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.
September 10, 1997 97-37
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ==========
_______________
PRODUCT: Flower Jam. Recall# F-802-7.
CODE: None.
MANUFACTURER:Zeinoun El-Hakim, Tripoli, Lebanon.
RECALLED BY: Baroody Imports Clifton, New Jersy, by letter,
on May 22, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION:Virgirina, Maine, New Jersy, Nw York.
QUANTITY: 30 cases.
REASON: The products contains unapproved color
additives.
_____________
PRODUCT: Bonnie Ellen's Sugar Free Imported Gummi
Bears, Bonnie Ellen's Sugar Free Salt Water
Taffy. Recall# F-804/805-7.
CODE: All mislabled (old label) product.
MANUFACTURER:Bonnie Ellen's Candy Company Inc.,Sauk Rapids,
Minnesota.
RECALLED BY: Manufacturer, by letter on July 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION:Nationwide.
QUANTITY: 150/3.25 ounce bags, 1200/2.7 ounce bags were
distributed.
REASON: Some packages of both products contain
undeclared Yellow #5, Yellow #6, Red #3 and
aspartame without aspartame warning statement.
_____________
PRODUCT: Vanilla Ice Cream. Recall # F-715-7.
CODE: Lot# 050698.
MANUFACTURER:Kemps Food Incorporated, Lancaster,
Pennsylviana.
RECALLED BY: Manfacturer, by telephone on July 9, 1997.
Firm-initiated recall on-going.
DISTRIBUTION:Pennsylviana, West Virgirnia, Ohio.
OUANTITY: 8,988 half-gallon containers were distributed.
REASON: Undeclared wheat flour and corn flour. Some
containers actually Cookies N' Cream Ice.
Cream.
_____________
PRODUCT: Brown Sugar. Recall# F-806-7.
CODE: Lot# 4692 /46106.
MANUFACTURER:Domino's Sugar Corporation, Baltimore,
Maryland.
RECALLED BY: Manufacurer, on/about May 5, 1997.
Firm-initiated recall on-going.
DISTRIBUTION:Not determined.
QUANTITY: 2 million pounds.
REASON: The product is unfit for food due to
off-taste, off-odor and color.
Products have been associated with reports
of mouth, throat and gastrointestinal
irriation.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT: Canada Dry Tonic Water Contains Quinine.
Recall #F-635-7.
CODE: 7170.
2
MANUFACTURER:Coca Cola Bottling of North
England,Londonderry, New Hampshire.
RECALLED BY: Coca Cola Bottling of North England,Inc.,
Bedford, New Hampshire, by fax on July 16,
1997. Firm-initiated recall on-going.
DISTRIBUTION:Connecticut, Massachusetts, New Hampshire,
Vermont, Maine.
QUANTITY: 100 cases were distributed.
REASON: Undeclared sugar. The product, labeled as
"diet" actually contains regular tonic water.
RECALLS AND FIELD CORRECTIONS: DRUGS --
CLASS III ==========
_____________
PRODUCT: Baclofen Tablets. Recall #D-257/258-7
CODE: 10 milligram Lot # 24061, 24382, 24383, 26051,
24970, 24971, 26356, 26357, 26358, 24467,
26468, 26469, 26470.
20 milligram Lot # 24059, 24384,24385, 24964,
24972, 24973, 26353, 26354, 26355.
MANUFACTURER:Teva Pharmaceuticals USA, Incorporated,
Sellerville, Pennsylvianna.
RECALLED BY: Manufacturer, by letter, on July 21, 1997.
Firm-initiated recall on-going.
DISTRIBUTION:Nationwide.
QUANTITY: None remain on market.
REASON: Lack of assurance product will maintain
stability through labeled expiration
date.(Impurity)
_____________
PRODUCT: Baclofen tablets. Recall# D-259/260-7.
CODE: Lot numbers for 10 milligram: 7B634,7F804,
6V356, 7F799. Lot number for 20 milligram.
7A512
MANUFACTURER:UDL Labortories,Incorporated, Rockford
Illinois.
RECALLED BY: Manufacturer, by letter on July 24, 1997.
Firm initiated recall on-going.
DISTRIBUTION:Nationwide.
QUANTITY: 17184 unit cartons 10 miligrams, 2499 unit
cartons 20 miligrams.
REASON: Lack of assurance product will maintain
stability through labeled expiration
date.(Impurity)
____________
PRODUCT: Guaifenesin LA Caplets. Recall# D-241-7
CODE: Lot # 199.
MANUFACTURER:Pharmafab, Incorporated, Forth Worth, Texas.
RECALLED BY: Alphagen Labortories,Incorporated, by
facsimile on June 18, 1997. Firm-initiated
recall .
DISTRIBUTION:Nationwide.
QUANTITY: 864 bottles were distributed.
REASON: Product was mislabled. Some bottles may
contain pancreatic enzyme capsules.
3
_____________
PRODUCT: Baclofen Tablets, Recall# D-261-7.
CODE: Lot # 3541-021.
MANUFACTURER:Biocraft Labortories, Incorporated, Elmwood
Park, New Jersey.
RECALLED BY: Vangard Labs, Incorporated, Glasgow, Kentucky.
DISTRIBUTION:Ohio, Kentucky, Tennessee, North Carolina, New
Jersey, Minnesota, California.
QUANTITY: 104 cartons were distributed.
REASON: The manufacturer cannot assure that the
product will meet stability specifications
through its labeled expiration date.(Impurity)
_____________
PRODUCT: Milltown 600 tablets. Recall# D-263-7
CODE: Lot # 5F1032A
MANUFACTURER:Wallace Labortories, Cranbury, New Jersey.
RECALLED BY: Carter-Wallace, Cranbury, New Jersey, by
telephone on May 21, 1997. Firm-initiated
recall complete.
DISTRIBUTION:Nationwide.
QUANTITY: 627 bottles were distributed.
REASON: Dissolution failure.(Stability)
_____________
PRODUCT: Bisacodyl Tablets Recall# D-262-7.
CODE: Lot# 15253, 15368.
MANUFACTURER:Butler PharmaPac, Incorporated, Eligin,
Illinois.
RECALLED BY: Upsher-Smith Laboratories, Incorporated,
Minneapolis, Minnesota. Firm-initiated recall
on-going.
DISTRIBUTION:Nationwide.
QUANTITY: 4,089 boxes were distributed.
REASON: Product failed to meet potency and
disintegration requirements.(Stability)
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_____________
PRODUCT: (1)Red Blood Cells (2) Platelets (3)Recovered
Plasma. Recall# B-1315/B-1317-7.
CODE: Unit # for Red Blood Cells: (1)10510-4685,
10507-4632, 10503-7921. Unit # for Platelets:
(2)10503-7921. Unit # for Recovered Plasma:
(3)10507-4632, 10503-7921.
MANUFACTURER: United Blood Services, Scottsdale, Arizona.
RECALLED BY: Blood System, Incorporated, Scottsdale,
Arizona,on March 19, 1997. Firm-initiated
recall on-going.
DISTRIBUTION: Arizona, Switzerland.
4
QUANTITY: 6 units were distributed.
REASON: Blood products, collected from a doner who
had body piercing performed within 12 months
of donation.
____________
PRODUCT: (1)Red Blood,(2) Platelets,(3) Recovered
Plasma. Recall# B-1318/B-1320-7.
CODE: (1) 14001-6400,(2) 14002-6029,(3) 14001-6400,
14002-6029.
MANUFACTURER: United Blood Services, Lafayette, Louisanna.
RECALLED BY: Blood System, Incorporated, Scottsdale,
Arizona, by letter, on June 13, 1997 and June
27, 1997. Firm-initiated recall on-going.
DISTRIBUTION: Florida, Louisanna.
QUANTITY: 5 units were distributed.
REASON: Blood products, collected form a donaor who
had previously been deferred.
____________
PRODUCT: Recovered Plasma Recall# B-1321-7
CODE: Unit# 10214-7160
MANUFACTURER: United Blood Services, Scottsdale, Arizona.
RECALLED BY: Blood System, Incorporated, Scottsdale,
Arizona, by letter, on June 13, 1997.
Firm-initiated recall complete.
DISTRIBUTION: Switzerland
QUANTITY: 1 unit was distributed.
REASON: Blood product, which tested negative for the
antibody to HIV-1, but was collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot
negative, was distributed.
____________
PRODUCT: (1)Red Blood Cells,(2) Reovered Plasma.
Recall# B-1322-7, B-1323-7.
CODE: (1)20023-5639, (2) 20023-5639.
MANUFACTURER: United Blood Services, Lafayette, Lousianna.
RECALLED BY: Blood System, Incorporated, Scottsdale,
Arizona, by letter, on June 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION: Louisanna, Switzerland.
QUANTITY: 2 units were distributed.
REASON: Blood product, which tested negative for the
antibody to HIV-1, but was collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot
negative, was distributed.
___________
PRODUCT: Red Blood Cells, Platelets, Recovered Plasma,
Recall # B-1328/B-1330-7.
CODE: Unit# 22057-3971
MANUFACTURER: United Blood Services, Las Vegas, Nevada.
5
RECALLED BY: Blood System, Incorporated, Scottsdale,
Arizona, by letter, on June 24 and 27, 1997.
Firm-initiated recall on-going.
DISTRIBUTION:Nevada, Arizona, Switzerland.
QUANTITY: 3 units were distributed.
REASON: Blood products, collected from a donor who had
previously been deferred, were distributed.
____________
PRODUCT: Red Blood Cells, Platelets, Recovered Plasma,
Recall# B-1374/B-1376-7.
CODE: Unit# 10141-8314.
MANUFACTURER:United Blood Services, Scottsdale, Arizona.
RECALLED BY: Blood System, Incorporated, Scottsdale,
Arizona, by letter, on May 27, 1997 or July
14, 1997. Firm-initiated recall complete.
DISTRIBUTION:Arizona, Switzerland.
QUANTITY: 3 units were distributed.
REASON: Blood product, which tested negative for the
antibody to HIV-1, but was collected from a
donor who previously tested repeatedly
reactive for anti-HIV-1, Western blot
negative, was distributed.
____________
PRODUCT: Red Blood Cells, Fresh Frozen Plasma.
CODE: B-1380/1381-7
Unit# 23131-0111, 23131-4401, 23131-7432,
23032-4589.
MANUFACTURER:United Blood Services, Billing, Montana.
RECALLED BY: Blood System, Incorporated, Scottsdale,
Arizona, by letter, on May 31, 1996.
Firm-initiated recall complete.
DISTRIBUTION:Montana, New York.
QUANTITY: 8 units were distributed.
REASON: Blood products, collected from a donor who
tested non-reactive for anti-HTLV-I, but
previously tested repeatedly reactive for
anti-HTLV-I, WB negative on the first donation
and indeterminate on the second was
distributed.
____________
PRODUCT: (1)Fresh Frozen Plasma,(2)Recovered Plasma,(3)
Red Blood Cells,(4) Red Blood Cells Washed,
(5)Cryoprecipitate,(6) Platelets.
Recall# B-1273/B-1278-7
CODE: Unknown.
MANUFACTURER: United Blood Services, Scottsdale, Arizona.
RECALLED BY: Blood System, Incorporated, Scottsdale,
Arizona, by letter, on July 10, 1997.
Firm-initiated recall on-going.
DISTRIBUTION: Arizona, Calfornia, Nevada, new york, North
Carolina, Utah, Switzerland.
6
QUANTITY: (1) 5 units,(2)6 units,(3) 9 units,(4)1 unit,
(5)4 units,(6)6 unit were distributed.
REASON: Blood products, collected from a dono0r who
was implicated in a post transfusion hepatitis
case, were distributed.
____________
PRODUCT: (1)Red Blood Cells,(2) Platelets,(3) Fresh
Frozen Plasma,(4) Recovered Plasma.
Recall# B-1297/B-1300-7.
CODE: (1) units 10509-7896, 10229-9679,10178-6284,
10163-8337, 10156-7087, 10166-9255, 10161-3083,
(2) units 10178-6284, 10229-9679, 10156-7087,
(3) units 10509-7896, 10178-6284, 10156-7087,
(4) units 10161-3083, 10229-9679, 10163-8337.
MANUFACTURER:United Blood Services, Scottsdale, Arizona.
RECALLED BY: Blood System, Incorporated, Scottsdale,
Arizona, by letter, on February 5, 1997.
Firm-initiated recall complete.
DISTRIBUTION:Arizona, North Carolina, New York,
Switzerland.
QUANTITY: 16 units were distributed.
REASON: Blood products, collected from a donor who was
implicated in a post transfusion hepatitis
case, were distributed.
____________
PRODUCT: (1)Red Blood Cells,(2) Platelets,(3) Recovered
Plasma. Recall # B-1371/1373-7.
CODE: (1) 10237-1912, 10241-9242, 10488-2494, (2)
10241-9242, (3) units 10237-1912, 10241-9242.
MANUFACTURER:United Blood Services, Scottsdale, Arizona.
RECALLED BY: Blood System, Incorporated, Scottsdale,
Arizona, by letter, on May 27, 1997.
Firm-initiated recall on-going.
DISTRIBUTION:Illinois, Arizona, Switzerland.
QUANTITY: 6 Units were distributed.
REASON: Blood products, which were collected from a
donor who received a tatoo within 12 months of
donation were distributed.
____________
PRODUCT: Hemocare Blood Bank Data Management Systems
Computer Software, Release Version 5.1 & 3.1.
Recall #B-1258-7
CODE: Unknown.
MANUFACTURER:Mediware Information Systems,Inc., Mulville,
New York.
RECALLED BY: Manufacturer, by letter on July 9, 1997 and
August 4, 1997. Firm-initiated recall on-going.
DISTRIBUTION:Nationwide, Canada.
QUANTITY: 219 systems were distributed.
7
REASON: Computer software, that contains programming
errors which could potentially result in the
release of mistyped blood products, was
distributed.
____________
PRODUCT: Red Blood Cells, Platelets, Fresh Frozen
Plasma, Recovered Plasma.
Recall # B-1333/B-1336-7.
CODE: Contact center for exact codes.
MANUFACTURER:United Blood Services, Las Vegas, Nevada.
RECALLED BY: Blood System, Incorporated, Scottsdale,
Arizona, by letter, on March 12, 1997.
Firm-initiated recall complete.
DISTRIBUTION:Arizona, North Carolina, New Jersy, Nevada,
Switzerland.
QUANTITY: 28 units were distributed.
REASON: Blood products, collected from a donor who was
implicated in a post transfusion hepatitis
case, were distributed.
_____________
PRODUCT: (1)Red Blood Cell,(2) Red Blood Cells,
Irradiated,(3)Pheresis(Autologous),(4)Platelets,
(5)Cryoprecipitate,(6) Fresh Frozen Plasma,
(7)Recovered Plasma. Recall # B-1355/1361-7.
CODE: Contact CBER for specific unit numbers.
MANUFACTURER:Topeka Blood bank, Incorporated, Topeka,
Kansas.
RECALLED BY: Manfacturer, by telephone and letter on June
23, 1997. Firm-initiated recall on-going.
DISTRIBUTION:Arkansas, California, Flordia, Georgia,
Kansas, Missouri, Tennesse.
QUANTITY: (1) 354 Units, (2)4 units, (3) 2 units, (4)46
units,(5) 40, units,(6) 65 units,(7)228 units.
REASON: Blood products, wich were collected from a
donor in which infectious disease testing was
performed improperly and were distributed.
_____________
PRODUCT: Red Blood Cells, Recovered Plasma Recall #
B-1366/1367-7.
CODE: Units K07883.
MANUFACTURER:Topeka Blood Bank, Incorporated, Topeka,
Kansas.
RECALLED BY: Manfacturer,by letter on June 2, 1997.
Firm-initiated recall complete.
DISTRIBUTION:Kansas
QUANTITY: 2 units were distributed.
REASON: Blood products, wich were collected from a
donor in which infectious disease testing was
performed improperly and were distributed.
8
____________
PRODUCT: (1)Whole Blood,(2) Platelets,(3) Leukocytes.
Recall # B-1382/B-1384-7
CODE: Contact CBER for specific unit numbers.
MANUFACTURER:New York Blood Services, New York, New York.
RECALLED BY: Manufacturer, by letter on July 14, 1997.
Firm-initiated recall on-going.
DISTRIBUTION:Arizona, Califorina, Flordia,
Massachusetts,Maryland, New York, New Jersy,
Pennsylvianna, Tennesse, Texas, Utah.
QUANTITY: (1) 6 units, (2)809 units, (3) 15 units.
REASON: Blood products may have been improperly
tested for viral markers between September 1,
1996 and November 20, 1996, and were
distributed.
____________
PRODUCT: Platelets Recall# B-1352-7.
CODE: Unit 3222131.
MANUFACTURER:Sylvan N. Goldman Center, Oklahoma Blood
Institute, Oklahoma City, Oklahoma.
RECALLED BY: Manfacturer, by telephone on October 18, 1996.
Firm-initiated recall complete.
DISTRIBUTION:Texas.
QUANTITY: 1 unit.
REASON: Blood product that was collected from a donor
who was exposed to hepatitis A, was
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_____________
PRODUCT: Red Blood Cells, Platelets. Recall # B-1324/
B-1325-7.
CODE: Units 36022-8354, 36022-4146.
MANUFACTURER:Blood Systems, Incorporated, Scottsdale,
Arizona
RECALLED BY: United Blood Services, Ventura, California, by
letter on June 16, 1997. Firm-initiated
recall complete.
DISTRIBUTION:California, North Carolina, Switzerland.
QUANTITY: 2 units
REASON: Blood products, which tested negative for the
antibody to the hepatitis B core antigen, but
were collected from a donor who previously
tested reactive for anti-HBc, were
distributed.
_____________
PRODUCTS: Fresh Fresh Plasma. Recall#B-1326/B-1327-7
CODE: Unit# 16031-8957.
MANUFACTURER:United Blood Systems, Incorporated, Meridian,
Missouri.
9
RECALLED BY: Blood Systems, Incorporated,Scottsdale,
Arizona by letter on June 16, 1997.
Firm-initiated recall complete.
DISTRIBUTION:Calfornia.
QUANTITY: 2 units.
REASON: Blood products, which tested negative for the
antibody to the hepatitis B core antigen, but
were collected from a donor who previously
tested reactive for anti-HBc, were distributed
___________
PRODUCTS: Red Blood Cells and Fresh Frozen Plasma.
Recall#B-1331/B-1332-7
CODE: Unit 36021-9850.
MANUFACTURER:Blood Systems, Incorporated, Scottsdale,
Arizona.
RECALLED BY: United Blood Services, Meridian, Mississippi,
by letter on June 11, 1997. Firm-initiated
recall complete.
DISTRIBUTION:Calfornia.
QUANTITY: 2 units were distributed.
REASON: Blood products, which tested negative for the
antibody to the hepatitis B core antigen, but
were collected from a donor who previously
tested reactive for anti-HBc, were
distributed.
_____________
PRODUCT: Fresh Frozen Plasma. Recall# B-1377-7.
CODE: Unit 16335-5904
MANUFACTURER:Blood Systems, Incorporated, Hattiesburg,
Mississippi.
RECALLED BY: Manfacturer, by telephone on January 6, 1997.
DISTRIBUTION:Mississippi.
QUANTITY: 1 unit was distributed.
REASON: Blood product, which was not frozen within 8
hours of Whole Blood collection, was
distributed.
_____________
PRODUCT: Platelets Pheresis, Leukoreduced. Recall
#B-1349-7.
CODE: Unit 50P17694
MANUFACTURER:American Red Cross Blood Services, Toledo,
Ohio.
RECALLED BY: Manufacturer, by telephone on June 24, 1997.
Firm initiated recall complete.
DISTRIBUTION:Calfornia.
QUANTITY: 1 unit
REASON: Platelets not stored under continuous
agitation were distributed.
10
_____________
PRODUCT: Source Plasma. Recall # B-1351-7
CODE: Units 33748E, 35607E, 35902E, 34923E.
MANUFACTURER:Bloomington Plasma, Incorporated.
RECALLED BY: Manufacturer, by fax on March 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION:North Carolina.
QUANTITY: 1 unit
REASON: Blood products, collected from a new donor who
had no syphilis testing performed, were
distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES --
CLASS II =========
_______________
PRODUCT: Ultra Sound Imaging System Probe. Recall# Z-891-7.
CODE: Lot # 1000 thur 1056.
MANUFACTURER:Diasonics Ultrasound, Incorported, Santa
Clara, Calfornia.
RECALLED BY: Maufacturer,by letter on July 25, 1997.
Firm-initiated recall complete.
DISTRIBUTION:Nationwide.
QUANTITY: 45 units were distributed.
REASON: Some of their production probes have the
potential to exceed the FDA limitfor Ispta 3
fo 430 mW/cm2.
______________
Product: Medex 60 inch Mini-Vol Extension Set with
Female and Male Luer Lock, Recall #Z-861-7.
Code: Lot #27C102003.
Manufacturer:Medex, Inc. Hillard, Ohio.
Recalled by: Manufacturer, by letter on July 30, 1997.
Firm-initiated recall on-going.
Distribution:Nationwide.
Quantity: 162 cases were distributed.
Reason: The product was assembled using incorrect
tubing, increasing the priming volume to
approximately 1.0 ml.
_______________
Product: (a) 6" Non-Sterile cotton Tip Applicators in
trays; (b) 3" Non-Sterile Cotton Tip
Applicators in trays; 6" Sterile Cotton Tip
Applicators in trays, Recall #Z-871/873-7.
Code: Lot #'s (a) 66010509 - 67040743, (b) 66080586
- 67020707; various lot numbers.
Manufacturer: Maxim Medical, Temecula, California.
Recalled by: Manufacturer, by letter on May 30,June 6 and
June 17, 1997. Firm initiated recall on-going.
Distribution:Nationwide.
11
Quantity: (a)89,197;(b) 47,489:(c) 2,642 units were
distributed.
Reason: The cotton tips of the applicators may
become detached during use.
_____________
Product: Radiation Protective Devices:
(1) Peak-Flex Aprons; (2) Peak-Flex S/P
Aprons; (3) Peak-Flex O/R Aprons;
(4)Flex-Buckle Aprons; (5) Peak Half Apron;
(6) Econo-Tie Aprons; (7) Peak-Weight Aprons;
(8) Coat S/P Aprons; (9) Dual S/P Aprons;
(10)Peak-Weight S/P Aprons; (11) Peak-Weight
O/R Aprons; (12) Peak Buckle Aprons; (13)
Flex-Vest; (14) Peak-Vest; (15) Flex-Skirt;
(16) Peak-Skirt; (17) Gonadal Shields 3"x5",
6"x7", 7"x9" set of three; (18) Scoliosis
Shawl; (19) Thyroid Collar (optional); (20)
Thyroid Collar (attached to any apron),
Recall #Z-876/883-7.
Code: Catalog Numbers: (1) F328185, F330205,
F332205,F332225, F332245, F334245, F336245,
F338245,F342245, (2) F728187,F730207 F732207,
F732227, F732247, F734247, F736227, F736247,
F738247, F742247; (3) F828185, F830205,
F832205, F832225, F832245, F834245, F836225,
F836245, F838245, F842245; (4) F928185,
F930205, F932205, F932225, F932245, F934245,
F936225, F936245,F938245, F942245, (5)
X112125, X112185, X112245, X118245,
X124245,(6) X230205, X232225, X232245,
X236225, X236245, X238245,(7) X328185,
X330205, X332205, X332225, X332245, X334245,
X336225, X336245, X338245, X342245; (8)
X430207, X432227, X432247, X436227, X436247,
X438247, (9) X530207, X532227, X532247,
X536227, X536247, X538247, (10) X728187,
X730207, X732207, X732227, X732247, X734247,
X736227, X736247, X738247, X742247, (11)
X828185, X830205, X832205, X832225, X832245,
X834245, X836225, X836245, X838245, X842245,
(12) X928185, X930205, X932205, X932225,
X932245, X934245, X936225, X936245, X938245,
X942245, (13) FV20207, FV22227, FV24247, (14)
XV20207, XV22227, XV24247, (15) FS18367,
FS20447, FS24487, (16) XS18367, XS20447,
XS24487, 17)X603055, X606075, X607095,
X635679, (18) X618065, (19) X605255, (20)
X608165.
Manufacturer:Peak International, Scottosboro, Alabama.
Recalled by: Manufacturer, by letter on July 3, 1997.
Firm-initiated recall ongoing.
Distribution:Nationwide.
Quantity: Unknown.
12
Reason: The radiation protection devices contain lead
contaminated with small amounts of radioactie
substances.
_______________
Product: Tuttnauer Table Autoclave Models 1730, 2340
and 2540 "M" and "E" series, Recall #Z-886-7.
Code: Serial #s 9204816 thru 9501300.
Manufacturer: Tuttnauer Company, Ltd., Isreal.
Recalled by: Manufacturer, by letter on August 5, 1997.
Firm initiated recall ongoing.
Distribution: Nationwide, International.
Quantity: 1,200 units were distributed.
Reason: The potential exists for the ball type thrust
bearing to fracture from over-tightening of
the door closing device, causing an explosive
release of steam from the autoclave.
_______________
Product: Solid Abutments and Retentive Anchors as
follows: (1) Solid Abutment 6 degrees height
4.0 mm; (2) Solid Abutment 6 degrees height
5.5 mm; (3) Solid Abutment 6 degrees height
7.0 mm; (4) Retentive Anchor, Recall
#Z-887/890-7.
Code: Lot #s (1) 1025, 1026, 1027, 1028; (2) 1032,
1034, 1035, 1036; (3) 1023, 1200, (4) 1021.
Manufacturer: Institut Strauman AG, Switzerland.
Recalled by: The Straumann Company, Walham, Massachusetts,
by letter on July 17, 1997. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 1,676 units were distributed.
Reason: The observed subsurface cracks can lead to
fractures of the devices.
_______________
Product: 12 French Self Cath Catheter, Recall #Z-898-7.
Code: Lot #2233, Catalog #20-00461.
Manufacturer: Mentor Urology, Inc., Minneapolis, Minnesota.
Recalled by: Manufacturer, by telephone on September 25,
1997 and by letter October 24, 1996.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 10, 650 catheters were distributed.
Reason: The immediate package which correectly
contained a 12 French catheter, was labeled
"Self-Cath Sterile Catheter 16 FR.
13
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III==========
_______________
Product: Revision Knee Implants Femoral Extension
Stems, Recall #Z-894/897-7.
Code: Lot #s 268931, 268951, 268961, 268411.
Manufacturer: Encore Orthopedics, Inc., Austin, Texas.
Recalled by: Manufacturer, by letter on August 11, 1997.
Firm-initiated recall ongoing.
Distribution: Germany.
Quantity: 39 units were distributed.
Reason: The products were not packaged with a looking
screw.
_______________
Product: Schneider Renal Standard Catheter Model 10012,
8F, 55cm length; Renal Short Standard
Catheters Model 10011, 8F 55cm length, Recall
#Z-884/885-7.
Code: Lot #s 2PS971203 (Model 10012); 2PT971201
(Model 10011).
Manufacturer: Schneider (USA) Inc. Pfizer Hospital products
Group, Minneapolis, Minnesota.
Recalled by: Manufacturer, by letter on August 11, 1997.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 25 catheters were distributed.
Reason: Mislabled.
CORRECTION FOR FOODS FROM SEPTEMBER 3, 1997. Nally's Fine
Foods Inc. Is the correct firm name.
END OF ENFORCEMENT REPORT FOR SEPTEMBER 10, 1997.
BLANK PAGES MAY FOLLOW.
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