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.
-12-
END OF ENFORCEMENT REPORT FOR JANUARY 19, 1994. BLANK PAGES MAY
FOLLOW.
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