FDA

Enforcement Report

May 12, 1999                              99-19


RECALLS AND FIELD CORRECTIONS:
FOODS -- CLASS I
________
PRODUCT
Lascco Seafood Cocktail, in 4 ounce glass jars. (Note: 
approximately a year ago the firm changed the name of this 
product from Seafood & Crab Cocktail to Seafood Cocktail.  Hence 
product may be on the market under both names.). Recall #F-372-9.
CODE
Product is not coded but can be identified by UPC code 
0-728404-7.
MANUFACTURER
Los Angeles Smoking and Curing Company, Inc., Los Angeles, 
California.
RECALLED BY
MANUFACTURER, by telephone on March 24, 1999, 
followed by letter, and by press release on March 26, 1999.  
Firm-initiated recall ongoing.
DISTRIBUTION
Nevada, California, Washington state, Alaska, Colorado, Idaho, 
Texas, Utah, Oklahoma, Hawaii, Arizona, Montana, Oregon.
QUANTITY
4,000 cases (12 jars per case) were distributed.
REASON
Product contains undeclared egg white, snow crab, wheat starch, 
and wheat flour.

________
PRODUCT
Lumpia products (Filipino style egg rolls):  a) Vegetable Lumpia 
(Plain); b) Lumpia Vegetable with Shrimp. Product packaging 
contains 14 pieces per bag and 14 bags per case.
Recall #F-375/376-9.
CODE
All product codes produced and distributed between September 22, 
1998 and February 8, 1999.  This code appears on the packaging of 
both products being recalled:  
"0009228-0002089".
MANUFACTURER
Fil-Am Specialty Foods, Inc., Los Angeles, California.
RECALLED BY
Manufacturer, by telephone on March 12, 1999, followed by mail 
and fax on March 22, 1999, and by press release on April 6, 1999. 
Firm-initiated recall complete.
DISTRIBUTION
California.
QUANTITY
a) 143 cases; b) 390 cases were distributed.
REASON
Products contain undeclared egg whites.

RECALLS AND FIELD CORRECTIONS:
FOODS -- CLASS II
________
PRODUCT
Macaroni & Cheese Dinners, in 7.25 ounce boxes, under the 
following labels: a) Safeway Mac `N Cheese; Distributed by 
Safeway Inc., UPC 21130-50598
b) Food Lion; Distributed by Food Lion, Inc., UPC 
35826-00491
c) Best Yet; Packed for Scrivner, Inc., UPC 42187-40712
d) IGA; Distributed by IGA, Inc., UPC 41270-81500
e) Sunny Select; Distributed by Super Store Industries, UPC 
17544-10677
f) Super C; Prepared for Briska Inc., UPC 62609-53881
g) Carriage Trade; Prepared for Continental Sales Ltd.,
UPC 56595-24206
h) Glencourt; Prepared for Glencourt Distributors, 
UPC 8203-50001.  Recall #F-369-9.
CODE
FEB2400C21, FEB2500A21, FEB2500B21, FEB2500C21, FEB2600A21, 
FEB2600B21, FEB2600C21, MAR0400B21 and MAR0400C21.
MANUFACTURER
Gilster-Mary Lee Corporation, Steeleville, Illinois.
RECALLED BY
Gilster-Mary Lee Corporation, Chester, Illinois, by press release 
on April 9, 1999, and by telephone on April 12, 1999, followed by 
fax.  Firm-initiated recall ongoing.
DISTRIBUTION
Alabama, California, Colorado, Florida, Mississippi, Nebraska, 
North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, 
Utah, Virginia, Wisconsin Canada.
QUANTITY
11,280 cases(48 boxes per case) were distributed; firm estimated 
that 50 percent of product remained on market at time of recall 
initiation.
REASON
Product may contain pieces of glass.
________
PRODUCT
Ultra Slim Fast Creamy Milk Chocolate Ready to Drink Meal, in 11 
ounce steel cans.  Recall #F-370-9.
CODE
BEST BY APRIL 2000 ETMC 9053 B02 **:**.
MANUFACTURER
Slim-Fast Nutritional Foods, LLC, Covington, Tennessee.
RECALLED BY
Slim-Fast Foods Company, West Palm Beach, Florida, by letter 
faxed on or about April 15, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Puerto Rico.
QUANTITY
7,613 cases (24 cans per case) were distributed.
REASON
Some cans of product are contaminated with a caustic cleaning 
solution.
________
PRODUCT
Periyar Banana Chips, net weight 200 grams.  
Recall #F-373-9.
CODE
All lots.
MANUFACTURER
Anns Outdoor Catering, Pala, P.O. Kerala, India.
RECALLED BY
Parel Overseas, Jersey City, New Jersey, by telephone on January 
28, 1999.  Completed recall resulted from sample analysis and 
follow-up by the New York State Department of Agriculture and 
Markets.
DISTRIBUTION
New York, Pennsylvania, Texas, Michigan.
QUANTITY
Approximately 40 cases were distributed.
REASON
The product contains undeclared FD&C Yellow No. 5.
______
PRODUCT
Holtermann's Cakes: a) Extra Moist Vanilla Square, packaged in a 
19 ounce cardboard box; b) Extra Moist Brides Cake, packaged in a 
18 ounce cardboard box.
Recall #F-377/378-9.
CODE
All product coded with "best if sold by" dates on or before OCT 6 
1998 (all date codes prior to the initiation of the recall).
MANUFACTURER
Albert Holtermann, Inc., Staten Island, New York.
RECALLED BY
Manufacturer, by visit 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
Approximately 100 boxes of each product were distributed.
REASON
a) This cake was found to contain undeclared FD&C Yellow No. 5, 
FD&C Yellow No. 6, FD&C Red No. 40, and FD&C Blue
No. 1. 
b) This cake was found to contain undeclared FD&C Yellow No. 5, 
FD&C Red No. 3, and FD&C Blue No. 1.
________
PRODUCT
Circus Treats brand Tiger Eye Jumbo Gum Balls, 96 pieces per 
plastic bag, net weight 960 grams.  Product of Egypt.
Recall #F-379-9.
CODE
None.
MANUFACTURER
Unknown.  Product of Egypt.
RECALLED BY
Sultana Crackers, Inc., Bronx, New York (importer), by letter on 
September 10, 1998.  Completed field correction (relabeling) 
resulted from sample analysis and follow-up by the New York State 
Department of Agriculture and Markets.
DISTRIBUTION
Undetermined.
QUANTITY
Firm estimates none remain on market.
REASON
Product contained an unapproved color additive.
________
PRODUCT
Sun Golden brand Almond Cookies, artificially flavored,
in 1 pound 8 ounce cardboard boxes.  Recall #F-380-9.
CODE
None.
MANUFACTURER
Sun Golden Cookies Corporation, Brooklyn, New York.
RECALLED BY
Manufacturer, by telephone and visit on November 9, 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
Approximately 4,000 boxes were distributed,
REASON
Product contained undeclared FD&C Yellow No. 6.
________
PRODUCT
Breaded frozen fish in poly lined cases:
a) Cod - 2 oz. pieces, in 10 lb cases 
b) Halibut pieces - 2 oz. pieces, 3 oz. pieces  (V.S.I. label),4 
oz. Pieces, 5 oz pieces, in 10 lb. Cases 
c) Halibut fillets - 4 oz. pieces in 10 lb. Cases.
d) Halibut patties - 3 oz. Pieces, 4 oz. pieces each in 10 lb 
cases.
e) Burgerville sandwich in 20 lb. cases
f) Burgerville Fish-N-Chips in 20 lb. cases.
Recall #F-386/391-9.
CODE
Products a-d: all products bearing date codes prior to Jan 01 99.
Products e-f: all products bearing date codes prior to and 
including Apr 08 99.
MANUFACTURER
Vancouver Seafood, Inc., Vancouver, Washington.
RECALLED BY
Manufacturer, by letter on April 22, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
a-d) Washington state, Oregon, California; 
e-f) Oregon.
QUANTITY
a-d) Approximately 3,970 pounds; e-f) Approximately 6,000-8,000 
pounds were distributed.
REASON
Products contain undeclared allergens as follows:
a-d  contain undeclared FD&C Yellow # 5, FD&C Yellow # 6, and 
dehydrated skim milk.

e-f  contain undeclared wheat flour, FD&C Yellow 5, FD&C Yellow 
#6,   and dehydrated skim milk.

RECALLS AND FIELD CORRECTIONS:
FOODS -- CLASS III
________
PRODUCT
Bee's Queen brand Pure Chinese Honey, in 10 ounce glass jars.  
Recall #F-371-9.
CODE
None.
MANUFACTURER
Shanghai Native Produce I/E Corporation, Shanghai, China.
RECALLED BY
Tai Wing Hong Importer, Inc., Brooklyn, New York, by letter on 
October 30, 1998.  Completed recall resulted from sample analysis 
and follow-up by the New York State Department of Agriculture and 
Markets.
DISTRIBUTION
New York.
QUANTITY
450 cartons (48 jars per carton) were imported; firm estimates 
none remains on the market.
REASON
The product, falsely labeled as "Pure Honey", is adulterated as 
it was found to contain sugars of cane or corn origin.
________
PRODUCT
Fred Meyer Parmesan Cheese, in 3 ounce cardboard container.
Recall #F-374-9.
CODE
June 02 99 MS2.
MANUFACTURER
Masson Cheese Corporation, Vernon, California.
RECALLED BY
Fred Meyer, Inc., Portland, Oregon, by E-mail on February 25, 
1999, and April 2, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Alaska, Washington state, Idaho, Montana, Oregon, Utah.
QUANTITY
156 cases (24 units per case) were distributed.
REASON
Product was contaminated with mold.
________
PRODUCT
Bottled flavored water in 20 fluid ounce plastic bottles, labeled 
in part, "Natural Choices Pure Water":
a) Strawberry Kiwi Twist; b) Lemon Kiwi Twist;
c) Tangerine Twist.  Recall #F-382/384-9.
CODE
Products are labeled with the production date and time.
a) Strawberry Kiwi: 04 29 98 1600 through 04 29 98 1615
b) Lemon Kiwi: 04 30 98 1015 through 04 30 98 1030
c) Tangerine: 04 30 98 1515 through 04 30 98 1530.
MANUFACTURER
Cascade Clear Water, Burlington, Washington.
RECALLED BY
Unique Labeling, Inc., Portland, Oregon, by fax  on March 17, 
1999.  Firm-initiated recall complete.
DISTRIBUTION
Utah.
QUANTITY
The firm estimated that there were 100 cases of each flavored 
water with suspect code distributed.
REASON
Product may have been contaminated with mold.

RECALLS AND FIELD CORRECTIONS:
COSMETICS -- CLASS II
________
PRODUCT
Wet'n Wild Mega Lash Mascara, packaged in tube-like containers.  
Recall #F-381-9.
CODE
Lot numbers:  161298 and 171298.
MANUFACTURER
AM Cosmetic Products Company, Brooklyn, New York.
RECALLED BY
AM Cosmetic Products Company, North Arlington, New Jersey, by 
letter on February 11, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
28,938 units were distributed.
REASON
Product is contaminated with Burkholderia cepacia.

RECALLS AND FIELD CORRECTIONS:
DRUGS -- CLASS II
________
PRODUCT
Compressed Oxygen USP, Rx in high pressure E and D size 
cylinders.  Recall #D-208-9.
CODE
Lot #31C992.
MANUFACTURER
Red Ball Oxygen Company, Inc., Shreveport, Louisiana.
RECALLED BY
Manufacturer, by telephone on April 12, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Louisiana and Texas.
QUANTITY
38 cylinders were distributed.
REASON
Failure to document the analysis of potency and identity testing.

RECALLS AND FIELD CORRECTIONS:
BIOLOGICS -- CLASS II
________
PRODUCT
Red Blood Cells.  Recall #B-733-9.
CODE
Unit #10592-2836.
MANUFACTURER
United Blood Services, Scottsdale, Arizona.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated January 
16, 1999.  Firm-initiated recall complete.
DISTRIBUTION
Arizona.
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;
d) Recovered Plasma.  Recall #B-736/739-9.
CODE
Unit numbers:  
a) 7436082  7438251  6747771  7438231  7437101  7618378
   7437094  7618397  7438239  6747754  7438253  7436081
   6747767  7436128  6747772  7437099  7437102  6747759
   7436109  7436089  7437095  7437093  7437092  7437104
   7437103  7463091  7437096  7436116  7437107
b) 6747754  6747767  7438253  7438239  7438231  6747771
   6747772  7438251  6747759; 
c) 7436130  7436128  6747759
d) 6747767  7436081.
MANUFACTURER
New York Blood Services, New York, New York.
RECALLED BY
Manufacturer, by letters dated August 19, 1998, followed by 
telephone and fax.  Firm-initiated recall complete.
DISTRIBUTION
New York and Switzerland.
QUANTITY
a) 29 units; b) 9 unit; c) 3 units; d) 2 units.
REASON
Blood products may have been incorrectly tested for antibody to 
the hepatitis C virus encoded antigen (anti-HCV).

RECALLS AND FIELD CORRECTIONS:
BIOLOGICS -- CLASS III
________
PRODUCT
Red Blood Cells.  Recall 729-9.
CODE
Unit #16340-3116.
MANUFACTURER
Blood Systems, Inc., Hattiesburg, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by telephone on 
September 24, 1997, and by letter dated October 22, 1997.  Firm-
initiated recall complete.
DISTRIBUTION
Mississippi.
QUANTITY
1 unit was distributed.
REASON
Blood products were collected from a donor who had taken the 
antibiotic Keflex, two days prior to donation.
________
PRODUCT
a) Red Blood Cells; b) Platelets.  Recall #B-731/732-9.
CODE
Unit #16339-7085.
MANUFACTURER
Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letter dated October 
9, 1997.  Firm-initiated recall complete.
DISTRIBUTION
Mississippi.
QUANTITY
1 unit of each component was distributed.
REASON
Blood products were collected from a donor taking the drug 
Navane.
________
PRODUCT
Platelets, Pheresis.  Recall #B-734-9.
CODE
Unit #36000-1481.
MANUFACTURER
United Blood Services, Ventura, California.
RECALLED BY
Blood Systems, Inc., Scottsdale, Arizona, by letters dated 
November 3, 1998, and January 15, 1999.  Firm-initiated recall 
complete.
DISTRIBUTION
California.
QUANTITY
1 unit was distributed.
REASON
Blood product was collected from a donor who had not been 
screened for antibodies and tested for syphilis.

RECALLS AND FIELD CORRECTIONS:

DEVICES -- CLASS II
________
PRODUCT
25 G Whitacre Needle Spinal Tray, intended to be used in the 
administration of a regional or local anesthesia to a patient. 
The tray contains 5% Lidocaine with 7.5% Dextrose, 2 ml.  Recall 
#Z-817-9.
CODE
Catalog #4965-25, Lot #903541, EXP August 2000.
MANUFACTURER
Sims Portex, Inc., Keene, New Hampshire.
RECALLED BY
Manufacturer, by telephone on March 26, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Colorado and Indiana.
QUANTITY
3 cases (10 units per case) were distributed.
REASON
Product labeled as sterile was not sterilized.
________
PRODUCT
Hyperinflation Sets and Resuscitator.  Recall #Z-831/832-9.
CODE
Lot Numbers:
98287-5025   98288-5062   98288-5084   98288-5085
98288-5087   98288-5089   98288-5090   98288-5091
98288-5093   98289-5094   98292-5118   98292-5123
98293-5128   98295-5222   98299-5251   98299-5260
98306-5404   98306-5419   98306-5420   98309-5463
98313-5475.
MANUFACTURER
Owens-BiGam Medical Company, Newland, North Carolina.
RECALLED BY
Manufacturer, by letter on November 25, 1998.  Firm-initiated 
recall complete.
DISTRIBUTION
Arizona, California, Colorado, Georgia, Illinois, Kansas, 
Louisiana, Maryland, Minnesota, Missouri, New Jersey, North 
Carolina, Ohio, Oregon, Pennsylvania, Texas.
QUANTITY
128 cases and 63 samples were distributed.
REASON
Damage to the oxygen tubing could cause leaks in the tubing that 
would result in inconsistent flow rates.
________
PRODUCT
Dual Purpose Rocker Instrument, Part #4009, 6.35" size, non-
powered surgical instrument intended to help introduce/seat the 
spinal brace rods deeper into the adult hooks or variable locking 
screws to allow easier application of the slider or hex nut.  
Recall #Z-852-9.
CODE
Lot numbers:  20072 and 20147.
MANUFACTURER
P.A.K Manufacturing, Inc., Melbourne, New Jersey (contract 
manufacturer).
RECALLED BY
Interpore Cross International, Irvine, California (responsible 
firm), by telephone on February 18 and 22, 1999, and by letter 
dated February 18, 1999.  Firm-initiated recall complete.
DISTRIBUTION
California, Kentucky, Illinois, Massachusetts, Michigan, 
Minnesota, Missouri, North Carolina, Nebraska, Tennessee, Texas, 
Virginia.
QUANTITY
27 units were distributed.
REASON
The device will not allow the proper assembly of a slider into a 
hook when used in accordance with the product instructions for 
use.
________
PRODUCT
a) 5 Fr Angiographic Catheters Model Nos. SPC-454D, SPC-454E, and 
SPC-454F; b) 5 Fr Pressure/Volume Catheters; Model Nos. SPC-465A, 
SPC-550, SSD-795, and SSD-814.
Recall #Z-853/854-9.
CODE
All lot numbers.
MANUFACTURER
Millar Instruments, Houston, Texas.
RECALLED BY
Manufacturer, by letter on March 19, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide, Canada, Japan.
QUANTITY
290 units were distributed.
REASON
A coagulated clot was found within the catheter which were made 
of nylon instead of polyurethane as specified in the firmís 
510(k).
________
PRODUCT
Quinton Q-Cath Hemodynamic Analysis System, a hemodynamic 
recording system, which acquires, displays, stores and may print 
out waveform data acquired from a patient undergoing a cardiac 
catheterization procedure:
a) Q-Cath; b) Q-Cath II; c) Q Cath II NT; d) Q-Cath DS;
e) Q-Cath Remote Station.  Recall #Z-855/859-9.
CODE
Units with version 4.5 software.
MANUFACTURER
Quinton Instrument Company, Bothell, Washington.
RECALLED BY
Manufacturer, by letter on October 1, 1998, followed by visit.  
Firm-initiated field correction ongoing.
DISTRIBUTION
Nationwide, Canada, The Netherlands, Thailand, New Zealand, 
Egypt.
QUANTITY
Approximately 81 units were distributed.
REASON
Device has potential to display previous patient's blood pressure 
________
PRODUCT
GEM Implantable Cardioverter Defibrillator: 
a) Model No. 7227Cx; b) Model No. 7227.
Recall #Z-860/861-9.
CODE
All serial numbers.
MANUFACTURER
Medtronic Med Rel, Inc., Humacao, Puerto Rico; Medtronic, 
Switzerland Manufacturing Operations, Tolochenaz, Switzerland.
RECALLED BY
Medtronic, Inc., Minneapolis, Minnesota, by letter on April 2, 
1999.  In the recall action, a voltage test is being used to 
identify defibrillators which have premature battery depletion.  
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Approximately 5,000 devices were distributed.
REASON
A high current drain in some of the defibrillators causes 
premature battery depletion.
________
PRODUCT
FlexiMount Ceiling Track Mount System with Trolly, Model 
#0102180, part of the mounting system designed to connect the 
Burton Outpatient Plus, Outpatient II, Coolspot and Coolspot 
lights to the ceiling.  Recall #Z-862-9.
CODE
Serial numbers:  940080-940250 and 97253-97313.
MANUFACTURER
Burton Medical Products Corporation, Chatsworth, California.
RECALLED BY
Manufacturer, by letter on April 13, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
122 units were distributed.
REASON
The device has the potential to fall because setscrews used to 
secure the down-tube on the trolley were omitted from the 
installation pack.
________
PRODUCT
Pressure Reduction Valve, Part #20132-065, a component of the 
Argon Plasma Coagulation (APC) Unit.  Recall #Z-863-9.
CODE
Serial numbers:  M0005001 to M0005050.
MANUFACTURER
ERBE, Tubingen, Germany,
RECALLED BY
ERBE USA, Inc., Marietta, Georgia, by visit and by letters sent 
on April 5, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and Canada.
QUANTITY
50 units with the affected serial numbers have been distributed.
REASON
The valve has the potential to separate from the Argon tank 
because it does not fit securely in the tank.
________
PRODUCT
NC-1 Floor to Ceiling Mount, an accessory to a microscope used 
for various surgical procedures.  Recall #Z-864-9.
CODE
Identification number is KBC 002, with fabrication (serial) 
Numbers 10-2044 and lower.
MANUFACTURER
Oberlikon Contraves, A.G., Zurich, Switzerland.
RECALLED BY
Carl Zeiss, Inc., Thornwood, New York, by letter on April 1, 
1999.  Firm-initiated field correction ongoing.
DISTRIBUTION
Florida, Kentucky, Texas, North Carolina, Illinois, Alabama, 
Missouri, Ohio, Louisiana, Arizona, Georgia, California, Hawaii, 
Delaware, Colorado, Utah, Pennsylvania, Arkansas.
QUANTITY
52 units were distributed.
REASON
The device has the potential to fall during use.
________
PRODUCT
Storz Silicone Tire Implant for Retinal Detachment Surgery
a) Catalog No. E5381 721 (287 Style); 
b) Catalog No. E5381 620 (78g Style).  Recall #Z-867/868-9.
CODE
Lot numbers:  a) MI70870, MI70880, MA83090, MC80850, MC80860, 
MC80870, and MC80880; b) MA81790.
MANUFACTURER
Vesta, Inc., Franklin, Wisconsin.
RECALLED BY
Bausch and Lomb Surgical, Inc., St. Louis, Missouri, by letter 
dated February 24, 1999 and the week of April 19, 1999.  Firm-
initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
473 pouches were distributed.
REASON
The package labeling may not correctly identify the size and 
style of the contents.
________
PRODUCT
Bayer ADVIA 120 Hematology System, a quantitative automated 
hematology analyzer that provides a leukocyte differential count 
and reticulocyte analysis for in-vitro-diagnostic use in clinical 
laboratories:
a) ADVIA 120 Hematology System, Catalog No. 453-0024-03;
b) ADVIA 120 Hematology System, Catalog No. 453-0024-04.
Recall #Z-869/870-9.
CODE
All serial numbers.
MANUFACTURER
Bayer Diagnostic Manufacturing Ltd., Swords, Co Dublin, Ireland.
RECALLED BY
Bayer Corporation, Elkhart, Indiana, by customer bulletin sent on 
February 9, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Approximately 920 units were distributed.
REASON
The device may give erroneous results because of the valve gasket 
deterioration in the Baso channel check valve, and the software 
designed will not flag significant discrepancies in the results 
between the two methodologies at extremely low counts.
________
PRODUCT
Ocufilcon D 55 Visibility Tinted Contact Lenses .
Recall #Z-871-9.  
CODE
Product Names (trade names)Involved In Recall:
Brand (-)(+):     Product Code:  Brand:        Product Code:
Aqualens Disp. 55    5133        Proflex 55            2210
Aqualens Disp. 55    5134        Proflex 55            2222
Aquatech 55          2225        Prosite 55            2252
Aquatech 55          2226        Prosite 55            2253
Clinasoft 55         2202        Sofmed 55             2228
Clinasoft 55         2214        Softech 55            2248
Diagnostic 55        2263        Softech 55            2249
Diagnostics 55       2262        Softique 55           2235
Hydroflex 55         2264        Softmed 55            2227
Hydron Biomedics 55  2208        Ultraflex 7/14 55     2201
Hydron Biomedics 55  2220        Ultraflex 7/14 55     2213
Hydrovue 55          2246        Veraflex Eyerned 55   5141
Hydrovue 55          2247        Versaflex 55          2250
Mediflex             2203        Versaflex 55          2251
Mediflex 55          2215        Versaflex Eyerned 55  5143
Optiflex             2209        Optiflex 55           2221
Optiform 55          2254        Optiform 55           2255
P Label Disp. 55     2223        Polysoft 55           2256
Polysoft 55          2257        Private Label 55      2211
Procon 55            2230        Procon 55             2229.
MANUFACTURER
Ocular Sciences, Inc., South San Francisco, California.
RECALLED BY
Manufacturer, by letter on April 26, 1999.  Firm-initiated recall 
ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
1,283,472 lenses were distributed.
REASON
Incomplete seal could compromise product sterility.
________
PRODUCT
Colleague 3 Volumetric Infusion Pump (Triple Channel) for 
continuous or intermittent delivery through clinically acceptable 
routes of administration such as intravenous, intra-arterial, 
subcutaneous, epidural or irrigation of fluid spaces 
applications.  Recall #Z-872-9.
CODE
Product Code P2M8153, All serial numbers.
MANUFACTURER
Baxter Healthcare PTE. Ltd. Singapore.
RECALLED BY
Baxter Healthcare Corporation, IV Systems Division, Round Lake, 
Illinois, by letter April 16, 1999.  Firm-initiated field 
correction ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
6,992 pumps were distributed.
REASON
A software communication error occurs predominately when all 
three channels are in use, causing an alarm condition 
(533:320:717:000) that will stop the function of all  of the 
channels in use.  The pump will alarm appropriately, alerting the 
user of the failure state.
________
PRODUCT
DMR2 Disposable Manual Resuscitators:
1.  Model No. ARXL;        2.  Model No. ARML;
3.  Model No. ARMLDP;      4.  Model No. ARPML;
5.  Model No. ARMS;        6.  Model No. ARXB; 
7.  Model No. ARMB;        8.  Model No. ARPMB;
9.  Model No. ARMBDP;      10. Model No. AVXL;
11. Model No. AVML;        12. Model No. AVPML;
13. Model No. AVMLDP;      14. Model No. AVMS;
15. Model No. AVXB;        16. Model No. AVMB;
17. Model No. AVPMB;       18. Model No. AVMBDP;
19. Model No. CRPML;       20. Model No. CRPMS;
21. Model No. CRPXB;       22. Model No. CRPMB;
23. Model No. CVPML;       24. Model No. CVPMS;
25. Model No. CVPXB;       26. Model No. CVPMB;
27. Model No. CVPMBDP;     28. Model No. IRPML;
29. Model No. IRPXB;       30. Model No. IRPMB;
31. Model No. IVPMS;       32. Model No. IVPXB;
33. Model No. IVPMB;       34. Model No. IVPMBDP.
Recall #Z-874/907-9.
CODE
All lots.
MANUFACTURER
Nellcor Puritan Bennett de Mexico S.A. de C.V., Tijuana, Mexico.
RECALLED BY
Mallinckrodt, Inc., St. Louis, Missouri, by letter on March 30, 
1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
Approximately 100,716 units were distributed.
REASON
The non-rebreathing valve (NRV) housing assembly may crack 
resulting in the swivel elbow fitting becoming loose and 
disengaging from the NRV during use.

RECALLS AND FIELD CORRECTIONS:
DEVICES -- CLASS III
________
PRODUCT
Medline Gripper Sport and Gripper II Latex Free Operating Room 
Shoe Covers: a) Catalog No. NON27752;
b) Catalog No. NON27758; c) Catalog No. NON27758R;
d) Catalog No. NON27759; e) Catalog No. NON27759R;
f) Catalog No. NON27852; g) Catalog No. NON27144;
h) Catalog No. NON27144XL.  Recall #Z-844/851-9.
CODE
Lot Numbers: 307892JC, 362750JC, 376467JC, 376495JC, 393363JC, 
393346JC.
MANUFACTURER
Hangzhou Jinchen Knitting & Textiles Co., Ltd., Hangzhou, China.
RECALLED BY
Medline Industries, Inc., Mundelein, Illinois, by undated letter 
on April 1, 1999.  Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
1,950 cases were distributed.
REASON
The latex free gripper pattern on the shoe covers is made of a 
water-soluble substance and may smear and may be more prone to 
slippage if exposed to water.
________
PRODUCT
a) Minnova Pelvic Floor Stimulation System;
b) InnoSence Pelvic Floor Stimulation and Electromyography 
System.  Both systems use mild electrical stimulation to help 
control urinary incontinence.  Recall #Z-865/866-9.
CODE
Various serial numbers.
MANUFACTURER
EMPI, Inc., St. Paul, Minnesota.
RECALLED BY
Manufacturer, by letter dated March 26, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
a) 126 units; b) 73 units were distributed.
REASON
Electrical short at a pin connector may change the location of 
the stimulation to an incorrect location.
________
PRODUCT
IMX HCG Calibrators, for in vitro diagnostic use.  The IMx hCG 
Assay is a Microparticle Enzyme Immunoassay (MEIA) for the 
quantitative and qualitative determination of Human Chorionic 
Gonadotropin (hCG) in human serum and plasma for the early 
detention of pregnancy.  Recall #Z-873-9.
CODE
Lot #3A63-01, List No. 47128Q100 EXP 8/9/99.
MANUFACTURER
Abbott Health Products, Inc., Barceloneta, Puerto Rico.
RECALLED BY
Manufacturer, by telephone and letter dated April 20, 1999.  
Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide and international.
QUANTITY
210 kits were distributed.
REASON
Decreased F calibrator rates may result in elevated control and 
patient values.
________
PRODUCT
Proclear Daily Wear Contact Lens.  Recall #Z-908-9.
CODE
Lot B814117.
MANUFACTURER
Biocompatibles Eyecare, Norfolk, Virginia.
RECALLED BY
Manufacturer, by telephone on April 14, 1999.  Firm-initiated 
recall ongoing.
DISTRIBUTION
Nationwide, Canada, United Kingdom.
QUANTITY
119 lenses were distributed.
REASON
Contact lenses optical power was mislabeled on product.

RECALLS AND FIELD CORRECTIONS:
VETERINARY PRODUCTS -- CLASS II
________
PRODUCT
RUMA Rich Black label Hi-Energy 20 Instant Calf Replacer 
(chlortetracycline 20 grams/ton), in 50 pound bags.
Recall #V-067-9.
CODE
Lot numbers:  8L1407, 8J2707, 9B0904.
MANUFACTURER
Strauss Feeds, Watertown, Wisconsin.
RECALLED BY
Manufacturer, by telephone on March 8, 1999.  Ongoing recall 
resulted from sample analysis and follow-up by the Wisconsin 
Department of Agriculture, Trade & Consumer Protection.
DISTRIBUTION
Iowa, South Dakota, Wisconsin.
QUANTITY
600 bags were distributed.
REASON
Product is superpotent - Chlortetracycline is four times the 
labeled amount.  Product was labeled to contain 20 gm/ton, 
analysis found 84 grams/ton.
_______
PRODUCT
Edge Mix Finisher #1 with CSP (Chlortetracycline 100 g/ton, 
Sulfathiazole 0.011% and Penicillin 50 g/ton custom mix bulk 
medicated swine pre-starter.  Recall #V-068-9.
CODE
Bulk feed with manufacture date of 4/2/99.
MANUFACTURER
Cargill, Inc., Flora, Illinois.
RECALLED BY
Manufacturer, by telephone on April 2, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
Indiana.
QUANTITY
6,020 pounds were distributed.
REASON
The medicated feed is manufactured with a CSP Type A medicated 
article and a CSP Type B medicated feed pack.  On 4/2/99 the mill 
used the wrong type B medicated feed packs which contained BMD 
(acitracin Methylene Disalycylate) instead of CSP.  Another feed 
was delivered at the same time  - Edge Mix Finisher #1 with 
fenbendazole.  The Edge Mix Finisher #1 with CSP was 
inadvertently dumped into the same bin as the fenbendazole feed.
________
PRODUCT
Nutrena Ringmaster TM Show Hog Grow/Fin (BMD- Bacitracin 
Methylene Disalycylate) Medicated, in 50 pound bags, used for 
increased rate of weight gain and improved feed efficiency.  
Recall #V-069-9.
CODE
Lot   STK275 - Formula 2888-A.
MANUFACTURER
Cargill Animal Nutrition Divison/Nutrena Feeds, Stockton, 
California.
RECALLED BY
Manufacturer, by telephone on January 6, 1999.  Firm-initiated 
recall complete.
DISTRIBUTION
California.
QUANTITY
943 bags were distributed.
REASON
Product is subpotent.  Product contained 19.2% of the labeled 
BMD.

MEDICAL DEVICE SAFETY ALERTS:
________
PRODUCT
Techstar XL and Prostarr XL Precutaneous Vascular Surgical 
Device, intended for the percutaneous deployment and tying of 
sutures for surgical closure of arterial puncture sites resulting 
from diagnostic and interventional procedure:
Models: TXL-431-06; TXLS-432-06; TXL-431-07; PXL-431-08;
PXL-431-10.  Safety Alert #N-005/009-9.
CODE
All codes.
MANUFACTURER
Perclose, Inc., Redwood City, California.
ALERTED BY
Manufacturer, by safety alert letters of April 28, 1999 
describing the labeling concerns and providing additional sticker 
labeling for placement on the outer packages.
DISTRIBUTION
Nationwide and international.
QUANTITY
23,960 units were distributed.
REASON
Misinterpretation of sterility labeling on the inner tray by 
users may result in contamination and inappropriate use of the 
trays after the outer pouch sterility barrier has been broken.


END OF ENFORCEMENT REPORT FOR MAY 12, 1999.


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