FDA

Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities.
 ENFORCE
11/03/1993

Recalls and Field Corrections:  Foods -- Class II -- 11/03/1993

November 3, 1993                                                   93-44

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II
=========================
_______________
PRODUCT        Sixteen-piece children's China tea set.  Recall #F-003-4.
CODE           CH160, SKN 2922079.
MANUFACTURER   Kinleex Industries, Taiwan.
RECALLED BY    Toys R Us, Inc., Paramus, New Jersey, by letter July 2,
               1993.  A recall poster has been distributed to all the
               firm's stores and warehouses to be displayed for the
               customers' review.  Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       18,000 sets were distributed; firm estimates 2 to 3 thousand
               sets remain on the market.
REASON         Products contained excess leachable lead.

_______________
PRODUCT        Contadina brand Seasoned Bread Crumbs, in 9 ounce paper
               canisters.  Recall #F-004-4.
CODE           LH221BC.
MANUFACTURER   Quality Bakery Product, Inc., Detroit, Michigan.
RECALLED BY    Nestle Foods Company, Glendale, California., by letter
               August 6, 1993, and by press release.   Firm-initiated
               recall complete.
DISTRIBUTION   Nationwide.
QUANTITY       63,000 units were distributed; firm estimates none remains
               on the market.
REASON         Product is contaminated with glass.

_______________
PRODUCTS       Land O'Lakes Spread with Sweet Cream, in 16 ounce tubs. 
               Recall #F-005-4.
CODE           All freshness dates for 1993 preceded by the letter "L" and
               located on the side of the plastic tub.
MANUFACTURER   Saffola Quality Foods, Inc., Los Angeles, California,
RECALLED BY    Land O'Lakes, Inc., Arden Hills, Minnesota, by issuing a
               full stock recovery August 24, 1993 and by press release on
               August 27, 1993.  Firm-initiated recall complete.
DISTRIBUTION   California, Oregon, Washington state, Alaska, Idaho.
QUANTITY       Firm estimates none remains on the market.
REASON         Product was contaminated with mold and 1,3-Pentadiene.


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III
========================
_______________
PRODUCT        Nature's Garden Super Vitura-100 Ultra Potent 1-Per-Day
               Vitamin/Mineral Supplement Oral Tablets, in bottles of 30,
               60, 180, 360.  Recall #F-532-3.
CODE           Lot #486-19.
MANUFACTURER   International Vitamin Corporation, Union, New Jersey.
RECALLED BY    Manufacturer, by letter July 15, 1992.  Firm-initiated
               recall complete.
DISTRIBUTION   Connecticut.
QUANTITY       50,000 tablets were distributed.
REASON         Product is subpotent in Vitamin A.

_______________
PRODUCT        Chicken of the Sea Chunk Light Tuna, in 6-1/8 ounce cans. 
               Recall #F-001-4.
CODE           JLS2F/K4CLB.
MANUFACTURER   VCS Samoa Packing Company, American Samoa.
RECALLED BY    Van Camp Seafood Company, Inc., San Diego, California, by
               telephone June 28, 1993, and by E-Mail message on July 1,
               1993.  Firm-initiated recall complete.
DISTRIBUTION   Ohio, West Virginia, New Jersey.
QUANTITY       97 cases were distributed.
REASON         Product is decomposed.

_______________
PRODUCT        Moisturizing Hair Lotion, Lustrasilk Moisure Max Oil
               Moisturizing Hair Lotion, in 8 ounce containers.
               Recall #F-014-4.
CODE           Case Code:  3147P3D18, Bottle date code:  3D18.
MANUFACTURER   CCL Custom Manufacturing, Inc., (Kolmar Labs, Inc.,)
               Memphis, Tennessee.
RECALLED BY    The Gillette Company, Boston, Massachusetts, by Fax on
               September 15, 1993.  Firm-initiated recall ongoing.

                                    -2-DISTRIBUTION   Virginia, Georgia, Illinois, Texas, New York, Florida,
               Colorado, Mississippi, California, Arkansas, Louisiana,
               Connecticut, Ohio, Pennsylvania, South Carolina, New Jersey,
               North Carolina.
QUANTITY       1,134 units were distributed.
REASON         Product is contaminated with Pseudomonas Putida.

_______________
PRODUCT        Pastry Perfection brand dough-based bakery products,
               produced from 8-4-93 to 8-18-93.  This includes (but not
               limited to) breads, rolls, bagels, and Danish pastries:
               1.  Whole Wheat Butter Top Thick Sliced, 24 ounce loaf;
               2.  Swirl Rye Deli Loaf, 24 ounce loaf;
               3.  Whole Wheat Ranch Bread, 24 ounce loaf;
               4.  White Texas Toast, 24 ounce loaf;
               5.  White Butter Top Thick Sliced, 24 ounce loaf;
               6.  White Butter Top, 24 ounce loaf;
               7.  White Sandwich Bread, 24 ounce loaf;
               8.  White Ranch Bread, 24 ounce loaf;
               9.  Sour Dough Deli Loaf Thick Sliced, 24 ounce;
               10. Jewish Light Rye Deli Loaf, 24 ounce loaf;
               11. Jewish Light Rye Deli Loaf Thick Sliced, 24 ounce; 
               12. Sour Dough Deli Loaf, 24 ounce;
               13. Dark Rye Deli Loaf, 24 ounce loaf;
               14. Egg Bread, 24 ounce loaf;
               15. Cracked Wheat Deli Loaf Thick Sliced, 24 ounce loaf;
               16. Eight Grain Deli Loaf Thick Sliced, 24 ounce loaf;
               17. Cracked Wheat Deli Loaf, 24 ounce loaf;
               18. Eight Grain Bread, 16 ounce loaf;
               19. Dark Rye Deli Loaf Thick Sliced, 24 ounce;
               20. Plain Deli Rolls Hinged, 6 count;
               21. Plain Deli Rolls Unsliced, 6 count;
               22. Seeded Deli Rolls Unsliced, 6 count;
               23. Plain Bagels, 5 count;
               24. Cinnamon Raisin Bagels, 5 count;
               25. Onion Bagels, 5 count;
               26. Squaw Bread, 16 ounce loaf;
               27. Sheepherder Loaf, 16 ounce;
               28. Whole Wheat Hamburger Buns, 8 count;
               29. White Cocktail Loaf;
               30. 7 inch Hamburger Buns, 4 count;
               31. English Muffins, 6 count;
               32. Sour Dough Deli Loaf Thick Sliced, 24 ounce.
               Recall #F-015/046-4.
CODE           None.
MANUFACTURER   Curry Bakery, Inc., Boise, Idaho.
RECALLED BY    Manufacturer, by letter delivered on or about August 23,
               1993.  Firm-initiated recall complete.
DISTRIBUTION   Idaho, Oregon.
QUANTITY       Undetermined.
REASON         Products were produced under unsanitary conditions.

                                    -3-RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS II -------------------------
_______________
PRODUCT        Transfilled Compressed Medical Oxygen in D and E Cylinders. 
               Recall #D-016-4.
CODE           All codes.
MANUFACTURER   South Shore Fire and Safety Equipment Dist. Inc., East
               Meadow, New York.
RECALLED BY    manufacturer, by letter beginning October 18, 1993.  Firm-
               initiated recall ongoing.
DISTRIBUTION   New York.
QUANTITY       81 cylinders were distributed.
REASON         Current good manufacturing practice deficiencies.


RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III
========================
_______________
PRODUCT        Stool Softener, Docusate Sodium, 100 mg, in bottles of 100
               capsules, soft-gel capsules used as an OTC drug  for
               prevention of hard dry stools.  Recall #D-013-4.
CODE           2441-2990 EXP 9/95, 2961-2990 EXP 1/96, 2171-3950 EXP 5/96.
MANUFACTURER   Tishcon Corporation, Westbury, New York.
RECALLED BY    Tischon Corporation, Salisbury, Maryland, by telephone
               October 1, 1993.  Firm-initiated recall complete.
DISTRIBUTION   Florida.
QUANTITY       Lot 2441-2990 - 1,452 100-capsule bottles;
               Lot 2961-2990 - 4,740 100-capsule bottles;
               Lot 2171-3950 - 4,200 100-capsule bottles.
REASON         Product labeling does not list a manufacturer or
               distributor.

_______________
PRODUCT        Suntrax International Sundate brand (a) Baby Sunblock Creme,
               SPF 25, topical OTC drug packaged in white plastic tubes;
               (b) Sunblock Oil SPF 10, OTC topical drug product packaged
               in clear amber plastic 12 ounce bottles.
               Recall #D-014/015-4.
CODE           Lot numbers:  15523; (b) 19023.
MANUFACTURER   Custom Packaging Services, Inc., West Palm Beach, Florida.
RECALLED BY    Manufacturer, by letter September 23, 1993.  Firm-initiated
               recall complete.
DISTRIBUTION   Florida.
QUANTITY       (a) 6,588 tubes; (b) 6,636 bottles were distributed.
REASON         Product separation.

_______________
PRODUCT        Enteric Coated Aspirin Tablets, 500 mg, packaged in 60
               tablet bottles, under the Peoples and Schein labels and 325
               mg, packaged in 100 tablet bottles, under the following
               labels:  Treasury Silver Saver, Good Health, Mason Home
               Remedies, Schein, Roval, Shop-N-Save, Freddy's, OSCO,
               Cardinal, and Legend.  Recall #D-017-4.

                                    -4-CODE           Lot numbers:  325 mg - E6002FA EXP 4/94 (Treasury Silver
               Saver), E6002FB EXP 3/94 (Good Health, Mason Home Remedies),
               E6002FC EXP 3/94 (Schein), E6002FD EXP 3/94 (Roval  Shop-N-
               Save, Freddy's), E6002FE EXP 3/94 (Shein), E6026FA EXP 4/94
               OSCO), E6026FB EXP 4/94 Shop-N-Save), E6026FC EXP 4/94
               (OSCO), E6026FD EXP 4/94 (Cardinal, Legend).  500 mg -
               E6001FA EXP4/94 (Peoples), E6001FC EXP 4/94 (Schein). 
MANUFACTURER   Time-Cap Labs, Farmington, New York.
RECALLED BY    Pennex Products Company, Inc., Verona, Pennsylvania, by
               letter August 30, 1993.  Firm-initiated recall complete.
DISTRIBUTION   Nationwide.
QUANTITY       Firm estimates 300 dozen bottles of the 500 mg tablets and
               1,632 dozen bottles of the 325 mg tablets remain on the
               market.
REASON         Product does not meet dissolution specifications.


RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS I
=====================
_______________
PRODUCT        (a) Red Blood Cells; (b) Platelets.  Recall #B-017/018-4.
CODE           Unit #29095-6897.
MANUFACTURER   United Blood Services (UBS), Chicago, Illinois.
RECALLED BY    Manufacturer, by telephone September 18, 1991.  Firm-
               initiated recall complete.
DISTRIBUTION   Illinois.
QUANTITY       1 unit of each component.
REASON         Blood Products, which tested repeatedly reactive for the
               antibody to the hepatitis C virus encoded antigen (anti-HCV)
               by both the enzyme immunoassay (EIA) and by the recombinant
               immunoblot assay (RIBA), were distributed.


RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT        (a) Red Blood Cells; (b) Platelets.  Recall #B-019/020-4.
CODE           Unit numbers:  29095-7919, 29095-0325. 
MANUFACTURER   United Blood Services (UBS), Chicago, Illinois.
RECALLED BY    Manufacturer, by telephone September 18, 1991.  Firm-
               initiated recall complete.
DISTRIBUTION   Illinois.
QUANTITY       2 units of each component.
REASON         Blood Products, which tested repeatedly reactive for the
               antibody to the hepatitis C virus encoded antigen (anti-HCV) 
               by EIA, were distributed.

_______________
PRODUCT        (a) Red Blood Cells; (b) Recovered Plasma.
               Recall #B-021\022-4.
CODE           Unit numbers:  7384491.

                                    -5-MANUFACTURER   Ehrling Bergquist Hospital, Department of the Air Force,
               Offutt AFB, Nebraska.
RECALLED BY    Manufacturer, by telephone June 15, 1993.  Firm-initiated
               recall complete.
DISTRIBUTION   Nebraska, California.
QUANTITY       1 unit of each component.
REASON         Blood products, which tested repeatedly reactive for
               hepatitis B Surface antigen (HBsAg), were distributed.

_______________
PRODUCT        Blood Grouping Reagent Anti-D (Anti-Rho) (Monoclonal-
               Polyclonal Blend) Bioclone.  Recall #B-023-4.
CODE           Lot numbers:  DB134A1, DB135A1.
MANUFACTURER   Ortho Diagnostic Systems, Inc., Raritan, New Jersey.
RECALLED BY    Manufacturer, by letter October 14, 1992, and by Fax October
               20, 1992.  Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide and international.
QUANTITY       2,072 kits of lot DB134A1 and 972 kits of lot DB135A1.
REASON         Reagents exhibit decreased reactivity with D positive red
               blood cells. 

_______________
PRODUCT        Source Plasma.  Recall #B-024-4.
CODe           Unit numbers:  35-068579, 35-069079, 35-069219.
MANUFACTURER   North American Biologicals, Inc., doing business as South
               Seattle Donor Center, Seattle, Washington.
RECALLED BY    North American Biologicals, Inc., Miami, Florida, by
               telephone November 6, 1991. Firm-initiated recall complete.
DISTRIBUTION   Kentucky, Austria.
QUANTITY       3 units.
REASON         Source Plasma, collected from a donor who reported a history
               of yellow jaundice, was distributed.

_______________
PRODUCT        (a) Red Blood Cells; (b) Recovered Plasma.
               Recall #B-028/029-4.
CODE           Unit numbers:  (a) 84860; (b) 66957, 69943, 76807, 82506,
               82671, 86990.
MANUFACTURER   Aultman Hospital Association, Canton, Ohio.
RECALLED BY    Manufacturer, by letter July 27, 1993. Firm-initiated recall
               ongoing.
DISTRIBUTION   Ohio, Maryland.
QUANTITY       (a) 1 unit; (b) 6 units.
REASON         Blood products, which tested negative for the antibody to
               the human immunodeficiency virus type 1 (anti-HIV-1), but
               were collected from a donor who previously tested repeatedly
               reactive for anti-HIV-1, were distributed.


RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
====================
_______________
PRODUCT        Fresh Frozen Plasma.  Recall #B-025-4.

                                    -6-CODE           Unit numbers:  36038-0142-01, 36038-0142-02, 36038-0142-03.
MANUFACTURER   United Blood Services, doing business as Blood Systems,
               Inc., Ventura, California.
RECALLED BY    Manufacturer, by telephone December 28, 1992.  Firm-
               initiated recall complete.
DISTRIBUTION   California.
QUANTITY       3 units.
REASON         Plasma, prepared more than eight hours after phelbotomy and
               labeled as Fresh Frozen Plasma, was distributed.

_______________
PRODUCT        Granulocyte Concentrate.  Recall #B-031-4.
CODE           Unit #480854.
MANUFACTURER   University of Texas, M.D. Anderson Cancer Center, Houston,
               Texas.
RECALLED BY    Manufacturer, by telephone December 31, 1991.  Firm-
               initiated recall ongoing.
DISTRIBUTION   Texas.
QUANTITY       1 unit.
REASON         Product which tested positive for syphilis was distributed.

_______________
PRODUCT        Platelets.  Recall #B-033-4.
CODE           Unit numbers:  09G86534, 09G86554, 09J68263, 09J68264,
               09J68266, 09J68267, 09J68268, 09J68269,
               09J68270, 09J68271, 09J68272, 09J68273,
               09J68274, 09J68275, 09J68276, 09J68278,
               09J68279, 09J68280, 09J68281, 09J68282,
               09J68283, 09J68284, 09J68285, 09J68286,
               09J68289, 09J68291, 09J68293, 09J68294,
               09J68295, 09J68297, 09J68298, 09J68299,
               09J68302, 09J68303, 09J68304, 09J68305,
               09J68306, 99J68307, 09J68308, 09J68310,
               09J68311, 09J68313, 09J68314, 09J68315,
               09J68316, 09J68317, 09J68319, 09J68323,
               09J68324, 09J68325, 09J68326, 09J68327.
MANUFACTURER   American Red Cross Blood Services, Omaha, Nebraska.
RECALLED BY    Manufacturer, by letter July 2, 1993.  Firm-initiated recall
               complete.
DISTRIBUTION   Nebraska.
QUANTITY       52 units.
REASON         Platelets not stored under continuous agitation were
               distributed.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
=======================
________________
PRODUCT        Shimadzu brand CT Scanners Models:
               (a) SCT-2000T11; (b) SCT-3000TC, (c) SCT-3000TF;
               (d) SCT-3000TX; (e) SCT-4500-T series; (f) SCT-5000TH;
               (h) SCT-5000TX.  Recall #Z-574/580-3.
CODE           All codes.

                                    -7-MANUFACTURER   Shimadzu Corporation, Nakagyo-Ku, Kyoto, Japan.
RECALLED BY    Shimadzu Corporation, Torrance, California.  FDA approved
               the firm's corrective action plan June 8, 1993.  Firm-
               initiated field correction ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       140 units were distributed.
REASON         Noncompliance with previously published dose information for
               computed tomography CT scanners.

_______________
PRODUCT        Marquest Medical Products: 
               (a) Whisper Jet Nebulizer, Product #123025;
               (b) Neonatal Circuit, Product #155200;
               (c) Neonatal Heated Wire Circuit, Product #155514;
               (d) Neonatal Heated Wire Circuit, Product #155518;
               (e) Stand Alone Connector, Product #177044;
               (f) Adult/Pediatric Ventilator Circuit, Product #545420.
               Recall #Z-776/781-3.
 CODE          Lot numbers:  (a) 307462, 307463; (b) 64480, 64631, 64632,
               64633, 64634, 65747, 65748, 67036; (c) 65010, 65462, 65463,
               65464, 65465, 65466, 65467, 65468, 65469, 65749, 65750,
               66177, 66178, 66179, 67037; (d) 65051, 65052, 65061, 65153,
               65154, 65155, 65156, 65157, 65158, 65159, 65160, 65161,
               65162, 65667, 65668, 65669, 65670, 65671, 65751,. 65752,
               66697, 66769, 66770, 66771, 66772, 66906, 66907, 66945,
               66946; (e) 65664, 66275, 67269; (f) 61594, 61595, 61596. 
MANUFACTURER   Marquest Medical Products, Inc., Denver, Colorado.
RECALLED BY    Manufacturer, by letter July 13, 1993.  Firm-initiated
               recall ongoing.
DISTRIBUTION   Nationwide, Canada, Saudia Arabia, Republic of China,
               Argentina.
QUANTITY       (a) 33 cases (50 per case); (b) 209 cases (20 per case);
               (c) 204 cases (20 per case); (d) 438 cases (20 per case);
               (e) 31 cases (100 per case); (f) 15 cases (20 per case).
REASON         The products contain 15 mm connectors with molding defects
               that may lead to breakage.

_______________
PRODUCT        Dilipan Hygroscopic Cervical Dilator.  The use of one
               dilator for 4 hours is approved for the termination of
               pregnancy in a patient of less than 16 weeks gestation. 
               Recall #Z-022-4.
CODE           Batch #D081892 EXP 5/94.
MANUFACTURER   Gynotech, Inc., Middlesex, New Jersey.
RECALLED BY    Manufacturer, by telephone between December 18, 1992 and
               December 21, 1992, and by Fax to international customers. 
               Firm-initiated recall ongoing.
DISTRIBUTION   New York, California, Illinois, New Jersey, Sweden, Belgium,
               Australia.
QUANTITY       5,700 units.

                                    -8-REASON         The safety or efficacy for the devices cannot be documented
               because the firm had distributed more dilators than were
               approved and could not account for the increased number.

_______________
PRODUCT        UterVac Rigid Vacuum Curettes used during OB/GYN procedures
               and intended for diagnostic and therapeutic uterine
               evacuation:
               (a) Size 8 mm curved; (b) UterVac Rigid Vacuum Curettes,
               Size 8 mm straight; (c) Size 9 mm curved; 
               (d) Size 12 mm curved; (e) Size 10 mm straight;
               Recall #Z-027/031-4.
CODE           (a) Catalog No. 3101011, Lot Nos. 100025 & 100009;
               (b) Catalog No. 3101002, Lot No. 100007;
               (c) Catalog No. 3101012, Lot No. 100023;
               (d) Catalog No. 3101015, Lot No. 100029; 
               (e) Catalog No. 3101004, Lot No. 100001.
MANUFACTURER   International Medical Technologies Group, Inc., Glens Falls,
               New York.
RECALLED BY    Manufacturer, by letter August 20, 1993 and by telephone to
               all consignees August 24, 1993.  Firm-initiated recall
               ongoing.
DISTRIBUTION   New Jesey, Texas, Alabama, Arkansas, Maine, Missouri,
               Florida.
QUANTITY       1,806 pieces.
REASON         Some of the devices were labeled as sterile, but never went
               through a sterilization process.

_______________
PRODUCT        Medifuse IV Administration Sets:  
               (a) Model #7103 - Pink; (b) Model #7105 - Beige;
               (c) Model #7110 - Blue; (d) Model #7115 - Yellow;
               (e) Model #7125 - Green; (f) 7130 - Gray; 
               (g) 7160 - Red.  Recall #Z-051/057-4.
CODE           (a) All lots; (b) All lots; (c) All lots except APR92M02;
               (d) All lots except C25500 and JUL93M02; 
               (e) All lots except OCT92M02 and MAR93M02; (f) All lots;
               (g) All lots.
MANUFACTURER   Goreki (Gor-Mil) Manufacturing, Milaca, Minnesota.
RECALLED BY    3M Infusion Therapy, St. Paul, Minnesota, by letter
               September 3, 1993.  Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide, Belgium, Argentina, the Netherlands.
QUANTITY       Approximately 15,000 units.
REASON         A defect at both ends of the tubing to hard plastic
               connections may cause leakage.

_______________
PRODUCT        Chem*i*c*a, sterilizing and disinfecting concentrate
               solution, in 1.6 ounce bottles.  Recall #Z-058-4.
CODE           Product #10-5516, all lots.
MANUFACTURER   Metrex Research Corporation, Parker, Colorado.

                                    -9-RECALLED BY    Manufacturer, by telephone beginning November 3, 1992. 
               Firm-initiated recall ongoing.
DISTRIBUTION   Connecticut.
QUANTITY       9,600 bottles.
REASON         Product does not meet the guidance requirements for a "high
               level disinfectant".


RECALLS AND FIELD CORRECTIONS:  VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT        Otipan, in 2 fluid ounce and 8 fluid ounce bottles, OTC, a
               cleansing solution for ears and skin.  Recall #V-002-4.
CODE           All lots.
MANUFACTURER   Vet-A-Mix, Inc., Shenandoah, Iowa
RECALLED BY    Harlmen, Inc., Omaha, Nebraska, by telephone August 26,
               1993.  Firm-initiated recall complete.
DISTRIBUTION   Texas, Nebraska, Ohio, New Mexico, Minnesota, Idaho,
               Pennsylvania, Washington state, Georgia, Michigan,
               Massachusetts, Oklahoma.
QUANTITY       5,628 2-fluid ounce bottles and 1,195 16-fluid ounce
               bottles.
REASON         Product is an unapproved new animal drug.


MEDICAL DEVICE SAFETY ALERTS: 
============================================

_______________
PRODUCT        ACT Sterilization "C" Series External Gasket Containers:
               (a)  Catalog No. C0711-3.0 
               (b)  Catalog No. C0711-3.5 
               (c)  Catalog No. C0711-4.0 
               (d)  Catalog No. C0711-4.5 
               (e)  Catalog No. C0711-5.0 
               (f)  Catalog No. C0711-6.0 
               (g)  Catalog No. C1212-3.0 
               (h)  Catalog No. C1212-3.5 
               (i)  Catalog No. C1212-4.0 
               (j)  Catalog No. C1212-4.5 
               (k)  Catalog No. C1212-5.0 
               (l)  Catalog No. C1212-6.0 
               (m)  Catalog No. C1217-3.0 
               (n)  Catalog No. C1217-3.5 
               (o)  Catalog No. C1217-4.0 
               (p)  Catalog No. C1217-4.5 
               (q)  Catalog No. C1217-5.0 
               (r)  Catalog No. C1217-6.0 
               (s)  Catalog No. C1223-3.0 
               (t)  Catalog No. C1223-3.5 
               (u)  Catalog No. C1223-4.0 
               (v)  Catalog No. C1223-5.0
               (w)  Catalog No. C1223-6.0. Safety Alert #N-005\028-4. 
CODE           All "C" series containers.

                                   -10-MANUFACTURER   Medin Corporation, Passaic, New Jersey.
ALERTED BY     American Container Technology, Inc. (ACT), Wallington, New
               Jersey, by letter June 30, 1993.
DISTRIBUTION   Nationwide, Canada, Singapore.
QUANTITY       Approximately 8,500 units.
REASON         There is a potential for malfunction with improper usage. 
               If the post weld breaks, the filter retention plate will not
               be secure causing compromised instrument sterility.

                                   -11-
                                     
END OF ENFORCEMENT REPORT FOR NOVEMBER 3, 1993.  BLANK PAGES MAY
FOLLOW.
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