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
01/19/1994

Recalls and Field Corrections:  Foods -- Class I -- 01/19/1994

January 19, 1994                                               94-3

RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS I
==========================
_______________
PRODUCT        Butter products and cream cheese:
               (a) Single serving butter portions wrapped in foil labeled
               Darigold 1 First Quality 1 Creamery Butter, 47 portions per
               pound, 17 pounds per box;
               (b) IGA Lightly Salted Creamery Butter, in 1 pound prints;
               (c) IGA Lightly Salted Butter Four Quarters, in retail
               boxes, 16 ounces;
               (d) Best Yet Sweet Cream Lightly Salted Butter 4 Quarters,
               in retail packages each holding 16 ounces;
               (e) Valley Maid Lightly Salted Butter in one pound prints;
               (f) Level Valley Dairy Unsalted Bulk Butter in boxes holding
               68 pounds per box;
               (g) Single-serving "47 cut" unsalted butter portions (47
               portions per pound) wrapped in foil, distributed by Level
               Valley Dairy;
               (h) Single-serving "60 cut" butter portions (60 portions per
               pound), lightly salted, wrapped in foil, distributed by
               Level Valley Dairy;
               (i) Single-serving "47 cut" butter portions (47 portions per
               pound), lightly salted, wrapped in foil, distributed by
               Monarch, Inc.;
               (j) Single-serving "60 cut" butter portions (60 portions per
               pound), lightly salted, wrapped in foil, distributed by
               Monarch, Inc.;
               (k) Level Valley single-serving Cream Cheese Portions, 600
               individually foil wrapped, 15.0 pounds.  
               Recall #F-158/161-4.  
CODE           (a) Jan 25 94, Jan 26 94, Jan 27 94, Jan 28 94, Jan 29 94,
               Jan 30 94, Feb 1 94, Feb 2 94, Feb 3 94, Feb 4 94, Feb 5 94,
               Feb 6 94, Feb 8 94, Feb 9 94;
               (b) Jan 12 94, and Jan 13.  Firm is also withdrawing lot Jan
               18 94 although this lot did not test positive, individually
               or as part of a composite; 
               (c) Jan 13 94.  Firm is also withdrawing lot Jan 19 94
               although this lot did not test positive, individually or as
               part of a composite sample, for pathogenic bacteria;
               (d) Jan 13 94.  Firm is also withdrawing lot Jan 19 94
               although this lot did not test positive individually or as
               part of a composite sample;
               (e) Jan 13; 94; (f) 4957, 4958, 4959, 4961, 4963, 4964,
               4965, 4971, 4972, 4977, 4978; (g) 4418-259, 4419-259;
               (h) 4314-262, 4318-262, 4314-264, 4589-264, 4588-265; 
               (i) 4588-265, 4587-265, 4586-265;
               (j) 4313-262, 4589-264; (k) 287, 288. 
MANUFACTURER   Level Valley Dairy Company, West Bend, Wisconsin.
RECALLED BY    Manufacturer, by letters of October 19 and 21, 1993, and
               November 1 and 2, 1993.  Firm-initiated recall complete.
DISTRIBUTION   California, Wisconsin, Illinois, Iowa, Minnesota, Nebraska,
               South Dakota, Indiana, Missouri, Tennessee, Florida,
               Georgia, North Carolia, South Carolina, Ohio.
QUANTITY       4,200 cases of Darigold Continental Chips (17 pounds per
               case); 1,313 36-pound cases of 16-ounce prints and 1-pound
               packages of quarters; 426 68-pound boxes of bulk butter; 712
               cases of Level Valley Continental Chips (17 pounds per case
               of 47 cut and 13.3 pounds per case of 60 cut chips); 431
               cases of Monarch Continental Chips (17 pounds per case of 47
               cut and 13.3 pounds per case of 60 cut chips); 205 cases of
               Level Valley Cream Cheese Mini-Bars (15 pounds per case)
               were distributed.
REASON         Product is contaminated with Listeria monocytogenes.

_______________
PRODUCT        Fresh crabmeat, in 16 ounce plastic containers with plastic
               snap-on lids:  (a) Jumbo Lump Crabmeat; (b) Backfin
               Crabmeat; (c) Special Crabmeat.  Recall #F-163/165-4.
CODE           2983, 2993, 3053, 3063, 3073, 3083, 3093, 3123, 3133.
MANUFACTURER   Cryotech Industries of North Carolina, Inc., Aurora, North
               Carolina.
RECALLED BY    Manufacturer, by telephone November 11, 1993.  Firm-
               initiated recall complete.
DISTRIBUTION   Maryland.
QUANTITY       Firm estimates none remains on the market.
REASON         Product is contaminated with Listeria monocytogenes.


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS II
=========================
_______________
PRODUCT        Ceramic Crocks, made in Mexico, engraved with "Marvel-
               Tek/Napco" on the bottom.  Recall #F-139-4.
CODE           None.
MANUFACTURER   Accents Company, Tijuana, B.C. Mexico.
RECALLED BY    Marvel-Tek/Napco, Baldwin Park, California, by letter April
               20, 1993.  The San Diego County Department of Health
               Services issued a press release April 14, 1993.  Firm-
               initiated recall complete.
DISTRIBUTION   California, Colorado, Florida, Missouri, Nebraska, Texas,
               Bermuda.
QUANTITY       201 crocks were distributed; firm estimates none remains on
               the market.
REASON         Product contains excessive amounts of leachable lead.

_______________
PRODUCT        Yoder's Pistachio Dessert, in 4 pound plastic tubs.
               Recall #F-156-4.
CODE           All product made after September 30, 1993 with pull dates
               from NOV 30 through JAN 30.
MANUFACTURER   I & K Distributors, Inc., Delphos, Ohio.
RECALLED BY    Manufacturer, by letter November 29, 1993. Firm-initiated
               field correction (relabeling) ongoing.
DISTRIBUTION   Ohio, Michigan, Illinois, Kentucky, Pennsylvania, Indiana.
QUANTITY       4,714 units were distributed; firm estimated that 373 units
               remained on the market at time of recall.
REASON         Product contains undeclared Pistachios and almonds.

_______________
PRODUCT        Yoder's Old Fashioned Bread Stuffing, in 2 pound plastic
               tubs.  Recall #F-167-4.
CODE           Pull dates DEC01 through JAN05 (all product made after
               October 25, 1993)
MANUFACTURER   I & K Distributors, Inc. Delphos, Ohio.
RECALLED BY    Manufacturer, by letter November 29, 1993.  Firm-initiated
               recall ongoing.
DISTRIBUTION   Ohio, Michigan, Illinois, Kentucky, Pennsylvania, Indiana.
QUANTITY       1,090 cases (6 tubs per case) were distributed; firm
               estimates 209 cases remain at the retail level.
REASON         Product contains an ingredient consisting in part of
               monosodium glutamate (MSG) but the MSG is not declared on
               the product label.


RECALLS AND FIELD CORRECTIONS:  FOODS -- CLASS III
========================
_______________
PRODUCT        McKenzie's Frozen Cut Green Beans in (a) 9 ounce boxes; (b)
               16 ounce plastic bags; (b) Flavorite Frozen Cut Green, in 16
               ounce plastic bags.  Recall #F-166-4.
CODE           Lot numbers:  (a) G2733A; (b) G3223B; (c) G0613A.
MANUFACTURER   Southern Frozen Foods, Division of Curtice-Burns, Inc.,
               Montezuma, Georgia.
RECALLED BY    Manufacturer, by letter December 20, 1993.  Firm-initiated
               recall ongoing.
DISTRIBUTION   Southeastern United States.
QUANTITY       (a) 1,077 cases; (b) 610 cases; (c) 763 cases.
REASON         Product is contaminated with rodent hairs and filth.

_______________
PRODUCT        Wheat flour, bleached, unbleached and high protein flour,
               packaged in single layer paper bags, 2 pound, 5 pound, 10
               pound, 25 pound 50 pound and 100 pound bags, under the
               following labels:  Western Family, Lady Lee, True Value,
               Stone-Buhr, IGA, Flavorite, Albertsons, Special Value,
               Springfield, Saver's Choice, Hy Top, Bonnie Hubbard,
               TownHouse, Stater Bros. Janet Lee, Centennial Crown, Vons,
               Fred Meyer, Shoppers Value, All Purpose, Haggen, Food Club,
               Shur Fine, Home & Garden, Ralphs.  Recall #F-123/125-4.
CODE           All product and sizes with code dates on or before September
               17, 1994 with the exception of Safeway accounts who have
               product codes dated on or before March 17, 1993.  All
               recalled product has a code date stamped in black ink. 
               Prior to and after this incident, the firm utilized blue ink
               in stamping the code date.
MANUFACTURER   Centennial Mills, a Division of ADM Milling, Spokane,
               Washington.
RECALLED BY    Centennial Mills, a Division of ADM Milling, Portland,
               Oregon, by telephone October 22, 1993, followed by letter.
               Firm-initiated recall complete. 
DISTRIBUTION   California, Oregon, Washington state, Idaho, Montana.
QUANTITY       The firm estimates 1,700,000 pounds remain at the wholesale
               level at the time of recall.
REASON         The wrong ink used to stamp date codes on bags imparted an
               off-odor in the flour.

_______________
PRODUCT        Milk and cream products:  (a) Lactaid 1% Lowfat Milk, 1
               quart with the following EXP dates:  11/7, 11/8, 11/9,
               11/12, 11/19, and 11/21;
               (b) Lactaid Nonfat Milk, 1 quart, EXP dates 11/7, 11/8,
               11/9, and 11/19;
               (c) Lactaid Nonfat with Calcium, 1 quart, EXP 11/21;
               (d) Chocolate Lactaid Milk, 1 quart, EXP 11/8;
               (e) Calcimilk (product is Lactaid with added calcium), 1
               quart EXP dates 11/7, 11/8, and 11/19; Calcimilk, Nonfat, 1
               quart EXP 11/21;
               (f) Half & Half (Turner label), 1 quart, EXP 11/9;
                   Half & Half (Crowley label), 1 quart, EXP dates 11/12,
                   11/13, and 11/19 and 1 pint EXP 11/12;
                   Half & Half (Dairylea label), 1 quart, EXP dates:  11/12
                   and 11/19, 1 pint EXP 11/19;
                   Half & Half (Cream-O-Land label), 1 quart, EXP 11/19;
               (g) Heavy Cream (Instant Whip label), 1 quart EXP 11/9;
                   Heavy Cream (Crowley label), 1 quart EXP 11/9;
                   Heavy Cream (Hood label), 1 quart, EXP 11/9;

                  Heavy Cream 40% (Crowley label), 1 quart, EXP 11/9;
               (h) Light Cream (Dairylea label), 1 quart EXP 11/7;
                   Light Cream (Crowley label) 1 quart EXP 11/7
                   Light Cream (Sunnymeadow), 1 quart, EXP 11/7;
               (i) Skim Milk (Hood label), 1 quart, EXP 11/7;
               (j) 2% Milk (Hood label), 1/2 pint (12 pack), EXP dates:
                   10/25, 11/7, 11/19, and 11/21;
                   2% Milk (Hood label), 1/2 pint (20 pack), EXP dates: 
                   10/18, 10/27;
               (k) Nestle Chocolate Quik (chocolate milk), 1 quart, 1 pint,
                   and 1/2 pint EXP 10/29;
                   Nestle Strawberry Quik (Strawberry flavored milk), 1
                   pint, EXP 10/27 and 11/8.  Recall #F-127/138-4.
CODE           The only codes are expiration dates as listed in product
               section.
MANUFACTURER   H.P. Hood, Inc., Oneida, New York.
RECALLED BY    Manufacturer, by memorandum September 27, 1993.  Firm-
               initiated recall complete.
DISTRIBUTION   Pennsylvania, Ohio, New York, New Jersey, Connecticut,
               Maryland, Indiana, Illinois, Virginia, Kentucky,
               Massachusetts, West Virginia.
QUANTITY       44,304 cases were distributed.
REASON         Products were spoiling prior to the expiration.


RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS II
=========================
_______________
PRODUCT        Liquid Medical Oxygen filled into 18 pound and 28 pound
               patient cryogenic vessels.  Recall  #D-104-4.
CODE           All fill dates.
MANUFACTURER   B & B Systems, Inc., doing business as Central Home Care,
               Freeport, New York.
RECALLED BY    Manufacturer, by visit on November 6 or 8, 1993.  Firm-
               initiated recall complete.
DISTRIBUTION   New York.
QUANTITY       17 units were distributed.
REASON         Current good manufacturing practice deficiencies.

_______________
PRODUCT        Lyophilized Levothyroxine Sodium Injection, 200 mcg/vial,
               used in the treatment of thyroid insufficiency, under Schein
               Pharmaceutical, Inc. label.  Recall #D-105-4.
CODE           Lot #93D770 EXP 11/94.
MANUFACTURER   Steris Laboratories, Inc., Phoenix, Arizona.
RECALLED BY    Manufacturer, by letter December 10, 1993.  Firm-initiated
               recall ongoing.
DISTRIBUTION   Nationwide and Puerto Rico.
QUANTITY       12,760 vials, individually cartoned, were distributed; firm
               estimates none remains on the market.
REASON         A portion of the lot was miscartoned into Dexamethasone
               Sodium Phosphate cartons.



RECALLS AND FIELD CORRECTIONS:  DRUGS -- CLASS III ------------------------
_______________
PRODUCT        Metoclopramide Injection USP, 150, mg/30 ml single dose
               vials, packed 6 vials per shelf carton.  Recall #D-106-4.
CODE           Lot #R2A194.
MANUFACTURER   Ben Venue Laboratories, Bedford, Ohio.
RECALLED BY    Cetus Oncology Corporation, Emeryville, California, by
               letter dated April 16, 1993.  Firm-initiated recall
               complete.
DISTRIBUTION   Nationwide.
QUANTITY       3,991 cartons (6 vials per carton) were distributed.
REASON         Label incorrectly declares sodium chloride content as 225 mg
               instead of 255 mg.  The carton and package insert are
               correct.

RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT        Red Blood Cells.  Recall #B-099-4.
CODE           Unit #2250328.
MANUFACTURER   Central Indiana Regional Blood Center, Inc., Indianapolis,
               Indiana.
RECALLED BY    Manufacturer, by letter March 2, 1992.  Firm-initiated
               recall ongoing.
DISTRIBUTION   Indiana.
QUANTITY       1 unit.
REASON         Blood product, which tested negative for the antibody to the
               human T-lymphotropic virus type I (anti-HTLV-I) but was
               collected from a donor who on two previous donations tested
               repeatedly reactive for anti-HTLV-I, was distributed.

_______________
PRODUCT        (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. 
               Recall #B-101/103-4.
CODE           Unit #36GQ04012.
MANUFACTURER   American Red Cross, Columbia, South Carolina.

RECALLED BY    Manufacturer, by telephone July 7, 1993, followed by letter
               July 16, 1993.  Firm-initiated recall ongoing.
DISTRIBUTION   (a) South Carolina; (b) Georgia; (c) California.
QUANTITY       1 unit of each component.
REASON         Blood products, collected from a donor with a medical
               history of cancer, were distributed.
 
_______________
PRODUCT        Platelets.  Recall #B-104-4.
CODE           Unit numbers:  49F28912, 49F28913, 49F28917, 49F28934.
MANUFACTURER   American Red Cross Blood Services, Tulsa, Oklahoma.
RECALLED BY    Manufacturer, by telephone March 3, 1992, and by letter
               dated August 12, 1992.  Firm-initiated recall complete.
DISTRIBUTION   Oklahoma.
QUANTITY       4 units.
REASON         Blood products, labeled with the incorrect expiration date,
               were distributed.

_______________
PRODUCT        (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
               (d) Platelets, Expired; (e) Recovered Plasma.
               Recall #B-105/109-4.
CODE           Unit numbers:  (a) 2216241, 3795388, 5417081; (b) 3795388,
               5417081; (c) 2216241, 5417081; (d) 2216241; (e) 3795388.
MANUFACTURER   BloodCare (formerly J.K. Susie Wadley Research Institute and
               Blood Bank), Dallas, Texas.
RECALLED BY    Manufacturer, by letter July 21, 1992 for Recovered Plasma
               and by letter February 8, 1993 for all other products. 
               Firm-initiated recall ongoing.
DISTRIBUTION   Texas, New Jersey, Florida.
QUANTITY       (a) 3 units; (b) 2 units; (c) 2 units; (d) 1 unit; (e) 1
               unit.
REASON         Blood products collected from a donor with a history of
               hepatitis were distributed.

_______________
PRODUCT        Fresh Frozen Plasma.  Recall #B-110-4.
CODE           Unit #20G64284.
MANUFACTURER   American Red Cross Blood Services, Boise, Idaho.
RECALLED BY    Manufacturer, by letter dated October 7, 1992.  Firm-
               initiated recall complete.
DISTRIBUTION   Idaho.
QUANTITY       1 unit.
REASON         Blood product, which tested negative for the antibody to the
               human immunodeficiency virus type 1 (anti-HIV-1) but was
               collected from a donor who previously tested repeatedly
               reactive for anti-HIV-1, was distributed.

_______________
PRODUCT        (a) Whole Blood; (b) Whole Blood Modified, Platelets
               Removed; (c) Red Blood Cells, Washed; (d) Red Blood Cells,
               Washed; (e) Platelets; (f) Platelets, Pheresis; (g) Fresh
               Frozen Plasma; (h) Platelets for Further Manufacture; (i)
               Recovered Plasma.  Recall #B-116/124-4.
CODE           Unit numbers:  (a) 1048618, 3026426, 3027505, 3036022,
               3040868, 5039107; (b) 1049499, 5038423; (c) 1044141,
               1046532, 1046829, 1047359, 1048005, 1048244, 1048711,
               1048786, 1049085, 1049841, 1050218, 1050770, 1051441,
               1052085, 1052353, 1053299, 1053598, 1060900, 1084242,
               1086652, 3027941, 3033326, 3033690, 3037083, 3038038,
               3040198, 3041704, 3048765, 3049723, 3050954, 3051924,
               5036409, 5038254, 5038270, 5038273, 5039414, 5039461,
               5040736, 5044757, 5045581, 6288205, 6288216, 6330164,
               6355013, 6355182, 9004615;
               (d) 5039463; (e) 1046829, 1048005, 1048244, 1048711,
               1048786, 1049085, 1049499, 1049841, 1050218, 1052085,
               1052353, 1053299, 1060900, 1086652, 3027941, 3033690,
               3038038, 3051924, 5036409, 5038254, 5038270, 5038273,
               5038423, 5039461, 5040736, 6288216, 6330164, 6355182,
               9004615; (f) 1089901; (g) 1049841, 1051441, 6330164;
               (h) 1044141, 1046532, 1047359, 1051441, 1053598, 1084242,
               3040198, 3049723, 3050954, 5039463, 5044757, 6288205;
               (i) 1044141, 1046532, 1046829, 1047359, 1048005, 1048244,
               1048618, 1048711, 1048786, 1049085, 1049499, 1050218,
               1052085, 1052353, 1053299, 1053598, 1060900, 1084242,
               1086652, 3026426, 3027505, 3027941, 3033326, 3033690,
               3037083, 3038038, 3040198, 3040868, 3041704, 3048765,
               3049723, 3051924, 5036409, 5038254, 5038270, 5038273,
               5038423, 5039414, 5039461, 5039463, 5040736, 5044757,
               5045581, 6288205, 6288216, 6355013, 6355182, 9004615.
MANUFACTURER   Northwest Florida Blood Center, Inc., Pensacola, Florida.
RECALLED BY    Manufacturer, by letter May 25, 1993.  Firm-initiated recall
               ongoing.
DISTRIBUTION   Florida, Pennsylvania, Washington state.
QUANTITY       (a) 6 units; (b) 2 units; (c) 46 units; (d) 1 unit; 
               (e) 29 units; (f) 1 unit; (g) 3 units; (h) 12 units;
               (i) 48 units.
REASON         Blood products, that tested negative for anti-HIV-1, but
               were collected from donors who previously tested repeatedly
               reactive for anti-HIV-1, were distributed.

_______________
UPDATE         Recall #B-389/402-2, Blood products, manufactured by Spokane
               & Inland Empire Blood Bank, Spokane, Washington, which
               appeared in the August 26, 1992 Enforcement Report has been
               re-evaluated.  The re-evaluation indicates that the reason
               for recall should be as follows:


               Blood products, which either tested repeatedly reactive for
               the antibody to the human immunodeficiency virus type 1
               (anti-HIV-1) by Enyme Immunoassay (EIA) or tested non-
               reactive for anti-HIV-1 but were collected from donors who
               previously tested repeatedly reactive for anti-HIV-1, were
               distributed.


RECALLS AND FIELD CORRECTIONS:  BIOLOGICS -- CLASS III
====================
_______________
PRODUCT        Albumin (Human) 5% Solution, in 50 ml bottles.
               Recall #B-100-4.
CODE           Lot #618102 EXP 2/27/94.
MANUFACTURER   Immuno-U.S., Inc., Rochester, Michigan.
RECALLED BY    Manufacturer, by telephone October 9 and 10, 1992, followed
               by letter November 25, 1993.  Firm-initiated recall
               complete.
DISTRIBUTION   California, Illinois, New Jersey, Virginia.
QUANTITY       3,780 units were distributed.
REASON         Albumin (Human) solution, labeled with the incorrect amount
               of protein, was distributed.

_______________
PRODUCT        (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma.
               Recall #B-125/127-4.
CODE           Unit #1059967.
MANUFACTURER   Northwest Florida Blood Center, Inc., Pensacola, Florida.
RECALLED BY    Manufacturer, by letter May 25, 1993.  Firm-initiated recall
               ongoing.
DISTRIBUTION   Florida, Pennsylvania, Washington state.
QUANTITY       1 unit of each component.
REASON         Blood products, that tested negative for anti-HIV-1, but
               were collected from donors who previously tested repeatedly
               reactive for anti-HIV-1, were distributed for transfusion.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS II
=======================
_______________
PRODUCT        Infant Radiant Warmers, used for resuscitation of premature
               babies:  (a) Borning Stabilet Model No. 200;
               (b) Borning Stabilet Model No. 300
               (c) Hill-Rom Stabilet Model 2000/3000
               (d) Hill-Rom Stabilet Model No. 2200/3200.
               Recall #Z-810/813-3.
CODE           None.
MANUFACTURER   Med*ex Diagnostic of Canada, Inc., British Columbia, Canada.
RECALLED BY    Hill-Rom Company, Inc., Batesville, Indiana, April 5, 1993
               and March 31, 1993.  Firm-initiated recall ongoing.
DISTRIBUTION   Nationwide and international.
QUANTITY       3,800 units.
REASON         The crossover valve is subject to sticking and leakage.

                                    -9-_______________
PRODUCT        (a) Mevatron 6; (b) Mevatron 12 Clinical Linear Accelerator
               with x-ray field, used for radiation therapy.
               Recall #Z-176/177-4.
CODE           (a) 1063, 1083, 1098, 1111, 1114, 1126, 1143, 1144, 1161,
               1192, 1196, 1307, 1315, 1321, 1333; (b) 1056, 1068, 1072,
               1077, 1087, 1091, 1094, 1103, 1138, 1151, 1168, 1247, 1304,
               1314.
MANUFACTURER   Accelerator Systems, International, Milpitas, California.
RECALLED BY    Manufacturer, by telephone May 27, 1993.  Firm-initiated
               recall complete.
DISTRIBUTION   Nationwide.
QUANTITY       29 units.
REASON         The radiation units are missing steel straps which allowed
               lead counterweights to shift and gantry to become
               unbalanced, causing a 180 degree rotation to unit's most
               stable position.  By not having steel straps in place, the
               lead sheets could shift and stress the retaining bolts until
               they failed, causing crushing injury to the patient.

_______________
PRODUCT        Hex Assembly Abutment, a dental implant used to attach a
               post during dental surgery.  Recall #Z-184-4.
CODE           Lot #9222.011, product #229-1692.
MANUFACTURER   Artech Corporation, Chantilly, Virginia.
RECALLED BY    Henry Schein, Inc., Port Washington, New York, by telephone
               October 28, 1993.  Firm-initiated recall ongoing.
DISTRIBUTION   California, Canada, Holland.
QUANTITY       9 units were distributed.
REASON         Product was distributed without premarket approval
               authority.

_______________
UPDATE         Recall Z-002/003-4, Electroencephalographs, Models NRS-24
               and NRS-4, manufactured by Lexicor Medical Technology,
               Boulder, Colorado,  which appeared in the October 20, 1993
               Enforcement Report as a Class III recall has been
               reclassified as Class II because of lack of a Section 510(k)
               premarket notification.  The reason for recall should read: 
               Devices were not manufactured in accordance with device good
               manufacturing practices requirements, and there was no
               premarket notification (Section 510(k)) clearance prior to
               marketing.


RECALLS AND FIELD CORRECTIONS:  DEVICES -- CLASS III
======================
_______________
PRODUCT        Source Decay for MicroSelection-HDR Unit, used for radiation
               therapy. Recall #Z-729-3.
CODE           All Nucletron MicroSelection-HDR Systems manufactured on
               February 29, 1992.
MANUFACTURER   Nucletron B.V., Waardgelder 1, The Netherlands.

RECALLED BY    Nucletron Corporation, Columbia, Maryland, by Technical
               Notes of March 5 and 6, 1992.  Firm-initiated recall
               complete.
DISTRIBUTION   Nationwide and international.
QUANTITY       242 high dose rate units.
REASON         When source information was entered before March 1992, the
               decay calculation skipped one day.  This may result in an
               inaccurate calibration of treatment dosage for the patient.

_______________
PRODUCT        Hill-Rom Genesis Birthing Beds, used in hospitals during
               labor, delivery and post-partum care:
               (a) Model P3551B; (b) Model P3552C; (c) Model P3553B;
               (d) Model P3554C.  Recall #Z-143/146-4.
CODE           All serial numbers of the above model numbers, manufactured
               between 2/90 and 12/91.
MANUFACTURER   Hill-Rom Company, Inc., Batesville, Indiana.
RECALLED BY    Manufacturer, by Maintenance Advisory letter dated June 22,
               1992.  Firm-initiated field correction complete.
DISTRIBUTION   Nationwide and international.
QUANTITY       3,380 beds were distributed.
REASON         Possible loose connection between head/seat sway bar and
               head motor drive assembly which could cause head of bed to
               suddenly drop from raised position.

_______________
PRODUCT        Deknatel Soft Thoracic Catheter.  Recall #Z-148-4.
CODE           Product #DSTC-12S, Lot #03091.
MANUFACTURER   Deknatel, Inc., Fall River, Massachusetts.
RECALLED BY    Manufacturer, by letter September 20, 1993.  Firm-initiated
               recall ongoing.
DISTRIBUTION   Nationwide.
QUANTITY       230 units were distributed.
REASON         The product is labeled with the incorrect size.

_______________
PRODUCT        ACA(R) Ammonia (AMON) Analytical Test Pack, for use on the
               ACA(R) Discrete Clinical Analyzer, an in-vitro diagnostic.
               Recall #Z-178-4.
CODE           Lot numbers:  N3078A EXP 4/1/94, X3047A EXP 4/1/94, R3077A
               EXP 4/1/94, W3102A EXP 4/1/94, W3102B EXP 4/1/94, W3103A EXP
               4/1/94, K3131A EXP 5/1/94, K3132A EXP 5/1/94, K3132B EXP
               5/1/94, K3133A EXP 5/1/94.
MANUFACTURER   EI Du Pont de Nemours & Company, Galsgow, Delaware.
RECALLED BY    EI Du Pont de Nemours & Company, Dupont Medical Products,
               Galsgow, Delaware, by letters dated June 23 and 25, 1993. 
               Firm-initiated recall complete.
DISTRIBUTION   Nationwide and international.
QUANTITY       Firm estimates none remains on the market.
REASON         Products were found to give inaccurate elevated ammonia
               results when testing patient samples.


MEDICAL DEVICE SAFETY ALERTS: 
============================================
_______________
PRODUCT        Diagnostic ultrasound systems:  (a) Ultramark 9 HDI (b)
               Ultramark 9 Color Flow 2.  The Ultramark 9 transmits
               ultrasound waves, receives the echoes, and generates images
               based on information contained in the echoes.  
               Safety Alert #N-002/003-4.
CODE           All units.
MANUFACTURER   Advanced Technology Laboratories (ATL), Bothell, Washington.
ALERTED BY     Manufacturer, by letter July 16, 1993.
DISTRIBUTION   Nationwide and international.
QUANTITY       (a) 1,887 units; (b) 1,688 units were distributed.
REASON         Potential for incorrect Doppler and M-mode measurement
               results from atypical use.  In general, the problems involve
               the potential to have display information on the screens
               which does not match with the display scaling on the
               currently set parameters.  The user guides describe the
               areas of operation where these types of problems can occur
               and how to prevent their occurrence.


SEIZURES:
=================================================================
_______________
PRODUCT        Pedolatum (over-the-counter wart and corn and callus removal
               drug product)(93-666-223).
CHARGES        New drug - There is not approved application in effect for 
               this article.  Misbranded - The article's label fails to
               bear adequate directions for use as required.
FIRM           King Laboratories, Dallas, Texas.
FILED          October 19, 1993; U.S. District Court for the Northern
               District of Texas, Dallas Division; Civil #3-93-CV-2106-G;
               FDC #66731.
SEIZED         November 2, 1993 - goods valued at approximately $7,500.

_______________
PRODUCT        Special Blend (powdered mixture promoted for pre-employment
               drug screening to cleanse, bind, absorb, and expel unwanted
               toxins and impurities from the urine)(93-617-103, et al.).
CHARGES        New drug - There is no approved application in effect for
               this article.  Misbranded - The article's labeling fails to
               bear adequate directions for its intended use, for the
               conditions for which it is promoted, orally or by written
               literature, and it is not exempt from this requirement.
FIRM           Zydot Unlimited, Inc., Tulsa, Oklahoma.
FILED          July 30, 1993; U.S. District Court for the Northern District
               of Oklahoma; Civil #93-C-683-E; FDC #66692.
SEIZED         August 23, 1993 - goods valued at approximately $30,000.

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