FDA

Enforcement Report

September 1, 1999                                  99-35


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
________
PRODUCT
Unpasteurized Orange Juice, Margarita Mix.  Recall # 
F-660/661-9
CODE
All juice with an "enjoy by" date of July 7, 1999 or eailer.
MANUFACTURER
Sun Orchard, Inc., Tempe, AZ
RECALLED BY
Manufacturer, on June 25, 1999 by phone. Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
99120 gallons.
REASON
The product may be contaminated with Salmonella.


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II
_______
PRODUCT
"New Mak's Egg Noodle" packaged in plastic bags, net weight 5 
pounds. Labeled 
as Keep Refrigerated.  Recall #F-643-9.
CODE
None.
MANUFACTURER
New Mak's Noodle Manufacturing, Inc., New York, New York.
RECALLED BY
Manufacturer, by letter on April 21, 1999.  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
Undetermined.
REASON
The product contains undeclared FD&C Yellow #5.
________
PRODUCT
Merengue Cookies. Recall #F-650-9 
CODE
NONE
MANUFACTURER
LaBayamesa Corp., North Bergen, NJ
RECALLED BY
Manufacturer, by phone on June 14, 1999. Firm-initiated recall 
complete.
DISTRIBUTION
New York
QUANTITY
40 containers.
REASON
This product contains undeclared FD&C Yellow No.5 FD&C Yellow No. 
6, FD&C No. 3, FD&C Red No. 40, and FD&C Blue No.1


RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
________
PRODUCT
Platelets. Pheresis.  Recall #B-1157-9.
CODE
Unit numbers: 31123-3850-01, 31123-3850-02.
MANUFACTURER
Blood Systems, Inc.., Tupelo, Mississippi.
RECALLED BY
Recalling Firm:Blood Systems, Inc.., Scottsdale, Arizona by 
telephone on December 30, 1998 and by letter dated January 7, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
Mississippi.
QUANTITY
2 Units were distributed.
REASON
Blood product had an unacceptably high platelet yield.

_______
PRODUCT
Fresh Frozen Plazma.  B-1172-9.
CODE
Unit Numbers:
20LY15001, 20LY15002, 20LY15006, 20LY14986, 20LY14987, 20LY14988, 
20LY14989, 20LY14990, 20LY14991, 20LY14992,
20LY14993, 20LY14994, 20LY14995, 20LY14996, 20LY14997,
20LY14998, 20LY14999, 20LY15000.
MANUFACTURER
American Red Cross (Lewis and Clark Region), Boise, Idaho
RECALLED BY
Manufacturer, by telephone on July 23, 1998 and September 15, 
1998 and letters dated September 15, 1998, and October 20, 1998. 
  
DISTRIBUTION
Utah
QUANTITY
18 Units were distributed.
REASON
Blood products, for which freeze time was as not documented, were 
distributed.

_______
PRODUCT
a)Red Blood cells. Recall # B-1166-9
b)Red Blood Cells Washed. Recall # B-1167-9
CODE
a)Unit 22399-9534
b)Unit 22401-6772
MANUFACTURER
Blood, Services Inc., Las Vegas, NV.
RECALLED BY
Blood Systems, Inc., Scottsdale, Az., by letter dated October 22, 
1998. A Second Letter was sent on December 9, 1998. Firm-
initiated recall complete
DISTRIBUTION
Nevada.
QUANTITY
2 Units.
REASON
Blood products were collected  from a donor who reported having 
lived in an area designated as endemic for marlaria.
________
PRODUCT
a) Red Blood Cells. Recall # B-1168-9
b)Platelets for Manufacture. Recall # B-1169-9 (Class III recall)
CODE
Unit 0715683
MANUFACTURER
Bergen Community Regional Blood Center.  D.B.A. Community Blood 
Services, Paramus, NJ.
RECALLED BY
Manufacturer, by letter on March 1, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
Texas and New Jersey
QUANTITY
1 unit each.
REASON
Blood products were collected  from a donor who reported having 
traveled to an area designated as endemic for marlaria.

________
PRODUCT
Red Blood Cells and Recovered Plasma. Recall 
# B-1170/1171-9.
CODE
Unit 42R45149
MANUFACTURER
American Red Cross Blood Services(Northern Ohio Region), 
Cleveland, Oh.
RECALLED BY
Manufacturer, on May 10, 1999 by letter.  Firm-initiated recall 
complete.
DISTRIBUTION
Ohio and Switzerland
QUANTITY
1 unit of each.
REASON
Blood products were collected from a donor taking the drug 
Methotrexate, were distributed. 
_______
PRODUCT
Red Blood Cells. Recall # B-1174-9
CODE
Unit 22401-5484
MANUFACTURER
United Blood Services, Las Vegas, NV.
RECALLED BY
Blood Systems, Inc., Scottsdale, Az , by telephone on July 26, 
1998. Firm-initiated recall complete.
DISTRIBUTION
Nevada.
QUANTITY
1 Unit.
REASON
Blood products were collected from a donor who reported having 
traveled to an area designated as endemic for marlaria.
_______
PRODUCT
Red Blood Cells, Platelets, Fresh Frozen Plasma. Recall # B-
1175/1177-9
CODE
Unit W89514
MANUFACTURER
Healthcare Provider Services, Inc., Providence, RI
RECALLED BY
Manufacturer, on April 20, 1999 by telephone. Firm-initiated 
recall complete.
DISTRIBUTION
New York and Rhode Island.
QUANTITY
1 Unit of each.
REASON
Blood products were collected from a donor who reported having a 
history of jaundice, were distributed.



RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
________
PRODUCT
Red Blood Cells, Fresh Frozen Plasma. Recall # B-1139/1140-9 
CODE
Unit 22399-8574
MANUFACTURER
Blood Services, Inc., Las Vegas, NV
RECALLED BY
Blood Systems, Inc., Scottsdale, AZ., by telephone on September 
16. 1998 and by letter dated October 6, 1998. Firm-initiated 
recall complete. 
DISTRIBUTION
Nevada
QUANTITY
1 Unit each.
REASON
Blood Products, collected from a donor with a history of 
Thrombolic Thrombocytopenia Purpura, were distrubuted. 

________
PRODUCT
Source Plasma.  Recall # B-1180-9
CODE
Unit 98CIAB5517
MANUFACTURER
Community Bio-Resources, Inc., Cedar Rapids, IA
RECALLED BY
Manufacturer, on Noverber 5, 1998, by Fax.  Firm-initiated recall 
complete.
DISTRIBUTION
Austria.
QUANTITY
1 Unit 
REASON
The blood was collected from a donor whose medical history 
screening was not performed.


RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I 
________
PRODUCT
Indigo Bare-Tip fiberoptic.  Recall #Z-1224-9
CODE
LF020
MANUFACTURER
Ethicon Endo-Surgery, Inc. Albuquerque, NM
RECALLED BY
Indigo Medical, Inc., Cincinnato, Oh, on August 6, 1999 by 
telephone and letter dated August 6, 1999.  Firm-initiated recall 
ongoing. 
DISTRIBUTION
TN, PA, AR, KY and NY.
QUANTITY
9 units
REASON
I fiberoptic tip is contaminated.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II 
_______
PRODUCT
a)Rotablator RotaLink Plus Pre-connected Exchangeable            
                  Rotational Atherectomy System  Z-1220-9
b)Rotational RotaLink Coronary Advancer Z-1221-9
c)Rotablator RotaLink Peripheral Adavncer Z-1222-9

CODE
Cat NOS.a) 23631-002-23631-007, 23631-015, 23631-016,
b) 22782-001A0, 22782-0010
c) 11381-90
MANUFACTURER
Boston Scientific Corporation, Redmond, WA
RECALLED BY
Manufacturer, by          . Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY

REASON
Braking mechanism may fail to sucure guidewire during use.

_______
PRODUCT
3-D Imgcomp Utility User Manual Update, Z-1223-9
CODE
All Versions (2.72b & 3.07d)
MANUFACTURER
Precision Therapy International, Inc., Norcross, GA
RECALLED BY
Manufacturer, by letters faxed on February 10, 1999. Field 
correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
190 Manuals
REASON
A design error may lead to a serious miscalculation of radiation 
dose. 

________
PRODUCT
Mimi-Acutack 1.5 mm Cannulated Hex Driver Tip, Part #HAD-L-0815. 
 Recall #Z-1225-9
CODE
HWC
MANUFACTURER
ACUMED, INC., Beaverton, OR.
RECALLED BY
Manufacturer, on July 6 and 12, 1999  by faxed Recall noitice. 
Firm-initiated recall on-going.
DISTRIBUTION
Nationwide.
QUANTITY
4 each.
REASON
The Hex driver tips may prevent the Mini-Acutrak Bone Screw from 
seating properly.



_______
PRODUCT
CryoValve (Heart valve) , Z-1228/1229-9
CODE
Model no. AV00, Serial No. 6222366
Model no. PV00, Serial No. 6222374
MANUFACTURER
Cryolife, Inc., Kennesaw, GA
RECALLED BY
Manufacturer, by letter on August 5, 1999.  Firm-initiated recall 
completed.
DISTRIBUTION
Nationwide.
QUANTITY
1 each
REASON
Does not meet current guidelines regarding serodilution of 
plasma. 


RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
________
PRODUCT
STRAUMANN INTRAsurg 500, an AC powered drilling device intended 
to supply power to and serve as a base for other dental devices 
such as a dental handpiece during dental and maxillofacial 
surgery.  Z-1215-9.
CODE
Serial #ís: 824-828, 830, and 831.
MANUFACTURER
KAVO DENTAL GmBH
Biberach-Riss, Germany
RECALLED BY
The Straumann Co., Waltham Massachusetts, by __________ on June 
30, 1999.  Firm-initiated recall ongoing. 
DISTRIBUTION
Arizona, California, Deleware, Massachusetts, Montana, Texas.
QUANTITY
7 Units were distributed.
REASON
Software error may cause unit to shutdown prior to reaching 
preset torque limit.
							
________
PRODUCT
APLIGRAF (GRAFTSKIN), indicated for use with standard therapeutic 
compression for the treatment of non-infected partial and full 
thickness skin ulcers due to venous insufficiency of greater than 
1-month duration which has not responded to conventional therapy. 
 Recall #Z-1219-9.
CODE
LOT NUMBER:
GS9906.22.03.1A 
Unit Numbers: 42, 43,45, 46, 47, 50, 52-74, and 76
LOT NUMBER:
GS9906.22.03.2A
Unit Numbers: 1, 3, 5, 6, 9, 10, 11, 12, 13, 15, 16, 17, 18, 19, 
21, 22, 23, 24, 25, 26,28, 29, 30, 31, 32, 34, EXP July 22, 1999.
MANUFACTURER
ORGANOGENESIS INC.
CANTON,Massachussets
RECALLED BY
Novartis Pharmaceuticals Corp. (Global Distributor), East 
Hanover, New Jersey by 
Telephone on on July 21, 1999, followed by letter on July 22, 
1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Alabama, Arizona, California, Georgia, Illinois, Indiana, New 
York, Massachusetts, Maryland, Maine, Michigan, Missouri, North 
Carolina, Ohio, Pennsylvania, South Carolina, Texas.
QUANTITY
58 units were distributed.
REASON
products ph may be out of specification due to
packaging error.