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.
April 14, 1999 99-15
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I
________
PRODUCT
Imitation Crabmeat in 2 pound packages. Recall #F-333-9.
CODE
All codes listed are followed by the UPC code 07210: F1118A, F1118B, F1118C,
F1118D, F0139A, F0139B, F0139C, F0139D , F0209A, F0209B, F0209C, F0209D,
F0559A, F0559B, F0559C, F0559D, F0619A, F0619B, F0619C, F0619D, F0619E,
F0209A, F0209B, F0209C, F0209D.
MANUFACTURER
Unisea Foods, Inc., Redmond, Washington.
RECALLED BY
Manufacturer, by telephone on March 4, 1999. Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania.
QUANTITY
Approximately 77,000 20-pound cases were distributed.
REASON
Product contains undeclared egg whites.
________
PRODUCT
Braum's Ice Cream and Frozen Yogurt Pies in 28 ounce net weight pie tins:
a) Chocolate Pecan Ice Cream Pie
b) Mint Chocolate Chip Ice Cream Pie
c) Pumpkin Ice Cream Pie
d) Strawberry Cheesecake Ice Cream Pie
e) Cappuccino Chunky Choc. Frozen Yogurt Pie.
Recall #F-334/338-9.
CODE
All lots manufactured prior to February 9, 1999. Last production code:
a) 9021; b) 9019; c) 9039; d) 8264; e) 9020.
MANUFACTURER
Braum's Ice Cream and Dairy Stores, Tuttle, Oklahoma.
RECALLED BY
Braum's Ice Cream and Dairy Stores, Oklahoma City, Oklahoma, by telephone and
E-mail on February 23, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Arkansas, Kansas, Missouri, Oklahoma, Texas.
QUANTITY
Firm estimated none remained on market at time of recall initiation.
REASON
Products contain undeclared eggs.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________
PRODUCT
Processed frozen carrots and mixed frozen vegetables:
1. Schwan's Stir Fry, 32 oz. poly labeled "Schwan's STIR FRY VEGETABLES **",
product is packed 12/32oz bags/case, case similarly labeled.
2. Scandinavian blend, 32 oz. poly bag, labeled in part "SIMPLOT CLASSIC **
Scandinavian Blend**". Product is packed 12/32 oz. bags/case, 24 lb. case
similarly labeled.
3. Stir fry under three labels in poly bags. In November the Schwan's Canada
replaced the Haugin's label on the cases.
a) "Schwan's STIR FRY VEGETABLES", 12/32 oz. poly/case.
b) Poly bag and case labeled "Schwan?s Canada STIR FRY VEGETABLES"
c) Poly bag labeled "Schwan's Canada STIR FRY VEGETABLES", cases labeled
"HAUGIN?S FARM BRAND FROZEN STIR FRY VEGETABLES" Product is packed
12/32 oz. bags (US) or 12/1Kg (Canadian) per case.
4. Pasta blend under three labels in poly bags. In May the Schwan?s
CANADA replaced the Haugin's cases. The poly bags and cases labeled:
a)"Schwan?s SUMMER GARDEN PASTA BLEND ** NET WT. 32 oz
***",
b) Cases labeled "HAUGIN?S FARM BRAND". Poly bags labeled "Schwan's
CANADA", packed 12/1kg per case.
c) Cases and poly bags labeled "Schwan?s CANADA", packed 12/1kg per case
5. Diced carrots under two labels:
a) Poly bag labeled in part "SIMPLOT CLASSIC ** Diced
Carrots **" packed 12/30 oz. poly bags per case.
24 lb. case similarly labeled.
b) Non-labeled poly bag, case labeling "THE INN ** DICED CARROTS **
NET WT 50***"
6. Shoestring carrots under three labels:
a) Poly bag labeled in part "Simplot CLASSIC SHOESTRING CARROTS
** NET WT. 32 OZ". Product packed 12/32 oz. per case. 24 Lb. case
similarly labeled.
b) Clear plastic lined case, case labeled in part
"SANDRIDGE SHOESTRING CARROTS ** NET WT 40 LBS***"
c) Clear plastic lined case, case labeled in part "CHEF AMERICA SHOESTRING
CARROTS ** 40#***"
7. Vegetable blend under the Classic label. This product is intended for
restaurant use. Poly bags do not contain labeling, bags packed 12/32 oz.
bags/case. Case labeled "Classic Sugar Snap Peas SS Corn SS Carrots".
8. Vegetable blend, Seiyu 3 way mixed vegetables, 20/500 gr., destined
for Japanese market. Product labeled in Japanese. Product is distributed
by Nichirei.
9. Peas and carrots blend under 2 labels:
a) Polar brand in 2 sizes: clear poly lined case, case
labeled in part "***POLAR Peas & Diced Carrots NET WT.
20 LBS.***"; and poly bags labeled in part "***POLAR
Peas and Diced Carrots NET WT. 40 OZ*** contained in
30 lb. cases similarly labeled.
b) Poly bags labeled in part "***All Kitchens Peas &
carrots ** NET WT. 40 OZ.***" packed 12/40 oz. Per
case, case similarly labeled.
10. Petite peas and carrots blend, 32oz. poly bags labeled in part "SIMPLOT
CLASSIC ** Peas and Shoestring Carrots**", packed 12/32 oz. per case,
30 lb. case similarly labeled.
11. Peas and diced carrots, 40 oz. poly bags labeled in part "**SIMPLOT
CLASSIC ** Peas and Diced Carrots **". Packed 12/40 oz. per 30 lb. case,
case similarly labeled.
12. Mixed vegetables in non-labeled poly lined 40lb. case, case labeled in
part "All Kitchens ** 20 LB BULK ** MIXED VEGETABLES"
13. Mixed vegetables under two labels:
a) "Ligo I.Q.F. MIXED VEGETABLES" 12/1 KG
b) "NICHIREI MIXED VEGETABLES NET Wt. 1Kg"
14. Mixed vegetables with Japanese labeling. Case states packed by
J.R. Simplot, Boise, Idaho. Product distributed by Nichirei.
15. Polar brand mixed vegetables, 2 sizes: bulk -clear poly bags in
cases labeled in part "POLAR MIXED VEGETABLES ** NET WT 20 LBS***";
and poly bags labeled in part "POLAR Mixed Vegetables NET WT. 40 ozs.***"
packed 12/40 oz. bags per case, 30 lb. cases similarly labeled.
16. ACME brand in plastic bags labeled Acme Mixed Vegetables. Product
is cased 24/10 oz. and 12/32 oz.
17. Classic brand mixed vegetables in plastic bag labeled in part "SIMPLOT
CLASSIC ** Mixed Vegetables NET WT. 40 OZ.**", packed 12/40 oz.
per case, case similarly labeled.
18. Bulk diced carrots contained in poly lined totes. Totes contain a
tote ticket/tote tag with J.R. Simplot's name, product code, day code.
The diced carrots are in 1,400 lb. totes.
a) Diced A1
b) Diced A3
19. Bulk shoestring carrots contained in poly lined totes. Totes contain
a tote ticket/tote tag with J.R. Simplot's name, product code, day code.
The shoestring carrots are in 1,100 lb. totes.
a) Shoestring A1
b) Shoestring A3. Recall #F-300/318-9
CODE
Most of the products utilize the same type of coding system,
i.e., 8CW247 00:00 2-5 63
1st digit = year
2nd/3rd digit = plant (CW is the Quincy, WA plant)
247 = Julian date
00:00 = military time (all times are involved in the recall)
2-5 = designates the line number (line 2, line 3, etc.)
last two digits = ?
1. Schwan's Stir Fry 12/32 oz.:
8CW247 00:00 2-5 63, 8CW248 00:00 2-5 63,
8CW259 00:O0 2-5 63, 8CW260 00:00 2-5 63,
8CW261 00:00 2-5 63, 8CW288 00:00 2-5 64,
8CW289 00:00 2-5 64, 8CW290 00:00 2-5 64,
2. Classic Scandinavian 12/32 oz.
8CW62, 8CW63, 8CW78, 8CW79, 8CW257, 8CW258
3. Schwan's stir fry, 12/32 oz.
8CW63 00:00 2-5 57, 8CW64 00:00 2-5 57,
8CW90 00:00 2-5 57, 8CW91 00:00 2-5 58,
8CW98 00:00 2-5 58, 8CW99 00:00 2-5 58,
8CW119 00:00 2-5 58, 8CW120 00:00 2-5 58
Schwan's Canada/Haugins stir fry 12/1 Kg (either label
would be used)
8CW118 00:00 2-5 58, 8CW119 00:00 2-5 58
4. Schwan's summer pasta 12/32 oz.
8CW70 00:00 2-5 57, 8CW71 00:00 2-5 57,
8CW72 00:00 2-5 57, 8CW93 00:00 2-5 58,
8CW94 00:00 2-5 58, 8CW204 00:00 2-5 61,
8CW205 00:00 2-5 61, 8CW211 00:00 2-5 61,
8CW212 00:00 2-5 61, 8CW268 00:00 2-5 63,
8CW269 00:00 2-5 63, 8CW270 00:00 2-5 63,
8CW328 00:00 2-5 65, 8CW329 00:00 2-5 65
Schwan's Canada/Haugins Pasta 12/1 Kg
8CW71 00:00 2-5 57, 8CW72 00:00 2-5 57,
8CW238 00:00 2-5 62, 8CW239 00:00 2-5 62
5. Classic diced carrots 12/32 oz.
8CW290, 8CW291
Inn Foods diced, 50 lb.
7CW277, 7CW278
6. Classic shoestring carrots, 12/32 oz.
8CW27, 8CW28, 8CW225, 8CW226, 8CW278, 8CW279
Sandridge shoestring, 40 lb.
8CW254, 8CW255
Chef America shoestring, 40 lb.
8CW225, 8CW226
7. Classic vegetable blend, 12/32 oz.
8CW62, 8CW63
8. Seiyu vegetable blend, 20/500 gr.
99.04.24/H 7CW29700:00, 99.04.25/H 7CW29800:00
9. Polar peas & carrots, 20 lb.
7CW297, 7CW298, 8CW50, 8CW51
Polar peas & carrots, 12/40 oz.
7CW292, 7CW293, 7CW302, 7CW303
All Kitchen peas & carrots, 12/40 oz.
7CW302, 7CW303,
10. Classic petite peas & carrots, 12/32 oz.
8CW76, 8CW77, 8CW281, 8CW282
11. Classic peas & carrots, 12/40 oz.
7CW302, 7CW303, 8CW6, 8CW7
12. All Kitchen mixed vegetables, 20 lb.
7CW295, 7CW296
13. Ligo mixed vegetables, 12/1kg
8CW290 00:00 2-5 00.10.17, 8CW291 00:00 2-5 00.10.18
Nichirei mixed vegetables, 12/1 kg
99.05.03/H 7CW30700:00, 99.05.04/H 7CW30800:00,
99.05.10/H 7CW31400:00, 99.05.11/H 7CW31500:00,
99.08.19/H 8CW5000:00, 99.08.20/H 8CW5100:00
14. Nichirei mixed vegetables, 20 kg
99.04.17/H 7CW29000:00, 99.04.18/H 7CW29100:00
15. Polar mixed vegetables, 20 lb.
8CW103, 8CW104, 8CW154, 8CW155, 8CW156, 8CW157, 8CW158,
8CW159, 8CW160
Polar mixed vegetables, 12/40 oz.
7CW290, 7CW291
16. Acme mixed vegetables, 24/10 oz.
D208UW 00:00 1-4, D218UW 00:00 1-4
Acme mixed vegetables, 12/32 oz.
D168UW 00:00 1-4, D178UW 00:00 1-4,
G088UW 00:00 1-4, G098UW 00:00 1-4
17. Classic mixed vegetables, 12/40 oz.
8CW286, 8CW287
18. Diced A1 carrots in 1,400 lb. totes
7CW267, 7CW268, 7CW269, 7CW270, 7CW271, 7CW272, 7CW273,
7CW274, 7CW285, 7CW286, 7CW287
Diced A3 carrots in 1,400 lb. totes
7CW268, 7CW269, 7CW270, 7CW271
19. Shoestring carrots A1 (1/8x1/8x1.5) in 1,100 lb. totes
7CW285, 7CW286
Shoestring carrots A3 (1/8x1/8x1.5) in 1,100 lb. totes
7CW285, 7CW286, 7CW287
Shoestring carrots A3 (1/8x1/8x1.5) in 1,100 lb. totes
7CW286, 7CW287, 8CW68, 8CW69, 8CW70
Shoestring carrots A3 (1/8x1/8x1.5) in 1,100 lb. totes
7CW286, 7CW287, 8CW84
Shoestring carrots A3 (1/8x3/16x1.5) in 1,100 lb. totes
7CW304, 7CW309.
MANUFACTURER
J.R. Simplot Company, Boise, Idaho.
RECALLED BY
Manufacturer, by fax on December 23, 1998, and January 13, 1999.
Firm-initiated recall complete.
DISTRIBUTION
Nationwide, Japan, Canada.
QUANTITY
Firm distributed: 806,100 pounds of bulk carrots for further processing;
620,200 pounds of bulk carrots in totes; 31,379 cases of diced carrots
and products containing diced carrots and 58,716 cases of shoestring
carrots and products containing shoestring carrots.
REASON
The carrot component of the products contains elevated levels of lead.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________
PRODUCT
Fortaz ADD-Vantage Vials (Ceftazidime for injection) 1 g, Rx indicated
for the treatment of patients with infections caused by susceptible
strains of the designated organisms for various diseases.
Recall #D-168-9.
CODE
Lot numbers: B8419AA and B8769AF.
MANUFACTURER
Glaxo Wellcome, Inc., United Kingdom.
RECALLED BY
Glaxo Wellcome, Inc., Zebulon, North Carolina, by letter dated
March 15, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
2,178 units of lot B8419AA and 669 units of lot B8769AF were distributed.
REASON
Lack of assurance of sterility (process validation failure-media simulation).
________
PRODUCT
Lyophilized Rx antibiotics for injection packaged in single dose
ADD-Vantage vials, for use only with ADD-Vantage Flexible Diluent
Containers:
a) Cefazolin for Injection (lyophilized), Equivalent to 1-gram cefazolin,
For I.V. Infusion only, Single dose ADD-Vantage Vial, NDC #0074-4732-03;
b) Tazicef, Ceftazidine for Injection, Equivalent to 2 grams ceftazidine,
For I.V. Infusion Only, Single dose ADD-Vantage Vial. NDC#0007-5091-01.
Recall #D-169/170-9.
CODE
Lot numbers: a) 43-002-DA EXP 7/1/00; b) 43-003-DA
EXP 7/1/00.
MANUFACTURER
SmithKline Beecham, Conshohocken, Pennsylvania.
RECALLED BY
Abbott Laboratories, Abbott Park, Illinois, by letter on March 26, 1999.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
a) 73,825 vials; b) 6,000 vials were distributed, with firm estimating
that 1,500 vials of Cefazolin and 1,000 vials of Tazicef remaining on
market at time of recall initiation.
REASON
Lack of assurance of sterility.
________
PRODUCT
Goldline brand Genatap Liquid, Antihistamine/Nasal Decongestant (each
15mL contains brompheniramine maleate 2 mg/phenylpropanolamine hydrochloride
12.5 mg), in 4 fluid ounce bottles, Rx. NDC #0182-2000-37. Recall #D-172-9.
CODE
Lot #9A05 EXP 1/2001.
MANUFACTURER
Bio-Pharm, Inc., Levittown, Pennsylvania.
RECALLED BY
Zenith Goldline Pharmaceuticals, Inc., Miami, Florida, by telephone on
March 10-11, 1999, followed by letter dated March 11, 1999.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
2,678 bottles were distributed; firm estimated that 2,018 bottles remained
on market at time of recall initiation.
REASON
Mislabeling - The immediate bottle label is incorrect, indicating the
product to be Genahist Liquid (Diphenhydramine HCl). The holding carton
is correctly labeled as Genatap liquid and the product in the bottle
is Genatap.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________
PRODUCT
Bidex Tablets (Guaifenesin 800 mg) in 100 tablet bottles, Rx indicated
for the temporary relief of coughs associated with respiratory tract
infections, and related conditions such as pharyngitis, bronchitis,
and asthma. NDC #45985-637-01. Recall #D-165-9.
CODE
Lot #J980755A.
MANUFACTURER
Mikart, Inc., Atlanta, Georgia.
RECALLED BY
Manufacturer, by letters on March 10 and 24, 1999. Firm-initiated
recall ongoing.
DISTRIBUTION
Alabama, Florida, Georgia, Illinois, Kentucky, Louisiana, Mississippi,
Missouri, Nevada, North Carolina, Pennsylvania, Tennessee, Texas,
Virginia.
QUANTITY
2,910 bottles were distributed.
REASON
Foreign particles - Carbon from raw material filtering.
________
PRODUCT
Duratuss G (Guaifenesin 1200 mg) in 500 tablet, bottles, indicated for
the temporary relief of coughs associated with respiratory tract
infections, and related conditions such as pharyngitis, bronchitis,
and asthma. NDC #50474-620-50. Recall #D-166-9.
CODE
Lot #J980725A.
MANUFACTURER
Mikart, Inc., Atlanta, Georgia.
RECALLED BY
Manufacturer, by letter on March 10, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Georgia.
QUANTITY
1,080 bottles were distributed.
REASON
Foreign particles - Carbon from raw material filtering.
________
PRODUCT
Myleran Tablets (busulfan), 2 mg, in 25 tablet bottles, indicated for
the palliative treatment of chronic myelogenous leukemia. Recall #D-167-9.
CODE
Lot #8G1422.
MANUFACTURER
Glaxo Wellcome, Inc., Zebulon, North Carolina.
RECALLED BY
Manufacturer, by letter on February 24, 1999.
DISTRIBUTION
Nationwide.
QUANTITY
8,426 units were shipped.
REASON
Subpotent (stability).
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
________
PRODUCT
Testoderm TTS, Testosterone Transdermal Patch System, 5 mg, 30 patches
individually pouched, Rx for the controlled delivery of testosterone
by means of a once-daily application of a transdermal system and is
indicated for replacement therapy in males for conditions associated
with a deficiency or absence of endogenous testosterone.
NDC #17314-4717-3. Recall #D-171-9.
CODE
Lot #193473 EXP 12/99.
MANUFACTURER
ALZA Corporation, Vacaville, California.
RECALLED BY
Manufacturer, by letter dated March 15, 1999. Firm-initiated recall
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
81,000 systems were distributed.
REASON
Stability - Product may not maintain ethanol levels within specification
prior to expiry date (pouch seal defect).
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
_________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Single Donor Plasma;
d) Buffy Coat; e) Recovered Plasma. Recall #B-624/628-9.
CODE
Unit numbers: a) 53GN16815, 53FX68587, 53FN41188, 53FQ56243; b) 53FQ56243;
c) 53FQ56243; d) 53FX68587; e) 53GN16815, 53FX68587, 53FN41188.
MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY
Manufacturer, by letter dated September 17, 1998. Firm-initiated recall
complete.
DISTRIBUTION
Maryland, District of Columbia, New Jersey.
QUANTITY
a) 4 units; b) 1 unit; c) 1 unit; d) 1 unit; e) 3 units were distributed.
REASON
Blood products were collected from a donor with a history of hepatitis.
________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells Leukocytes Reduced; c) Platelets;
d) Fresh Frozen Plasma; e) Recovered Plasma.
Recall #B-635/639-9.
CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of
Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER
Blood Systems, Inc., Hattiesburg, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated January 27, 1998,
and by telephone. Firm-initiated recall complete.
DISTRIBUTION
Mississippi, Texas, New York, Switzerland.
QUANTITY
a) 99 units; b) 2 units; c) 48 units; d) 38 units; e) 65 units were
distributed.
REASON
Blood products were collected from donors whose suitability was not
adequately determined.
________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukocytes Removed.
Recall #B-645/646-9.
CODE
Unit numbers: a) 16340-9953, 16340-9952, 16340-9950,
16340-9955, 16340-9957, 16340-9949, 16340-9958;
b) 16340-9954, 16340-9951, 16340-9956.
MANUFACTURER
Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on November 24,
1997. Firm-initiated recall complete.
DISTRIBUTION
Mississippi.
QUANTITY
a) 7 units; b) 3 units were distributed.
REASON
Blood products were collected from donors who were not correctly tested
for hemoglobin.
________
PRODUCT
Red Blood Cells. Recall #B-654-9.
CODE
Unit #21FS17033.
MANUFACTURER
American Red Cross, Richland, Washington (Collecting Facility).
RECALLED BY
American Red Cross, Portland, Oregon, by letter dated October 29, 1998.
Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.
________
PRODUCT
Red Blood Cells. Recall #B-657-9.
CODE
Unit #16LW26646.
MANUFACTURER
American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY
Manufacturer, by letter dated February 1, 1999. Firm-initiated recall
complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who lived in an area considered
endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-658/659-9.
CODE
Unit #42M94036.
MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letter dated January 12 and 19, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Ohio and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of hepatitis A.
________
PRODUCT
Red Blood Cells. Recall #B-660-9.
CODE
Unit #50J56275 and 50J56276.
MANUFACTURER
American Red Cross Blood Services, Toledo, Ohio.
RECALLED BY
Manufacturer, by letter dated February 11, 1999. Firm-initiated
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
2 units were distributed.
REASON
Blood products were collected from donors who traveled to an area
considered endemic for malaria.
________
PRODUCT
Red Blood Cells. Recall #B-661-9.
CODE
Unit #50G59597.
MANUFACTURER
American Red Cross Blood Services, Toledo, Ohio.
RECALLED BY
Manufacturer, by telephone on January 5, 1999. Firm-initiated recall
complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor with an unacceptable hematocrit.
________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-662/663-9.
CODE
Unit numbers: a) 1530838, 1530830, 1531194; b) 1529457 and 1529469.
MANUFACTURER
Central Kentucky Blood Center, Lexington, Kentucky.
RECALLED BY
Manufacturer, by telephone on December 2, 1998. Firm-initiated recall
complete.
DISTRIBUTION
Kentucky.
QUANTITY
a) 3 units; b) 2 units were distributed.
REASON
Blood products corresponded to a unit of pooled platelets which was positive
for coagulase negative Staphylococcus, and implicated in a transfusion
reaction.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________
PRODUCT
Platelets. Recall #B-629-9.
CODE
Unit #16340-2803.
MANUFACTURER
Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated October 8, 1997.
Firm-initiated recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit was distributed.
REASON
Blood product was prepared from a whole blood unit that had discrepant
start and end times documented.
________
PRODUCT
Fresh Frozen Plasma. Recall #B-630-9.
CODE
Unit #16341-1766.
MANUFACTURER
Blood Systems, Inc., Jackson, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 11,
1998, and by letter dated February 12, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Mississippi and Nevada.
QUANTITY
1 unit was distributed.
REASON
Blood products were prepared from whole blood units that had discrepant
start and end times documented, or no end time documented.
________
PRODUCT
Platelets. Recall #B-631-9.
CODE
Unit #16342-1983.
MANUFACTURER
Blood Systems, Inc., Hattiesburg, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 13,
1998, and by letter dated March 3, 1998. Firm-initiated recall complete.
DISTRIBUTION
Mississippi.
QUANTITY
1 unit was distributed.
REASON
Blood product was prepared from a whole blood unit that had discrepant
start and end times documented.
________
PRODUCT
a) Platelets; b)Fresh Frozen Plasma. Recall #B-632/633-9.
CODE
Unit numbers: a) 16341-2938; b) 16341-1320 and 16341-0500.
MANUFACTURER
Blood Systems, Inc., Jackson, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on January 6 and
13, 1998, and by letter dated February 2, 1998. Firm-initiated recall complete.
DISTRIBUTION
Mississippi.
QUANTITY
a) 1 unit; b) 2 units were distributed.
REASON
Blood products were prepared from whole blood units for which there was no
documentation of the collection time.
_______
PRODUCT
Fresh Frozen Plasma. Recall #B-634-9.
CODE
Unit #16341-1001.
MANUFACTURER
Blood Systems, Inc., Jackson, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on February 17, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit was distributed.
REASON
Blood product was prepared from a unit of whole blood with an extended
collection time.
________
PRODUCT
Red Blood Cells. Recall #B-643-9.
CODE
Unit #16343-8779.
MANUFACTURER
Blood Systems, Inc., Jackson, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on September 9,
1998. Firm-initiated recall complete.
DISTRIBUTION
Mississippi.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Red Blood Cells. Recall #B-644-9.
CODE
Unit #16340-8725.
MANUFACTURER
Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on November 1, 1997.
Firm-initiated recall complete.
DISTRIBUTION
Mississippi.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Red Blood Cells. Recall #B-648-9.
CODE
Unit #16339-4110.
MANUFACTURER
Blood Systems, Inc., Jackson, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on October 13, 1997,
and by letter dated October 21, 1997. Firm-initiated recall ongoing.
DISTRIBUTION
Mississippi.
QUANTITY
1 unit was distributed.
REASON
Blood product was not refrigerated within eight hours of collection.
________
PRODUCT
Red Blood Cells. Recall #B-649-9.
CODE
Unit #16339-4663.
MANUFACTURER
Blood Systems, Inc., Jackson, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on September 23,
1997. Firm-initiated recall complete.
DISTRIBUTION
Mississippi.
QUANTITY
1 unit was distributed.
REASON
Blood products were not refrigerated within eight hours of collection.
________
PRODUCT
Platelets. Recall #B-652-9.
CODE
Unit #04F50757.
MANUFACTURER
American Red Cross, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by letter dated December 17, 1998. Firm-initiated recall
complete.
DISTRIBUTION
Massachusetts.
QUANTITY
1 unit was distributed.
REASON
Blood product was prepared from a whole blood unit that had discrepant
start and end times documented.
________
PRODUCT
Red Blood Cells. Recall #B-653-9.
CODE
Unit #16343-0423.
MANUFACTURER
Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on March 16, 1998.
Firm-initiated recall complete.
DISTRIBUTION
Mississippi.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor whose body temperature was below
the acceptable range and not verified to be accurate.
_______
PRODUCT
Fresh Frozen Plasma. Recall #B-656-9.
CODE
Unit #6175730, 6350104.
MANUFACTURER
Life Share Blood Centers, Beaumont, Texas.
RECALLED BY
Life Share Blood Centers, Shreveport, Louisiana, on or about November 30,
1999. Firm-initiated recall complete.
DISTRIBUTION
Louisiana.
QUANTITY
1 unit was distributed.
REASON
Unlicensed blood products were distributed in interstate commerce.
RECALLS AND FIELD CORRECTIONS: DEVICES -- II
________
PRODUCT
Accutemp Disposable Battery Operated hand held Cauteries.
Recall #Z-781/782-9.
CODE
Catalog # 84-44000, Lot Nos. 14358100, 16313200 and 16644100
Catalog #84-42000, Lot No. 14507500(Letters sent 1/29/99)
Expanded lot numbers for recall (letters sent out on March 24, 1999)
Catalog Nos. Lot Nos.
8442000 16133500
8442000 16676700
8442000 16724700
8442000 16724900
8442000 16751000
8442000 16896000
8442000 16896100
8442000 16896200
8442000 16896300
8442000 16958600
8442000 16958700
8442000 16958800
8442000 17080400
8442000 17080500
8442000 17080600
8442000 17080700
8442000 17119400
8442000 17150500
8442000 17150700
8442000 17150800
8442000 17362300
8442000 17421100
8442000 17617800
8442000 17625400
8442000 17625500
8442000 17744200
8443000 16436500
8443000 16620600
8443000 16620700
8443000 16644200
8443000 16644300
8443000 16896600
8443000 16896700
8443000 16896900
8443000 17080800
8443000 17080900
8444000 14012400
8444000 16308500
8444000 16644100
8444000 16897000
8445000 14696800
8445000 16264100
8445000 16388900
8445000 16436600
8445000 16511600
8445000 16897100
8446000 13053000
8446000 16436700
8446000 16593500
8446000 16898900.
MANUFACTURER
Xomed, Inc., Jacksonville, Florida.
RECALLED BY
Manufacturer, by letter on January 29, 1999, and March 24, 1999.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
11,881 boxes were distributed.
REASON
Sterility barrier (packaging) may be open thereby compromising
sterility.
________
PRODUCT
EndoSonics Oracle MegaSonics 5-64 PTCA Catheter, indicated for
percutaneous angioplasty to reduce coronary stenosis and improve
perfusion: Model numbers 35825, 35830, 35835, 35840.
Recall #Z-783/786-9.
CODE
Lot Numbers: 011999 and 012699.
MANUFACTURER
EndoSonic Corporation, Rancho Cordova, California.
RECALLED BY
Manufacturer, by telephone or by visit on March 15, 1999, and by letter
on March 19, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
250 units were distributed.
REASON
Failure of the balloon to meet the rated burst pressure as labeled.
________
PRODUCT
128XP Diagnostic Ultrasound Imaging System, Model 128XP with
Rev. 27.122 and 27.125. Recall #Z-787-9.
CODE
Rev. 27 software with the OB calculations option are affected by this
system.
MANUFACTURER
Acuson Corporation, Mountain View, California.
RECALLED BY
Manufacturer, by letter dated February 16, 1999. Firm-initiated field
correction ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
637 units were distributed.
REASON
There is a potential error condition related to OB Reports printed
after diagnosis.
________
PRODUCT
InstaTrak Straight Aspirators, Cat.No. ENT-100AS
InstaTrak 90 Degree Aspirator, Cat. No. ENT-101AM
InstaTrak 7 French Aspirator, Cat. No. ENT-100AS-P
The aspirators are accessories used with the InstaTrak System.
They are disposable hand-held instruments used as a single use
aspiration as well as localization device. Model InstaTrak Straight
Aspirators, Cat.No. ENT-100AS
InstaTrak 90 Degree Aspirator, Cat. No. ENT-101AM
InstaTrak 7 French Aspirator, Cat. No. ENT-100AS-P.
Recall #Z-788/790-9.
CODE
InstaTrak Straight Aspirator, Lot #'s:JAZ8270, JAZ8301, JAZ8334, JAZ8338
InstaTrak 90 Degree Aspirator, Lot #: JAZ8288
InstaTrak 7 French Aspirator, Lot #: JAZ8350
MANUFACTURER
Visualization Technology, Inc., Wilmington, Massachusetts.
RECALLED BY
Manufacturer, by letter on March 31, 1998. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, Egypt, Germany.
QUANTITY
3,890 units were distributed.
REASON
Outer pouch has incomplete seal compromising the sterility of the inner
pouch.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________
PRODUCT
BBL Baird-Parker Prepared Plated Media, for the isolation and presumptive
identification of coagulase-positive staphylococci from clinical specimens,
foods, air, water, and other materials. Recall #Z-762-9.
CODE
Catalog Numbers: 4397214 and 4397725; Lot #101312NAIX
EXP 10/21/97.
MANUFACTURER
Becton Dickinson Microbiology Systems, Madison, Wisconsin.
RECALLED BY
Becton Dickinson Microbiology Systems, Sparks, Maryland, by fax letters
dated October 15, 1997. Firm-initiated recall complete.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
50 boxes of 20 plates each of Catalog 97214 and 75 cartons of 100 plates
each of Catalog #97725
were distributed.
REASON
Product was contaminated by mold.
________
PRODUCT
BBL Trichosel Broth, Modified, with 5% Horse Serum, used for the isolation
and cultivation of Trichomonas species.
Recall #Z-765-9.
CODE
Lot #: 1013F8NYJB - EXP 9/1/98.
1013F8NYLL - EXP 9/1/98. Catalog #4398323.
MANUFACTURER
Becton Dickinson Microbiology Systems, Madison, Wisconsin.
RECALLED BY
Becton Dickinson Microbiology Systems, Sparks, Maryland, by telephone
on May 5, 1998. Firm-initiated recall complete.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
138 boxes of 10 tubes each were distributed.
REASON
Bacterial contamination.
________
PRODUCT
Abbott TestPack Rotavirus and Abbott TestPack Rotavirus with Control,
an in-vitro diagnostic enzyme immunoassay for the rapid detection of
Rotavirus antigen from human fecal specimens:
a) Abbott TestPack Rotavirus - 20 Tests,
List No. 6896-16,;
b) Abbott TestPack Rotavirus with Control, 20 Tests,
List No. 6896-25. Recall Z-791/792-9.
CODE
Lot numbers: 49023M200 and 50406M100.
MANUFACTURER
Abbott Laboratories, North Chicago, Illinois.
RECALLED BY
Abbott Laboratories, Abbott Park, Illinois, by letter dated March 16, 1999.
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
1,065 kits were distributed.
REASON
The Conjugate Reagent 3 vial dispenses drops which are too large and
does not contain enough reagent to complete the 20 tests claimed in
the label.
________
PRODUCT
STA Coag Control N + P and STA System Control N + P, in-vitro diagonistic
device used for measurements of various prothrombin, thermoplastin times,
thrombin/anti-thrombin times, and fibrinogen:
a) STA Coag Control N + P, Catalog No. 00679;; and
b) STA System Control N + P, Catalog No. 00678.
Recall #Z-793/794-9.
CODE
a) Lot Numbers: 9624621, 970271, 970631, 971602, 971603, and 972371;
b) 963402, 963403, 970503, 971141, and 972541.
MANUFACTURER
Diagnostica Stago, Franconville, France.
RECALLED BY
American Bioproducts Company, Parsippany, New Jersey, by letter faxed
from February 11, 1998 to March 19, 1998, and mail letter dated March
16, 1998. Firm-initiated field correction complete.
DISTRIBUTION
Alabama, California, Colorado, District of Columbia, Florida, Georgia,
Hawaii, Illinois, Louisiana, Massachusetts, Missouri, Nebraska,
New Jersey, New York, Pennsylvania, Tennessee, Virginia.
QUANTITY
a) 5,514; b) 2,325 kits were distributed.
REASON
The control N fibrinogen values are out of range.
________
PRODUCT
STA Coag Control N + P and STA System Control N + P, in-vitro diagnostic
used for measurements of various prothrombin, thermoplastin times,
thrombin/anti-thrombin times and fibrinogen:
a) STA Coag Control N + P, Catalog No. 0679;
b) STA System Control N + P, Catalog No. 0678.
Recall #Z-795/796-9.
CODE
Lot Numbers: a) 9624621, 970271, 970631, 971602, 971603, and 972371;
b) 963402, 963403, 970503, 971141, 972541.
MANUFACTURER
Diagnostica Stago, Frankonville, France.
RECALLED BY
American Bioproducts Company, Parsippany, New Jersey, by letter faxed
from January 29, 1998 to February 27, 1998, and by mail letter dated
February 27, 1998. Firm-initiated field correction complete.
DISTRIBUTION
Arizona, District of Columbia, Florida, Maryland, New Jersey, New York,
Pennsylvania, Virginia.
QUANTITY
a) 6163 kits; b) 2,325 kits were distributed.
REASON
The PTTA control P values are out of range.
________
PRODUCT
Extension Set used with the Quantum PD Night Exchange System to extend
the patient line on tubing sets with Easy-Lock compatible patient connectors:
a) Catalog #5C4391P - English label; b) R5C4391 - European label.
Recall #Z-797/798-9.
CODE
All lots.
MANUFACTURER
Baxter Healthcare Corporation, Mountain Home, Arkansas.
RECALLED BY
Baxter Healthcare Corporation, McGaw Park, Illinois,
by letter dated March 25, 1999. Firm-initiated recall ongoing
DISTRIBUTION
Nationwide and international.
QUANTITY
496,000 units were distributed.
REASON
Sets were assembled with the blue clamp at the wrong end of the set.
________
PRODUCT
Lubricated Latex Condoms, individually packaged for vending machines.
Condoms may have the following brands on the plastic wrapper inside
the cardboard display pack: Temptation, Pure Gold, Pure Platinum,
and Sunrise.
Recall #Z-799-9.
CODE
All condoms with the EXP 5/02.
MANUFACTURER
Hankook Latex Gongup Company, Ltd., Churchon, Kangwon DO, KS200-160, Korea.
RECALLED BY
Vend America, Inc. (V.A.I.), Lake Bluff, Illinois, by visit on March 11,
1999. Firm-initiated recall ongoing.
DISTRIBUTION
Indiana, Illinois, Wisconsin.
QUANTITY
3,600 units were distributed.
REASON
Outer packages has an extended expiration date.
END OF ENFORCEMENT REPORT FOR APRIL 14, 1999.
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