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.



February 10, 1999                                      
99-06

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________
PRODUCT
Allergenic Extract - Beef 40,000 PNU/mL. Recall #B-403-9.

CODE
Lot #F241-29-1H1.

MANUFACTURER
Greer Laboratories, Inc., Lenoir, North Carolina.

RECALLED
Manufacturer, by telephone and letter on December 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
Montana, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia.

QUANTITY
14 vials were distributed.

REASON
Allergenic extract labeled with an extended expiration date and incorrect PNU/mL.

________
PRODUCT
Allergenic Extract - Standardized Timothy Grass Pollen. Recall #B-404-9.

CODE
Lot G28-17B-2UF5.

MANUFACTURER
Greer Laboratories, Inc., Lenoir, North Carolina.

RECALLED
Manufacturer, by telephone on December 11 and 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
California, Kansas, Maryland, Minnesota, Ohio, Tennessee, Texas.

QUANTITY
8 vials were distributed.

REASON
Allergenic extract was labeled with an extended expiration date.

________
PRODUCT
Platelets, Pheresis. Recall #B-431-9.

CODE
Unit #04LP28019.

MANUFACTURER
American Red Cross, Dedham, Massachusetts.

RECALLED
Manufacturer, by letter dated January 31, 1997. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts.

QUANTITY
1 unit was distributed.

REASON
Blood product had a high white cell count.

________
PRODUCT
a) Red Blood Cells; b) Red Blood Cells, Leukocytes-Reduced; c) Platelets; d) Pheresis; e) Platelets For Further Manufacture; f) Recovered Plasma. Recall #B-432/437-9.

CODE
Unit numbers: a) C33009, C33084, C33085, C33219, C33253, F64743, F64749, F64894, L71773, L71834, L71992, L72321, L72322, L72323, L72326, W01678; b) C33045; c) C33045; d) L72281; e) C33084; f) C32855, C32931, C33045, C33084, C33085, F64601, F64894, F64918, L71730, L71773, L71992, L72321, L72322, L72323, L72326, W01678.

MANUFACTURER
Southeastern Community Blood Center, Tallahassee, Florida.

RECALLED
Manufacturer, by letters on January 9, 1996, and October 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
Florida, Georgia, New York.

QUANTITY
a) 16 unit; b-e) 1 unit of each component; g) 16 units were distributed.

REASON
Blood products were tested for anti-HCV and anti-HBC using equipment that had failed repeatability testing.

________
PRODUCT
Cryoprecipitated Antihemophilic Factor. Recall #B-439-9.

CODE
Unit #0001576.

MANUFACTURER
Universal Blood Foundation, Miami, Florida.

RECALLED
Manufacturer, by telephone on December 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
Florida.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor who tested repeat reactive for anti-HCV.

________
PRODUCT
Red Blood Cells. Recall #B-440-9.

CODE
Unit #0001789.

MANUFACTURER
Universal Blood Foundation, Miami, Florida.

RECALLED
Manufacturer, by telephone on December 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
Florida.

QUANTITY
1 unit was distributed.

REASON
Blood product tested reactive for syphilis.

________
PRODUCT
Red Blood Cells. Recall #B-441-9.

CODE
Unit numbers: 0001546, 0001547, 0001552, 0001528, 0001501, 000278, 0001517, 0001520, 0001529, 0001511.

MANUFACTURER
Universal Blood Foundation, Miami, Florida.

RECALLED
Manufacturer, by fax on October 22, 1998. Firm-initiated recall complete.

DISTRIBUTION
Florida.

QUANTITY
10 units were distributed.

REASON
Blood products tested repeatedly reactive for either HIV, HBC, HCV or HTLV-1, or had an elevated ALT or positive antibody screen.

________
PRODUCT
a) Red Blood Cells; b) Platelets. Recall #B-443/444-9.

CODE
Unit #50LF03380.

MANUFACTURER
American Red Cross Blood Services, Toledo, Ohio.

RECALLED
Manufacturer, by letter dated May 27, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

________
PRODUCT
Red Blood Cells. Recall #B-445-9.

CODE
Unit #40FL23893.

MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.

RECALLED
Manufacturer, by letter dated January 5, 1999. Firm-initiated recall complete.

DISTRIBUTION
Illinois.

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-446-9.

CODE
Unit #2256910 and 2256912.

MANUFACTURER
The Blood Center of New Jersey, Inc., East Orange, New Jersey.

RECALLED
Manufacturer, by letter dated June 16, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Jersey.

QUANTITY
2 units were distributed.

REASON
Blood products were colleted from donors who reported travel to an area designated as endemic for malaria.

________
PRODUCT
Red Blood Cells. Recall #B-447-9.

CODE
Unit #0168140.

MANUFACTURER
The Blood Center of New Jersey, Inc., East Orange, New Jersey.

RECALLED
Manufacturer, by telephone on September 2, 1998, and by letter dated September 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Jersey.

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
a) Red Blood Cells; b) Red Blood Cells Leukocytes Reduced; c) Platelets, Pheresis; d) Recovered Plasma. Recall #B-449/452-9.

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.

LABORATORY
American Red Cross, National Testing Laboratory, Portland, Oregon.

RECALLED
American Red Cross, Boise, Idaho, by letter between January 2, 1998, and February 6, 1998, or September 22, 1998. Firm-initiated recall complete.

DISTRIBUTION
California, Idaho, Montana, Washington state, Puerto Rico, Switzerland.

QUANTITY
a) 116 units; b) 4 units; c) 8 units; d) 127 units were distributed.

REASON
Blood products were incorrectly tested for syphilis.

________
PRODUCT
Platelet, Pheresis. Recall #B-454-9.

CODE
Unit #6261067.

MANUFACTURER
Long Island Blood Services, a Division of New York Blood Center, Melville, New York.

RECALLED
Manufacturer, by telephone on August 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
New York.

QUANTITY
1 unit was distributed.

REASON
Blood product had an unacceptable platelet count.

________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma for Manufacturing Non-Injectables. Recall #B-455/456-9.

CODE
Unit #24KM29453.

MANUFACTURER
American Red Cross Blood Services, Louisville, Kentucky.

RECALLED
Manufacturer, by letter dated March 11, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana and Massachusetts.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor with a history of hepatitis.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________
PRODUCT
Platelets. Recall #B-405-9.

CODE
Unit #8038245.

MANUFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED
Manufacturer, by letter dated November 18, 1998. Firm-initiated recall complete.

DISTRIBUTION
Florida.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected from a donor whose arm inspection and skin disease status had not been documented.

________
PRODUCT
Red Blood Cells. Recall #B-429-9.

CODE
Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.

MANUFACTURER
American Red Cross, Dedham, Massachusetts.

RECALLED
Manufacturer, by telephone and fax on September 4, 1998, and by letter dated September 14, 1998. Firm-initiated recall complete.

DISTRIBUTION
Massachusetts, Maine, New Hampshire, New York, Vermont.

QUANTITY
122 units were distributed.

REASON
Blood products had high white cell counts.

________
PRODUCT
Red Blood Cells. Recall #B-438-9.

CODE
Unit #8029006.

MANUFACTURER
LifeShare, Inc., Elyria, Ohio.

RECALLED
Manufacturer, by telephone on November 17, 1998, and by letter dated December 1, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

REASON
Blood product was collected in an anticoagulant Citrate Phosphate Adenine Solution (CPA-1) bag that exceeded its expiration date.

________
PRODUCT
Red Blood Cells, Irradiated. Recall #B-448-9.

CODE
Unit numbers: 0661127, 0692311, 0683207, 0693348, 0693328, 0699130, 0693349, 0668996, 0693265, 0699106.

MANUFACTURER
Bergen Community Regional Blood Center, doing business as Community Blood Services, Paramus, New Jersey.

RECALLED
Manufacturer, by telephone on August 20, 1998, and by letters dated either August 20, 1998, or August 21, 1998, or August 24, 1998. Firm-initiated recall complete.

DISTRIBUTION
New Jersey.

QUANTITY
10 units were distributed.

REASON
Blood products were labeled with extended expiration dates.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________
PRODUCT

5 Models of Alaris Signature Edition Infusion Pumps, may be used
to deliver variety of fluids over a broad range of infusion rates
from multiple fluid container types:
a) Model 7000 Single Channel, general purpose infusion pump;
b) Model 7100 Single Channel, advanced feature, 110V, domestic
infusion pump;
c) Model 7200 Dual Channel, advanced feature, 110V, domestic
infusion pump;
d) Model 7101 Single Channel, advanced feature, 220V, internal
infusion pump;
e) Model 7201 Dual Channel, advanced feature, 220V, internal
infusion pump.  Recall #Z-553/557-9.

CODE
All pumps with Serial Numbers less than 3365599.

MANUFACTURER
Alaris Medical Systems, Inc., San Diego, California.

RECALLED
Manufacturer, by letter dated November 4, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
a) 1,132 units; b) 17,282 units; c) 7,746 units; d) 989 units; e) 332 units were distributed.

REASON
The improper installation of a spring in the pumping mechanism assembly may result in uncontrolled flow.

________
PRODUCT
Sterile 12-Ply Hydrogel Saturated Gauze: a) Hydrogel Saturated 2 x 2 Dressing; b) Hydrogel Saturated 4 x 4 Dressing. Recall #Z-558/559-9.

CODE
000331008, 00239008, 000239008, 00223008, 000203008, 000176008, 000303008.

MANUFACTURER
Gentell, Inc.,Trevose, Pennsylvania.

RECALLED
Manufacturer, by letter on January 15, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
14,042 units were distributed.

REASON
The devices were distributed as sterile devices without assurance that they were sterile.

_______
PRODUCT
Bard Vascular Graft Sizer, a caliper type device designed to assist a physician in determining the inner and outer diameter of a patient's blood vessel and the appropriate vascular graft diameter. Recall #Z-560-9.

CODE
Lot Numbers: 08GG0092, 08AH0046, 08AH0047, 08AH0048, 08AH0049, 08AH0050.

MANUFACTURER
Bard Vascular Systems, Division, Billerica, Massachusetts.

RECALLED
Impra, Subsidiary C.R. Bard, Inc., Tempe, Arizona, by letter dated December 17, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alaska, Kansas, Maryland, Missouri, North Carolina, New Mexico, Pennsylvania, Ohio, Texas, Virginia, France, Ireland, Switzerland, Thailand.

QUANTITY
3,268 units were distributed.

REASON
Placement of the device in the packaging resulted in the device being pushed through the sterile seal in the pouch, compromising the sterility of the device.

________
PRODUCT
ACS RX Comet VP Coronary Dilatation Catheter, Product Part No. 1001280-15. Recall #Z-562-9.

CODE
Lot No. 8101951.

MANUFACTURER
Guidant Corporation, Advanced Cardiovascular Systems, Temecula, California.

RECALLED
Manufacturer, by telephone and letter on December 9, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Texas, Pennsylvania, Michigan, Wisconsin, Colorado, Nevada, Wyoming, California, Illinois, Missouri, Arizona, Iowa, Washington, Florida, Ohio.

QUANTITY
59 units were distributed.

REASON
The placement of incorrect balloon size information on the side arm of the catheter could result in the use of a 3.5 mm balloon in a 3.0 mm vessel.

________
PRODUCT
Patient Hoist Slings: a) Standard Sling, Model MAA2000-XS, extra small, brown MAA2000-S, small, red MAA2000-M, medium, yellow MAA2000-L, large, green MAA2000-XL, extra large, blue; b) Padded Sling, Model MAA4000-XS, extra small, brown MAA4000-S, small, red MAA4000-M, medium, yellow MAA4000-L, large, green MAA4000-XL, extra large, blue; c) Mesh Sling, Model MAA4060-XS, extra small, brown MAA4060-S, small, red. Recall #Z-563/569-9.

CODE
All MAA series Models, Sizes and Colors are affected, except any slings with time clock faces engraved on the plastic clip, or with a Washing Instruction Tag with a CE mark on it are not subject to the recall.

MANUFACTURER
Arjo Ltd., Gloucester, UKGL1 2SL.

RECALLED
Arjo, Ltd., Morton Grove, Illinois, by letter dated December 21, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Approximately 110,000 slings were distributed.

REASON
The attachment clips (Zytel EFE 8018, 14% glass filled super-tough nylon 66) on the patient hoist slings may crack along the vertical axis due to a molding defect, affecting slings manufactured between July 1994 and December 1996.

________
PRODUCT
Venture HomeFill Complete Home Oxygen Concentrator System. Recall #Z-570-9.

CODE
All serial numbers beginning with either 98A through 98J, or 11897K.

MANUFACTURER
Invacare Respiratory Products, Sanford, Florida.

RECALLED
Invacare Corporation, Elyria, Ohio, by letter on January 15, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
832 units were distributed.

REASON
Device was marketed without an approved 510(k).

________
PRODUCT
Bivona Adjustable Hyperflex Tracheostomy Tube and Bivona Adjustable Hyperflex Tracheostomy Tube Kit, intended for temporary airway access in a tracheotomized patient when determining the optimal tube length for the patient: a) Bivona Adjustable Hyperflex Tracheostomy Tube, Catalogue No. 67HA60; b) Bivona Adjustable Hyperflex Tracheostomy Tube Kit, Catalogue No. 67HAKT. Recall #Z-571/572-9.

CODE
Lot Numbers: a) 783920; b) 804900.

MANUFACTURER
Bivona Medical Technologies, Division of UroQuest Medical Corporation, Gary, Indiana.

RECALLED
Manufacturer, by letter on November 1, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Alabama, Arizona, California, Hawaii, Indiana, Illinois, Maryland, Massachusetts, Michigan, Minnesota, Nebraska, Pennsylvania, South Carolina, Texas, Virginia, Italy, Spain.

QUANTITY
47 units.

REASON
The adjustable neck flange was slipping when wet, even though the locking mechanism was secured. ________
PRODUCT
Oral RAE Tracheal Tubes, indicated for use in airway management during those surgical procedures involving the head, neck, or mouth:

a) Oral Rae Preformed Tracheal Tube, Uncuffed, Sterile, Rx
SIZE (mm.)          CATALOG NO.
3.0                 86263
3.5                 86264
4.0                 86265
4.5                 86266
5.0                 86267
5.5                 86268
6.0                 86269
6.5                 86270
7.0                 86271
b) Oral Rae Preformed Tracheal Tube, Cuffed, Sterile, Rx
SIZE (mm.)          CATALOG NO.
4.0                 86209
4.5                 86199
5.0                 86200
5.5                 86201
6.0                 86202
6.5                 86203
7.0                 86204
7.5                 86205
8.0                 86206
8.5                 86207
9.0                 86208
c) Nasal Rae Preformed Tracheal Tube, Cuffed, Sterile, Rx
SIZE (mm.)          CATALOG NO.
6.0                 86212
6.5                 86213
7.0                 86214
7.5                 86215
8.0                 86216
d) Nasal Rae Preformed Tracheal Tube, Uncuffed, Sterile, Rx
SIZE (mm.)          CATALOG NO.
3.0                 86283
3.5                 86284
4.0                 86285
4.5                 86286
5.0                 86287
5.5                 86288
6.0                 86289
6.5                 86290
7.0                 86291.  Recall #Z-573/576-9.

CODE
All codes.

MANUFACTURER
MMJ SA de CV (Mallinckrodt Medical), Juarez, Mexico.

RECALLED
Mallinckrodt, Inc., St. Louis, Missouri, letter dated November 18, 1998, and by fax on January 19, 1999. Firm-initiated recall complete.

DISTRIBUTION
Nationwide and international.

QUANTITY
2,149,233 units were distributed; firm estimated that 10% remained on market at time of recall initiation.

REASON
The connectors can come apart from the tube after being firmly seated.

________
PRODUCT
Oral RAE Tracheal Tubes, cuffed, sterile, Rx, 7.5 mm, Catalog #86205, indicated for use in airway management during those surgical procedures involving the head, neck, or mouth. Recall #Z-577-9.

CODE
Lot #M035070.

MANUFACTURER
MMJ SA de CV (Mallinckrodt Medical), Juarez, Mexico.

RECALLED
Mallinckrodt, Inc., St. Louis, Missouri, by telephone on December 4, 1998, followed by letter dated December 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
California, Tennessee, Pennsylvania, New York, Washington state, Georgia, Oklahoma, Texas, Nebraska, New Jersey, Indiana, Michigan, Canada.

QUANTITY
670 units (67 boxes of 10 each) were distributed; firm estimated that 10 percent remained on market at time of recall initiation.

REASON
The device was packaged with the connector fully seated to the tube instead of partially seated as intended, and included instructions that are for when the device is not fully seated, therefore, the user may try to manipulate the connector causing it to not fit tightly on reconnection to the tube.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________
PRODUCT
Zinnanti Uterine Manipulator/Injector (ZUMI) 4.5, Part #1151, a sterile disposable catheter used to lift and manipulate the uterus, under the following labels: BEI Medical Systems, Davol, and Surgimed-MLB. Recall #Z-561-9.

CODE

Lot numbers: 065122, 065123, 065124, 065603, 066253, 066594, 066877, 067313, 067500, 067504.

MANUFACTURER
The Kendall Company, Argyle, New York.

RECALLED
BEI Medical Systems, Teterboro, New Jersey, by letters from August 5, 1998 to September 1, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
3,135 boxes (37,620 pieces ) were distributed.

REASON
The handle may crack allowing the balloon to not inflate or deflate.

END OF ENFORCEMENT REPORT FOR FEBRUARY 10, 1999.

####