FDA

Enforcement Report

April 21, 1999
99-16

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I

________
PRODUCT

Cut salad products:


1. a) SYSCO IMPERIAL 2 X 2 LCR LETTUCE, NET WT. 20 LBS
   b) SYSCO IMPERIAL LETT. LCR 2 X 2" W/GB, NET WT. 5 LBS
   c) CUSTOM CUTS LCR LETT, NET WT. 20 LBS
2. SYSCO IMPERIAL LETT. LCR MIX 2" X 2", NET WT. 5 LBS
3. a) SYSCO IMPERIAL LETT. ALL AMER SALAD W/ROM, NET WT. 20 LBS 
(4/5#)
   b) SYSCO IMPERIAL LETT. ALL AMER SALAD W/ROM, NET WT. 5 LBS
4. SYSCO IMPERIAL CABB. RED SHD. 1/8", NET WT. 5 LBS.
 
Recall #F-339/342-9.
CODE
Best by 01/24/99 through 02/09/99;
MANUFACTURER
Custom Cuts, St. Paul, Minnesota.
RECALLED BY
Manufacturer, by letter on February 3, 1999.  Completed recall 
resulted from sample analysis and follow-up by the Wisconsin 
Department of Agriculture.
DISTRIBUTION
Wisconsin, Minnesota, Iowa, Nebraska.
QUANTITY
Approximately 9,000 pounds were distributed.
REASON
Products may be contaminated with Listeria monocytogenes.
________
PRODUCT
Frozen Mamey, a cut up tropical fruit in 24/14 ounce retail 
packages per case, in 12/14 ounce retail packages per case and 
6/5 pound bulk packages per case under the following brand names:
a) "El Sembrador" brand distributed by L.J. General        
International Corp., Miami, FL 33142, labeled in 
part:"***ElSembradorxxx100% NATURAL FROZEN MAMEY NET WT. 14 oz. 
(397 grs.)***DIST. BY L & J GENERAL INTERNATIONAL***MIAMI, FL 
33142 TEL. (305)638-5161**PRODUCT OF GUATEMALA***"
b) "El Sembrador" brand distributed by L.J. General International 
Corp., Miami, FL 33142, labeled in part: "***El Sembrador**100 % 
NATURAL**MAMEY**NET WT. 14 oz. (397 grs.)**DIST. BY** L & J 
GENERAL INTERNATIONAL**MIAMI, FL 33142 TEL. (305)638-
5161**PRODUCT OF HONDURAS***"
c) "La Fe" brand distributed by Gonzalez & Tapanes Foods, Inc., 
North Bergen, N.J. 07042, labeled in part: "***La 
Fe***MAMEY***NET WT.14 oz. (397 grams)***Product of Guatemala" 
d) "La Fe" brand distributed by Gonzalez & Tapanes Foods, Inc., 
North Bergen, N.J. 07042, labeled in part: "***La Fe **MAMEY**NET 
WT.14 oz. (397 grams)**Product of Honduras***" 
e) Bulk product in 5 lb packages with no brand name labeled in 
part: "***MAMEY***Mammea americana***Net Weight 5 Lbs. Product of 
Guatemala*** BY AGRODEX***Amatitlan***".  Recall #F-343-9.
CODE
All product on the market at time of recall initiation.
MANUFACTURER
Agrodex S.A., Amatitlan, Guatemala and Centrex San Pedro Sula, 
Honduras.
RECALLED BY
Jagua Trading Group Corporation, Miami, Florida, by letters on 
February 26, 1999, and March 5, 1999.  Firm-initiated recall 
ongoing.  See also FDA talk paper T99-11 dated February 20, 1999, 
and FDA press release P99-6 dated March 8, 1999. 
DISTRIBUTION
Florida, New Jersey, California, Connecticut, New York, Georgia, 
Arizona, Illinois, Louisiana, Pennsylvania, Massachusetts, Rhode 
Island, North Carolina.
QUANTITY
Approximately 9,445 cases were distributed.
REASON
Product was epidemiologically associated with an outbreak of 
typhoid fever caused by Salmonella typhi.
________
PRODUCT
World Classic brand Frozen Raw Shrimp, in 16 ounce plastic bags.
The following counts are involved: 26/30 count; 16/20 count, 
36/40 count and 51/60 count.  Recall #F-344-9.
CODE
Not Coded.
MANUFACTURER
TOPCO Associates, Skokie, Illinois (own-label distributor);
Mid-Pacific Seafoods, Vernon, California (repacker).
RECALLED BY
Penn-Traffic Company, Inc., Syracuse, New York, by telephone and 
fax dated November 20, 1998.  Completed recall resulted from 
sample analysis and follow-up by the New York State Department of 
Agriculture and Markets.
DISTRIBUTION
New York, Ohio, Pennsylvania, West Virginia.
QUANTITY
Quantities received and retrieved/returned are as follows:
16/20 count:   Received 7,500 bags
Returned 3,139 bags (43% retrieved)
26/30 count:   Received 3,000 bags
Returned 2,258 bags (75% retrieved)
36/40 count:   Received 38,000 bags
Returned 23,309 bags (61% retrieved)
51/60 count:   Received 45,000 bags
Returned 25,949 bags (58% retrieved).
REASON
Product contained undeclared sulfites.
________
PRODUCT
Frozen Mamey in 14 ounce retail packages.  Recall #F-348-9.
CODE
All product on the market at the time of the recall.
MANUFACTURER
Coco, S.A., La Escuadrilla, Guatemala.
RECALLED BY
L & J General International, Miami, Florida, by visit and by 
letter hand delivered or faxed on or about March 11, 1999.  
Firm-initiated recall ongoing.  See also FDA talk paper T99-11 
dated February 20, 1999, and FDA press release P99-6 dated March 
8, 1999.
DISTRIBUTION
Florida, New York, Georgia, Ohio, North Carolina.
QUANTITY
Approximately 3,104 cases were distributed.
REASON
Product was epidemiologically associated with an outbreak of 
typhoid fever caused by Salmonella typhi.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
________
PRODUCT
Senor Murphy Candymakers brand Caramel Corn with Nuts, packaged 
in 8 ounce clear cellophane bags.  Recall #F-345-9.
CODE
None.
MANUFACTURER
Senor Murphy Candymakers, Inc., Santa Fe, New Mexico.
RECALLED BY
Manufacturer.  All product was pulled from the stores and from 
the manufacturing site.  Firm-initiated recall complete.
DISTRIBUTION
New Mexico.
QUANTITY
Firm estimates none remains on the market.
REASON
Product did not bear an ingredient statement and contains 
peanuts, pecans and pine nuts.
________
PRODUCT
Ultrameal Natural Country Peach Flavor, a powdered beverage 
product, in 22.2 ounce jars.  Recall #F-346-9.
CODE
0119038.
MANUFACTURER
HealthComm International, Inc., Gig Harbor, Washington.
RECALLED BY
Manufacturer, by telephone on or about April 1, 1999, followed by 
letter.  Firm-initiated recall ongoing.
DISTRIBUTION
New Hampshire, Florida, Minnesota, Oklahoma, Colorado.
QUANTITY
2,922 jars were distributed.
REASON
Product contains undeclared dairy ingredients.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III
________
PRODUCT
Nestle Carnation Follow-Up Infant Formula, intended for babies, 4 
months of age or older who are eating cereal and other baby 
foods, in 32 fluid ounce cans.  Recall #F-332-9.
CODE
Order         Consumer      Case Production     Can Production
Unit Code     Unit Code     Code                Code
50000-12101   50000-12001   8196EW3448          8196EWFR3448
50000-12101   50000-12001   8196EW3449          8196EWFR3449.
MANUFACTURER
Nestle Food Company, Nutritional Products Division, Eau Claire, 
Wisconsin.
RECALLED BY
Nestle USA, Inc., Glendale, California, by sales bulletin, and by 
telephone and/or visit beginning March 3, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide and Guam.
QUANTITY
12,651 cases (6 cans per case) were distributed.
REASON
Product has a lumpy, curdled appearance.
________
PRODUCT
Greer brand Applesauce, in 16 ounce metal cans.  Recall #F-347-9.
CODE
FJ7XAH and FJ8XAH.
MANUFACTURER
McCall Farms, Inc., Effingham, South Carolina.
RECALLED BY
Manufacturer, by visit on or about February 25, 1999.  
Firm-initiated recall complete.
DISTRIBUTION
Georgia, North Carolina, South Carolina.
QUANTITY
25,225 cases of code FJ7XAH and 40,440 cases of code FJ8XAH were
manufactured and distributed; firm estimated that 10-20% remained
in retail stores at time of recall initiation.
REASON
Product is held in detinned cans.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I
________
PRODUCT
GH Release Oral Liquid (2-(3H)- Furanone dihydro), OTC in 32 
fluid ounce bottles.  Recall #D-185-9.
CODE
All lot codes.
MANUFACTURER
Phillips Pharmatech Labs, Inc., Largo, Florida.
RECALLED BY
Oxygen Performance, Inc., also known as FURY, Clearwater, 
Florida, by letters on February 1 and 22, 1999.  Firm-initiated 
recall ongoing.  See also FDA talk paper T99-5 dated January 21, 
1999.
DISTRIBUTION
California, Florida, Georgia, Alabama, Iowa.
QUANTITY
2,500 bottles were distributed.
REASON
Product is an unapproved new drug.
________
PRODUCT
GH Revitalizer Oral Liquid (2-(3H)- Furanone dihydro), OTC in 32 
fluid ounce bottles, labeled for use for bodybuilding and sleep 
purposes.  Recall #D-186-9.
CODE
All lot codes.
MANUFACTURER
GH Revitalizer, also known as HI-IR Industries, Orange Park, 
Florida.
RECALLED BY
Manufacturer, by letter dated February 9, 1999.  Firm-initiated 
recall ongoing. See also FDA talk paper T99-5 dated January 21, 
1999.
DISTRIBUTION
Nationwide.
QUANTITY
Approximately 3,600 bottles were distributed; firm estimates none 
remains on the market.
REASON
Product is an unapproved new drug.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
________
PRODUCT
Oxygen USP, Rx in cryogenic home vessels.  Recall #D-173-9.
CODE
Serial numbers:  93040130 and 93041441.
MANUFACTURER
Health First, Richmond, Virginia.
RECALLED BY
Manufacturer, by telephone on December 14, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Virginia.
QUANTITY
2 vessels were distributed.
REASON
Current good manufacturing practice deficiencies including 
failure to perform potency assays.

RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III
________
PRODUCT
Liothyronine Sodium, USP, bulk powder, Rx, packaged in 250 mg, 
1g, and 5g units, for further manufacture or prescription 
compounding by pharmacies.  Recall #D-187-9.
CODE
Lot numbers: ML0014, NJ0033, NF0248, and NF0301.
MANUFACTURER
Medisca, Inc., Plattsburgh, New York (domestic supplier bulk 
drug); Topchem S.R.L., Milano, Italy (foreign bulk drug 
supplier).
RECALLED BY
Spectrum Quality Products, Gardena, California, by certified mail 
and telephone beginning March 9, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
California, Connecticut, Idaho, Illinois, Indiana, Louisiana, 
Maryland, Montana, New Mexico, New York, Texas, Utah, Wisconsin.
QUANTITY
13 250-mg bottles; 11 1-g bottles; 2 5-g bottles were 
distributed.
REASON
Misbranded - Product is actually levothyroxine not 
liothyronine sodium as labeled 

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
________
PRODUCT
Platelets, Pheresis.  Recall #B-650-9.
CODE
Unit numbers: 16340-6977-01, 16340-6977-02, 16342-6440-02, 
16342-6405, 16342-6445-01, 16342-6448-01, 16342-6502-01, 
16342-3615-01, 16344-3679-01, 16344-3679-02, 16344-3683-01, 
16344-3678-02, 16344-3709, 16344-3678-01.
MANUFACTURER
Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on 
September 15, 1998, and by letter dated October 7, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
Mississippi.
QUANTITY
14 units were distributed.
REASON
Blood products either had an unacceptable platelet count or a 
high white blood cell count.
________
PRODUCT
Autologous Frozen Red Blood Cells.  Recall #B-651-9.
CODE
Unit #04FS92390.
MANUFACTURER
American Red Cross Blood Services, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by telephone on August 13, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Massachusetts.
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-664/666-9.
CODE
Unit #5033126.
MANUFACTURER
BloodCare, doing business as Carter BloodCare, Dallas, Texas.
RECALLED BY
Manufacturer, by letter dated October 20, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Texas and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were distributed after receipt of information 
concerning a post donation illness.
________
PRODUCT
Red Blood Cells.  Recall #B-667-9.
CODE
Unit #21GK99343.
MANUFACTURER
American Red Cross Blood Services, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by telephone on September 21, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Massachusetts.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who subsequently tested 
repeatedly reactive for anti-HTLV-I/II, was not quarantined, and 
was distributed after receipt of the information.
________
PRODUCT
Red Blood Cells.  Recall #B-669-9.
CODE
Unit #40GE33944.
MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY
Manufacturer, by letter dated February 26, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who traveled to an area 
considered endemic for malaria.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma;
d) Source Leukocytes; e) Recovered Plasma.  Recall #B-670/674-9.
CODE
Unit numbers: a) 18S81283, 18FR23122, 18FS17582, 18R92419, 
18R90177, 18FR13960, and 18FR12412; b) 18FR23122 and 18R90177;
c) 18FR23122 and 18R92419; d) 18R90177; e) 18S81283, 18FS17582, 
18R90177.
MANUFACTURER
American Red Cross Blood Services, Lansing, Michigan.
RECALLED BY
Manufacturer, by letters dated September 25 and 29, 1998, October 
7 and 28, 1998, or by telephone on October 19, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
Pennsylvania, Massachusetts, Michigan, New Jersey.
QUANTITY
a) 7 units; b) 2 units; c) 2 units; d) 1 unit; e) 3 units were 
distributed.
REASON
Blood products were collected from a donor taking the drug, 
Methotrexate.
________
PRODUCT
Red Blood Cells.  Recall #B-675-9.
CODE
Unit numbers: H25283 and H32924.
MANUFACTURER
Regional Health Resource Center, Community Blood Services, 
Urbana, Illinois.
RECALLED BY
Manufacturer, by telephone on December 18, 1998, and by letter 
dated January 28, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Illinois.
QUANTITY
2 units were distributed.
REASON
Blood products were collected from a donor who reported travel to 
an area designated as endemic for malaria.
________
PRODUCT
Source Plasma.  Recall #B-676-9.
CODE
Unit #0490169765.
MANUFACTURER
NABI BioMedical Center, Grand Prairie, Texas.
RECALLED BY
NABI, Boca Raton, Florida, by fax on November 4, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
North Carolina.
QUANTITY
1 unit was distributed.
REASON
Blood products were collected from a donor who had been 
incarcerated.
________
PRODUCT
Source Plasma.  Recall #B-677-9.
CODE
Unit numbers:  0200192598, 0200192775, 0200193822.
MANUFACTURER
NABI BioMedical Center, Norman, Oklahoma.
RECALLED BY
NABI, Boca Raton, Florida, by fax on November 6, 1998 and 
February 2, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Germany.
QUANTITY
3 units were distributed.
REASON
Blood products were collected from a donor who had been 
deferred for high risk behavior.
________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced.  Recall #B-680-9.
CODE
Unit numbers: 4605949, 6700380, 6700378.
MANUFACTURER
LifeSource, Glenview, Illinois.
RECALLED BY
Manufacturer, by telephone on November 11, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois.
QUANTITY
3 units were distributed.
REASON
Blood products were collected using an unvalidated instrument, 
and were not properly tested for white blood cell counts.
________
PRODUCT
Red Blood Cells.  Recall #B-681-9.
CODE
Unit #50G60992.
MANUFACTURER
American Red Cross Blood Services, Toledo, Ohio.
RECALLED BY
Manufacturer, by letter dated February 22, 1999.  
Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product was mislabeled as CMV antibody negative.
________
PRODUCT
Red Blood Cells.  Recall #B-682-9.
CODE
Unit #16LP01429.
MANUFACTURER
American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY
Manufacturer, by telephone on June 24, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected in a manner that compromised the 
sterility of the unit.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
________
PRODUCT
Red Blood Cells.  Recall #B-668-9.
CODE
Unit numbers: 40GC36273 and 40LZ05383.
MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY
Manufacturer, by telephone on February 26, 1999, followed by 
letter dated March 4, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Illinois.
QUANTITY
2 units were distributed.
REASON
Blood products were leukoreduced by filtration greater than five 
days after collection.
________
PRODUCT
Platelets, Pheresis.  Recall #B-678-9.
CODE
Unit #LN03458.
MANUFACTURER
LifeSource, Glenview, Illinois.
RECALLED BY
Manufacturer, by telephone on October 1, 1998. 
Firm-initiated recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit was distributed.
REASON
A unit of Platelets, Pheresis was incompatible by crossmatch and 
was labeled as compatible and distributed for transfusion.
________
PRODUCT
Red Blood Cells, Leukocytes Reduced.  Recall #B-679-9.
CODE
Unit #H50049.
MANUFACTURER
Northern Illinois Blood Bank, Rockford, Illinois.
RECALLED BY
Manufacturer, by letter dated January 25, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit was distributed.
REASON
Red Blood Cells, leukoreduced by filtration greater than five 
days past the time of collection, were distributed for 
transfusion.
________
PRODUCT
Red Blood Cells.  Recall #B-684-9.
CODE
Unit numbers: 4755223, 4757802, 4760212, 8947389, 8941844, 
8385131, 8357717, 4761542, 8385143, 8358587, 8358138, 4757752, 
8947349, 8357627, 8941851, 8357645, 4760139, 8947350, 8947356, 
8359836, 8947347, 8382997.
MANUFACTURER
New York Blood Services, New York, New York.
RECALLED BY
Manufacturer, by telephone on September 13, 1998.  
Firm-initiated recall complete.
DISTRIBUTION
New York and New Jersey.
QUANTITY
22 units were distributed.
REASON
Blood product may have been shipped at unacceptable temperatures.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
_____
PRODUCT
Integris Family of X-ray Controls and Generators, general purpose 
fluoroscopy, urology, cardiology and interventional studies:
a) Integris H 1000; b) Integris H 3000; c) Integris BH 3000;
d) Integris HM 2000; e) Integris HM 3000; f) Integris H 5000F;
g) Integris H 5000C; h) Integris BH 5000; i) PolyDiagnost H;
j) Integris V 3000; k) Integris BV/BN 3000; l) Integris V 4000;
m) Integris V 5000.  Recall #Z-748/760-9.
CODE
See model numbers above.
MANUFACTURER
Phillips Medical Systems, Shelton, Connecticut.
RECALLED BY
Manufacturer.  FDA approved the firm's corrective action plan on 
April 6, 1999.  Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
1,086 units were distributed.
REASON
The diagnostic X-ray devices were found defective under the 
Federal performance standard for diagnostic X-ray systems and 
their major components. The defect occurs when the system is 
driven to maximum EER and the source to image receptor distance 
(SID) is moved to a shorter distance while continuing to make 
exposures.  In this manner of operation, the output may exceed 10 
R/min because the software will not update the output until the 
exposure control is released.  Therefore, the system is in 
violation of the EER limits of the standard (21 CFR 1020.32(d) 
and (e)).
________
PRODUCT
Tutoplast Process Dura Mater, either under the Pfrimmer-Viggo or 
Biodynamics International label, all sizes.  This tissue product is 
a solvent dehydrated, gamma-irradiated preserved human dura mater, 
indicated for use in neurosurgical applications. 
Recall #Z-800-9.
CODE
All sizes and all lots which bear an expiration date before April 
1999.
MANUFACTURER
Tutogen Medical US, Inc., formerly known as Biodynamics 
International US, Inc., Alachua, Florida.
RECALLED BY
Manufacturer, by letter faxed on March 12, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
New Hampshire, Florida, California, Pennsylvania, Minnesota, Iowa, 
Ohio, Utah, Oregon, Michigan, Maryland, Texas, Arizona, Tennessee, 
Illinois, New York, Colorado, Washington state.
QUANTITY
Undetermined.
REASON
Patients may potentially contract Creutzfeld-Jacob Disease (CJD) 
from an implanted piece of dura mater contaminated with the CJD 
prions.  The CJD can be due to inadequate donor screening and/or 
handling procedures by the German firm Pfrimmer-Viggo.
________
PRODUCT
Venturi Ventilator, used to provide a software that continously 
adapts to the patient's changing breathing demands and assures 
ventilation at the lowest pressure. The display monitor provides 
pertient patient parameters and waveforms.   Recall #Z-802-9.
CODE
Serial numbers: 970192, 970190, 970154, 970164, 970169, 970172, 
970138, 970161, 970163, 970185, 970176, 970174, 970173, 970166, 
970184, 970186, 970199, 970175, 970171, 970170, 970168, 970165.
MANUFACTURER
Cardiopulmonary Corporation, Milford, Connecticut.
RECALLED BY
Manufacturer, by letter on February 23, 1998, followed by visit. 
 Firm-initiated recall complete.
DISTRIBUTION
England.
QUANTITY
22 units were distributed.
REASON
Display monitor may go blank due to faulty inverter.
________
PRODUCT
Venturi Ventilator, provides a software that continuously adapts 
to the patient's changing breathing demands and assures 
ventilation at the lowest pressure.  Recall #Z-803-9.
CODE
Venturi Ventilator with Software Revision C.  Serial #970222.
MANUFACTURER
Cardiopulmonary Corporation, Milford, Connecticut.
RECALLED BY
Manufacturer, by letter on May 18, 1998.  Firm-initiated recall 
complete.
DISTRIBUTION
England.
QUANTITY
1 unit was distributed.
REASON
Software error may cause ventilator to deliver more than set 
tidal volume.
________
PRODUCT
I-125 RAPID Strand I-125 Seeds spaced within a Vicryl absorbable 
suture for permanent interstitial implantation of selected 
localized tumors for treatment of prostate cancer or unresectable 
tumors.  Recall #Z-804-9.
CODE
Model 7000, sales order 529590, lot P9030B.
MANUFACTURER
Medi-Physics, Inc., Arlington Heights, Illinois.
RECALLED BY
Nycomed Amersham Imaging, Princeton, New Jersey, by telephone on 
March 5, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Missouri.
QUANTITY
5 strands (50 seeds) were distributed.
REASON
Product was mislabeled with wrong activity range.
________
PRODUCT
I-125 Seeds, a welded titanium capsule containing Iodine-125 
adsorbed onto a silver rod.  Recall #Z-805-9.
CODE
Model 6711, Sales Order 472261, lot E1782.
MANUFACTURER
Medi-Physics, Inc., Arlington Heights, Illinois.
RECALLED BY
Nycomed Amersham Imaging, Princeton, New Jersey, by telephone on 
October 1, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Missouri and Florida.
QUANTITY
70 seeds were distributed.
REASON
Product was mislabeled with wrong activity range.

END OF ENFORCEMENT REPORT FOR APRIL 21, 1999. 

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