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 17, 1999                                         99-11

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

________
PRODUCT
Blue Nitro Vitality, (2(3H)-Furanone), in 32 fluid ounce bottles. Recall #D-134-9.

CODE
All lot numbers.

MANUFACTURER
Alpha Earth, Inc., Fort Lauderdale, Florida.

RECALLED BY
Manufacturer, by letter on February 5 and 6, 1999. Firm-initiated recall ongoing. See also FDA talk paper T99-5, January 21, 1999.

DISTRIBUTION
Georgia and Florida.

QUANTITY
Approximately 25,000 bottles were distributed.

REASON
Product is an unapproved new drug.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

________
PRODUCT
Lorazepam Tablets, USP, 2mg, in 100 tablet bottles, Rx antianxiety agent. NDC #52544-242-01. Recall #D-132-9.

CODE
Lot #PC-1163.

MANUFACTURER
Watson Laboratories, Inc., Subsidiary of Watson Pharmaceuticals, Inc., Miami, Florida.

RECALLED BY
Manufacturer, by letter on February 25, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
21,459 bottles were distributed.

REASON
Misbranding - Product bears incorrect expiration date of February 2001; exceeding the true date of February 2000.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

________
PRODUCT
E2 Sanitizing Hand Soap (Water, Quanternary ammonium chlorides ...), one (1) gallon plastic containers, under the Namico Inc. and U.S. Foodservice Inc. labels. Recall #D-133-9.

CODE
All production batch codes are subject to recall. All product remaining on the market.

MANUFACTURER
Carroll Company, Walbridge, Ohio.

RECALLED BY
Manufacturer, by letter on March 1, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Pennsylvania, North Carolina, Kentucky, Michigan, Minnesota, Missouri, Illinois, Maine, Virginia, Ohio.

QUANTITY
Firm estimated that a maximum of 520 gallons of product remained on market at time of recall initiation.

REASON
Lack of current good manufacturing practice compliance.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

________
PRODUCT
Source Plasma. Recall #B-477-9.

CODE
Unit #SA682761.

MANUFACTURER
Sera-Tec Biologicals Limited, Pittsburgh, Pennsylvania.

RECALLED BY
Manufacturer, by telephone on May 1, 1996. Firm-initiated recall complete.

DISTRIBUTION
Units were returned before they reachedd their destination.

QUANTITY
1 unit.

REASON
Blood product tested repeatedly reactive for anti-HCV and was not subject to additional testing.

________
PRODUCT
Platelets. Recall #B-568-9.

CODE
Unit #5069951.

MANUFACTURER
BloodCare, Dallas, Texas.

RECALLED BY
BloodCare, doing business as Carter BloodCare, Bedford, Texas, by letter dated either September 30, 1998, or October 7, 1998, and November 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas and Switzerland.

QUANTITY
1 unit was distributed.

REASON
Blood product corresponded to a unit of red blood cells that was implicated in a transfusion reaction and found to be contaminated with Staphylococcus, Coagulase negative.

________
PRODUCT
Platelets, Pheresis. Recall #B-570-9.

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

MANUFACTURER
American Red Cross, Tucson, Arizona.

RECALLED BY
Manufacturer, by letters dated either November 11, 1998 or December 15, 1998, and January 8, 1999. Firm-initiated recall complete.

DISTRIBUTION
Arizona and Oklahoma.

QUANTITY
134 units were distributed.

REASON
Blood products were collected from donors who had not been asked all of the required donor screening questions.

________
PRODUCT
Platelets. Recall #B-573-9.

CODE
Unit #42K07556.

MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.

RECALLED BY
Manufacturer, by telephone on December 1, 1998, and by letter dated December 9, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

REASON
Blood product was prepared from an overweight whole blood unit.

________
PRODUCT
Red Blood Cells. Recall #B-575-9.

CODE
Unit #1044607.

MANUFACTURER
Community Blood Center, Dayton, Ohio.

RECALLED BY
Manufacturer, by letter dated April 3, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

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-576-9.

CODE
Unit #1035071.

MANUFACTURER
Community Blood Center, Dayton, Ohio.

RECALLED BY
Manufacturer, by letter dated March 30, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

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
Platelets, Pheresis. Recall #B-580-9.

CODE
Unit numbers: 35Z10127-A and 35Z10127B.

MANUFACTURER
American Red Cross Blood Services, Roanoke, Virginia.

RECALLED BY
Manufacturer, by letter dated January 4, 1999. Firm-initiated recall complete.

DISTRIBUTION
Virginia.

QUANTITY
2 units were distributed.

REASON
Blood products had high platelet counts.

________
PRODUCT
Platelets, Pheresis. Recall #B-581-9.

CODE
Unit numbers: 24FH12080, 24FH12952, 24FH14488, 24FH15199, 24FH15643, 24FH13479.

MANUFACTURER
American Red Cross Blood Services, Louisville, Kentucky.

RECALLED BY
Manufacturer, by letter dated December 8, 1998, and January 8, 1999. Firm-initiated recall complete.

DISTRIBUTION
Kentucky, Indiana, Pennsylvania.

QUANTITY
6 units were distributed.

REASON
Blood products were mislabeled as CMV antibody negative.

________
PRODUCT
Source Plasma. Recall #B-587-9.

CODE
Unit numbers: 1941T001A, 19OTH247, 19OTH507, 19OTH593, 19OTH840, 19OVS537, 1941J269, 1941J044, 1941J347, 4942W484.

MANUFACTURER
Centeon Bio-Services, Inc., Fort Worth, Texas.

RECALLED BY
Manufacturer, by letters dated July 23, 1998 or August 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana, Illinois, Germany.

QUANTITY
10 units were distributed.

REASON
Blood product was collected from donors who were deferred for receipt of tattoos or a history of bleeding ulcers.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-563/564-9.

CODE
Unit #38FC39495.

MANUFACTURER
American Red Cross Blood Services, Fort Wayne, Indiana.

RECALLED BY
Manufacturer, by telephone on November 19, 1998, and November 2, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who took the drug Propecia.

________
PRODUCT
Recovered Plasma. Recall #B-569-9.

CODE
Unit #5069951.

MANUFACTURER
BloodCare, Dallas, Texas.

RECALLED BY
BloodCare, doing business as Carter BloodCare, Dallas, Texas, by letter dated either September 30, 1998, or October 7, 1998, and November 20, 1998. Firm-initiated recall complete.

DISTRIBUTION
Texas and Switzerland.

QUANTITY
1 unit was distributed.

REASON
Blood product corresponded to a unit of red blood cells that was implicated in a transfusion reaction and found to be contaminated with Staphylococcus Coagulase negative.

________
PRODUCT
Red Blood Cells. Recall #B-574-9.

CODE
Unit #1052776.

MANUFACTURER
Community Blood Center, Dayton, Ohio.

RECALLED BY
Manufacturer, by telephone on April 15, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio.

QUANTITY
1 unit was distributed.

REASON
Blood product was labeled with an extended expiration date.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-577/579-9.

CODE
Unit #4026468.

MANUFACTURER
Community Blood Center, Dayton, Ohio.

RECALLED BY
Manufacturer, by letter dated March 19, 1998, and by letter dated June 8, 1998. Firm-initiated recall complete.

DISTRIBUTION
Ohio, California, Switzerland.

QUANTITY
1 unit of each component was distributed.

REASON
Blood products were collected from a donor who had a history of ulcerative colitis.

________
PRODUCT
Platelets, Pheresis. Recall #B-584-9.

CODE
Unit #95K12132.

MANUFACTURER
National Institute of Health, Warren Grant Magnuson Clinical Center, NIH Clinical Center, Bethesda, Maryland.

RECALLED BY
Manufacturer, by letter on October 14, 1997. Firm-initiated recall complete.

DISTRIBUTION
District of Columbia.

QUANTITY
1 unit was distributed.

REASON
Blood product tested negative for anti-HCV, but was collected from a donor who previously tested repeatedly reactive for the antibody, RIBA negative.

________
PRODUCT
a) Platelets; b) Fresh Frozen Plasma. Recall #B-585/586-9.

CODE
Unit numbers: a) 13P71946, 13P71947, 13P71948, 13P71949, 13P71951, 13P71955, 13P71956, 13P71957, 13P71959, 13P71974, 13P72013, 13P72014, 13P72015, 13P72018, 13P72020, 13P72021, 13P72022, 13P72024, 13P72026, 13P72028, 13P72030, 13P72031, 13P72036; b) 13P71955 and 13P72018.

MANUFACTURER
American Red Cross Blood Services, Detroit, Michigan.

RECALLED BY
Manufacturer, by letter dated October 22, 1998. Firm-initiated recall complete.

DISTRIBUTION
Michigan.

QUANTITY
a) 23 units; b) 2 units were distributed.

REASON
Blood products were collected by apheresis using lactated Ringer's solution for priming, instead of normal saline.

________
PRODUCT
Source Plasma. Recall #B-588-9.

CODE
Unit numbers: 1941T001A, 19OTH247, 19OTH507, 19OTH593, 19OTH840, 19OVS537, 1941J269, 1941J044, 1941J347, and 4942W484.

MANUFACTURER
Centeon Bio-Services, Inc., Fort Worth, Texas.

RECALLED BY
Manufacturer, by letters dated July 23, 1998 or August 21, 1998. Firm-initiated recall complete.

DISTRIBUTION
Indiana, Illinois, Germany.

QUANTITY
10 units were distributed.

REASON
Blood products were collected from donors who were deferred for receipt of tattoos or a history of bleeding ulcers.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I

________
PRODUCT

Aluminum Oxygen Regulators, for use in portable and fixed oxygen
cylinders:
a) Model No. LSP 106; b) Model No. LSP 270; c) Model No. LSP 280;
d) Model No. LSP 370; e) Model No. LSP 735; f) All Robertshaw
Controls.  Recall #Z-693/698-9.

CODE
All codes.

MANUFACTURER
Allied Healthcare Products, Inc., St. Louis, Missouri.

RECALLED BY
Manufacturer, by press release and by letter faxed on February 4, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
Approximately 137,000 units were distributed.

REASON
Fires and explosions have been associated with use of aluminum regulators.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

________
PRODUCT
a) External Ventricular Monitoring Drainage Set; b) Drainage Accessory Kit. Recall #Z-691/692-9.

CODE
a) Catalog #910-118A; b) Catalog #910-122.

MANUFACTURER
NMT Neurosciences, Duluth, Georgia.

RECALLED BY
Manufacturer, by letter on January 12, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
California, Colorado, Connecticut, Florida, Georgia, Hawaii, North Carolina, Ohio, Tennessee, Texas, Washington state.

QUANTITY
77 sets were distributed.

REASON
The male luer lock fitting is deformed and does not fit the drainage bag therefore is not functioning as intended.

________
PRODUCT
Crow River Models 7684LA & 7684LAFF Vangater Personal Transit Lifts, an electro-mechanical wheelchair lift for American-made, full-sized vans with side doors. Recall #Z-713/714-9.

CODE
The affected units were shipped between 12/14/98 and 2/18/99. The units have serial numbers from 98120005 through 99010255, but not all units in this serial number range are affected.

MANUFACTURER
Crow River Industries, Inc., Brooten, Minnesota.

RECALLED BY
Manufacturer, by letter on February 5, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide, Canada, Kuwait, Spain

QUANTITY
192 units were distributed.

REASON
Weld failure could allow the device platform to free fall or deploy rapidly from the vertical (stowed) position to the horizontal (unstowed) position.

________
PRODUCT

Microvasive urology products Protegen Collagen Impregnated Sling
and VESICA Sling Kits With PROTEGEN:
a) Catalog No. 820-111, Vesica Drill in Kit with standard size
ProteGen;
b) Catalog No. 820-112, Vesica Drill in Kit with large size
ProteGen;
c) Catalog No. 820-116, Vesica Drill in Mini Kit with standard
size ProteGen;
d) Catalog No. 820-117, Vesica Drill in Mini Kit with large
ProteGen;
e) Catalog No. 820-121, ProteGen standard size; 
f) Catalog No. 820-122, ProteGen large size;
g) Catalog No. 820-131, Vesica Press in Kit with standard size
ProteGen;
h) Catalog No. 820-132, Vesica Press in Kit with large size
ProteGen;
i) Catalog No. 820-136, Vesica Press in Mini Kit with standard
size ProteGen;
j) Catalog No. 820-137, Vesica Press in Mini Kit with large size
ProteGen.  Recall #Z-717/726-9.

CODE
All lots.

MANUFACTURER
Meadox Division, Boston Scientific Corporation Wayne, New Jersey.

RECALLED BY
Boston Scientific Corporation, Microvasive Urology, Natick, Massachusetts, by letter on January 22, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
16,931 ProteGen Standard Size Slings and 6,466 ProteGen Large Size Slings were distributed.

REASON
Use of ProteGen in the treatment of female urinary incontinence is associated with higher than expected rate of vaginal erosion and dehiscence, and does not appear to function as intended.

________
PRODUCT
All Boehringer Mannheim Elecsys 2010 Immunoassay Analyzers with Software Versions (01)-(39), (02)-(13), (02)-(14), (03)-(08), (03)-(09) and (05)-(05)-CLAS connected system a) Boehringer Mannheim Elecsys 2010 Immunoassay Systems Analyzer with Disk System, Catalog No. 1568248; b) Boehringer Mannheim Elecsys 2010 Immunoassay Systems Analyzer with Rack System, Catalog No. 1804014. Recall #Z-729/730-9.

CODE
All Boehringer Mannheim Elecsys 2010 Immunoassay Analyzers with Software Versions (01)-(39), (02)-(13), (02)-(14), (03)-(08), (03)-(09) and (05)-(05)-CLAS connected system.

MANUFACTURER
Hitachi, Ltd., Instrument Division (HID), Japan.

RECALLED BY
Roche Diagnostics Corporation, Indianapolis, Indiana, by letter beginning on January 18, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and Canada.

QUANTITY
160 analyzers were distributed.

REASON
The test results may be mismatched and reported under the wrong sample number due to a software problem.

________
PRODUCT
Zoll "M Series" Defibrillator/Pacemaker, used to convert ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. Recall #Z-731-9.

CODE

M Series Device Corrective Action Serial Number Listing:
T98F00051   T98I00436   T98100443   T98F00067   T98I00445
T98F00091   T98I00446   T98F00123   T98I00448   T98I00450
T98F00124   T98I00452   T98F00129   T98I00454   T98I00458
T98F00135   T98I00460   T98I00462   T98F00140   T98I00467
T98F00143   T90I00468   T98F00146   T98I00476   T98F00150
T98I00477   T98F00153   T98I00481   T98I00483   T98F00156
T98I00486   T98I00489   T98F00158   T98I00491   T98F00162
T98I00493   T98F00163   T98I00495   T98I00497   T98F00165
T98I00501   T98I00503   T98F00166   T98I00505   T98I00511
T98F00169   T98I00513   T98F00171   T98I00514   T98F00173
T98I00516   T98F00175   T98H00178   T98I00519   T98H00180
T98I00520   T98H00181   T98I00522   T98I00529   T98H00184
T98I00531   T98H00187   T98H00189   T98I00532   
T98H00191   T98H00196   T98I00534   T98H00198   T98H00201
T98I00537   T98I00541   T98H00204   T98H00208   T98I00543
T98H00210   T98H00217   T98I00544   T98H00219   T98I00253
T98I00546   T98J00598   T98I00255   T98I00267   T98I00552
T98I00269   T98I00281   T98I00554   T98I00556
T98I00283   T98I00289   T98I00588   T98JO0590
T98I00291   T98I00303   T98J00595   T98J00598
T98I00305   T98I00321   T98J00600   T98I00323   T98I00337
T98J00602   T98J00605   T98I00339   T98I00345   T98J00611
T98I00347   T98J00613   T98I00348   T98J00615
T98I00350   T98I00365   T98J00618   T98I00367   T98I00375
T98J00620   T98I00377   T98I00379   T98J00624   T98J00627
T98I00381   T98J00629   T98I00382   T98J00631
T98I00384   T98I00395   T98J00632   T98I00397   T98I00405
T98J00635   T98I00407   T98J00637   T98J00639   T98I00408
T98J00642   T98J00644   T98I00411   T98I00418   T98J00647
T98I00420   T98J00648   T98I00422   T98I00431   T98J00650
T98I00433   T98J00653   T98I00434   T98J00655   T98J00657
T98J00659   T98K00752   T98J00661   T98JO0664   T98K00762
T98J00666   T98J00670   T98K00767   T98J00672   T98K00768
T98J00673   T98K00773   T98J00676   T98K00775   T98J00677
T98K00776   T98J00679   T98J00685   T98K00783
T98J00688   T98J00693   T98K00785   T98J00695   T98K00795
T98J00700   T98J00705   T98K00810   T98J00709   T98J00713
T98K00821   T98K00715   T98K00836   T98K00716   T98K00839
T98K00720   T98K00852   T98K00722   T98K00859   T90K00727
T98K00868   T98K00731   T98L00899   T98K00733   T98L00903
T98K00734   T98L00916   T98K00738   T98L00918   T98K00740
T95L00925   T98L00927   T98K00741   T98L00954
T98K00743   T98K00745   T98L00960   T98K00748  
T98L01019.

MANUFACTURER
Zoll Medical Corporation, Burlington, Massachusetts.

RECALLED BY
Manufacturer, by letter on February 1 and 2, 1999. Firm-initiated field correction ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
452 units were distributed.

REASON
Failure of a memory chip resulted in the failure of the unit to power on when turned to the "on" position.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

________
PRODUCT
Abbott Cell-Dyn 3000 Series Hematology Systems, Cell-Dyn Reticulocyte Reagent, when used in combination with Cell-Dyn 3500 reticulocyte software enables a whole blood specimen to be analyzed for reticulocytes. The Reticulocyte Reagent is intended for in vitro diagnostic use (outside the body). Recall #Z-715-9.

CODE
Lot numbers: 4249512, 424812, 4362312, 4362412, 4362512, 4368312, 4368412, 4484012, 4491712, 4597912, 4598012, 4599712, 459912, 4617712, 4617912, 4729312, 4729512, 4842912.

MANUFACTURER
Abbott Laboratories, Santa Clara, California.

RECALLED BY
Manufacturer, by letter on February 25, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide and international.

QUANTITY
1,780 kits were distributed.

REASON
These lots may exhibit elevated Reticulocyte results. In some cases, the results may exceed the normal range on normal specimens without a Reticulocyte data flag being observed.

END OF ENFORCEMENT REPORT FOR MARCH 17, 1999.

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