FDA

Enforcement Report

August 11, 1999                                   99-32

RECALLS AND FIELD CORRECTIONS FOODS -- CLASS II
________
PRODUCT
Golden Lion Brand Rice Crackers, in 6 ounce bags.
Recall #F-577-9.
CODE
None.
MANUFACTURER
Hua Feng Food Company, Ltd., Shuibu Taishan City, China.
RECALLED BY
Blooming Import Company, Inc., Brooklyn, New York, by letter 
dated March 3, 1999.  Completed field corrected resulted from 
sample analysis and follow-up by the New York State Department of 
Agriculture and Markets.
DISTRIBUTION
New York.
QUANTITY
92 cases (50 bags per case) were distributed.
REASON
Product contains four undeclared color additives:  Tartrazine, 
Sunset Yellow FCF, Erythrosine and Brilliant lue FCE, that do not 
appear to be certified.
________
PRODUCT
Chinese Birthday Bun, in 7.4 ounce (210g) plastic bags.
Recall #F-580-9.
CODE
None.
MANUFACTURER
Tombolo Development Corporation, Taipei, Taiwan.
RECALLED BY
Summit Import Corporation, New York, by letter dated April 23, 
1999.  Completed recall resulted from sample analysis and follow-
up by the New York State Department of Agriculture and Markets.
DISTRIBUTION
New York, New Jersey, Illinois, Florida, Massachusetts, District 
of Columbia.
QUANTITY
35 cartons were distributed.
REASON
Product contains the unapproved color additive
Ponceau 4R and it contains the uncertified color Erythrosine
(certifiable as FD&C Red No. 3). 
________
PRODUCT
Klein's Delights Pure Chocolate Lentils, packaged in 8 ounce 
rigid plastic tubs.  Recall #F-582-9.
CODE
None.
MANUFACTURER
Sigem Bvba Terlist, Antwerpen, Belgium.
RECALLED BY
Klein's Naturals Ltd., Brooklyn, New York, by visit beginning on 
November 20, 1998.  Completed field correction (relabeling) 
resulted from sample analysis and follow-up by the New York Sate 
Department of Agriculture and Markets.
DISTRIBUTION
New York.
QUANTITY
11,900 pounds were distributed.
REASON
The product declares several color additives in terms of the 
European designation which suggests the colors were not 
certified:
1) E132 - Indigotine - certifiable as FD&C Blue No. 2
2) E102 - Tartrazine - certifiable as FD&C Yellow No. 5 
3) E110 - Sunset Yellow - certifiable as FD&C Yellow No. 6.
_______
PRODUCT
Tostitos Brand All Natural SALSA in 10-3/4 ounce glass jars.  
Recall #F-583-9.
CODES
04JAN00 Y20 14:20 and 04JAN00 Y20 14:21.
MANUFACTURER
Dairy Farmers of America, also known as Mid-America Dairymen, 
Inc., Schulenberg, Texas.
RECALLED BY
Frito-Lay, Inc., Plano, Texas, by computer message to route sales 
persons on July 20, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
District of Columbia, Delaware, Maryland, New Jersey, 
Pennsylvania, Vermont, Virginia, West Virginia.
QUANTITY
538 jars were distributed.
REASON
Some jars of "Tostitos RESTAURANT STYLE SALSA CON QUESO" were 
inadvertently labeled as "Tostitos All Natural SALSA".  The salsa 
con queso product contains dairy ingredients, FD&C Yellow 5 and 
FD & C Yellow 6 that are not found in the all natural salsa and 
are not declared on the label.

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III
________
PRODUCT
Shan Shoei brand Honey, in 26.4 ounce, 63.5 ounce and 
105.8 glass jars.  Recall #F-579-9.
CODE
None.
MANUFACTURER
Shan Shoei Honey Company, Ltd., Tuku Chen Yun Lin Hsien, Taiwan.
RECALLED BY
Blooming Import Co., Inc., Brooklyn, New York, by letter dated 
December 18, 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
A total of 257 cases were distributed: 26.4 oz. (12 bottles per 
case) - 185 cases; 63.5 oz. (12 bottles per case) - 62 cases; 
105.8 oz. (10 bottles per case) - 10 cases.
REASON
Product is adulterated since it substituted sugars of cane or 
corn origin for the valuable constituent honey.
________
PRODUCT
Concord Grape Juice, under the Fruti Natural and Coloso labels.  
Recall #F-581-9.
CODE
Coloso Label     Fruti Natural Labels
11u9E28068       2159E2870
21u9E28069
21u9E26059.
MANUFACTURER
Procesadora Campo Fresco, Inc., Santa Isabel, Puerto, Rico.
RECALLED BY
Manufacturer, by telephone on June 10, 1999, followed by letter 
on June 11, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Puerto Rico.
QUANTITY
1,497 cases were distributed.
REASON
Product is falsely labeled as 100% pure grape juice but the brix 
level of 11.8 - 12 demonstrates the product is diluted grape 
juice.

RECALLS AND FIELD CORRECTIONS:  COSMETICS -- CLASS II
________
PRODUCT
Euro Teezer Natura Volumizing Gel, in 6 fluid ounce plastic 
tubes, packaged in a white box which is a kit called "Hair Care & 
Styling System".  Recall #F-584-9.
CODE
Lot numbers:  9D8861 and 9D8853.
MANUFACTURER
Stanford Personal Care Mfg, Inc., Saugus, California.
RECALLED BY
Euro Teezer, Granada Hills, California, by fax and telephone on 
June 4, 1999, and by letter on June 22, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Virginia and Pennsylvania.
QUANTITY
1,212 kits were distributed.
REASON
Some tubes of this product are contaminated with Citrobacter 
freundii, Serratia liquefaciens and Pseudomonas flourescens.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
________
PRODUCT
Red Blood Cells.  Recall #B-735-9.
CODE
Unit #11KC01556.
MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.
RECALLED BY
Manufactuer, by telephone on May 20, 1998, and by letter dated 
May 19, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Missouri.
QUANTITY
1 unit was distributed.
REASON
Blood product was not quarantined after receiving information 
concerning a post donation illness.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-849/850-9.
CODE
Unit Numbers 11LY97348, 11LY89722, 11LV20309.
MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.
RECALLED BY
Manufacturer, by letter dated November 17, 1998, or by fax on 
November 16, 1998.  Firm-initiated recall complete.
DISTRIBUTION
Missouri. California, Switzerland.
QUANTITY
3 units of each component were distributed.
REASON
Blood products were collected from a donor with a
history of hepatitis.
________
PRODUCT
a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma. 
 Recall #B-1013/1015-9.
CODE
Unit Numbers: 21Y44492, 21Y51404, 21GK75498 and 21FK96033.
MANUFACTURER
American Red Cross Blood Services, Portland, Oregon.
RECALLED BY
Manufacturer, by telephone and fax on April 6, 1999, and by 
letter dated April 13, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Oregon, Massachusetts, Minnesota, California, Switzerland.
QUANTITY
4 units of each component were distributed.
REASON
Blood products were collected from a donor with a history of 
cancer.
________
PRODUCT
Red Blood Cells.  Recall #B-1035-9.
CODE
Unit #01LS03577 
MANUFACTURER
American Red Cross Blood Services, Rochester, New York.
RECALLED BY
Manufacturer, by letter dated July 11, 1997.  Firm-initiated 
recall complete.
DISTRIBUTION
New York.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who traveled to an area 
considered endemic for malaria.
________
PRODUCT
Recovered Plasma.  Recall #B-1090-9.
CODE
Unit 3Y1534.
MANUFACTURER
Puget Sound Blood Center and Program, Seattle, Washington.
RECALLED BY
Manufacturer, by letter and fax on September 28, 1998.  Firm-
initiated recall complete.
DISTRIBUTION
Switzerland.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor taking the Proscar.
________
PRODUCT
Recovered Plasma.  Recall #B-1092-9
CODE
Unit #8B9004.
MANUFACTURER
Puget Sound Blood Center and Program, Seattle, Washington.
RECALLED BY
Manufacturer, by letter and fax on March 12, 1999.  Firm-
initiated recall complete.
DISTRIBUTION
Switzerland.
QUANTITY
1 unit was distributed.
REASON
Blood products were collected from a donor whose suitability was 
not adequately determined.
________
PRODUCT
Defense Blood Standard System (DBSS), Blood Bank Software.  
Recall #B-1094-9.
CODE
Software Versions 3.00 and 3.01.
MANUFACTURER
Electronic Data Systems (EDS), Herndon, Virginia.
RECALLED BY
U.S. Department of Defense (DBSS)\Composite Health Care System 2, 
Falls Church, Virginia, by E-mail on June 9 and 16, 1999.  Firm-
initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Utilized at 78 sites.
REASON
Blood bank computer software does not identify all potential 
duplicate donor records.
________
PRODUCT
a) Red Blood Cells; b) Plasma, Frozen.  
Recall #B-1095/1096-9.
CODE
Unit #40GC37973.
MANUFACTURER
American Red Cross Blood Services, Peoria, Illinois.
RECALLED BY
Manufacturer, by telephone on June 15, 1999, and by letter dated 
June 24, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Illinois.
QUANTITY
1 unit of each component was 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; c) Fresh Frozen Plasma;
d) Recovered Plasma.  Recall #B-1097/1100-9.
CODE
Unit numbers:  a) J31286, J45663, J58685, K06572, K46076, K65502, 
K85869, L05436; b) J45663, J58685, J88524, K46076, K65502, 
K85869, L05436; c) J88524; d) J31286, J45663, K06572, K46076, 
K65502, L05436.
MANUFACTURER
Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY
Manufacturer, by letter dated June 4, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Illinois, California, North Carolina, Virginia.
QUANTITY
a) 8 units; b) 7 units; c) 1 unit; d) 6 units were distributed.
REASON
Blood products tested negative for the antibody to the human 
immunodeficiency virus type 1 (HIV-1), but were collected from a 
donor who previously tested repeatedly reactive for the antibody, 
Western Blot negative.
________
PRODUCT
a) Red Blood Cells; b) Platelets; c) Recovered Plasma 
Recall #B-1101/1103-9.
CODE
Unit Numbers: a&c)  7630391, 7802540; b) 7802540.
MANUFACTURER
New York Blood Services (Center West), New York, New York.
RECALLED BY
New York Blood Center, Inc., New York, New York, by letter dated 
September 8, 1998.  Firm-initiated recall complete.
DISTRIBUTION
New York, New Jersey, Switzerland.
QUANTITY
a&c) 2 units of each component; b) 1 unit.
REASON
Blood products initially tested negative for HCV, but 
retrospectively tested repeatedly reactive for HCV, with a 
negative RIBA, or indeterminate RIBA with a negative PCR test.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
________
PRODUCT
Fresh Frozen Plasma.  Recall #B-1089-9.
CODE
Unit #8D8447.
MANUFACTURER
Puget Sound Blood Center, Seattle, Washington.
RECALLED BY
Manufacturer, by letter dated October 29, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Washington state.
QUANTITY
1 unit was distributed.
REASON
Blood product, collected from a donor who took the drug Propecia.
________
PRODUCT
Red Blood Cells, Apheresis, double bag.  Recall #B-1091-9.
CODE
Unit Numbers: 8959701, 8950506, 8950504, 8961576, 8961577.
MANUFACTURER
New York Blood Services (Westside), New York, New York.
RECALLED BY
Manufacturer, by fax and letter on April 5, 1999, and/or by 
telephone on April 5 and 9, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
New York.
QUANTITY
5 units were distributed.
Blood products were labeled with extended expiration dates.
________
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1104/1105-9.
CODE
Unit numbers 6515231 and 6755680.
MANUFACTURER
New York Blood Services (Center West), New York, New York.
RECALLED BY
New York Blood Center, Inc., New York, New York, by letter dated 
September 8, 1998.  Firm-initiated recall complete.
DISTRIBUTION
New York, New Jersey, Switzerland.
QUANTITY
2 units of each component was distributed.
REASON
Blood products initially tested negative for HCV, but 
retrospectively tested repeatedly reactive for HCV, with a 
negative RIBA, or indeterminate RIBA with a negative PCR test.
________
PRODUCT
Recovered Plasma.  Recall #B-1107-9.
CODE
Unit #11FN77060.
MANUFACTURER
American Red Cross Blood Services, St. Louis, Missouri.
RECALLED BY
Manufacturer, by letter dated June 11, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor whose arm inspection may 
not have been satisfactory.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- 
CLASS II
________
PRODUCT
Medrad Counterpoise System Product Number 75-4000-033.
Recall #Z-957-9.
CODE
All Product Manufactured between May 1995 and February 1999. 
MANUFACTURER
F. Walter Hanel GMBH DBA MAVIG, Munich, Germany.
RECALLED BY
Medrad, Inc., Indianola, Pennsylvania, by letter dated May 14, 
1999.  Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Approximately 1,004 units were distributed.
REASON
Dowel pins used in support assembly have potential to back out of 
position.
________
PRODUCT
Screwdriver Blade - Self-Retaining: a)  Part 313.922; 
b) Part 313.923.  Recall #Z-958/959-9.
CODE
Lot numbers:  a) A4GD466, A4GE246 THRU 251, A4GI665 THRU 666, 
A4GI985 THRU 986, A4GK114 THRU 116, A4GL610 THRU 934, A4GL985 
THRU 986, A4GM750 THRU 751, A4GO312 THRU 313, A4GO695 THRU 696, 
A4HC274, A4HD827, A4HG576, A4HG670 THRU 672, A4HM425, A4HM603, 
A4HM622 THRU 624, A4HS178 THRU 180, A4HT467, AND A4HV276; b) 
A4GE252 THRU 257, A4GL935 THRU 945, A4GP231, A4GP617, A4GQ563, 
A4HA221, A4HA703, A4HC275 THRU 276, A4HJ489, AND A4HM604 THRU 
610.
MANUFACTURER
Synthes (USA), West Chester, Pennsylvania.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letter sent on December 8, 
1998, followed by telephone or visit.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
4,391 units were distributed.
REASON
The inspection technique used to inspect the blades had the 
potential to miss some non-conforming blades.  In addition, a 
tolerance issue was noted between screwdrivers with blades on the 
lower end of the spec and screw slots on the upper end of the 
spec.
________
PRODUCT
Holding Sleeve Part #314.06.  Recall #Z-960-9.
CODE
Lot numbers:  A4HM912, A4HQ981, A4HR969, A4HT934, A4HU333, 
A4HX551, A4HY193, A4HZ523, and A4JA239.
MANUFACTURER
Synthes (USA), West Chester, Pennsylvania.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letter sent on February 16, 
1999, followed by telephone or visit.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
286 units were distributed.
REASON
An operation for crimping the back end of the sleeve was not on 
the process sheet or specifications for this product.
________
PRODUCT
Wire Tensioner, Part #393.742.  Recall #Z-963-9.
CODE
Lot numbers: 1008, 1009, 1011 THRU 1018, 1000027, 1000028, 
1001644, 1003894.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letter sent on November 16, 
1998.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide, Canada, Switzerland.
QUANTITY
512 units were distributed.
REASON
The wire tensioner may or may not accept a 2.0 mm guide wire.
________
PRODUCT
NPB-190 and NPB-195 Pulse Oximeter, Rx, intended for continuous 
noninvasive monitoring of functional oxygen saturation of 
arterial hemoglobin and pulse rate for use on adult, pediatric, 
and neonatal patients in hospital and home environments. Recall 
#Z-1154/1155-9.
CODE
All units produced prior to October 9, 1998.
MANUFACTURER
Nellcor Puritan Bennett, Inc., Mervue, Galway, Ireland.
RECALLED BY
Mallinckrodt, Inc., Hazelwood, Missouri, by letter on May 17, 
1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
9,001 units were distributed.
REASON
The devices fail to alarm when a pulse oximetry sensor became 
disconnected from the patient.
________
PRODUCT
Uro-View X-Ray Imaging Systems:  a)  Model 2600; b) Model 2500; 
c) Model 2000.  Recall #Z-1156/1158-9.
CODE
None.
MANUFACTURER
OEC Medical Systems, Inc., Salt Lake City, Utah.
RECALLED BY
Manufacturer, by letter July 19, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
951 units were distributed.
REASON
The leg extension can become disengaged and cause a patient to 
slide to the floor.
_______
UPDATE
Millennium VG Neuclear Medicine Scanner and Varicam Neuclear 
Medicine Scanner, Recall #Z-745/747-9 which appeared in the April 
7, 1999 Enforcement Report should read:
CODE:  Millennium VG or Varicam Systems with 
serial numbers below 10000 (ten thousand) except for the 
following list:
1001, 1756, 1839, 1840, 1890, 1891, 3010, 5008.

RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
________
PRODUCT
1.3 mm Box Plate: a) Part #421.095; b) Part #421.096.  Recall #Z-
961/962-9.
CODE
Lot numbers: a) A3LX014; b) A3LX015.
MANUFACTURER
Synthes (USA), Monument, Colorado
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letter sent on September 1, 
1998, followed by telephone or visit.  Firm-initiated recall 
ongoing.
DISTRIBUTION
California, Florida, Georgia, Kansas, Kentucky, Michigan, 
Minnesota, Missouri, North Carolina, New Jersey, Ohio, Oregon, 
Pennsylvania, Texas, Utah, Virginia, and one international 
account.
QUANTITY
144 units were distributed.
REASON
Plates were switched during processing resulting in a 5x10 mm box 
plated labeled as a 10x10 mm box plate and vice versa.  5x10 mm 
is part #421.095 and 10x10 mm is part #421.096.
________
PRODUCT
7.0 mm Cannulated Screw, 32 mm Thread, 70 mm Length. 
Recall #Z-964-9.
CODE
Part #209.070, Lot #3008307.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letter sent on November 23, 
1998, followed by telephone or visit.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
94 units were distributed.
REASON
Package is labeled as 7.0 mm cannulated screw, 32 mm thread, 70 
mm length. Package actually contains a 7.0 mm cannulated screw, 
16 mm thread, 70 mm length.
________
PRODUCT
Synthes (USA) Midfacial System.  Recall #Z-965-9.
CODE
Part #450-611, Lot #A31D232.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letter sent on February 4, 
1999, followed by telephone or letter.  Firm-initiated recall 
ongoing.
DISTRIBUTION
California, Florida, Maryland, Pennsylvania.
QUANTITY
61 units were distributed.
REASON
The device was anodized gold instead of greengray.
________
PRODUCT
Extraction Bolts for 3.5/4.0 screws.  Recall #Z-966-9.
CODE
Part Number 309.039 - Lot Numbers: 3919791 and 3915138.
MANUFACTURER
Synthes (USA), Monument, Colorado.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letter sent on March 4, 
1999, followed by telephone or visit.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
43 units were distributed.
REASON
Extraction bolts were misetched with 6.5/7.0 instead of 3.5/4.0
________
PRODUCT
MOX-100 DCM Disposable Organ Preservation Cassette, a sterile, 
single use, receptacle for transporting kidneys to be used as 
implanted organs.  Recall #Z-1112-9.
CODE
Sterile lots 287.296, 460.297, 575.298, 1545.299, and 2252.300.
MANUFACTURER
Waters Instruments, Inc., Rochester, Minnesota.
RECALLED BY
Manufacturer, by telephone on June 17 to 30, 1999, and by letter 
sent on June 30, 1999.  Firm-initiated field correction complete.
DISTRIBUTION
Nationwide and The Netherlands.
QUANTITY
340 cassettes were distributed.
REASON
The device sometimes leaks perfusate, a solution used to nourish 
and chill kidneys, causing a drop in the perfusate level.
________
PRODUCT
Outer Cannula for the C1/C2 Drill Guide.  Recall #Z-1115-9.
CODE
Part #396.372.311, Lot #A4GK253.
MANUFACTURER
Synthes (USA), West Chester, Pennsylvania.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letter on December 18, 1998. 
 Firm-initiated recall complete.
DISTRIBUTION
Indiana, Massachusetts, Pennsylvania, Washington state, Canada, 
Switzerland.
QUANTITY
10 units were distributed.
REASON
The cannula disengaged from the handle assembly at the solder 
joint.  The solder joint may not be adequate enough to hold the 
two components together.
________
PRODUCT
Screw/Post for Distractors:  a) Part #U44-640-14; 
b) Part #U44-640-16.  Recall #Z-1159/1160-9.
CODE
Lot numbers: a) A4HN447 THRU 448, A4HN496, A4HP272 THRU 
274, A4HP574, & A4HQ604 THRU 606;
b) A4HR056, & A4HR058.
MANUFACTURER
Synthes (USA), West Chester, Pennsylvania.
RECALLED BY
Synthes USA, Paoli, Pennsylvania, by letters on August 25, 1998. 
Firm-initiated recall complete.
DISTRIBUTION
Nationwide.
QUANTITY
379 units were distributed.
REASON
The pin contains features on the back end which prevent it from 
being inserted into the mating handle.


END OF ENFORCEMENT REPORT FOR AUGUST 11, 1999.  BLANK PAGES MAY 
FOLLOW

####