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
11/29/1995

ENFORCEMENT REPORT FOR 11/29/95

November 29, 1995 95-48

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Leader brand oral Electrolyte Solution, unflavored, in
1-liter or 4-pack of 8 ounce bottles. Recall #F-056-6.
CODE Lot #5163 or #5146 inked on top of bottle.
MANUFACTURER Universal Industries, Columbus, Mississippi.
RECALLED BY Cardinal Health, Inc., Dublin, Ohio, by E-mail notice on
October 19, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 1,000 1-liter bottles were distributed.
REASON Product has an off-color possibly due to the presence of
Aspergillus niger.

_______________
PRODUCT Canned Shrimp in hermetically sealed metal cans, drained
weight 4 ounces, net weight 6 ounces: (a) Canned Tiny
Shrimp; (b) Canned Broken Shrimp. Recall #F-057/058-6.
CODE Product codes are embossed on top of can.
(a) 0105CP 121194 0105CP 211294 0105CP 251294
0105CP 261294 0105CP 200295 0105CP 240295
0105CP 130295 0105CP 070195 0105CP 090195
0105CP 160195 0105CP 230195 0105CP 060295
0105CP 021395
(b) 0106CP 131294 0106CP 080495 0106CP 151294
0106CP 080195 0106CP 220695 0106CP 190195
0106CP 200195.
MANUFACTURER Continental Pacific Corporation, Ltd., Bangkok, Thailand.
RECALLED BY Orleans Food Company, New Orleans, Louisiana, by letter on
October 16, 1995. FDA-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 19,454 cases (12 4.25-ounce units per case) of
tiny shrimp and an undetermined amount of canned broken
shrimp were distributed.
REASON Product is adulterated due to decomposition.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Dilantin (extended Phenytoin Sodium Capsules, USP),
Kapseals, 30 mg, antiepileptic drug. Recall #D-021-6.
CODE Lot #27324L EXP 4/96.
MANUFACTURER Warner Lambert Company, Lititz, Pennsylvania.
RECALLED BY Manufacturer, by letter dated October 3, 1995, followed by
telephone. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimates none remains on the market.
REASON Product does not meet dissolution specifications.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Phenylpropanolamine HCl 75 mg, Extended Release Black
Capsules, in bottles of 1,000, OTC product used to control
appetite to aid weight loss. Recall #D-022-6.
CODE Lot #1256 (some units were labeled with a 9/95 EXP date and
some were labeled with a 9/96 EXP date).
MANUFACTURER Richwood Pharmaceutical Company, Inc., Valley Stream, New
York.
RECALLED BY Manufacturer, by letter November 13, 1995. FDA-initiated
recall ongoing.
DISTRIBUTION Indiana, Michigan, New Jersey, New Mexico.
QUANTITY 490 bottles were distributed.
REASON Product does not meet dissolution specifications.

_______________
PRODUCT Hytone Hydrocortisone Ointment, USP, (a) 2.5%; (b) 1.0%,
under Dermik Laboratories label, Rx topical corticosteroid.
Recall #D-023/024-6.
CODE Lot numbers: (a) MN1146, MN1408, MN1268, MN1194, MN1062,
MN1032, MN1031, MN0966, MN0879, MN0777; (b) MN1205, MN1036,
MN0880, MN0432.
MANUFACTURER Rhone-Poulenc Rorer Pharmaceuticals, Collegeville,
Pennsylvania.
RECALLED BY Manufacturer, by letter dated September 28, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 90% of lot MN1146 remained on market at
time of recall initiation.
REASON Product does not meet homogeneity specifications.

-2-_______________
PRODUCT All package types and sizes of RHINOCAPS brand
over-the-counter decongestant-analgesic capsules and
RHINOCAPS brand analgesic-decongestant-antipyretic capsules
containing phenylpropanolamine HCl, aspirin, and
acetaminophen in combination. Recall #D-025-6.
CODE Lots numbers: 54-413, 54-211, 54-151, 54-144, 53-156,
52-249, and 52-248.
MANUFACTURER Ferndale Laboratories, Inc., Ferndale, Michigan.
RECALLED BY Manufacturer, by letter dated october 30, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 5.7 million capsules were distributed.
REASON Subpotency of the phenylpropanolamine ingredient.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Red Blood Cells. Recall #B-055-6
CODE Unit numbers: 10G78690, 10G78965, 10Q01062, 10H17598,
10G90230.
MANUFACTURER American Red Cross, Springfield, Missouri.
RECALLED BY Manufacturer, by letter dated June 22, 1994. Firm-initiated
recall complete.
DISTRIBUTION Missouri, Arkansas, Kentucky.
QUANTITY 5 units.
REASON Blood product, which was collected and subsequently
determined to be positive, was distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-059/060-6.
CODE Unit #53C66103.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated February 15, 1995. Firm-
initiated recall complete.
DISTRIBUTION Maryland, Washington, D.C.
QUANTITY 1 unit.
REASON Blood products, collected from a donor who had traveled to
an area designated as endemic for malaria, were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-061-6.
CODE 53FC38285.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated March 14, 1995. Firm-
initiated recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who had resided in an
area designated as endemic for malaria, was distributed.

-3-_______________
PRODUCT Platelets, Pheresis. Recall #B-062-6.
CODE Unit #53LF28980.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter on June 29, 1995. Firm-initiated
recall complete.
DISTRIBUTION Maryland.
QUANTITY 1 unit.
REASON Blood product, collected from a donor who had traveled to an
area designated as endemic for malaria, was distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-065-6.
CODE Unit #4541040.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY Manufacturer, by telephone on April 25, 1995. Firm-
initiated recall complete.
DISTRIBUTION Mississippi.
QUANTITY 1 unit.
REASON Blood product, which was collected from an ineligible donor,
was distributed.

_______________
PRODUCT Dader Mono-Type Blood Grouping Reagent Anti-D
Monoclonal/Polyclonal Blend, used in determining the
presence of the D antigen on erythrocytes of donors and
patients. Recall #B-066-6.
CODE Lot numbers: MPD14-1A, MPD14-1B, MPD14-1C, MPD14-1D, MPD15-
1A, MPD15-1B, MPD15-1C.
MANUFACTURER Dade International, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter sent on or about September 27, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Mexico, Chile, Guatemala, Brazil, South Africa.
QUANTITY 7,874 units were distributed.
REASON Reagent products with confirmed weaker than expected results
when performing D antigen testing, were distributed.

_______________
PRODUCT Platelets. Recall #B-082-6.
CODE Unit #24KJ00639.
MANUFACTURER American National Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated May 26, 1995. Firm-initiated
recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit.
REASON Blood product, which was prepared from whole blood collected
with an extended collection time, was distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-085/087-6.

-4-CODE Unit numbers: (a) 24GV35936, 24GV43866, 24GV50185,
24GV56035, 24GV59184, 24GV61906, 24GS33864, 24GV71228,
24GF00299, 24GF01216; (b) 24GV35936, 24GV43866, 24GV50185,
24GV59184, 24GV61906, 24GS33864; (c) 24GV35936, 24GV43866,
24GV50185, 24GV56035, 24GV59184, 24GV61906, 24GS33864,
24GV71228, 24GF00299, 24GF01216.
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated March 15 and 16, 1995. Firm-
initiated recall complete.
DISTRIBUTION California, Illinois, Indiana, Kentucky, and 1 foreign
account.
QUANTITY (a) 10 units; (b) 6 units; (c) 10 units.
REASON Blood products, which were collected from two donors who
previously tested repeat reactive for anti-HIV, were
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF; (c) Recovered
Plasma. Recall #B-089/091-6.
CODE Unit #24LF09796.
MANUFACTURER American National Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated March 8, 1995. Firm-initiated
recall complete.
DISTRIBUTION Kentucky, California.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor who was at
risk for possible exposure to hepatitis, were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma.
Recall #B-092/094-6.
CODE Unit numbers: (a) 24LZ35022, 24LH90208, 24LJ70875,
24LM65671, 24LJ48667, 24LJ46540, 24LH56047, 24LC06295; (b)
24LH90208, 24LJ46540; (c) 24LJ46540.
MANUFACTURER American National Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letters dated April 17, 1995. Firm-
initiated recall complete.
DISTRIBUTION Kentucky and California.
QUANTITY (a) 8 units; (b) 2 units; (c) 1 unit.
REASON Blood products, which were collected from a donor who had a
medical history of cancer, were distributed.

_______________
PRODUCT Platelets, Pheresis. Recall #B-097-6.
CODE Unit #P15296.
MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa.
RECALLED BY Manufacturer, by telephone on January 3, 1994. Firm-
initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit.
REASON Blood product, labeled with an incorrect expiration date,
was distributed.

-5-_______________
PRODUCT Source Plasma. Recall #B-101-6.
CODE Unit #FT08005093.
MANUFACTURER Serologicals, Inc., Asheville, North Carolina.
RECALLED BY Serologicals, Inc., Clarkston, Georgia, by facsimile on July
7, 1995. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit.
REASON Blood product, which was collected from a donor who had sex
with an intravenous drug (IV) user, was distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets-Pooled.
Recall #B-102/103-6.
CODE Unit numbers: (a) KC63586; (b) LP16697.
MANUFACTURER Blood Center of Central Iowa, Des Moines, Iowa.
RECALLED BY Manufacturer, by letter dated March 23, 1995. Firm-
initiated recall complete.
DISTRIBUTION Iowa, California, New York.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor with a
medical history of cancer, were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-106-6.
CODE Unit #40FR11027.
MANUFACTURER American National Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by telephone on August 18, 1995, followed by
letter dated August 22, 1995. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, which was collected from a donor who had
visited an area designated as endemic for malaria, was
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-107/108-6.
CODE Unit numbers: (a) 40FE79163 and 40FE80973; (b) 40FE80973.
MANUFACTURER American National Red Cross, Peoria, Illinois.
RECALLED BY Manufacturer, by telephone followed by letter on September
5, 1995. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY (a) 2 units; (b) 1 unit.
REASON Blood products, which were collected from a donor who had
visited an area designated as endemic for malaria, were
distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-109-6.
CODE Unit #40FZ08542 and 40FZ09110.
MANUFACTURER American National Red Cross, Peoria, Illinois.

-6-RECALLED BY Manufacturer, by letter dated September 22, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Illinois, American Samoa.
QUANTITY 2 units.
REASON Blood products, which were collected from a donor who had
visited an area designated as endemic for malaria, were
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-110/111-6.
CODE Unit #F80143.
MANUFACTURER Central California Blood Center, Fresno, California.
RECALLED BY Manufacturer, by letter dated July 26, 1995. Firm-initiated
recall complete.
DISTRIBUTION Washington state, California.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor with a
previous history of hepatitis, were distributed.

_______________
PRODUCT Plasma. Recall #B-112-6.
CODE Unit numbers: 29123-6671 and 29123-6682.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on February 9, 1995, followed by
letter dated February 15, 1995. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 2 units.
REASON Units of Plasma, which were incorrectly labeled as Fresh
Frozen Plasma, were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
_______________
PRODUCT Recovered Plasma. Recall #B-056-6.
CODE Unit numbers: 10G78690, 10G78965, 10H17598, 10G90230.
MANUFACTURER American Red Cross, Springfield, Missouri.
RECALLED BY Manufacturer, by letter dated June 22, 1994. Firm-initiated
recall complete.
DISTRIBUTION Missouri, Arkansas, Kentucky.
QUANTITY 4 units.
REASON Blood products, which were collected and subsequently
determined to be positive, were distributed.

_______________
PRODUCT (a) Gamma Zyme-F Supplemental Reagents for Ficin-Panel Kit;
(b) Gamma Ficin Solution, with Gamma's Ficin-Panel One & Two
Systems. Recall #B-057/058-6.
CODE Lot numbers: (a) EF25-1; (b) ENZ109-1.
MANUFACTURER Gamma Biologicals, Inc., Houston, Texas.

-7-RECALLED BY Manufacturer, by letter dated July 24, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON Supplemental reagent products demonstrated inability to
enzyme-treat Red Blood Cells and/or spontaneous
agglutination.

_______________
PRODUCT Red Blood Cells. Recall #B-078-6.
CODE Unit #Z19370.
MANUFACTURER The Blood Center of Central Iowa, Des Moines, Iowa.
RECALLED BY Manufacturer, by telephone on June 2, 1993. Firm-initiated
recall complete.
DISTRIBUTION Iowa.
QUANTITY 1 unit.
REASON Blood product, which was labeled with an incorrect
expiration date, was distributed.

_______________
PRODUCT Platelets, Pheresis. Recall #B-081-6.
CODE Unit #01KL01109.
MANUFACTURER American Red Cross, Rochester, New York.
RECALLED BY Manufacturer, by letter dated June 5, 1994. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
REASON Unlicensed blood product, was distributed in interstate
commerce.

_______________
PRODUCT Red Blood Cells. Recall #B-083-6.
CODE Unit #19KP07172.
MANUFACTURER American National Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated October 13, 1994. Firm-
initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit.
REASON Blood product, which was labeled with an incorrect
expiration date, was distributed.

_______________
PRODUCT Source Plasma. Recall #B-084-6.
CODE Unit #PK27242.
MANUFACTURER Community Bio-Resources, Inc., Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated August 11, 1994. Firm-
initiated recall complete.
DISTRIBUTION Austria.
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.
-8-_______________
PRODUCT Red Blood Cells Leukocytes Removed. Recall #B-088-6.
CODE 19GG32700, 24LS74092, 24LY27612, 24LG80743, 24LQ64732,
24LQ64755, 24LQ64758, 24LQ64765, 24LS74883, 24LY31281,
24LQ70368.
MANUFACTURER American National Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated May 16, 1995. Firm-initiated
recall complete.
DISTRIBUTION Kentucky.
QUANTITY 11 units.
REASON Blood products, which were labeled with incorrect expiration
dates, were distributed.

_______________
PRODUCT Recovered Plasma. Recall #B-095-6.
CODE Unit numbers: 24LZ35022, 24LH90208, 24LJ70875, 24LM65671,
24LJ48667, 24LC06295.
MANUFACTURER American National Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letters dated April 17, 1995. Firm-
initiated recall complete.
DISTRIBUTION Kentucky and California.
QUANTITY 6 units.
REASON Blood products, which were collected from a donor who had a
medical history of cancer, were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-096-6.
CODE Unit #25FG42573.
MANUFACTURER American Red Cross Blood Services, Syracuse, New York.
RECALLED BY Manufacturer, by telephone on August 23, 1994. Firm-
initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Blood product, which was labeled with an incorrect
expiration date, was distributed.

_______________
PRODUCT Platelets, Pheresis. Recall #B-099-6.
CODE Unit #01KP03293.
MANUFACTURER American Red Cross, Rochester, New York.
RECALLED BY Manufacturer, by letter dated February 17, 1994. Firm-
initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Blood product, untested for syphilis, was distributed.

_______________
PRODUCT Recovered Plasma. Recall #B-100-6.
CODE Unit #18M92160.
MANUFACTURER American National Red Cross, Lansing, Michigan.
RECALLED BY Manufacturer, by letter dated March 22, 1994. Firm-
initiated recall complete.

-9-DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASON Blood product, which was collected from a donor with a
medical history of cancer, was distributed.

_______________
PRODUCT Recovered Plasma. Recall #B-104-6.
CODE Unit numbers KC63586 and LP16697.
MANUFACTURER Blood Center of Central Iowa, Des Moines, Iowa.
RECALLED BY Manufacturer, by letter dated March 23, 1995. Firm-
initiated recall complete.
DISTRIBUTION Iowa, California, New York.
QUANTITY 2 units.
REASON Blood products, which were collected from a donor with a
medical history of cancer, were distributed.

_______________
PRODUCT Red Blood Cells-Irradiated. Recall #B-105-6.
CODE Unit #18Q54120.
MANUFACTURER American National Red Cross, Lansing, Michigan.
RECALLED BY Manufacturer, by facsimile on or about November 1, 1994.
Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASON Blood product, which was labeled with an incorrect
expiration date, was distributed.

_______________
PRODUCT Source Plasma. Recall #B-113-6.
CODE Unit numbers: XK9971, PK12810, XK25685, XK21754, XK19624.
MANUFACTURER Community Blood and Plasma Corporation, Louisville,
Kentucky.
RECALLED BY Manufacturer, by letter dated August 11, 1994. Firm-
initiated recall complete.
DISTRIBUTION Michigan and Austria.
QUANTITY 5 units.
REASON Blood products, collected from donors who previously tested
positive for HBsAg, were distributed.

_______________
PRODUCT Platelets. Recall #B-116-6.
CODE Unit numbers 59G30474 and 59G30530.
MANUFACTURER American National Red Cross, Flint, Michigan.
RECALLED BY Manufacturer, by telephone on March 24, 1995, followed by
letter dated March 30, 1995. Firm-initiated recall
complete.
DISTRIBUTION Michigan.
QUANTITY 2 units.
REASON Blood products, which were exposed to unacceptable shipping
temperatures, were distributed.

-10-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT A.I.M. Cancellous Locking Screws, 65 mm, used in the
surgical placement of the A.I.M. Titanium Femoral and Tibial
Nail Systems:
(a) Part No. 1030-60; (b) Part No. 1030-65;
(c) Part No. 1030-70; (d) Part No. 1030-75;
(e) Part No. 1030-80; (f) Part No. 1030-85;
(g) Part No. 1030-90; (h) Part No. 1030-95;
(i) Part No. 1030-100; (j) Part No. 1030-105;
(k) Part No. 1030-110; (l) Part No. 1030-115.
Recall #Z-142/153-6.
CODE Lot Numbers B3454, B3455, B3456, B3457, B3458, B3530, B3531,
B3532, B3533, B3534, B3535, B3536.
MANUFACTURER Ace Medical Company, El Segundo, California.
RECALLED BY Manufacturer, by letter April 21, 1992. Firm-initiated
recall complete.
DISTRIBUTION Oregon, Indiana, Illinois, New York, Austria, Japan,
Germany, Denmark, Netherlands, Belgium.
QUANTITY Firm estimates none remains on market.
REASON The 65 mm cancellous locking screws were manufactured as 60
mm, instead of the correct specification of 65 mm.

_______________
PRODUCT Screw Guide 5.5 mm, Part #1530, used in conjunction with a
Proximal Jig (part 1520) in the surgical placement of the
A.I.M. Titanium Tibial Nail. Recall #Z-154-6.
CODE Lot #C2698.
MANUFACTURER Ace Medical Company, El Segundo, California.
RECALLED BY Manufacturer, by letter February 4, 1993. Firm-initiated
recall complete.
DISTRIBUTION Tennessee, Ohio, California, Utah, Wisconsin, Texas, Italy,
Japan, Korea.
QUANTITY 120 units were distributed; firm estimates none remains on
the market.
REASON Some of the screw guides were oversized and would not fit
into the holes provided in the Proximal Jig.

_______________
PRODUCT A.I.M. Femoral Jig Adaptor, Part #1044, used in conjunction
with an Interface Jig (Part #1143) in the surgical placement
of the A.I.M. Titanium Femoral Nails. Recall #Z-155-6.
CODE Work order numbers: B101, 2212, 3374.
MANUFACTURER Ace Medial Company, El Segundo, California.
RECALLED BY Manufacturer, by letter September 21, 1992. Firm-initiated
recall complete.
DISTRIBUTION Missouri, Illinois, Florida, Louisiana, Tennessee, Oregon,
Indiana, Japan, Italy, Spain, Korea.
QUANTITY 161 units were distributed; firm estimates none remains on
the market.
REASON Some of the Jig Adaptors had damaged or broken threads
incurred during use.

-11-_______________
PRODUCT A.I.M. Tibial Nail Part #1512, components are surgically
implanted into the interior central part of the tibial bone
across a fracture or break in the bone: (a) 33.0 cm;
(b) 34.5 cm. Recall #Z-156/157-6.
CODE Lot numbers: (a) C462; (b) C464.
MANUFACTURER Ace Medical Company, El Segundo, California.
RECALLED BY Manufacturer, by telephone on April 2, 1992. Firm-initiated
recall complete.
DISTRIBUTION Texas, Florida, Tennessee, California, Missouri.
QUANTITY 49 units were distributed; firm estimates none remains on
the market.
REASON The 34.5 cm part was labeled as 33.0 cm, and vice versa.

_______________
PRODUCT A.I.M. Tibial Nail Proximal Jig, part #1520, used in the
surgical placement of the A.I.M. Titanium Tibial Nail.
Recall #Z-158-6.
CODE Lot #B2393 and C593.
MANUFACTURER Ace Medical Company, El Segundo, California.
RECALLED BY Manufacturer, by telephone February 26, 1992. Firm-
initiated recall complete.
DISTRIBUTION Pennsylvania, Texas, Florida, Tennessee, Japan, Italy.
QUANTITY 155 units were distributed; firm estimates none remains on
the market.
REASON Upon removal of the proximal jig from the rod, the sleeve
portion broke free and stayed in the rod during surgery.

_______________
PRODUCT Fischer 5 mm Half Pin, Titanium 185 mm length x 45 mm thread
length, Part #FF-10185.45, used to secure a 2/3 or 1/3
titanium ring to the ankle or femur area. Recall #Z-159-6.
CODE Lot #D919.
MANUFACTURER Ace Medical Company, El Segundo, California.
RECALLED BY Manufacturer, by letter August 3, 1993. Firm-initiated
recall complete.
DISTRIBUTION Indiana, Alabama, Japan, Korea.
QUANTITY 79 pins were distributed; firm estimates none remains on the
market.
REASON Some of the 5 mm Half Pins with part #FF-10185.45 had a
thread length of 25 mm instead of 45 mm.

_______________
PRODUCT Aerotech I Aerosol Inhalation Device, Product numbers CA-
1112, CA-1124, CA-1312, CA-1324, used with the Aerosol
Inhalation System for radioimaging in the localization and
diagnosis of lung disease. Recall #Z-160-6.
CODE Lot # 8394124, 8404124, 8414124, 8424124, 8434124, 8444124,
8454124, 8464124, 4894324, 4904324, 4914324, 4924324,
0914112, 0204312, 8323124, 0193312, 8333124, 8344124,
8354124, 4874324, 8293124, 0903112, 0183312, and 8303124.
MANUFACTURER Instrumentation Industries, Inc., Bethal Park, Pennsylvania
(component vendor).
-12-RECALLED BY CIS-US, Inc., Bedford, Massachusetts, by letters dated May
23, 1994, and June 3, 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide, Australia, Mexico, Canada.
QUANTITY 39,911 units were distributed.
REASON The "T" component cracks and could allow radioactive
contamination to exist within the shield.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
_______________
PRODUCT Dade Immunoassay Controls Comprehensive Tri-Level Kits
containing two vials each level equivalent to 5 ml each,
intended to assist in monitoring accuracy and precision in
clinical assays. Recall #Z-133/136-6.
CODE (a) Catalog No. B5700-5, Lot No. IACK-26M;
(b) Catalog No. B5700-6, Lot No. IAC1-116M;
(c) Catalog No. B5700-7, Lot No. IAC2-216M;
(d) Catalog No. B5700-8, Lot No. IAC3-316M.
MANUFACTURER Dade International, Miami, Florida.
RECALLED BY Manufacturer, by letter on October 2, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 2,450 kits were distributed.
REASON The assay values for level III Ferritin and all levels of
Estradiol were erroneous when used with the OPUS System.

_______________
PRODUCT Dade Immunoassay Controls Comprehensive Tri-Level and
Reagents, intended to assist in monitoring accuracy and
precision in clinical assay. Recall #Z-137/140-6.
CODE (a) Catalog No. B5700-05,-05A1,-S Lot No. IACK-27;
(b) Catalog No. B5700-06,-06A1 Lot No. IAC1-127;
(c) Catalog No. B5700-07,-07A1 Lot No. IAC2-227;
(d) Catalog No. B5700-08,-08A1 Lot No. IAC3-327.
Recall #Z-137/140-6.
MANUFACTURER Dade International, Miami, Florida.
RECALLED BY Manufacturer, by letter on or about September 25, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 2,450 kits were distributed.
REASOn The package inserts were incorrect in that Incstar Free T4
values were entered under Free T3 and the mean of level 1
was entered as 0.13 instead of 1.3.

_______________
PRODUCT DADE CK/LD Comprehensive Electrophoresis Control, Catalog
#B5111-1, for use in quality control of analytical and
separation procedures for enzymes, isoenzymes and proteins.
Recall #Z-141-6.
CODE Lot #LD/CK-19 EXP 1/7/97.
MANUFACTURER Dade International, Miami, Florida.
RECALLED BY Manufacturer, by letter on or about September 25, 1995.
Firm-initiated recall ongoing.
-13-DISTRIBUTION Nationwide and international.
QUANTITY 1,647 units were distributed.
REASON Incorrect Mean Value and Expected Range for Stratus CKMB
were stated in the product insert.

SAFETY ALERT
==============================================================
_______________
PRODUCT Autopheresis-C(r) Plasmapheresis System: (a) N-001-6, (b)
N-002-6; (c) N-003-6. Safety Alert #N-001/003-6.
CODE (a) Model A-200; (b) Model A-201; (c) Model A-401.
MANUFACTURER Baxter Healthcare Corporation, Largo, Florida.
ALERTED BY Baxter Healthcare Corporation, Deerfield, Illinois, by
letter issued April 13, 1995.
DISTRIBUTION Nationwide.
QUANTITY 4,633 instruments were distributed.
REASON Automated donor plasmapheresis system could possibly cause
the saline dilution of the test sample, which is used for
viral marker testing, if the operator's manual is not
followed.

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END OF ENFORCEMENT REPORT FOR NOVEMBER 29, 1995. BLANK PAGES MAY
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