FDA

Enforcement Report

June 2, 1999                                          99-22

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
________
PRODUCT
Rich Flower brand Dried Sweet Potato, in 7 ounce rigid plastic 
bags, product of China.  Recall #F-437-9.
CODE
None.
MANUFACTURER
Garden Food (Shenzhen) Company, Ltd., China (packer).
RECALLED BY
CL Import Company, Inc., Brooklyn, New York (importer), by 
telephone on October 19, 1998.  Completed field correction 
(relabeling) resulted from sample analysis and follow-up by the 
New York State Department of Agriculture and Markets.
DISTRIBUTION
New York.
QUANTITY
2 cases were distributed.
REASON
Product contained undeclared sulfites.
________
PRODUCT
Italian Sun Dried Tomatoes, in 16 ounce cryovac, plastic bags.  
Recall #F-440-9.
CODE
None.
MANUFACTURER
Undetermined.
RECALLED BY
Mrs. Mazzula's Food Products, Inc., Edison, New Jersey 
(repacker), by press release on April 1, 1999, and by letter on 
April 9, 1999. Ongoing field correction (relabeling) resulted 
from sample analysis and follow-up by the New York State 
Department of Agriculture and Markets.
DISTRIBUTION
New Jersey.
QUANTITY
110 cartons (12 bags per case) were distributed.
REASON
Product contains undeclared sulfites.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma. 
Recall #B-719/721-9.
CODE
Unit numbers:  a) 28LN13640, 28LQ15071; b) 28LQ15071; 
c) 28LN13640, 28LX04404.
MANUFACTURER
American Red Cross Blood Services, Charelston, South Carolina.
RECALLED BY
American Red Cross Blood Services, Savannah, Georgia, by letter 
or fax on either February 17 or 18, 1998, or by telephone on 
February 16, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Georgia, South Carolina, Puerto Rico, California, Switzerland.
QUANTITY
a) 2 units; b) 1 unit; c) 2 units were distributed.
REASON
Blood products were collected from a donor with a history of 
hepatitis.
________
PRODUCT
Red Blood Cells.  Recall #B-793-9.
CODE
Unit #41LX27263.
MANUFACTURER
The American National Red Cross, Birmingham, Alabama.
RECALLED BY
Manufactaurer, by letter dated September 2, 1998. 
 Firm-initiated recall complete. 
DISTRIBUTION
Alabama.
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-794-9.
CODE
Unit #41FQ57714.
MANUFACTURER
The American National Red Cross, Birmingham, Alabama.
RECALLED BY
Manufacturer, by letter dated October 5, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Alabama.
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) Platelets; c) Fresh Frozen Plasma.
Recall #B-798/800-9.
CODE
Unit Numbers: a) 11-147280; b) 11-147280, 11-159274; 
c) 11-147280, 11-159274.
MANUFACTURER
United Blood Services, El Paso, Texas.
RECALLED BY
Manufacturer, by letter dated February 3, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Texas and New York.
QUANTITY
a) 1 unit; b) 2 units; c) 2 units were distributed.
REASON
Blood products tested negative for HBsAg, but were collected from 
a donor who previously tested repeatedly reactive for HbsAg.
________
PRODUCT
Platelets Pheresis.  Recall #B-801-9.
CODE
Unit numbers:  	049FP06220, 049FP06493, 049FP06508, 
049GP00525, 049GP00671, 049GP00713.
MANUFACTURER
American Red Cross Blood Services, Waco, Texas.
RECALLED BY
American Red Cross Blood Services, Tulsa, Oklahoma, by letters 
dated January 20, 1999, and February 19, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Texas.
QUANTITY
6 units were distributed.
REASON
Blood products had unacceptable platelet counts.
________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall #B-803/804-9.
CODE
Unit numbers: 5102179 and 5084896.
MANUFACTURER
BloodCare, doing business as Carter BloodCare, Dallas, Texas.
RECALLED BY
Manufacturer, by letter dated December 10, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Texas.
QUANTITY
2 units of each component were distributed.
REASON
Blood products were collected from a donor who reported travel to 
an area designated as endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall #B-805/806-9.
CODE
Unit numbers:  a) 11315-1160, 11316-4855, 11317-0095,
11317-6777 b) 11315-1160, 11316-4855.
MANUFACTURER
United Blood Services, El Paso, Texas.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated January 
26, 1999.  Firm-initiated recall complete.
DISTRIBUTION
New Mexico and Texas.
QUANTITY
a) 4 units; b) 2 units were distributed.
REASON
Blood products were collected from a donor who reported travel to 
an area designated as endemic for malaria.
________
PRODUCT
Platelets, Pheresis.  Recall #B-809-9.
CODE
Unit #49P42789.
MANUFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY
Manufacturer, by telephone on January 31, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Oklahoma.
QUANTITY
1 unit was distributed.
REASON
The first half of a split Platelets, Pheresis unit, implicated in 
a transfusion reaction, was found to be contaminated with 
Staphylococcus aureus.  The second half of the unit was 
distributed.
________
PRODUCT
Source Plasma.  Recall #B-810-9.
CODE
Unit 98YARC7412  (Donor Id. A00576590).
MANUFACTURER
Community Bio-Resources, Inc., Fayetteville, Arkansas.
RECALLED BY
Community Bio-Resources, Inc., Hoover, Alabama, by fax dated 
December 4, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Austria.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had received an MMR 
vaccination within four weeks of donation.
_______
PRODUCT
a) Red Blood Cells; b) Platelets, Pheresis.
Recall #B-811/812-9.
CODE
Unit numbers:  a) 55R15127; b) 55FQ00336.
MANUFACTURER
American Red Cross Blood Services, Little Rock, Arkansas.
RECALLED BY
Manufacturer, by letter dated April 8, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Arkansas.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who had sexual contact 
with someone who had lived in an HIV Group O risk area.
________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-813/814-9.
CODE
Unit #5064631.
MANUFACTURER
BloodCare, doing business as Carter BloodCare, Dallas, Texas.
RECALLED BY
Manufacturer, by fax on November 3, 1998, and by letter dated 
November 16, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who reported exposure 
to the Human Immunodeficiency Virus (HIV) and a diagnosis of 
gonorrhea.
________
PRODUCT
Platelets, Pheresis.  Recall #B-824-9.
CODE
Unit numbers: 020GE01167A, 020GE01167B, 020GE01170.
MANUFACTURER
American Red Cross, Missoula, Montana.
RECALLED BY
American Red Cross, Boise, Idaho, by telephone on or about June 
15, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Montana.
QUANTITY
3 units were distributed.
REASON
Platelets were not stored under continuous agitation, and at 
unmonitored temperatures.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
________
PRODUCT
Red Blood Cells.  Recall #B-795-9.
CODE
Unit numbers: 26KM06849, 26KM06829, 26KG16035, 26KH42282, 
26KM07605, 26FQ10019, 26KM06833, 26FM41708, 26FM41662, 26FS12649, 
26FF19780, 26KM08572, 26KM08574, 26FN05156, 26FN05157.
MANUFACTURER
The American National Red Cross, Mobile, Alabama.
RECALLED BY
Manufacturer, by letter dated January 28, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Mississippi, Alabama, Florida.
QUANTITY
15 units were distributed.
REASON
Blood products were labeled with extended expiration dates.
________
PRODUCT
Fresh Frozen Plasma.  Recall #B-796-9.
CODE
Unit numbers:  41GG09184, 41GG09187, 41GG09193, 41GG09195, 
41LW67431, 41LW67476, 41FL73908, 41FN37849, 41FQ52478, 41FR38544, 
41FY88316, 41GE29173, 41FE12427, 41FE12444, 41FE12445, 41FE12461, 
41FE12498, 41FE12504.
MANUFACTURER
The American National Red Cross, Mobile, Alabama.
RECALLED BY
Manufacturer, by telephone and letter on April 7, 1998.  Firm-
initiated recall complete.
DISTRIBUTION
Florida.
QUANTITY
18 units were distributed.
REASON
Blood products for which temperature after shipment was not 
recorded upon receipt was distributed.
________
PRODUCT
Red Blood Cells.  Recall #B-797-9.
CODE
Unit #21GL27310.
MANUFACTURER
The American National Red Cross, Mobile, Alabama.
RECALLED BY
Manufacturer, by letter dated February 16, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Alabama.
QUANTITY
1 unit was distributed.
REASON
Blood product for which temperature after shipment was not 
recorded upon receipt was distributed.
________
PRODUCT
Fresh Frozen Plasma.  Recall #B-802-9.
CODE
Unit numbers: 11FF44971, 11FM29589, 11FN66110, 11FN68771, 
11FN68787, 11G27530, 11G27535, 11G28487, 11L82736, 11L84277, 
11L84283, 11L84333, 11M79345, 11M79366, 11Q63435, 11Q65065, 
11R36716, 11V18277, 11V18854, 11W42422.
MANUFACTURER
The American National Red Cross, Mobile, Alabama.
RECALLED BY
Manufacturer, by telephone on February 11, 1998, followed by 
letter dated February 16, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Alabama.
QUANTITY
20 units were distributed.
REASON
Blood products for which temperature after shipment was not 
recorded upon receipt were distributed.
________
PRODUCT
a) Whole Blood; b) Red Blood Cells.  Recall #B-807/808-9.
CODE
Unit numbers:  a) 0499840; b) 0499861.
MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, Texas.
RECALLED BY
Manufacturer, by letter dated March 2, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Texas.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products may have been stored at unacceptable temperatures.
________
PRODUCT
Red Blood Cells.  Recall #B-815-9.
CODE
Unit #26FJ22302.
MANUFACTURER
American Red Cross Blood Services, Mobile, Alabama.

RECALLED BY
Manufacturer, by telephone on April 8, 1998, followed by letter 
dated April 13, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Alabama.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Red Blood Cells, Irradiated.  Recall #B-817-9.
CODE
Unit numbers: 26FJ22855, 26FJ22841, 26FF22763, 26FJ22866.
MANUFACTURER
American Red Cross Blood Services, Mobile, Alabama.
RECALLED BY
Manufacturer, by telephone on April 16, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Alabama.
QUANTITY
4 units were distributed.
REASON
Blood products were labeled with extended expiration dates.
________
PRODUCT
Red Blood Cells, Irradiated.  Recall #B-819-9.
CODE
Unit #26KM11000.
MANUFACTURER
American Red Cross Blood Services, Mobile, Alabama.
RECALLED BY
Manufacturer, by telephone on October 12, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Alabama.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Red Blood Cells.  Recall #B-820-9.
CODE
Unit #26KM03068.
MANUFACTURER
American Red Cross Blood Services, Mobile, Alabama.
RECALLED BY
Manufacturer, by telephone on September 27, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Alabama.

QUANTITY
1 unit was distributed.
REASON
Blood product was shipped at an unacceptable temperature.
________
PRODUCT
Fresh Frozen Plasma.  Recall #B-821-9.
CODE
Unit numbers: 26FS14337, 26FM51203, 26FM51207, 26FP44904.
MANUFACTURER
American Red Cross Blood Services, Mobile, Alabama.
RECALLED BY
Manufacturer, by telephone on August 20, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Alabama.
QUANTITY
4 units were distributed.
REASON
Blood products were stored at an unacceptable temperature.
________
PRODUCT
Red Blood Cells, Irradiated.  Recall #B-822-9.
CODE
Unit numbers: 26FF23540 and 26FL07437.
MANUFACTURER
American Red Cross Blood Services, Mobile, Alabama.
RECALLED BY
Manufacturer, by telephone on June 8 and 9, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Alabama.
QUANTITY
2 units were distributed.
REASON
Blood products were labeled with extended expiration dates.
________
PRODUCT
Red Blood Cells, Irradiated.  Recall #B-823-9.
CODE
Unit #26KM09880.
MANUFACTURER
American Red Cross Blood Services, Mobile, Alabama.
RECALLED BY
Manufacturer, by letter dated March 18, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Alabama.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled with an extended expiration date.
________
PRODUCT
Recovered Plasma.  Recall #B-825-9.
CODE
Unit #16LY52966.
MANUFACTURER
American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY
Manufacturer, by fax on December 4, 1998.  Firm-initiated recall 
complete.
DISTRIBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Blood product corresponded to a unit of Platelets which was 
positive for Enterobacter aerogenes and implicated in a 
transfusion reaction.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- 
CLASS II
________
PRODUCT
Scimed Ranger 20 mm Percutaneous Transluminal Coronary 
angioplasty (PTCA) Dilatation Balloon Catheter.
Recall #Z-923-9.
CODE
Model: H74914361251, Lot numbers:  2293535 and 2293538.
MANUFACTURER
Boston Scientific Corporation, Ireland, Ltd., Galway, Ireland.
RECALLED BY
Boston Scientific /Scimed, Maple Grove, Minnesota, on April 30, 
1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
54 catheters were distributed.
REASON
The wrong/unvalidated sterilization process was used for the two 
recalled lots.
________
PRODUCT
Innovative Implants and Cover Screws.  Recall #Z-926-9.
CODE
Catalog #OSS610, Lot #77963.
MANUFACTURER
Implant Innovations, Inc., Palm Beach Gardens, Florida.
RECALLED BY
Manufacturer, by telephone on April 30, 1999, and by letter faxed 
on May 11, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
New York, Illinois, Germany, Japan.
QUANTITY
25 implants.
REASON
Product was mislabeled as 6.0mm when it was actually 5.0mm.
________
PRODUCT
Model Visulas Laser System, used in ophthalmology:
a) Model No. 532; b) Model No. 532 Combi; c) Model No. 690s;
d) Model No. 732S; e) Model Yag II Plus. 
Recall #Z-929/933-9.
CODE
a) Model No. 532; b) Model No. 532 Combi; c) Model No. 690s;
d) Model No. 732S; e) Model Yag II Plus.
MANUFACTURER
Carl Zeiss, Inc., Thornwood, New York.
RECALLED BY
Manufacturer.  FDA approved the firm's corrective action plan on 
May 19, 1999.  Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
a) 20; b) 15; c) 15; d) 1; e) 35 units were distributed.
REASON
Device failed to comply with 21 CFR 1040.11(a)(2) in that the 
operator's manual lacked calibration procedures.
________
PRODUCT
Model CVX-300 Excimer Laser, used in cardiology.
Recall #Z-934-9.
CODE
Model CVX-300. (ANY SERIAL NUMBERS?)
MANUFACTURER
Spectranetics Corporation, Colorado Springs, Colorado.
RECALLED BY
Manufacturer.  FDA approved the firm's corrective action plan on 
May 20, 1999.  Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
128 units were distributed.
REASON
The device failed to comply with 21 CFR 1040.10(f)(1) in that the 
protective housing had a narrow gap allowing direct line-of-sight 
access to the Class IV beam.
________
PRODUCT
Model E2000 Ruby Laser System.  Recall #Z-935-9.
CODE
Model E2000.
MANUFACTURER
Palomar Medical Products, Inc., Lexington, Massachusetts.
RECALLED BY
Manufacturer.  FDA approved the firm's corrective action plan on 
May 20, 1999.  Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
7 units were distributed.
REASON
The device failed to comply with 21 CFR 1040.11(a)(2) in that the 
operator's manual lacked calibration procedures.
________
PRODUCT
Eagle 3000 Floorloader Steam Sterilizer.  Recall #Z-936-9.
CODE
Various serial numbers.

MANUFACTURER
Steris Corporation, Erie Pennsylvania.
RECALLED BY
Steris Corporation, Mentor, Ohio, by Customer Notifications on 
March 10, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, Canada, Korea, Hong Kong, Taiwan.
QUANTITY
67 units were distributed.
REASON
There is an error in the control system software, which causes 
the chamber temperatures to exceed the upper limit.
________
PRODUCT
Tissue Suture Anchors, used to reattach soft tissue to bone 
during surgery:  a) Part No. PAE5K - OBL RC5 R.0 mm Suture 
Anchor; b) Part No. PAS2K - PeBA S 2.8 mm Suture Anchor. Recall 
#Z-937/938-9.
CODE
Lot numbers:  a) A1305B, A1205B, A1405B, A1505B, A0906B, A1006B, 
A1106B, A0708B, A0807BM, A1007B, A1507B, A2907B, A0211B, A0311B, 
A1612B, A1712B, A2701C, A2801C,  A2901C, A3101C; b) A0406B, 
A1505B, A1905B, A0206B, A0806B, A1106B, A1806B, A1906B, A0607B, 
A0907B, A1607B, A0608B.
MANUFACTURER
Southmedic, Inc., Ontario, Canada (assembler/packager).
RECALLED BY
Orthopaedic Biosystems, Ltd., Inc., (OBL), Scottsdale, Arizona 
(specification developer/responsible firm), by letters dated 
January 27, 1999, February 12 and 17, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTUTION
Nationwide.
QUANTITY
15,162 units were distributed.
REASON
The sterility of the lots cannot be assured due to a packaging 
defect that occurred during the heat sealing process.
________
PRODUCT
Portable Oxygen Generator:  a) Model 5LX02; 
b) Model 6LX02.  Recall #Z-939/940-9.
CODE
All codes manufactured between August 1998 through March 31, 
1999.
MANUFACTURER
Invacare Corporation, Sanford, Florida.
RECALLED BY
Invacare Corporation, Elyria, Ohio., by letter on May 21, 1999.  
Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
29,106 units were distributed.
REASON
Oxygen concentrators had a high incidence of reported circuit 
board failures.
________
PRODUCT
Patient Scale, Model RSC600.  Recall #Z-941-9.
CODE
All units manufactured between October 1, 1998 and March 31, 
1999.
MANUFACTURER
Invacare Corporation, Elyria, Ohio.
RECALLED BY
Manufacturer, by letter dated April 30, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
188 units were distributed.
REASON
Screw, which secures scale, may become disengaged, causing 
patient/occupant to fall from scale.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
a) Cobe Renalyte Rx Acid Concentrate For Bicarbonate Dialysate, 
2-K and 2.5 Ca, Product Number 012-116-004; b) Cobe Renalyte Rx 
Acid Concentrate for Bicarbonate Dialysate, 2-K, product number 
012-111-004.  Recall #Z-927/928-9.
CODE
Lot G8H074.
MANUFACTURER
DiChem Concentrates, Inc., Lewisberry, Pennsylvania.
RECALLED BY
Gambro Healthcare, Deland, Florida, by telephone on November 5, 
1998, followed by letter dated November 17, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Massachusetts, Illinois, New Jersey, West Virginia, Pennsylvania, 
Connecticut, New York, South Carolina, Ohio, Delaware, Missouri, 
Virgin Islands.
QUANTITY
1,095 cases (4 one-gallon bottles per case) were distributed.
REASON
Some product was mislabeled as product code 012-111-004 
bicarbonate dialysate.
________
UPDATE
Coxial Biopsy System, manufactured by Allegiance Healthcare 
Corporation, Clearwater, Florida, which appeared in the May 19, 
1999 Enforcement Report is a Class III recall.

END OF ENFORCEMENT REPORT FOR JUNE 2, 1999.