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
10/30/1991
Recalls and Field Corrections: October 30, 1991
FOODS
Class I - A situation in which there is a reasonable
probability that the use of, or exposure to, a violative
Product will cause serious adverse health consequences or
death.
Product: Fresh Frozen Coconut Milk, in 8 ounce frozen plastic
pouches, Product of Thailand. Recall #F-001-2.
Code: None.
Manufacturer: Champ Group Enterprises Company, Ltd., Yanawa Bangkok,
Thailand.
Recalled by: Eastland Food Corporation, Columbia, Maryland, by
letters and visits beginning the third week of September.
Firm-initiated recall ongoing.
Distribution: All states east of the Mississippi River.
Quantity: Unknown. All product distributed by firm.
Reason: Product is contaminated with Vibrio Cholera 01, Ogawa El Tor.
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Class II - A situation in which the use of, or exposure to
a violative product may cause temporary or medically
reversible adverse health consequences or where the
probability of serious adverse health consequences is
remote.
NONE
Class III - A situation in which the use of, or exposure
to a violative product is not likely to cause adverse
health consequences.
NONE
COSMETICS
NONE
HUMAN DRUGS AND BIOLOGICS
Class I -
NONE
Class II -
Product: (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen
Plasma; (d) Recovered Plasma. Recall #B-017/020-2.
Code: Unit numbers: (a) DS9028; (b) DS9028 and 411043;
(c) 010793; (d) DS9028.
Manufacturer: Spokane & Inland Empire Blood Bank, Spokane, Washington.
Recalled by: Manufacturer, by telephone June 7, 17 and 27, 1991, and
by letters of June 19 and 26, 1991. Firm-initiated recall
ongoing.
Distribution: Washington state, California.
Quantity: (a) 1 unit; (b) 2 units; (c) 1 unit; (d) 1 unit.
Reason: Blood products, which tested: 1) repeatably reactive
for the antibody to the human immunodeficiency virus
type 1 (anti-HIV-1); or 2) non-reactive for anti-HIV-1
but were collected from donors who previously tested
anti-HIV-1 repeatably reactive, were released.
----
Product: Source Plasma. Recall #B-025-2.
Code: Unit numbers: N-42718-049, N-043046-049, B-20144-049,
B-20123-049.
Manufacturer: Preferred Blood Products, Inc., Fort Worth, Texas.
Recalled by: Manufacturer, by letters of August 19, 1991, and September
25, 1991 and by telephone on or about August 23, 1991.
Firm-initiated recall ongoing.
Distribution: New York.
Quantity: 4 units.
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Reason: Blood components, which tested either repeatably reactive
for hepatitis B surface antigen (HBsAg), or were collected
from a donor who previously tested repeatably reactive
for HBsAg, were distributed.
----
Product: Recovered Plasma. Recall #B-027-2.
Code: Unit #1606415.
Manufacturer: Horton Memorial Hospital, Middletown, New York.
Recalled by: Manufacturer, by telephone and letter September 6, 1991.
Firm-initiated recall complete.
Distribution: Pennsylvania.
Quantity: 1 unit.
Reason: Blood product, which tested initially reactive for
the antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), was distributed.
----
Class III -
Product: Triamcinolone Acetonide 0.025% Topical Cream,
in 15 gram and 80 gram tubes, an Rx product under the
NMC, Geneva, and Major labels. Recall #D-481-1.
Code: All lot numbers beginning with 0 or 9 of both the 15
gram and 80 gram tube sizes.
Manufacturer: NMC Laboratories, Inc., Glendale, New York.
Recalled by: Manufacturer, by letter on or about February 28, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 106,544 tubes of the 15 gram size and
approximately 128,033 tubes of the 80 gram size
were distributed.
Reason: Potency not assured through expiration date.
----
Product: Atropine Sulfate, Injection, USP 0.4 mg/ml (1/150 gr)
25 1-ml single dose vials per unit carton. An Rx
product. Recall #D-015-2.
Code: Lot #1386 EXP 8/94.
Manufacturer: Luitpold Pharmaceuticals, Inc., Shirley, New York.
Recalled by: Manufacturer, by letter October 3, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: Approximately 88,700 single-dose vials were distributed;
firm estimates 80 - 95% of the recalled product remains
on the market.
Reason: Product carton and labeling incorrectly declare the
presence of sodium chloride as an ingredient
for isotonicity.
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Product: (a) Red Blood Cells; (b) Platelets; (c) Recovered
Plasma. Recall #B-021/023-2.
Code: Unit numbers M13758 and M19352.
Manufacturer: Spokane & Inland Empire blood Bank, Spokane, Washington.
Recalled by: Manufacturer, by telephone June 17 and 27, 1991.
Firm-initiated recall ongoing.
Distribution: Washington state, California.
Quantity: 2 units of each component.
Reason: Blood products, which tested non-reactive for anti-HIV-1
but were collected from donors who previously tested
anti-HIV-1 repeatably reactive, were released.
----
Product: Platelets, Pheresis. Recall #B-026-2.
Code: Unit numbers: 12T34103 through 12T34132.
Manufacturer: American Red Cross, Charlotte, North Carolina.
Recalled by: Manufacturer, by letter May 21, 1991. Firm-initiated
recall complete.
Distribution: North Carolina, California.
Quantity: 30 units.
Reason: Blood products, which were untested for syphilis, were
distributed.
----
Product: Recovered Plasma. Recall #B-031-2.
Code: Unit #29KE01259.
Manufacturer: Rockingham Memorial Hospital, Harrisonburg, Virginia.
Recalled by: Manufacturer, by telephone on or about September 1,
1991. Firm-initiated recall complete.
Distribution: Maryland.
Quantity: 1 unit.
Reason: Blood product, which tested repeatably reactive for
hepatitis B surface antigen (HBsAg), was distributed.
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DEVICES AND RADIOLOGICAL PRODUCTS
Class I -
NONE
Class II -
Product: (a) Hydrocurve II (Bufilcon A) 45% water is a spherical
daily wear soft contact lens used to improve the vision
of non-diseased eyes for persons who are: nearsighted
(myopic), farsighted (hyperopic), or have had cataract
surgery (aphakic);
(b) CSI-T (Crofilcon A) Contact Lens, a hemispherical lens
for non-aphakic extended wear, indicated to correct
astigmatism. Recall #Z-1018/1019-1.
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Code: Lot numbers and EXP dates: (a) BRAHL 11/94, BRAHO 07/94;
(b) CRAIA 08/92.
Manufacturer: Sola/Barnes-Hind, Sunnyvale, California.
Recalled by: Sola/Barnes-Hind, San Diego, California, by letter
February 6, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, Puerto Rico, Canada, England, France,
Germany, Holland, Italy, Spain, Mexico, Taiwan.
Quantity: (a) 842 units; (b) 675 units were distributed;
firm estimates that few, if any, mislabeled lenses
remain on the market.
Reason: Product labels incorrectly state the lens parameters,
base curve(BC) and Diameter (DIA).
----
Product: Soft contact lenses:
(a) Softmate I (Bufilcon A) a soft contact lens for
extended wear and daily wear to improve the vision of
persons who are: nearsighted (myopic), farsighted
(hyperopic), or have had cateract surgery (aphakic);
(b) CSI (Crofilcon A), a daily wear soft contact lens used
for the correction of nearsightedness or corneal
astigmatism;
(c) CSI-T (crofilcon A), a soft contact lens for
non-aphakic extended wear, indicated to correct astigmatism.
Recall #Z-1020/1022-1.
Code: Lot numbers and EXP dates: (a) BBJAC 08/95;
(b) CBCWT 12/95, CBEEG 02/96; (c) CBDZS 02/96.
Manufacturer: Sola/Barnes-Hind, Sunnyvale, California.
Recalled by: Sola/Barnes-Hind, San Diego, California, by
letter April 30, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide, Puerto Rico, Virgin Islands, Canada,
England, Holland, Singapore.
Quantity: (a) 660; (b) 716; (c) 288 lenses were distributed; firm
estimates that few, if any, mislabeled lenses remain on
the market.
Reason: The labels are printed with the wrong lens parameters,
Base Curve (BC) and Diameter (DIA).
----
Product: Command Micro Electric Handswitch with cord, Model #296-9,
used with the Command Micro Electric System for small
bone surgical applications. Recall #Z-1089-1.
Code: Serial numbers 090848 through 091102.
Manufacturer: LaGrange Assemblies, Division of Electri-Tec, Inc.,
LaGrange, Indiana.
Recalled by: Stryker Corporation, Surgical Instruments Division,
Kalamazoo, Michigan, by telephone December 5, 1989,
followed by letter of January 26, 1990 and
June 4, 1990. Firm-initiated recall complete.
Distribution: Nationwide, Australia, Brazil, Hong Kong, Japan, Holland.
Quantity: 79 units were distributed.
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Reason: Assembly error may cause device to short causing
patient burn.
----
Product: Model DTV Camera with zoom capability used in
fluoroscopic systems. Recall #Z-001-2.
Code: All serial numbers.
Manufacturer: ADAC Laboratories, Milpitas, California.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan September 3, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: 14 units were distributed.
Reason: Noncompliance with performance standard for x-ray products
in that when the zoom is used, the area irradiated exceeds
the visible area of image receptor.
----
Product: Saracap A.G. Monitor, Model 20010, monitor for
capnography and anesthetic monitoring. Recall #Z-002-2.
Code: All serial numbers.
Manufacturer: PPG Industries, Inc., Biomedical Systems Division,
Lenexa, Kansas.
Recalled by: Manufacturer, by letter July 3, 1990, followed by
visit. Firm-initiated field correction complete.
Distribution: Nationwide and international.
Quantity: 571 units were distributed; firm estimates all units
were corrected.
Reason: The device may have a loose or oxiding wire connection
within the Saracap AG analyzer section which may cause a
drift or temporary loss of anesthetic agent and nitrous
oxide concentration readings.
----
Product: Saracap A.G., Model 20010, Monitor for Capnography and
anesthetic monitoring. Recall #Z-003-2.
Code: All serial numbers.
Manufacturer: PPG Industries, Inc., Lenexa, Kansas.
Recalled by: Manufacturer, by letter July 3, 1990, followed by
visit. Firm-initiated field correction ongoing.
Distribution: Nationwide.
Quantity: 571 units were distributed.
Reason: When the device is in the "standby" mode, pulse oximetry
(Sa02) readings may be obtained but the alarms for the
pulse oximetry are not active.
----
Product: Exhalation Valve - Water Trap and Diaphragm Holder:
(a) Exhalation Valve - Water Trap with Bracket,
Model PS 53;
(b) Exhalation Valve - Water Trap, Model PS 54;
(c) Exhalation Valve Water Trap, Model part number
090-193710 (Marquest Medical product number);
(d) Diaphragm Holder, Model PS 16-3 (a component of all
of the above. Recall #Z-004/007-2.
Code: All product shipped between May 1, 1990 and January 31,
1991.
Manufacturer: Instrumentation Industries, Inc., Bethel Park,
Pennsylvania.
Recalled by: Manufacturer, by letter June 21, 1991. Firm-initiated
recall ongoing.
Distribution: Nationwide.
Quantity: 197 units of Model PS 53; 630 units of Model PS 54;
and 158 units of Model PS 16-3 were distributed.
Reason: A defect in the component may cause prolonged expiratory
time, increased expiratory resistance, autopeep and variable
inspiratory pause time during ventilation.
----
Product: Percu Guide Lesions Marking systems Loop Type 20
gauge x 5 cm needle with 17.5 cm wire guide and 2.5 cm
stiffening cannula attached, sterile, single-use only.
Recall #Z-010-2.
Code: Catalog #N205, Lot #4461GD.
Manufacturer: Hart Enterprises, Wyoming, Michigan.
Recalled by: E-Z-EM, Inc., Westbury, New York, by telephone May 20,
1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 413 units were distributed.
Reason: Guidewires which should be used in the 20 gauge 10 cm
needles were used for this lot of 20 gauge 5 cm needles.
----
Product: Gates Energy Cyclon Batteries, 6 volt and 12 volt, used
in Nellcor N-200 Pulse Oximeters: (a) Part #P6A81138;
(b) Part #086100274. Recall #Z-011/012-2.
Code: Catalog #3150.
Manufacturer: Nellcor Inc., Hayward, California (N-200 in 1987 & 1988).
Gates Energy Products, Inc., San Jose, California
(batteries).
Recalled by: Nellcor, Inc., Hayward, California, by letter
May 17, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 7,466 batteries were distributed.
Reason: The devices may leak acid.
----
Product: Scanditronix Accelerators used for photon and electron
patient radiotherapy. Recall #Z-017-2.
Code: Model MM22.
Manufacturer: Scanditronix Inc., Essex, Massachusetts.
Recalled by: Manufacturer, by letter July 9, 1990. Firm-
initiated recall ongoing.
Distribution: Nationwide.
Quantity: 3 units were distributed.
Reason: The dosecounters count can be much slower than normal and
indicate doserate is low, though the true delivered
doserate is normal.
----
Product: TMP brand 52 French Single Atrial Perfusion Cannula,
Product #211052-000, a sterile prescription device used
to cannulate the right atrium for cardiopulmonary by-pass
procedures. Recall #Z-018-2.
Code: Lot #112030.
Manufacturer: Surgimedics/TMP, Texas Medical Products, The Woodlands,
Texas.
Recalled by: Manufacturer, by letter July 19 and 25, 1991. Firm-
initiated recall ongoing.
Distribution: Texas, The Netherlands.
Quantity: 225 units were distributed.
Reason: Packaging defects which may compromise the sterility
of the product.
----
Product: Silicone Gel-Filled Breast Prostheses:
(a) Silastic II Mammary High Performance, Catalog Nos.
99849999, 99859999;
(b) Silastic Mammary Gel/Saline, Catalog Nos. P380000,
P3810000, P3820000, P3830000, P3850000, P3860000,
P3870000, P3890000.
(c) Silastic Rubin Mammary High Profile Contour, Catalog
Nos. P5220120, P5220175, P5220215, P5220235, P5220260,
P5220315, P5220350, P5220425, P5220450;
(d) Silastic II Mammary Low Profile Round, Catalog Nos.
PC140090, PC140095, PC140305, PC140340, PC140370,
PC140800, PC141200, PC141300;
(e) Silastic Mammary High Profile Round, Catalog Nos.
PC150050, PC150085, PC150260, PC150285, PC150315,
PC150325, PC150350, PC150380, PC150425, PC150450,
PC150475, PC150535, PC150650, PC150700, PC150750,
PC150800, PC150830, PC150900;
(g) Silastic II Mammary Teardrop, Catalog Nos. PC170160,
PC170650, PC170750, PC170800, PC170950, PC171100,
PC171200;
Silastic II Mammary Implant Special Order:
Catalog Nos. PCF00029 - Silastic II Stacked Mammary;
PCF00030 - Silastic II Tri Stacked Mammary;
PCF10015 - Silastic Gel Nipple;
PCF10021 - Silastic II Mammaray Implant Fixation Patch;
PCF10029 - Silastic II Stacked Mammary Location 1;
PCF10034 - Silastic Textured Nipple 4 cm;
PCF10039 - Silastic II Mammary Elliptical Small;
PCF12403 - Silastic II Double Lumen Mammary;
PCF20015 - Silastic Gel Nipple;
PCF30015 - Silastic Gel Nipple Medium;
PCF30029 - Silastic II Stacked Mammary Location 3;
PCF30034 - Silastic Textured Nipple Implant 5 cm;
PCF40015 - Silastic Gel Nipple Large;
PCF40029 - Silastic II Stacked Mammary Location 4;
PCF40034 - Silastic Textured Nipple Implant 6 cm;
PCF50029 - Silastic II Mammary with Nipple;
PCF50034 - Silastic Textured Areola Implant 4.25 cm.
Recall #Z-019/025-2.
Code: All lots and all codes.
Manufacturer: Dow Corning Wright, Inc., Arlington, Tennessee.
Recalled by: Manufacturer, by memorandum July 9, 1991 and by
letter August 16, 1991. Firm-initiated recall ongoing.
Distribution: Nationwide.
Quantity: 1,190 units were distributed.
Reason: Products were on the market after July 9, 1991, without a
premarket approval application (PMA), as required by the
final rule of April 10, 1991, pursuant to Section 515(b) of
the FD&C Act.
----
Product: Computerized Tomographic Series 9800 X-Ray Systems:
(a) All CT9800 Quick Systems with 46-278373G1,
46-278327G2, 46-237745G1, 46-237745G3, 46-237745G4
single bay computer systems manufactured prior to March
15, 1991, using Software Version SE and above. Also
Non-Quick Systems 46-218710G1, 46-218710G22, 46-21710G801;
(b) 46-229674G801, 46-218710G805 Single Bay Computer
Systems with Software Versions QE (and above);
(c) All CT9800 Quick Systems with 46-237745G1 Single
Bay Computer Systems manufactured prior to December 30,
1988; using SA, SB, SC, SF, or SFA software; and
applying to customers who have not signed an operating
and basic service limited agreement. Recall #Z-026/028-2.
Code: All serial numbers.
Manufacturer: GE Medical Systems, New Berlin, Wisconsin.
Recalled by: GE Medical Systems, Waukesha, Wisconsin, by letter
August 31, 1991. Firm-initiated field correction ongoing.
Distribution: Nationwide and international.
Quantity: 2,115 units were distributed.
Reason: Use of certain exam numbers on the scanner can result in
an inability to display the exam.
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Product: Medtronic Model 3625 SCS Screener, spinal cord stimulator,
used for temporary stimulation of the spinal cord to
determine the efficacy of an implantable pulse generator for
pain relief and to assist in determining lead position.
Recall #Z-029-2.
Code: Range of serial numbers include NAC00 ----P from 1004 to
1584, 2902 to 2951, and 3052 to 3132.
Manufacturer: Medtronic, Inc., Neurological Division, Columbia Heights,
Minnesota.
Recalled by: Manufacturer, by visit beginning August 7, 1991.
Firm-initiated recall ongoing.
Distribution: Nationwide and international.
Quantity: 191 units were distributed.
Reason: The device exhibits an ON condition with the "ON"
indicator light flashing, but there is no output, due
to failure of an operational amplifier integrated
circuit. This failure could result in false
conclusions for the reason for no stimulation and result
in the delay and/or failure for adequate treatment.
----
Product: CA 125 RIA Kit, an in-vitro diagnostic kit for the
quantitative measurement of cancer antigen 125 (CA 125)
in serum of women with primary epithelial invasive ovarian
cancer, excluding those with cancer of low malignant
potential. Recall #Z-031-2.
Code: Product #800-011, Lot #4K0761.
Manufacturer: Centocor, Inc., Malvern, Pennsylvania.
Recalled by: Manufacturer, by telephone September 24, 1991, followed
by letter. Firm-initiated recall ongoing.
Distribution: Distributors in Illinois and California.
Quantity: 500 kits were distributed.
Reason: Under certain environmental conditions, product may
degrade due to poorly sealed bottles.
----
Product: Angiography Digital Subtraction Units:
(a) Model #DAR 200; (b) Model #DAR 1200.
Recall #Z-035/036-2.
Code: All serial numbers.
Manufacturer: Shimadzu Medical Systems, Gardena, California.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan September 25, 1991. Firm-initiated field
correction ongoing.
Distribution: Nationwide.
Quantity: (a) 2 units; (b) 12 units were distributed.
Reason: Noncompliance with performance standard for x-ray
products in that they emit or cause the emission of
electronic product radiation which is unnecessary to the
accomplishment of its primary purpose.
----
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Product: Model 630 Dye Laser System, also known as PDT Laser
System Model 630. Recall #Z-037-2.
Code: Undetermined.
Manufacturer: Laser Therapeutics, Inc., Buellton, California.
Recalled by: Manufacturer. FDA approved the firm's corrective action
plan October 9, 1991. Firm-initiated field correction
ongoing.
Distribution: Domestic.
Quantity: 1 unit was distributed.
Reason: Noncompliance with performance standards for laser products
in that the calibration procedure provided in the user
information failed to provide a procedure for actual
calibration of the measurement system and that the aperture
label was not affixed in close proximity to the laser
aperture.
----
Product: Industrial Robot for Laser Products. Recall #Z-038-2.
Code: Undetermined.
Manufacturer: Gelzer Systems Company, Waterville, Ohio.
Recalled by: Manufacturer. FDA approved the firm's corrective
action plan August 2, 1991. Firm-inititiated field
correction ongoing.
Distribution: Minnesota.
Quantity: 1 unit was distributed.
Reason: Noncompliance with performance standards for laser
products in that the method of incorporation of the
certified laser system covered required warning labels.
----
Class III -
Product: Kits containing an assortment of crowns of different
types for tooth restorations and boxes of two types of
crowns to refill the kits:
(a) Unitek 3M Primary Stainless Steel Molar Crowns,
112 crowns, catalog #902150;
(b) Unitek 3M Permanent Stainless Steel Molar Crowns,
84 crowns, catalog #902350;
(c) Unitek 3M Stainless Steel Primary Molar LR6, 5 molars
per box, product #900-246;
(d) Unitek 3M Stainless Steel Permanent Molar UL-4,
5 molars per box, product number 900-314.
Recall #Z-013/016-2.
Code: Lot numbers: (a) P910324 and P910522;
(b) P910430 and P910530; (c) P910213; (d) P910618.
Manufacturer: 3M Unitek, Monrovia, California.
Recalled by: 3M Dental Products Division, St. Paul, Minnesota, by
letter August 14, 1991. Firm-initiated recall complete.
Distribution: Nationwide and international.
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Quantity: 200 kits were distributed.
Reason: One type of temporary dental crown was mislabeled on
the crown as to its type.
----
Product: Tryptic Soy Agar with 5% Sheep Blood/EMB - Biplate.
Recall #Z-032-2.
Code: Lot #8659 dated 8/9/91, EXP 9/24/91.
Manufacturer: Northeast Laboratory Services, Inc., Waterville, Maine.
Recalled by: Manufacturer, by telephone September 14, 1991.
Firm-initiated recall ongoing.
Distribution: New England states and Pennsylvania.
Quantity: 1,300 kits were distributed.
Reason: Product is mislabeled in that "Selective Strep Agar" had
been placed in the position reserved for the tryptic soy
agar.
----
Product: Whale Scientific Metanephrine Urinalysis Test Kit.
Recall #Z-034-2.
Code: Lot #2294. Product Code 6104, 6104-1, 6101, 6150
EXP 5/11/93.
Manufacturer: Whale Scientific, Inc., Commerce City, Colorado.
Recalled by: Manufacturer, by letter March 19, 1991. Firm-initiated
recall ongoing.
Distribution: New Jersey, South Carolina, Saudi Arabia, England,
Germany, Israel, Yugoslavia, India.
Quantity: 112 kits were distributed.
Reason: The instruction manual contains incomplete instructions.
----
VETERINARY PRODUCTS
Class I -
NONE
Class II -
Product: (a) Purina Lean Generation Chow Gro-Fin Pak W/O, bulk
nonmedicated swine feed;
(b) Purina Lean Generation Chow 321 40T, bulk medicated
swine feed;
(c) Purina Lean Generation Chow Concentrate w/o, bulk
nonmedicated swine feed;
(d) Purina Sow Chow 2901, in 50 lb bags, nonmedicated
animal feed supplement (swine);
(e) Purina Lean Generation Chow-Gro-Fin Pak w/o, bulk
nonmedicated swine feed in crumble form.
Recall #V-002/006-2.
Code: Lot numbers: 7-11-91, 43-071591, 7-16-91.
Manufacturer: Purina Mills, Inc., Sioux City, Iowa.
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Recalled by: Manufacturer, by telephone August 6-8, 1991.
Firm-initiated recall complete.
Distribution: Iowa, Nebraska, South Dakota.
Quantity: 86,000 pounds were distributed; firm estimates none
remains on the market.
Reason: Products were improperly sequenced with no
intervening flush during manufacture.
----
Class III -
NONE
Seizure Actions Filed:
Product: Medical Gas Cylinders Containing Oxygen USP
(90-543-615).
Charge: Current good manufacturing practice deficiencies.
Firm: North American Medical Supplies Inc., Rochester,
New York.
Filed: September 11, 1991 - U.S. District Court for the
Western District of New York; Civil #91-6374L,
FDC #66251.
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