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.
March 18, 1998 98-11
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============
_______________
PRODUCT Pumpkin Butter in glass jars, under the
following brand names: "AMISH PUMPKIN BUTTER,
HOME-MADE STYLE", Packaged by Miller's Orchard
Nappanee, Indiana labeled as 8 oz. and 16 oz.
"Die Bock Kich Bakery PUMPKIN BUTTER" labeled
as 8 oz. and 1 Pint, Distributed by Das
Dutchman Essenhaus Amish Country Kitchen 240
U.S. 20 Middlebury, Indiana 46540
"HOME-STYLE 'PUMPKIN PIE IN A JAR' PUMPKIN
BETTER The Better Butter", labeled as 8 oz.
and 15.5 oz., Shelton Farms, Niles, Michigan.
Recall #F-279-8.
CODE None.
MANUACTURER Miller's Orchard, Inc., Nappanee, Indiana.
RECALLED BY Manufacturer, by telephone on January 12-14,
1998. Firm-initiated recall ongoing.
DISTRIBUTION Arizona, California, Indiana, Michigan, New
York, Ohio.
QUANTITY 1,247 cases (12 jars per case) were
distributed.
REASON The product had been manufactured and
processed without the firm having filed
scheduled process for the product, without a
thermal process (open kettle processing was
used with a hot pack), and in a plant
unregistered with FDA by personnel who had not
attended a Better Process Control School or
its equivalent.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS
II ============
_______________
PRODUCT Bayer, Trasylol (Aprotinin Injection) Sterile
Solution, 10,000 K.I.I./mL (1.4 mg/mL), Single
Dose Vial, 100ml, NDC 0026-8196-36, 200ml, NDC
0026-8197-63, Rx indicated for prophylactic
use to reduce perioperative blood loss and the
need for a blood transfusion in patients
undergoing cardiopulmonary bypass in the
course of repeat coronary artery bypass graft
surgery. Recall #D-099-8.
CODE 100ml vials Lot# 7JAB, EXP 6/99
100ml vials Lot# 7LAC, EXP 6/99
200ml vials Lot# 7JFB, EXP 7/99.
MANUFACTURER Bayer AG, Leverkusen, Germany.
RECALLED BY Bayer Pharmaceutical Division, West Haven,
Connecticut (labeler), by letter dated
February 26, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY US Lot # 7JAB (Bayer Germany 965863K) 13,980
Vials released 11/21/97.
US Lot # 7LAC (Bayer Germany 965863K) 15,942
Vials released 1/9/98.
US Lot # 7JFB (Bayer Germany 967050E) 8,436
Vials released 11/24/97.
REASON Foreign particulate - One vial was found to
contain a birch tree seed.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ===========
_______________
PRODUCT Sufentanil Citrate Injection, USP, 50 mcg/mL
sufentanil, in 2 and 5 mL ampules, 10 ampules
per box, Rx, indicated for IV administration
as an analgesic adjunct in patients who are
intubated and ventilated, as a primary
anesthetic agent for the induction and
maintenance of anesthesia in patients
undergoing major surgical procedures, and for
epidural administration as an analgesic
combined with low dose bupivacaine during
labor and vaginal delivery, under the ESI
(Elkins-Sinn) and VHA Plus labels. Recall
#D-098-8.
CODE Lot 016077 EXP 1/98 - NDC 0641-5143-33
Lot 016103 EXP 1-98 - NDC 0641-1143-33
Lot 016115 EXP 1/98 - NDC 0641-5142-33.
MANUFACTURER Wyeth-Ayerst/ESI/Lederle Laboratories, Cherry
Hill, New Jersey, a subsidiary of the American
Home Products Corporation.
RECALLED BY Manufacturer, by letter on July 14, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 4,807 boxes (10 ampules per box) were
distributed.
REASON Product contaminated with the preservative
methylparaben.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ========
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-448/449-8.
CODE Unit #29GM34115.
MANUFACTURER American Red Cross, Greenville, North
Carolina.
RECALLED BY American Red Cross Blood Services, Norfolk,
Virginia, by letter dated May 21, 1996, and by
fax on May 17, 1996. Firm-initiated recall
complete.
DISTRIBUTION Virginia and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of cancer.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-654/655-8.
CODE Unit #53M09259.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated November 5,
1997. Firm-initiated recall complete.
DISTRIBUTION Maryland and Pennsylvania.
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
indeterminate.
_______________
PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF
c) Recovered Human Serum; d) Recovered Plasma.
Recall #B-671/674-8.
CODE Unit numbers: a) 31H93392, 31G07008, 31R55310
b) 31H93392 and 31G07008.
c) 31H93392 and 31G07008
d) 31H93392, 31G07008, and 31R55310
MANUFACTURER American Red Cross Blood Services, Buffalo,
New York.
RECALLED BY American Red Cross Blood Services, Rochester,
New York, letter dated August 26, 1997.
Firm-initiated recall complete.
DISTRIBUTION New York, Massachusetts, California.
QUANTITY a) 3 units; b) 2 units; c) 2 units; d) 3 units
were distributed.
REASON Blood products tested negative for the
hepatitis B surface antigen (HBsAg), but were
collected from donors who previously tested
repeatedly reactive for HBsAg.
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c)
Platelets, Pooled. Recall #B-675/677-8.
CODE Unit numbers: a) 4735003, 4766325, 4813867; b)
4735003; c) 4713812.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by letter dated May 6, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY a) 3 units; b) 1 unit; c) 1 unit was
distributed.
REASON Blood products were collected from a donor who
traveled to a area considered endemic for
malaria.
_______________
PRODUCT Platelets. Recall #B-678-8.
CODE Unit numbers: 12429-0432, 12429-0431,
12429-0424, 12429-0423.
MANUFACTURER United Blood Services, Albuquerque, New
Mexico.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on February 2, 1998. Firm-initiated
recall complete.
DISTRIBUTION New Mexico.
QUANTITY 4 units were distributed.
REASON Blood products were prepared from units of
Whole Blood which were shipped at an
unacceptable temperature.
_______________
PRODUCT Red Blood Cells. Recall #B-681-8.
CODE Unit #24KE16456.
MANUFACTURER American Red Cross Blood Services, Louisville,
Kentucky.
RECALLED BY Manufacturer, by letter dated December 2,
1997. Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product was stored at an unacceptable
temperature.
_______________
PRODUCT Platelets, Pheresis. Recall #B-682-8.
CODE Unit #49P36498.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by telephone on October 27,
1997. Firm-initiated recall complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product which tested positive for CMV
antibody, was labeled as negative for CMV.
_______________
PRODUCT Red Blood Cells. Recall #B-683-8.
CODE Unit #GW27208.
MANUFACTURER Metropolitan Washington Blood Bank, Bethesda,
Maryland.
RECALLED BY Manufacturer, by letter dated March 1, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for the antibody
to the hepatitis B core antigen (anti-HBc),
but was collected from a donor who previously
tested repeatedly reactive for anti-HBc on two
separate occasions.
_______________
PRODUCT Red Blood Cells. Recall #B-684-8.
CODE Unit #1432581.
MANUFACTURER Central Kentucky Blood Center, Lexington,
Kentucky.
RECALLED BY Manufacturer, by telephone on October 30,
1997. Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product was distributed after receipt of
post donation information indicating that the
donor was in a high risk category.
_______________
PRODUCT a) Whole Blood; b) Red Blood Cells; c)
Platelets; d) Cryoprecipitated AHF; e)
Recovered Plasma; f) Platelets, for further
manufacture; g) Buffy Coat.
Recall #B-686/692-8.
CODE Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301)
827-6220 for individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Baltimore,
Maryland.
RECALLED BY Manufacturer, by letter dated July 28, 1997 or
by fax on July 22, 1997, followed by letter
dated September 22, 1997. Firm-initiated
recall complete.
DISTRIBUTION Maryland, Virginia, District of Columbia, New
Jersey, Massachusetts, Pennsylvania,
California, North Carolina, New York,
Switzerland.
QUANTITY a) 1 unit; b) 31 units; c) 13 units; d) 3
units; e) 29 units; f) 1 unit; g) 1 unit 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, and was incorrectly
reentered.
_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-694/695-8.
CODE Unit numbers: a)01Q11541, 01T18359; b)
01Q11541.
MANUFACTURER American Red Cross Blood Services, Rochester,
New York.
RECALLED BY Manufacturer, by letter dated February 7 or
17, 1996. Firm-initiated recall complete.
DISTRIBUTION Illinois, New York, Massachusetts.
QUANTITY a) 2 units; b) 1 unit was distributed.
REASON Blood products were collected from donors who
reported travel to areas designated as
endemic for malaria.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-696/697-8.
CODE Unit #12416-5449.
MANUFACTURER United Blood Services, Albuquerque, New
Mexico.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter or fax dated July 31, 1996.
Firm-initiated recall complete.
DISTRIBUTION New Mexico and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
had body piercing within twelve months of
donation.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-698/699-8.
CODE Unit #21GV00620.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letters on January 28 and 29,
1998. Firm-initiated recall complete.
DISTRIBUTION Oregon and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
with a history of cancer.
_______________
PRODUCT Red Blood Cells. Recall #B-700-8.
CODE Unit numbers 21GH89244 and 21GJ84044.
MANUFACTURER American Red Cross Blood Services, Portland,
Oregon.
RECALLED BY Manufacturer, by letter dated February 2,
1998. Firm-initiated recall complete.
DISTRIBUTION Oregon and California.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who
traveled to an area considered endemic for
malaria.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III =======
_______________
PRODUCT Red Blood Cells, Leukoreduced.
Recall #B-648-8.
CODE Unit #038FC28677.
MANUFACTURER American Red Cross Great Lakes Region, Fort
Wayne, Indiana.
RECALLED BY Manufacturer, by letter dated October 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
had no hemoglobin check recorded during
screening.
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-679/680-8.
CODE Unit #GW26850.
MANUFACTURER Metropolitan Washington Blood Bank, Bethesda,
Maryland.
RECALLED BY Manufacturer, by telephone on February 13,
1997. Firm-initiated recall complete.
DISTRIBUTION District of Columbia and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor
whose arm inspection was not documented.
_______________
PRODUCT Red Blood Cells. Recall #B-685-8.
CODE Unit #29KH18206.
MANUFACTURER American Red Cross Blood Services, Norfolk,
Virginia.
RECALLED BY Manufacturer, by telephone on June 27, 1997.
Firm-initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
had no hemoglobolin result documented.
RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II ==========
_______________
PRODUCT Kendall Anesthesia/Breathing Circuits, used to
ventilate or administer anesthesia to the
patient during surgery:
a) Standard Anesthesia Breathing Circuits
b) Pediatric Anesthesia Breathing Circuits
c) Jackson-Reese Circuits
d) Customer Special Anesthesia Breathing
Circuits. Recall #Z-272/275-8.
CODE All lots as follows: 10101, 10107, 10113
10114, 10115, 10118, 10119, 10138, 10143
10145, 10146, 10149, 10153, 10165, 10172,
10173, 10174, 10175, 10180, 10181, 10185,
10189, 10191, 10192, 10193, 10197, 10199,
10200, 10204, 10205, 10207, 10208, 10209
10210, 10211, 10212, 10214, 10215, 10216
2430, 2432, 2434, 2435, 2442, 2447, 2448
2449, 2450, 2451, 2453, 2464, 2724, 2767
2854, 4123, 4183, 4936,4937, 4938, 4941
6381, 6622, 6677, 6679, 6787, 6791, 6794
6797, 6798, 6872, 6878, 6893, 8624, 8627
8632, 8664, 8667, 8683, 8686, 8687, 8688
8710, 8715, 8723, 8782, 8811, 9421, 9424
9425, 9445, 9521, 5997.
MANUFACTURER Especialidades Medicas Kenmex, A Subsidiary of
Tyco International, Ltd., Tijuana, Mexico.
RECALLED BY Kendall Healthcare Products Company,
Mansfield, Massachusetts, by letter dated July
21, 1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 35,837 cases (900,651 units) were distributed.
REASON Circuit may disconnect during use, thus
potentially interfering with the ability to
ventilate a patient or administer anesthesia.
_______________
PRODUCT Mobile Surgical Stretchers and Chairs:
a) Mobile Surgical Stretcher, Model 578EYE-PC
b) Mobile Surgical Stretcher, Model 578EYE-SS
c) Ambulatory Surgical Chair, Model ASCEYE-00
d) Electric Motorized Ambulatory Surgical
Chair, Model ESCEYE-00
e) Electric Motorized Ambulatory Surgical
Chair, Model ESDEYE-00. Recall #Z-370/374-8.
CODE Devices manufactured between May 20, 1997 and
November 1, 1997.
MANUFACTURER Hausted, Inc., Medina, Ohio.
RECALLED BY Manufacturer, by letter on October 28, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Australia.
QUANTITY 122 units were distributed.
REASON The headrest adjustment assembly allows for
the possibility of slippage if the set screw
used to hold a lock collar in place is not
properly tightened as it is in some instances.
_______________
PRODUCT Lead Aprons, Skirts, Vests, and Thyroid
Shields, shielding products used for radiation
protection. Recall #Z-389/391-8.
CODE All devices shipped after 1/29/97 through
6/16/97 to specific consignees based on
identified suspect vinyl lead rolls received.
MANUFACTURER Burkhart Roentgen International, Inc., St.
Petersburg, Florida.
RECALLED BY Manufacturer, by letter on June 16, 1997,
followed by telephone. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 232 devices were distributed.
REASON Radiation protection devices may contain small
amounts of radioactive substances.
_______________
PRODUCT CholestoChek Total Cholesterol Screening Test,
promoted as an over-the-counter Home Screening
Test Kit to determine Total Cholesterol.
Recall #Z-392-8.
CODE All unexpired codes.
MANUFACTURER Technical Chemicals and Products, Inc. (also
known as Health Mark Diagnostics L.L.C.)
Pompano Beach, Florida.
RECALLED BY Manufacturer, by letter on February 3, 1998.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,415 kits were distributed.
REASON Lack of 510k for over-the-counter marketing.
_______________
PRODUCT Marlow Balloon Cannula 5mm, Sterile, used for
minimally invasive laproscopic surgery to
provide access for operative and diagnostic
instrumentation. Recall #Z-393-8.
CODE Reorder #ML0500D, Lot #61-282-05-49.
MANUFACTURER OEM - Franz Medical Development, LTD., Mentor,
Ohio.
RECALLED BY CooperSurgical, Inc., Shelton, Connecticut, by
telephone on July 24, 1997 followed by fax.
Firm-initiated recall complete.
DISTRIBUTION California, Illinois, Maryland, Ohio, Texas,
Virginia.
QUANTITY 840 units were distributed.
REASON Balloon Cannula may burst or leak at bonding
site.
_______________
PRODUCT Hewlett Packard Multifunction Electrode Pads,
used with the HP Codemaster and Codemaster 100
Defibrillator/Monitors, intended as a
multifunction external pad for ECG monitoring:
a) M1749A-Adult U.S. Pads
b) M1749B-Adult IEC Pads
c) M1749B-Pediatric US Pads.
Recall #Z-394/396-8.
CODE Lot numbers: a) 040897, 050897, 020997, 030997
b) 200897; c) 260897.
MANUFACTURER OEM Manufacturer: Cardiotronics Systems, Inc.,
a Division of Ballard Medical Products,
Carlsbad, California.
RECALLED BY Hewlett Packard Company, Medical Products
Group, Andover, Massachusetts, by letter dated
January 16, 1998. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 4004 boxes of lot M1749A(10sets/bx); 250
boxes of lot M1749B, and 100 boxes of lot
M1749D(sets/box) were distributed.
REASON The conductive gel may deteriorate to a liquid
thus making the electrode pads unusable
because they will not adhere to a patient and
may not provide adequate electrical
stimulation.
_______________
PRODUCT Lead Aprons and Thyroid Collars, designed to
be worn during surgical procedures:
a) Standard Front, Catalog #101
b) Surgical Drop, Catalog #103
c) Two Wing Velcro, Catalog #105
d) 2" Buckle Front, Catalog #109
e) Lumbar Support Cinch Front, Catalog #120
f) Special Procedure, Catalog #201
g) Special Procedure Coat with Lumbar Cinch,
Catalog 207
The above lead aprons models are followed by
the letters L, M, S and P. Also, Model 105
may be preceded by the letter E.
h) Half Aprons, Catalog #401
The half aprons catalog number is followed by
the letters A, C or T.
i) Thyroid Collar, Catalog #501
The thyroid collars catalog number is followed
by the letters A or B. Recall #Z-397/405-8.
CODE See above.
MANUFACTURER Supplier of radioactive lead vinyl sheets:
The Kennedy Company, Scottsboro, Alabama
Supplier of radioactive lead powder:
Taracorp Industries, Granite City, Illinois
Source of radioactive lead:
Midco Industries, St. Louis, Missouri
RECALLED BY Davis Lead Aprons, Inc., Houston, Texas, by
letter dated June 13, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Alabama, Arizona, Georgia, Kentucky,
Louisiana, North Carolina, Tennessee, Texas.
QUANTITY Quantity Distributed: 179 units--15 model
101, 8 model 103, 13 model 105, 22 model E105,
5 model 109, 21 model 120, 1 model 201, 3
model 207, 9 model 401, and 66 model 501.
REASON The radiation protection devices contain lead
contaminated with small amounts of radioactive
substances.
_______________
PRODUCT Silicone "Squeegee" Capsule Polisher, Catalog
and Part #125-23, used by ophthalmic surgeons
for polishing the inside of the capsule during
IOL/cataract surgery. Recall #Z-406-8.
CODE Lot #70702.
MANUFACTURER Eagle Laboratories, Rancho Cucamonga,
California.
RECALLED BY Manufacturer, by letter dated September 15,
1997. Firm-initiated recall ongoing.
DISTRIBUTION California, Illinois, Louisiana,
Massachussets, Texas, Virginia, Wisconsin.
QUANTITY 480 units were distributed.
REASON The sterility of the device may be compromised
due to incomplete pouch package seals.
_______________
PRODUCT Zimmer Versys Cemented Stem Inserter Clamp,
Catalog #00-7896-051-00, used to hold the stem
on the inserter during placement and impaction
into the femoral canal. Recall #Z-407-8.
CODE Lot numbers: 51899100, 51899200, 51899300.
MANUFACTURER Zimmer, Inc., Warsaw, Indiana.
RECALLED BY Manufacturer, by letter dated November 13,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 202 units were distributed.
REASON The ball tip of the femoral inserter clamp
broke during, possibly due to usage in an
unintended manner.
END OF ENFORCEMENT REPORT FOR MARCH 18, 1998. BLANK PAGES MAY FOLLOW.
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End of Enforcement Report for
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