distributors, Inc., Delphos, Ohio.
RECALLED BY Manufacturer, by visit between May 17 and 19, 1995, followed
by press release May 19, 1995. Firm-initiated recall
complete.
DISTRIBUTION Ohio.
QUANTITY 1,922 containers were distributed.
REASON Product is contaminated with Listeria monocytogenes.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
_______________
PRODUCT Imitation Low-Moisture Part-Skim Mozzarella Cheese,
shredded, in 8 ounce packages. Recall #F-672-5.
CODE Sell by JUL 04-95 0
MANUFACTURER Great Lakes Cheese of Wisconsin, Inc., Plymouth, Wisconsin.
RECALLED BY Manufacturer, by telephone May 5, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Florida.
QUANTITY 603 cases (12 packages per case) were distributed.
REASON The "imitation" low moisture part skim mozzarella cheese is
actually "real" low moisture part skim mozzarella cheese.
_______________
PRODUCT Chocolate Pineapple Wedges and Chocolate apricot jellies:
(a) Milk Chocolate Pineapple Wedges; (b) Dark Chocolate
Pineapple Wedges; (c) Milk Chocolate Apricot Jellies; (d)
Dark Chocolate Apricot Jellies, in 6 pound or 12 pound bulk
cases. Recall #F-673/676-5.
CODE None.
MANUFACTURER Philadelphia Candies, Inc., Sharon, Pennsylvania.
RECALLED BY Manufacturer, by letter June 1, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Pennsylvania, Ohio, New Hampshire, Georgia, Michigan, New
York, Vermont.
QUANTITY Undetermined.
REASON Product contains undeclared FD&C Yellow No. 5.
_______________
PRODUCT Marzipan Candy, in 6 pound or 12 pound bulk cases with no
ingredient statement. Recall #F-678-5.
CODE None.
MANUFACTURER Philadelphia Candies, Inc., Sharon, Pennsylvania.
RECALLED BY Manufacturer, by letter June 1, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Pennsylvania, Ohio, New Hampshire, Georgia, Michigan, New
York, Vermont.
QUANTITY Undetermined.
REASON Product contains undeclared almonds.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Sundae Cones: (a) Country Delight Sundae Cones, 18 fluid
ounces, 6 cones; (b) Just Say "Nuts" Sundae Cones, 18 fluid
ounces, 6 cones; (c) Sundae Cones, 24 pack, 24 cones per
box. Recall #F-656/658-5.
CODE Lot numbers: 1005, 1075, 1155 (6-pack); 0905, 1005, 1075,
1085, 1155 (24-pack).
MANUFACTURER Schoep's Ice Cream Company, Inc., Madison, Wisconsin.
RECALLED BY Manufacturer, by telephone April 26, 1995, followed by
letter April 28, 1995. Firm-initiated recall complete.
DISTRIBUTION Illinois, Michigan, Minnesota, Wisconsin.
QUANTITY 3,048 packs of 6 cones per pack and 3,403 packs of 24 cones
per pack were distributed.
REASON Product contains peanuts that are contaminated with glass.
_______________
PRODUCT (a) Custom Cuts Specialty LCR Salad Mix, in 10 pound plastic
bags; (b) Custom Cuts Matchstick Carrots, in 5 pound plastic
bags; (c) Beckman's Garden To Go American Stir Fry in 12
ounce bags. Recall #F-668/670-5.
CODE (a&b) Use by 5/23, 5/24, 5/25, 5/26; (c) All lots.
MANUFACTURER Beckman's Produce, Inc., St. Paul, Minnesota.
-2-
RECALLED BY Manufacturer, by telephone May 20, 1995. Firm-initiated
recall complete.
DISTRIBUTION Minnesota, North Dakota, Wisconsin.
QUANTITY (a) 317 cases (2 bags per case); (b) 14 cases (4 bags per
case); (c) 120 packages were distributed; firm estimates
none remains on the market.
REASON Product was contaminated with metal pieces.
_______________
PRODUCT Lieber's Dark Chocolate Raspberry Jell Bars, in 6 ounce
boxes containing 10 individual chocolate squares.
Recall #F-677-5.
CODE None.
MANUFACTURER Barton's, Altoona, Pennsylvania.
RECALLED BY Lieber's Chocolate & Food Products, Inc., doing business as
Lieber's Kosher Food Specialties, Inc., Brooklyn, New York,
by telephone during the week of May 9-13, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION New York, New Jersey, California, Michigan.
QUANTITY Approximately 230 cases were distributed.
REASON Product is adulterated due to mold.
_______________
PRODUCT Green Giant Spinach and Pasta Accents Florentine: (a)
Harvest Fresh Spinach, in 9 ounce boxes; (b) Cut Leaf
Spinach in Butter Sauce, in 10 ounce boxes; (c) Cut Leaf
Spinach, in 1 pound plastic bags; (d) Pasta Accents
Florentine, Pasta, Carrots, Spinach in a Three Cheese Sauce,
in 1 pound plastic bags. Recall #F-679/682-5.
CODE Lot numbers: (a) K4M07, K4M08; (b) J4M31, K4M01 through
K4M04; (c) A5P21 through A5P24, B5S12, C5S01, C5S07, C5S21,
C5S24, C5S27, D5S03, E5S04; (d) B5S10, B5S13, B5S16, B5S22
through B5S24, C5S504, C5S10, C5S17, D5S07, D5S08, D5S12,
D5S13, D5S21.
MANUFACTURER Del Mar Food Products Corporation, Watsonville, California.
RECALLED BY The Pillsbury Company, Minneapolis, Minnesota, by electronic
mail June 6, 1995, followed by visit, and by press release
issued June 2 and 6, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Korea.
QUANTITY 259,021 cases of 9 and 10 ounce boxes of spinach (12 boxes
per case); 42,470 cases of 1 pound bags of spinach (12 bags
per case); 51,864 cases of pasta accents (12 bags per case).
REASON Product is adulterated due to insect and rodent filth.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Source Plasma. Recall #B-431-5.
CODE Unit numbers: PG04605, XG00277, XG00653, XG01148,
XG01468, XG01977, XG02770, XG03129, XG04272, XG05175,
XG05752, XG06035, XG06568, XG07090, XG07911, XG08488,
XG08759, XG09487, XG09746, XG24657, XG24738, XG24826,
-3-
XG25465, XG28633, XG29094, XG29319, XG29674, XG31304,
XG31442, XG31633, XG31846, XG31887, XG32115, XG32562,
XG32614, XG32808, XG33319, XG33464, XG33558, XG33980,
XG34110, XG34457, XG34517, XG34656, XG35125, XG35234,
XG35486, XG35723, XG36374, XG36438, XG36492, XG36912,
XG37455, XG37575, XG41357, XG41549, XG41861, XG43023,
XG44150, XG84634, XG84639, XG85481, XG85712, XG85834,
XG86067, XG86194, XG86539, XG86631, XG87015, XG95214,
XG95728, XG96117, XG96369, XG96736.
MANUFACTURER Community Bio-Resources, Inc., Columbus, Georgia.
RECALLED BY Manufacturer, by letter dated August 11, 1994. Firm-
initiated recall complete.
DISTRIBUTION Michigan and Austria.
QUANTITY 74 units.
REASON Blood products, which tested negative for the hepatitis B
surface antigen (HBsAg), but were collected from donors who
previously tested repeatedly reactive for HBsAg, were
distributed.
_______________
PRODUCT Source Plasma. Recall #B-432-5.
CODE Unit numbers: XG41873, XG42518, XG42626, XG43321, XG44398,
XG44825, XG45514.
MANUFACTURER Community Bio-Resources, Inc., Columbus, Georgia.
RECALLED BY Manufacturer, by letter dated August 11, 1994. Firm-
initiated recall complete.
DISTRIBUTION Austria.
QUANTITY 7 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, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-433/436-5.
CODE Unit numbers: (a) 1052513, 1066600, 1089363, 1092909,
1104627, 1114624; (b) 1066600, 1089363, 1092909, 1104627,
1114624; (c) 1052513, 1089363; (d) 1066600, 1092909,
1104627, 1114624.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, by letters dated May 12 and 13, 1994, and
February 1 and 16, 1995. Firm-initiated recall complete.
DISTRIBUTION Missouri, Kansas, Tennessee.
QUANTITY (a) 6 units; (b) 5 units; (c) 2 units; (d) 4 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, were distributed.
-4-
_______________
PRODUCT (a) Whole Blood CPDA-1; (b) Red Blood Cells; (c) Platelets;
(d) Recovered Plasma; (e) Platelets, For Further
Manufacture. Recall #B-437/441-5.
CODE Unit numbers: (a) 3039293; (b) 7508211, 7509933, 3050933,
7515501; (c) 7509933; (d) 7508211, 7509933, 3050933,
7515501; (e) 7515501.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, by letters dated May 12 and 13, 1994, February
1 and 16, 1995, and March 2, 1995. Firm-initiated recall
complete.
DISTRIBUTION Missouri, Arizona, Kansas, Tennessee, Massachusetts.
QUANTITY (a) 1 unit; (b) 4 units; (c) 1 unit; (d) 4 units; (e) 1
unit.
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, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF; (d) Recovered Plasma. Recall #B-442/445-5.
CODE Unit numbers: (a) 0057716, 0073084, 1075648, 0110105; (b)
0057716, 1075648, 0110105; (c) 0110105; (d) 0057716,
0073084, 1075648, 0110105.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, by letters dated May 12, 1994, February 1 and
16, 1995, and April 28, 1995. Firm-initiated recall
complete.
DISTRIBUTION Kansas, Missouri, Tennessee, California.
QUANTITY (a) 4 units; (b) 3 units; (c) 1 unit; (d) 4 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, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets For Further Manufacture;
(c) Recovered Plasma. Recall #B-448/450-5.
CODE Unit #2066924.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, by letters dated May 12 and 13, 1994, and
February 1 and 16, 1995. Firm-initiated recall complete.
DISTRIBUTION Kansas, Massachusetts, Tennessee.
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, were distributed.
-5-
_______________
PRODUCT (a) Whole Blood CPDA-1; (b) Red Blood Cells; (c) Red Blood
Cells - Leukocytes Removed; (d) Platelets; (e) Fresh Frozen
Plasma; (f) Cryoprecipitated AHF. Recall #B-451/456-5.
CODE Unit numbers: (a) 4511866; (b) 4506357, 4511782, 4512738,
4514302, 4514334, 4514429, 4514706, 4516070, 4516290,
4516339, 4520050, 4525028, 8035239; (c) 4511927, 4520640;
(d) 4506357, 4511782, 4511927, 4512738, 4514302, 4516070,
4516339, 4520762; (e) 4506357, 4511927, 4512738, 4514706,
4516339, 4520050, 4525028; (f) 4514334.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, either by telephone April 3 and 6, 1995, or by
letters dated April 6 and 24, 1995. Firm-initiated recall
complete.
DISTRIBUTION Texas, Illinois.
QUANTITY (a) 1 unit; (b) 13 units; (c) 2 units; (d) 8 units; (e) 7
units; (f) 1 unit.
REASON Blood products, which were improperly tested for the
antibody to the human T-lymphotropic virus type I (anti-
HTLV-I), were distributed.
_______________
PRODUCT: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Recovered Plasma. Recall #B-457/460-5.
CODE Unit numbers: (a) 7809603 and 7802079;
(b) 7809603 and 7802079; (c) 7802079; (d) 7809603.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by letter dated April 26, 1995. Firm-
initiated recall complete.
DISTRIBUTION Illinois, Switzerland.
QUANTITY (a) 2 units; (b) 2 units; (c) 1 unit; (d) 1 unit.
REASON Blood products, which were collected from a donor who had
sexual contact with an individual diagnosed with hepatitis
C, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
========================
_______________
PRODUCT Marquette 24V/1.6AH Rechargeable Nickel-Cadmium (NICAD)
Battery (pack), Part #409366-001, used with Responder Series
1500 Defibrillators and Responder Series 1200/1250
Defibrillators. Recall #Z-937-5.
CODE All lot numbers.
MANUFACTURER Energizer Power Systems, Division of Eveready Battery
Company, Gainesville, Florida (battery pack cells).
RECALLED BY Marquette Electronics, Inc., Milwaukee, Wisconsin, by letter
sent June 12, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 4,838 batteries were distributed; firm estimated that 2,000-
3,000 batteries were still in use at time of recall
initiation.
REASON Premature battery failure.
-6-
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT MeriTrans Disposable Pressure Transducer with Pigtail Cable.
Recall #Z-777-5.
CODE Catalog #MER200, Lot #234387.
MANUFACTURER Merit Medical Systems, Inc., South Jordan, Utah.
RECALLED BY Manufacturer, by visit or by telephone beginning August 3,
1994. Firm-initiated recall complete.
DISTRIBUTION Alabama, Florida, New Hampshire, New Mexico, Texas, Utah.
QUANTITY 126 units were distributed; firm estimates none remains on
market.
REASON The primary sterile barrier is unsealed in some of the
devices due to packaging error.
_______________
PRODUCT Datascope System 97 intra-Aortic Balloon Pump, for use as a
patient aid during pre-, intra-, or post-operative open
heart surgery; for use within patients demonstrating
unstable angina; and use within patients with left main
artery occlusion or poor left ventricle function.
Recall #Z-793-5.
CODE Catalog #0998-00-0104. All serial numbers below 1130
(inclusive).
MANUFACTURER Datascope Corporation, Paramus, New Jersey.
RECALLED BY Manufacturer, by letter dated January 26, 1994. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 83 units were distributed.
REASON Devices fail to operate on AC power even when they are
plugged to AC outlets.
_______________
PRODUCT Intermedics Orthopedics 7 mm screw fixation tibial insert, a
prescription device used in conjunction with the Natural-
Knee System to replace a diseased or otherwise dysfunctional
knee joint: (a) Catalog #6200-01-807; (b) Catalog #6200-01-
907; (c) 6200-02-807; (d) 6200-02-907; (e) 6200-03-807; (f)
6200-03-907; (g) 6200-05-807; (h) 6200-05-907; (i) 6200-06-
807; (j) 6200-06-907; (k) 6200-07-807; (k) 6200-07-907.
Recall #Z-803/814-5.
CODE All serial numbers.
MANUFACTURER Intermedics Orthopedics, Inc. (IOI), Austin, Texas.
RECALLED BY Manufacturer, by telephone July 27, 1994, followed by letter
dated August 16, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 7,324 units were distributed; firm estimates none remains on
the market.
REASON Product was distributed in commerce without 510(k) approval.
_______________
PRODUCT PLV-102 Ventilator. Recall #Z-817-5.
CODE Serial numbers VV940406 to VV941122 inclusive.
-7-
MANUFACTURER Lifecare, Westminster, Colorado.
RECALLED BY Manufacturer, by letter in February 1995, followed by
telephone. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 307 units.
REASON A potential intermittent electrical problem with a
transistor on the bulkhead heatsink assembly may cause
internal batteries not to charge or to overcharge and become
hot. Further, the ventilator may randomly switch to DC
battery operation when there has been no AC power failure.
_______________
PRODUCT Kodak Remote Capture & Ancillary Image Server, used to enter
patient study information, store images and send images to
particular destinations for clinical viewing and diagnosis.
Recall #Z-878-5.
CODE Lot numbers: K361-5829, K361-5830,K361-5947, K361-5948,
K361-5886, K361-5887, K361-5940, K361-5851, & one Beta unit
used in testing.
MANUFACTURER Kodak Health Imaging Systems, Inc., Dallas, Texas.
RECALLED BY Manufacturer, by telephone April 13, 1995, followed by
letter dated April 12, 1995. Firm-initiated recall
complete.
DISTRIBUTION Georgia, Massachusetts, New York, Canada.
QUANTITY 9 units were distributed; firm estimates none remains on the
market.
REASON Data corruption and/or lost or delayed images could impair
the system's function and result in an image inappropriate
for diagnostic use and/or significant delay in diagnosis.
_______________
PRODUCT BP/Clinic #1100-C Sit Down Blood Pressure Machine, sold to
various locations such as pharmacies to be used by customers
in monitoring their blood pressure. Recall #Z-934-5.
CODE All units.
MANUFACTURER Angle Manufacturing Company, Tracy City, Tennessee
(cabinet).
RECALLED BY CardioAnalysis Systems, Winchester, Tennessee, by issuing
Service Bulletin 4H in March 1994. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 1,644 units were distributed.
REASON Possible injury may occur to patients because of loose
hinges on the chair portion of the device.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT (a) Lang Jet Tooth Shade Acrylic Self Curing Resin Powder, a
self curing acrylic resin for making long term, more color
stable, temporary crown and bridge resstorations, packaged
in 1 ound plastic bottles; (b) Splintline Tooth Shade, in 1
pound bottles. Recall #Z-926/927-5.
-8-
CODE Lot #36194.
MANUFACTURER Lang Dental Manufacturing Company, Inc., Wheeling, Illinois.
RECALLED BY Manufacturer, by letter dated November 10, 1994. Firm-
initiated recall complete.
DISTRIBUTION Florida, New York, Pennsylvania, New Jersey, Maryland,
California, Minnesota, Ohio, Indiana, South Korea, Sweden.
QUANTITY Approximately 9 bottles were distributed.
REASON Some bottles labeled as Jet Tooth Shade actually contained
Splintline Tooth Shade.
_______________
PRODUCT Vidas Toxoplasma Gondii Serological Reagent Kits (TXC),
intended for use with a Vidas instrument as an automated
qualitative enzyme - linked fluorescent immunoassay for the
detection of total anti-Toxoplasma gondii antibodies in
human serum or plasma. Recall #Z-929-5.
CODE Catalog #30211, Lot numbers: 941111-0, 950421-0.
MANUFACTURER bioMerieux sa, Marcy, France.
RECALLED BY bioMerieux Vitek, Inc., Rockland, Massachusetts, by letter
September 9, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 58 kits were distributed.
REASON Mislabeled -- The C2 TV (test value) ranges for two TXC kits
had been set too narrowly due to improper range
calculations.
_______________
PRODUCT The Gen-Probe Pace 2 Test Kit, for the detection of
Chlamydia Trachomatis in endocervical, male urethral, and
conjunctival specimens. Recall #Z-938-5.
CODE Catalog #1792 EXP dates between 12/3/94 and 1/22/95.
MANUFACTURER Gen-Probe, Inc., San Diego, California.
RECALLED BY Manufacturer, by letter dated October 20, 1994. Firm-
initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 16,723 kits were distributed.
REASON One of the normal probes for the kit was omitted and a probe
for the detection of N. Gonorrhoeae (NG) was included with
the remaining normal probes.
-9-
END OF ENFORCEMENT REPORT FOR JULY 12, 1995. BLANK PAGES MAY FOLLOW.
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