FDA

Enforcement Report

November 3, 1999                                               99-44

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II
_______
PRODUCT
Liquid Pasteurized Whole Eggs in white colored square shaped 
plastic buckets with a paper label affixed to the exterior of the 
bucket, 30, pounds and in plastic drums of approximately 55-
gallon volume size with black plastic lids with each drum 
containing 450 pounds of product.
Recall #F-004-0.
CODE
The lot number is 196-9 that reflects product manufactured on 
7/15/99.
MANUFACTURER
Hi Point Industries, L.L.C., Norco, California.
RECALLED BY
Manufacturer, by telephone on July 21, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
California.

QUANTITY
14 450-pound drums or 6,300 pounds and 1,180 30-pound buckets or 
35,400 pounds were distributed.
REASON
Product is contaminated with Salmonella C-1.
________
PRODUCT
PowerAde Mountain Blast in 11.5 ounce cans.  
Recall #F-009-0.
CODE
Lot 9203MD.
MANUFACTURER
The Minute Maid Company, for Coca-Cola USA at Coca-Cola Bottling 
Company of Chicago, Niles, Illinois.
RECALLED BY
Coca-Cola USA Operations, Atlanta, Georgia, by E-mail or fax on 
August 18, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Alabama, Florida, Georgia, Kansas, Louisiana, Tennessee, 
Wisconsin.
QUANTITY
5.346 cases (24 cans per case) were distributed.
REASON
Some cans actually contain Lemon-Lime flavor.  The Lemon-Lime 
flavor contains FD&C Yellow No. 5 Lake and brominated vegetable 
oil that are not listed as ingredients on the Mountain Blast 
flavor.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III
________
PRODUCT
AMROS, Pure Natural, Mixed Nuts Honey, in 14 ounce jars.
Recall #F-008-0.
CODE
None.
MANUFACTURER
AMROS The Second, Inc., Somerset, New Jersey.
RECALLED BY
Manufacturer, by letter sent on August 25, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Minnesota, Missouri, Washington state.
QUANTITY
6 cases (12 jars per case) were distributed.
REASON
Product does not bear an ingredient statement.
________
PRODUCT
PowerAde Mountain Blast, in 20 ounce PET containers.
Recall #F-012-0.
CODE
9112CC.
MANUFACTURER
The Minute Maid Company for Coca-Cola USA at United Packers, 
Inc., Chattanooga, Tennessee.
RECALLED BY
Coca-Cola USA Operations, Atlanta, Georgia, by E-mail and fax on 
September 3, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Alabama, Arkansas, California, Florida, Georgia, Kentucky, 
Louisiana, Mississippi, New Mexico, North Carolina, Ohio, 
Oklahoma, South Carolina, Tennessee, Texas.
QUANTITY
23,924 cases (24 units per case) were distributed; firm estimated 
that 2,471 cases remained on market at time of recall initiation.
REASON
Product is contaminated with mold.

RECALLS AND FIELD CORRECTINS:  BIOLOGICS -- CLASS II
________
PRODUCT
Blood Bank Control Systems. Recall #B-020-0.
CODE
Software versions 4.0 and greater.
MANUFACTURER
Blood Bank Computer Systems, Kent, Washington.
RECALLED BY
Manufacturer, by letter dated September 1, 1998.  Firm-initiated 
field correction complete.
DISTRIBUTION
California, Florida, Illinois, Kansas, Pennsylvania, Texas, 
Washington State.
QUANTITY
14 systems were distributed.
REASON
Computer software contains programming errors that could 
potentially result in the release of a unit that has not been 
tested for antibodies.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-021/023-0.
CODE
Unit #04R37916.
MANUFACTURER
American Red Cross, Dedham, Massachusetts.
RECALLED BY
Manufacturer, by letter dated June 3, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
New York and Maine.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor with a history of 
cancer.
________
PRODUCT
a) Red Blood Cells; b) Source Leukocytes for Manufacture.
Recall #B-026/027-0.
CODE
Unit #0700265.
MANUFACTURER
Bergen Community Regional Blood Center, Paramus, New Jersey.
RECALLED BY
Manufacturer, by fax and/or letter on February 19, 1999.  Firm-
initiated recall complete.
DISTRIBUTION
New Jersey and New York.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who reported travel to 
an area designed as endemic for malaria.
________
PRODUCT
Red Blood Cells.  Recall #B-032-0.
CODE
Unit #49W24412.
MANUFACTURER
American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY
Manufacturer, by letter dated July 13, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had lived in an area 
designated as endemic for malaria.
________
PRODUCT
Red Blood Cells.  Recall #B-033-0.
CODE
Unit #42S66951.
MANUFACTURER
American Red Cross Blood Services, Cleveland, Ohio.
RECALLED BY
Manufacturer, by telephone eon June 16, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product was labeled as leukoreduced but did not undergo 
leukoreduction.
________
PRODUCT
Red Blood Cells.  Recall #B-047-0.
CODE
Unit #3008296.
MANUFACTURER
Wellmont Health System, doing business as Bristol Regional 
Medical Center, Bristol, Tennessee.
RECALLED BY
Manufacturer, by letter dated September 14, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
North Carolina.
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-048-0.
CODE
Unit #29F28068.
MANUFACTURER
American Red Cross Blood Services, Norfolk, Virginia.
RECALLED BY
Manufacturer, by letter dated February 16, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Virginia.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who reported having 
lived in an area designated as endemic for malaria.
________
PRODUCT
Platelets, Pheresis, Leukoreduced, Irradiated.
Recall #B-049-0.
CODE
Unit #16KF20408, part 2.
MANUFACTURER
American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY
Manufacturer, by letter dated August 6, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Ohio.
QUANTITY
1 unit was distributed.
REASON
Blood product was incorrectly labeled as HLA matched.
________
PRODUCT
a) Whole Blood; b) Red Blood Cells; 
c) Red Blood Cells, Deglycerolized; d) Platelets;
e) Platelets, Pheresis; f) Fresh Frozen Plasma;
g) Fresh Frozen Plasma, Pheresis; h) Cryoprecipitated AHF;
i) Recovered Plasma.  Recall #B-050/058-0.
CODE
FDA, Center for Biologics Evaluation and Research, Contact Office 
of Compliance (301) 827-6220 for individual unit numbers 
recalled.
MANUFACTURER
New York Blood Services (Center West), New York, New York.
RECALLED BY
Manufacturer, by letter dated June 24, 1999, followed by 
telephone or fax on July 21, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
New York, New Jersey, California, Switzerland.
QUANTITY
a) 3 units; b) 36 units; c) 1 unit; d) 12 units; e) 2 units; f) 
12 units; g) 4 units; h) 2 units; i) 23 units were distributed.
REASON
Blood products may not have been tested in accordance with the 
manufacturer's instructions for either HCV or HbsAg.
________
PRODUCT
a) Red Blood Cells, Irradiated; b) Platelets, Pheresis, 
Irradiated, Leukocytes Reduced.  Recall #B-059/060-0.
CODE
Unit Numbers:  a) X48625 and X51412; b) X46101.
MANUFACTURER
Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY
Manufacturer, by letter dated September 2, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois.
QUANTITY
a) 2 units; b) 1 unit was distributed.
REASON
Blood products lacked documentation of irradiation.
________
PRODUCT
Cryoprecipitated AHF.  Recall #B-061-0.
CODE
Unit Numbers:  53KQ54716, 53KR41958, 53KR41963, 53V88521, 
53KX35154, 53KX35155, 53KX35159, 53KX35160, 53KS38864, 53KS38867, 
53Q73963.
MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY
Manufacturer, by telephone on March 30, 1999, and by letter dated 
April 5, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Maryland and District of Columbia.
QUANTITY
11 units were distributed.
REASON
Blood products were incorrectly processed.
________
PRODUCT
Red Blood Cells.  Recall #B-062-0.
CODE
Unit Numbers: 29K17294, 53GM21762, 04W07543.
MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY
Manufacturer, by telephone on June 21, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Maryland.
QUANTITY
3 units were distributed.
REASON
Blood products had been stored at unsuitable temperatures.
________
PRODUCT
Red Blood Cells.  Recall #B-064-0.
CODE
53FL72908, 53FL72921, 53GL98643, 53GL98646, 53M80764, 53J49805, 
53L07668, 53GL98638.
MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY
Manufacturer, by telephone on December 1, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Maryland.
QUANTITY
8 units were distributed.
REASON
Blood products were shipped under unsuitable temperatures.
________
PRODUCT
Source Plasma.  Recall #B-072-0.
CODE
Units Numbers:
0460093369, 0460093796, 0460094429, 0460094577, 0460095257, 
0460095360, 0460096091, 0460096327, 0460096919, 0460097084, 
0460098070, 0460098680, 0460099083, 0460099657, 0460099910, 
0460100486, 0460101017, 0460101449, 0460101679, 0460102098, 
0460102503, 0460102803, 0460103346, 0460103641, 0460104012, 
0460104305, 0460105080, 0460105538, 0460111501, 0460112096, 
0460112276, 0460112893, 0460113524, 0460113786, 0460114539, 
0460114876, 0460115382, 0460115748, 0460116210, 0460116502, 
0460117042, 0460117285, 0460118020, 0460118258, 0460118723,
0460119051, 0460119869, 0460120687, 0460121017, 0460121755, 
0460122173, 0460122559, 0460123065, 0460123442, 0460124969, 
0460125535, 0460125991, 0460126608, 0460127188, 0460127377, 	
0460128166, 0460128405, 0460129463, 0460129998, 0460130361, 
0460131088, 0460131410, 0460133409, 0460135648, 0460136077, 
0460136863, 0460137543, 0460138018, 0460138239, 0460139194,
0460140109, 0460140475, 0460141015, 0460141977, 0460142478, 
0460143124, 0460144640, 0460145657, 0460146057, 0460147105, 
0460147581, 0460148111, 0460148816, 0460149341, 0460149754, 
0460152191, 0460153434, 0460153954, 0460155404, 0460156089,
0460089621, 0460090231, 0460090643, 0460091315, 0460091897, 
0460092103, 0460092720, 0460092897, 0460106426, 0460106793, 
0460107237, 0460107596, 0460108054, 0460108267, 0460109319, 
0460109531, 0460110153, 0460110571, 0460110988, 0460069539,
0460069764, 0460071017, 0460071435, 0460071905, 0460072558, 
0460072881, 0460074373, 0460081025, 0460081246, 0460081810, 
0460081946, 0460082592, 0460082710, 0460083411, 0460083519, 
0460084499, 0460084706, 0460085245, 0460085661, 0460086577, 
0460086727, 0460087820, 0460088008, 0460088567, 0460088809, 
0460089267, 0460132235, 0460132597.
MANUFACTURER
Nabi Biomedical Center, Dallas, Texas.
RECALLED BY
Manufacturer, by fax on February 5, 1999, and March 23, 1999.  
Firm-initiated recall complete.
DISTRIBUTION
New York, Korea, Germany, Switzerland.
QUANTITY
143 units were distributed.
REASON
Blood products tested negative for anti-HCV, but were collected 
from a donor who previously tested reactive for anti-HCV.

________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
Recall #B-073/075-0.
CODE
Unit #479882.
MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
RECALLED BY
Manufacturer, by letter dated February 4, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Minnesota and Switzerland.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor who had body piercing 
within 12 months of donation.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
________
PRODUCT
Source Plasma.  Recall #B-010-0.
CODE
Unit numbers: 09111608, 09111615, 09111622, 09111639, 09111646, 
09111653, 09111660, 09111677, 09111684, 09111691, 09111707, 
09111714.
MANUFACTURER
Seramed, Inc., Tacoma, Washington.
RECALLED BY
Manufacturer, by telephone and fax on December 21, 1998.  Firm-
initiated recall complete.
DISTRIBUTION
California.
QUANTITY
12 units were distributed.
REASON
Blood products tested negative for all required viral marker 
tests, were distributed prior to testing.
________
PRODUCT
Corneas.  Recall #B-011-0.
CODE
Unit numbers:  20837 LC and 20837 RC.
MANUFACTURER
Lions Eye Bank of Delaware Valley, c/o Willis Eye Hospital, 
Philadelphia, Pennsylvania.
RECALLED BY
Lions Eye Bank of Delaware Valley, Philadelphia, Pennsylvania, by 
telephone and fax on June 15, 1999, and by letter dated June 16, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
Florida and Texas.
QUANTITY
2 units were distributed.
REASON
Corneas were collected from a donor who tested repeatedly 
reactive for the HIV p-24 antigen, and non-comfirmable by PCR.
________
PRODUCT
Corneas.  Recall #B-012-0.
CODE
Unit numbers:  99-1001 and 9-1002.
MANUFACTURER
Georgia Eye Bank, Inc., Atlanta, Georgia.
RECALLED BY
Manufacturer, by telephone and letter on July 13, 1999.  Firm-
initiated recall complete.
DISTRIBUTION
Georgia and Japan.
QUANTITY
2 units were distributed.
REASON
Corneas were collected from a donor who tested repeatedly 
reactive for the HIV p-24 antigen, and non-confirmable by PCR.
________
PRODUCT
Source Plasma.  Recall #B-017-0.
CODE
30GP08319, 30GP08329, 30GP08330, 30GP08358, 30GP08368, 30GP08376, 
30GP08377.
MANUFACTURER
American National Red Cross, Ashley, Pennsylvania.
RECALLED BY
Manufacturer, by telephone on April 17, 1998, and by fax on April 
22, 1998.  Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
7 units were distributed.
REASON
Unlicensed blood products were distributed in interstate 
commerce.
________
PRODUCT
a) Red Blood Cells; b) Fresh Frozen Plasma.
Recall #B-024/025-0.
CODE
Unit #LW64240.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
RECALLED BY
Manufacturer, by telephone on December 16, 1998, and July 2, 
1999, and by letters dated January 18, 1999, and July 6, 1999.  
Firm-initiated recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor taking the drug 
Sulfasalazine.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma; c) Red Blood Cells for 
Manufacturing Use; d) Platelets for Use in Manufacturing Non-
Injectable Products.  Recall #B-028/031-0.
CODE
Unit Numbers:  a) 259392; b) 259392, 273070
c) 273070; d) 275600, 281147, 322010.
MANUFACTURER
Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
RECALLED BY
Manufacturer, by letter dated February 19, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Florida, Minnesota, Switzerland.
QUANTITY
a) 1 unit; b) 2 units; c) 1 unit; d) 3 units were distributed.
REASON
Blood products tested non-reactive for anti-HIV-2, but were 
collected from donors who previously tested repeatedly reactive 
for anti-HIV-2, were distributed.
________
PRODUCT
Panglobulin, Immune Globulin Intravenous (Human), in 12 gram 
vials.  Recall #B-039-0.
CODE
Lots 01839-00023, 01839-00012.
MANUFACTURER
ZLB Central Laboratory, Bern, Switzerland.
RECALLED BY
American Red Cross, Rosslyn, Virginia, by letter on August 20, 
1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
7,963 vials distributed.
REASON
Two lots of Immune Globulin Intravenous (Human), that exceeded 
the residual moisture specification.
________
PRODUCT
Platelets, Pheresis.  Recall #B-040-0.
CODE
Unit #LH47927.
MANUFACTURER
The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
RECALLED BY
Manufacturer, by telephone on July 7, 1999, and by letter dated 
July 6, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had not been 
questioned about the use of the drug Soriatane (acitretin),
________
PRODUCT
a) Whole Blood; b) Red Blood Cells, Leukocytes Reduced; c) 
Platelets; d) Platelets, Pooled.  Recall #B-041/044-0.
CODE
Unit Numbers: a) LX69787; b) Q99456; c) KZ33284; d) FP96554.
MANUFACTURER
The Blood center of Southeastern Wisconsin, Milwaukee, Wisconsin.
RECALLED BY
Manufacturer, by letter dated July 6, 1999, or by telephone on 
November 17, 1998, December 27, 1998, and/or July 2, 1999.  Firm-
initiated recall complete.
DISTRIBUTION
Wisconsin.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from donors who had not been 
questioned about the use of the drug Soriatane (acitretin).
________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall #B-045/046-0.
CODE
Unit Numbers: a) 19GF42933, 19GT17811, 19GG56965, 40GL64478, 
40GL64465; b) 19GL16084.
MANUFACTURER
American Red Cross Blood Services, Nashville, Tennessee.
RECALLED BY
Manufacturer, by letter dated May 13, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Tennessee.

QUANTITY
a) 5 units; b) 1 unit was distributed.
REASON
Blood products had been stored at unacceptable temperatures.
________
PRODUCT
Platelets.  Recall #B-063-0.
CODE
Unit Numbers:  53FN47150, 53T66446, 53FX71803, 53FX71794, 
53T66456, 53K29270, 53FX71807.
MANUFACTURER
American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY
Manufacturer, by letter dated November 13, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Maryland.
QUANTITY
7 units were distributed.
REASON
Blood products were shipped at an unacceptable temperature.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
________
PRODUCT
Dialyzer Control:
a) Centrysystem 3 Catalog Nos.:  
333103-001 - US 115v Centrysystem 3, BPM
333103-101 - US 115v Centrysystem 3 Single Needle, BPM
333103-121 - Euro 240v Centrysystem 3, Single Needle, BPM
333103-201 - US 115v Centrysystem 3+, BPM
333103-301 - US 115v Centrysystem 3+, Single Needle, BPM
333104-001 - US 115v Centrysystem 3, No Options
333104-101 - US 115v Centrysystem 3, Single Needle
333104-121 - Euro 240v Centrysystem 3, Single Needle
333104-201 - US 115v Centrysystem 3+, No Options;
b) Spare Transducer Assembly Catalog numbers:
501036-000 - Arterial/Venous Pressure Transducer Spare 
   Assembly
501212-003 - Cartridge Holder Spare Assembly
501249-220 - Transducer Connector Spare Assembly.  
Recall #Z-064/065-0.
CODE
a) All devices manufactured after 11/01/1998, and all 
devices repaired with affected spares assemblies that were 
shipped after 11/01/1998.  Includes machine serial numbers  
3C39644 through 3C42411 (with exclusion of 460 devices within 
that range but released prior to 11/01/1998).
b) Lot numbers with prefix 11C, 12C, 01D, 02D, 03D, 04D, 05D, 
06D.  
MANUFACTURER
Gambro Renal Care Products, Lakewood, Colorado.
RECALLED BY
Manufacturer, by letter on August 24, 1999.  Firm-initiated field 
correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
1,442 of the affected machines are in US distribution and 307 
were shipped to international distributors.  Also, 204 Transducer 
Spare Kits , 133 Cartridge Holder Spare Kits, and 3 Transducer 
Connector Spare Kits were distributed domestically.  
International distribution of these kits was 108, 8, and 0, 
respectively.
REASON
The dialyzer alarm does not sound when the Maximum Arterial 
Pressure Alarm Limit is challenged.
________
PRODUCT
Soflex UV-Absorbing Silicone PC Intraocular Lenses Model:  LI51U 
& LI61U.  Recall #Z-066/067-0.
CODE
Lot Numbers 390T, 4BG1, 4BG7, 4CRA and 4DV1.
MANUFACTURER
Bausch and Lomb Surgical, Clearwater, Florida.
RECALLED BY
Manufacturer, by letter on September 14, 1999.  Firm-initiated 
recall ongoing..
DISTRIBUTION
Nationwide.
QUANTITY
252 lenses were distributed; firm estimated that 124 units 
remained on market at time of recall initiation.
REASON
Intraocular lenses may exhibit a cloudy appearance.
________
PRODUCT
LifeStyle MV2 Multifocal, Hydrophilic, Sterile Contact Lenses in 
blister packs, Rx product.  Recall #Z-073-0.
CODE
All lots.
MANUFACTURER
St. Shine Optical Company, Ltd., Taiwan, Republic of China.
RECALLED BY
The LifeStyle Company, Inc., Morganville, New Jersey, by letter 
dated August 30, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Approximately 147,840 units were distributed.
REASON
The contact lenses contain sorbic acid that is not declared on 
the labeling and may cause a burning sensation in the patient's 
eye.
________
PRODUCT
Locking Blot Measuring Device, used to determine the required 
length of the locking bolt:
a) Part number 357.792; b) and Part number 357.113.311.
Recall #Z-075/076-0.
CODE
Lot numbers:  a) A4GG415; b) lot A4GF199. 
MANUFACTURER
Synthes USA, West Chester, Pennsylvania.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by E-mail on November 7, 1997. 
 Firm-initiated recall complete.
DISTRIBUTION
Arkansas, Florida, Minnesota, North Carolina, New Jersey, 
Pennsylvania, Germany.
QUANTITY
22 units were distributed.
REASON
The ball that attaches to the measuring slider of the device may 
detach.
________
PRODUCT
Synthes Anatomical Locking Plate System, used to treat fractures 
of long bones such as the femur:
a) Part number 422.340.111; b) Part number 422.341.111; 
c) Part number 422.344.111; d) Part number 422.345.111; 
e) Part number 422.348.111 and f) Part number 422.349.111.
Recall #Z-078/083-0.
CODE
Lot numbers:  a) N2002, N2002.1, N2003, N2004, N2005;
b) N2003, N2003.1, N2004, N2005; c) N2001, N2001.1, N2002, N2003, 
N2004, and N2005; d) N2001, N2001.1, N2002, N2003, N2004, N2005; 
e) N2001, N2001.1, N2002, N2003, N2004, N2005; f) N2001, N2001.1, 
N2002, N2003, N2004, N2005.
MANUFACTURER
Mathys Medical Ltd., Bettlach, Switzerland.
RECALLED BY
Synthes (USA), Paoli, Pennsylvania, by E-mail on December 19, 
1997.  Firm-initiated recall complete.
DISTRIBUTION
Alabama, Colorado, Florida, Mississippi, North Carolina, 
New York.
QUANTITY
288 units were distributed.
REASON
The fatigue strength of the plates did not meet the original 
specification.
________

PRODUCT
Proximal Femoral Nail (PFN) System, used to ream a hole for the 
insertion of a femoral neck screw.  Recall #Z-084-0.
CODE
Part #357.044, Lot Numbers 1006 through 1015.
MANUFACTURER
Stratec Medical, Eimattstrasse, Switzerland.
RECALLED BY
Synthes (USA), Paoli, Pennsylvania, by E-mail on September 2, 
1997, and December 1, 1997.  Firm-initiated recall complete.
DISTRIBUTION
California, Connecticut, Illinois, Pennsylvania, Canada.
QUANTITY
14 units were distributed.
REASON
The tip of the device may break when it comes in contact with a 
bent guidewire.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
Navarre 6 French J-Curve Universal Drainage Catheter, Product 
reference number NUD6J, used only in non-vascular drainage 
procedures, and are intended to be used for abscess, cyst, and 
other general purpose drainage applications.  Recall #Z-023-0.
CODE
Lot 990610, Use by 2002-04.
MANUFACTURER
Navarre Biomedical, Ltd., Plymouth, Minnesota.
RECALLED BY
Manufacturer, by memorandum on September 17, 1999.  Firm-
initiated recall complete.
DISTRIBUTION
Georgia, Indiana, Pennsylvania, Australia, Canada.
QUANTITY
105 catheters were distributed.
REASON
The catheter size was incorrectly identified at the tops of the 
pouch labels of the catheters as 8 French (inside diameter), 
rather than as the actual size (6 French).
________
PRODUCT
Pelvic Implant Set Graphic Case for Self-Tapping Screws, used to 
organize and store implants including tapping screws.  Recall #Z-
070-0.
CODE
Part #306.20, Lot #VC2671.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes (USA), Paoli, Pennsylvania, by E-mail on November 25, 
1997.  Firm-initiated recall complete.
DISTRIBUTION
California, Georgia, Iowa, South Carolina.
QUANTITY
4 units were distributed.
REASON
Mislabeling - The rack in the graphic case that hold the self 
tapping screws is labeled with the part numbers for the standard 
screws instead of the self tapping screws.
________
PRODUCT
Synthes Mandibular Modular Fixation System.
Recall #Z-074-0.
CODE
Part number 449.014, Lot A3KJ682.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes (USA), Paoli, Pennsylvania, by E-mail on October 18,1997. 
 Firm-initiated recall complete.
DISTRIBUTION
Alabama, California, Colorado, Florida, Hawaii, Michigan, 
Missouri, North Carolina, New York, Ohio, Pennsylvania, South 
Carolina, Texas, Washington, Wisconsin.
QUANTITY
43 units were distributed.
REASON
One of the outer labels of the device was purple instead of blue. 
 A purple label corresponds with 2.4-mm plates.  The 
color of the label is used to indicate the diameter of the 
screw that is used with the plate. The label still read 
what type and length the plate was in the package.  The 
user would have realized that the color was incorrect.
________
PRODUCT
Pelvic Implant Set Graphic Case for Self-Tapping Screws.
Recall #Z-077-0.
CODE
Part #306.20, Lot VC2671.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes (USA), Paoli, Pennsylvania, by E-mail on November 25, 
1997.  Firm-initiated recall complete.
DISTRIBUTION
California, Georgia, Iowa, South Carolina.
QUANTITY
4 units were distributed.
REASON
Mislabeling - The rack in the graphic case that hold the self 
tapping screws is labeled with the part numbers for the standard 
screws instead of the self tapping screws.
________
PRODUCT
Synthes TI-6AI-7NB Unreamed Femoral Nail, used for intramedullary 
stabilization for femoral shaft and subtrochanteric fractures, 
ipsilateral femoral neck and shaft fractures and impending 
pathologic fractures of the femur..  Recall #Z-087-0.
CODE
Part number 464.34S, Lot A3CX522.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes (USA), Paoli, Pennsylvania, by letter sent on April 8, 
1998.  Firm-initiated recall complete.
DISTRIBUTION
Arizona, California, Colorado, Florida, Massachusetts, Missouri, 
North Carolina, Nebraska, New Jersey, New York, Ohio, 
Pennsylvania.
QUANTITY
6 units were distributed.
REASON
Mislabeling - The package was labeled as "9 x 340 mm Titanium 
Unreamed Femoral Nail" but contained an "11 x 340 mm Titanium 
Unreamed Femoral Nail".
________
PRODUCT
Synthes Unreamed Humeral Nail (URHN).  Recall #Z-088-0.
CODE
Part number 458.40S, Lot #A3JL013.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes (USA), Paoli, Pennsylvania, by E-mail on September 19, 
1997, followed by visit.  Firm-initiated recall complete.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
95 units were distributed.
REASON
The locking bolts were packaged as 40 mm in length but were 
actually 42mm in length.
________
PRODUCT
Bone Staple(s): a) Part #282.80; b) Part #282.82.
Recall #Z-089/090-0.
CODE
Lot Numbers: a) 2022, 2031, 2032, 2033, and 2034; b) 2026.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes (USA), Paoli, Pennsylvania, by E-mail on October 10, 
1997.  Firm-initiated recall complete.
DISTRIBUTION
California, Kansas, Missouri, North Carolina, New York, Ohio, 
Oklahoma, Pennsylvania, Texas.
QUANTITY
250 units were distributed.
REASON
Mislabeling - The package label states "intended for femoral 
fractures and osteotomies" which is not applicable for this 
device.
________
PRODUCT
Saw Guide Assembly, Right and Left, HTO System, used as a guide 
for a bone saw: a) Part #P94025.013111; 
b) Part P94025.014011.  Recall #Z-091/092-0.
CODE
Lot numbers:  a) A4GF675; b) A4GF681.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes (USA), Paoli, Pennsylvania, by fax and telephone on 
September 22, 1997.  Firm-initiated recall complete.
DISTRIBUTION
Missouri, Mississippi, Germany.
QUANTITY
6 units were distributed.
REASON
The stud that is used to secure the saw guide to the guidewire 
may loosen from the base.
______
UPDATE
The following two recalls which appeared in the October 6, 1999 
Enforcement Report were re-classified from Class II to Class III 
recalls and should read as follows:
PRODUCT
Model 35040 Keithley Therapy Dosimeter, intended use for 
calibration of dosimetry of therapeutic radiation treatment 
machine for high-energy accelerators, cobalt 60, and 
brachytherapy equipment. Recall #Z-1261-9.
CODE
Serial Numbers:  69450-69469;  80276-80295;  82666-82685;  
81909-81928;  and 86087-86106. 
MANUFACTURER
Inovision Radiation Measurements, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letters on July 8, 1999, and September 10, 1999. 
Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
89 units.
REASON
A 1.6 Amp fuse may have been installed where a 1 Amp is 
specified. 
________
PRODUCT
The Tracker Display Model #35360A is sold with the Detector Model 
#35300A and marketed together as the Keithley Model #90100 
Tracker System, a radiation measurement system intended for use 
in quality assurance programs for high 
energy accelerators, and cobalt 60 machines.
Recall #Z-1262-9.
CODE
Serial Numbers: 83728-83747 and 84582-84601.
MANUFACTURER
Inovision Radiation Measurements, Cleveland, Ohio.
RECALLED BY
Manufacturer, by letters on July 8, 1999, and September 10, 1999. 
 Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
40 units.
REASON
A 1.6 Amp fuse may have been installed where a 1 Amp is 
specified. 

RECALLS AND FIELD CORRECTIONS:  VETERINARY PRODUCTS -- CLASS III
________
PRODUCT
Consolidated Nutrition Metabalance 15/25 and Consolidated 
Nutrition Metabalance 25/45, in 50 pound bags, containing 100 
gm/ton chlortetracycline, 0.011% sulfamethazine and 50 gm/ton 
penicillin - complete feed for starter pigs 
Recall #V-038-0.
CODE
Lot Nos  - Metabalance 15/25  - GLO4799
Metabalance 25/45 - GLO429 - 50 lb bag
GLO489 - bulk
GLO609 - 50 lb. bag
GLO639 - bulk
GLO699 - bulk
GLO689 - 50 lb bag
GLO839 - bulk
GLO909 - bulk (2 batches).
MANUFACTURER
Consolidated Nutrition, L.C., Glencoe, Minnesota.
RECALLED BY
Consolidated Nutrition, L.C., Omaha, Nebraska, by telephone on or 
about July 14, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Minnesota.
QUANTITY
78 50-lb bags of Metabalance 15/25, 484 50-lb bags and 61,800 
pounds of bulk of Metabalance 25/45 were distributed.
REASON
Products were manufactured with incorrect Type A Medicated 
Article  - Aureozol 500 containing sulfathiazole.
________
PRODUCT
a) Bulk Consolidated Nutrition Commercial 25/50 Medicated  
containing 100 gm/ton chlortetracycline, 0.011% sulfamethazine 
and 50 gm/ton penicillin complete feed for starter pigs - 
b) Bulk Consolidated Nutrition Metabalance 25/45 containing 100 
gm/ton chlortetracycline, 0.011% sulfamethazine and 50 gm ton 
penicillin complete feed for starter pigs-.
c) Alliance Animal Health Super 250 8463 Medicated, containing 10 
gm/lb chlortetracycline, 2.2% sulfamethazine and 5 gm/lb 
penicillin Type B premix for cervical abscesses, bacterial swine 
enteritis, prevention of these diseases during stress, weight 
gain and increased feed efficiency
d) Alliance Animal Health Advanced Stress Formula Aureo SP-250 
Option 8541 Medicated, containing 4 gm/lb chlortetracycline, 
0.88% sulfamethazine and 2 gm/lb penicillin, type B premix - 
treatment of cervical abscesses, bacterial swine enteritis, 
prevention of these diseases during stress and maintenance of 
weight gains and growth promotion.  Recall #V-039/042-0.
CODE
Lot Numbers:  a) LM 3418, LM3518, LM3638, LM0199, LM0399, LM0689, 
LM0849, LM0919, LM0989, LM1189, LM1319, LM1659, LM1799; b) LM0089 
and  LM1379; c) LM1529; d) LM3388 and LM0289.
MANUFACTURER
Consolidated Nutrition, L.C., LeMars, Iowa.
RECALLED BY
Consolidated Nutrition, Omaha, Nebraska, by telephone on July 14, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
a) South Dakota; b) South Dakota; c) Iowa and Indiana; 
d) Indiana, South Dakota, Nebraska, Iowa.
QUANTITY
a) 129,620 pounds; b) 27,680 pounds; c) 155 20-pound bags; d) 236 
25-pound bags were distributed.
REASON
Products  were manufactured using incorrect Type A Medicated 
Article, Aureozol 500 containing sulfathiazole.
________
PRODUCT
Consolidated Nutrition Metabalance 25/45 10485AXU Medicated 
containing 100 gm/ton chlortetracycline, 0.011% sulfamethazine 
and 50 gm/ton penicillin completed feed for starter pigs.  Recall 
#V-043-0.
CODE
Lot Numbers:  NA0999, NA1199, NA1319, NA1389, and NA1449.
MANUFACTURER
Consolidated Nutrition, L.C., Nappanee, Indiana.
RECALLED BY
Consolidated Nutrition, L.C., Omaha, Nebraska, by telephone on 
July 14, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Michigan, Ohio, Indiana.
QUANTITY
555 50-pound bags were distributed.
REASON
Product was manufactured with incorrect Type A Medicated Article, 
Aureozol 500 containing sulfathiazole.
________
PRODUCT
Aureozol 500 Granular Type A Medicated Article - containing 
40lb/chlortetracycline calcium complex equivalent to 
chlortetracycline HCl, 8.8%, 40 g lb sulfathiazole, 20 g lb. 
Penicillin   Recall #V-044-0.
CODE
Lot D821-3.
MANUFACTURER
Consolidated Nutrition, Omaha, Nebraska.
RECALLED BY
Manufacturer, by telephone on or about July 14, 1999.  
Firm-initiated recall complete.
DISTRIBUTION
Illinois, Minnesota, Indiana, Iowa.
QUANTITY
48 50-pound bags were distributed.
REASON
Aureozol 500 shipped to 4 plants under incorrect ingredient 
number 70192. Aureomix 500.   Feed manufactured from this 
shipment contained the incorrect sulfa drug.  

END OF ENFORCEMENT REPORT FOR NOVEMBER 3, 1999.

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