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.

May 21, 1997 97-21

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ============
_______________
PRODUCT Island Oasis Frozen Strawberry Daiquiri Cocktail Mix, packed in
quart cardboard containers. Recall #F-407-7.
CODE Julian codes on or before: 2786 (ie. 2776, 2766, 2756, to 0016).
(From product produced at Florida Juice Plant). Product coded as:
2226*, 2228*, 2229*, 2232*, 2270*, 2327* (From product
produced at J.R. Wood Plant).
Note: * refers to shift code (only the first four numbers are relevant).
MANUFACTURERS Florida Juice, Lakeland, Florida; J.R. Wood, Inc., Atwater,
California.
RECALLED BY Island Oasis Frozen Cocktail Company, Inc., Walpole,
Massachusetts, by telephone on April 11, 1997, followed by fax.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 40,154 cases (12 32-ounce containers per case) were distributed.
REASON The product was processed from strawberry lots that were associated
with a March 1997 illness outbreak of hepatitis A in Michigan.

_______________
PRODUCT New West Foods brand Frozen Sliced Strawberries in 30 pound and
6.5 pound plastic pails. Recall #F-408-7.
CODE Lot numbers: 30 pound pails: NW100662, NW011573, NW011574,
N100461, N100462, N100463, N011572, N011573, and N011574;
6.5 pound pails: N072161, N072162, N072163, N072261, N072262,
N072263, N072061, N072062, and N072063.
MANUFACTURER New West Foods, Watsonville, California.
RECALLED BY Manufacturer, by telephone followed by letters sent April 1 and 2,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 89,432 30-pound containers and 26,360 6.5-pound containers were
distributed.
REASON The product was packed from strawberry lots that were associated
with a March 1997 illness outbreak of hepatitis A in Michigan.

_______________
PRODUCT (a) Frozen Strawberry Fruit Bar in 4 fluid ounce packs; (b) Frozen
Strawberry Drink Mix in 64 fluid ounce containers.
Recall #F-409/410-7.
CODE The shipping cartons have the code which is a six digit date code.
The date codes for the frozen fruit bars are: 10-07-96; 10-08-96; 10-10-96; 10-31-96 and 11-04-96. The date code for the drink mix is
10-14-96.
MANUFACTURER Natural Fruit Corporation, Hialeah, Florida.
RECALLED BY Manufacturer, telephone by telephone on or before April 16, 1997,
followed by letter. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Canada.
QUANTITY (a) 14,272 boxes (24 bars per box); (b) 172 cases (6-gallon jugs per
case) were distributed.
REASON These products were processed from one of the strawberry lots that
was associated with a March 1997 illness outbreak of hepatitis A in
Michigan.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
==========
_______________
UPDATE Medeva's (Rochester, New York) Zaroxolyn Tablets (Metolazone
Tablets USP), 2.5 unit dose, Recall #D-158-7, which appeared in the
April 23, 1997 Enforcement Report has been extended to include lot
#60750.

-2-RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Source Plasma. Recall #B-456-7.
CODE Unit #NF076782.
MANUFACTURER Sera-Tec Biologicals Limited Partnership, Nutter Fort, West
Virginia.
RECALLED BY Sera-Tec Biologicals Limited Partnership, Harrisburg, Pennsylvania,
by letter dated March 12, 1997. Firm-initiated recall complete.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported body
piercing the day prior to donation.

_______________
PRODUCT Red Blood Cells. Recall #B-457-7.
CODE Unit #4524558.
MANUFACTURER Life Source, Glenview, Illinois.
RECALLED BY Manufacturer, by telephone on January 14, 1997. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a history of hepatitis
A.

_______________
PRODUCT Cryoprecipitate AHF. Recall #B-561-7.
CODE Unit #2185159.
MANUFACTURER Central Indiana Regional Blood Center, inc., Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone on January 18, 1996. Firm-initiated
recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product had an extended expiration date.

_______________
PRODUCT Red Blood Cells. Recall #B-644-7.
CODE Unit numbers: 55H43486, 55S69176, 55H39267, 55H36074.
MANUFACTURER American Red Cross Blood Services, Little Rock, Arkansas.
RECALLED BY Manufacturer, by telephone on September 5, 1996. Firm-initiated
recall complete.
DISTRIBUTION Arkansas.
QUANTITY 4 units were distributed.
REASON Blood products tested negative for the antibody to the hepatitis C
virus encoded antigen (anti-HCV), but were collected from a donor
who previously tested repeatedly reactive for anti-HCV.
-3-_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF. Recall #B-652/653-7.
CODE Unit #21GJ69700.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated March 14, 1997. Firm-initiated recall
complete.
DISTRIBUTION California and Washington state.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of
Hodgkins Disease.

_______________
PRODUCT Red Blood Cells. Recall #B-671-7.
CODE Unit #6012121.
MANUFACTURER Southern Oklahoma Blood Institute, Ardmore, Oklahoma.
RECALLED BY Oklahoma Blood Institute, Oklahoma City, Oklahoma, by telephone
and fax on November 24, 1995. Firm-initiated recall ongoing.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who emigrated from an
area considered endemic for malaria.

_______________
PRODUCT Platelets, Pheresis. Recall #B-674-7.
CODE Unit numbers: 53GP00989, 53GP00587.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
RECALLED BY Manufacturer, by letter dated October 31, 1996. Firm-initiated recall
complete.
DISTRIBUTION Maryland.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor who traveled in an area
considered endemic for malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-675-7.
CODE Unit #7172108.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone on January 27, 1997, followed by letter
dated February 4, 1997. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had been deferred
for ear piercing within the previous 12 months.

-4-_______________
PRODUCT Red Blood Cells. Recall #B-676-7.
CODE Unit numbers: 11001932, 11001936, 11001941, 11001942,
14000273, 30000810, 30000811, 30000831, 31002929, 33001270,
33001308, 34002807, 34002815, 34002816, 34002820.
MANUFACTURER W.E. and Lela I. Stewart Blood Center, Inc., Tyler, Texas.
RECALLED BY Manufacturer, by telephone on October 29, 1996. Firm-initiated
recall complete.
DISTRIBUTION Texas.
QUANTITY 15 units were distributed.
REASON Blood products were prepared in a manner that could compromise
the sterility of the products.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma. Recall #B-677/679-7.
CODE Unit #8135810.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by letter dated January 16, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois and Switzerland.
QUANTITY 1 unit of each component.
REASON Blood products were collected from a donor who reported a history
of cancer.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma. Recall
#B-680/682-7.
CODE Unit #7461857.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by letter dated February 12, 1997. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who reported a history
of cancer.

_______________
PRODUCT Red Blood Cells. Recall #B-683-7.
CODE Unit #8530570.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacture, by letter dated February 12, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
Quantity 1 unit was distributed.
REASON Blood product was collected from a donor who reported a history of
cancer.

-5-_______________
PRODUCT Samplink Access Device, used during the blood donation process to
obtain a sample of the donors blood from the bloodline.
Recall #B-684-7.
CODE Catalog #4R4215. All lots.
MANUFACTURER Migada Ltd., Kiryat Shmona, Israel.
RECALLED BY Migada, Inc., Englewood Cliffs, New Jersey, by letters dated March
10 and 12, 1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 1,800,000 units were distributed.
REASON When the latex cover is being retracted down past the lip that holds
the cover onto the needle, the lip then prevents the latex cover from
sliding back into place when the vacuum tube is removed from the
needle. This leaves the needle unsealed, allowing blood to leak from
the tip of the needle. Also, the needle is puncturing the side of the
latex cover. This leaves the needle unsealed, allowing blood to leak
from the tip of the needle.

_______________
PRODUCT Red Blood Cells. Recall #B-685-7.
CODE Unit numbers: 53FQ38126, 53GQ39718, 53GZ77973, 53GZ77977,
53GE04251, 53GE04252, 53GE04254, 53FC47822, 53FJ27576,
53GN84210, 53GZ78681.
MANUFACTURER American Red Cross, Baltimore, Maryland.
RECALLED BY Manufacturer, by telephone on July 7, 13, 14, 18, 1995, and by
letters dated July 27, August 2, 24, and 28, 1995. Firm-initiated
recall complete.
DISTRIBUTION Maryland, Pennsylvania, District of Columbia.
QUANTITY 11 units were distributed.
REASON Blood products carried an extended expiration date due a computer
error.

_______________
PRODUCT (a) Red Blood Cells; (b) Red Blood Cells, Leukocyte free; (c)
Platelets; (d) Recovered Plasma. Recall #B-686/689-7.
CODE Unit numbers: (a) 152-9633, 214-6277, 300-2130, 300-2452, 300-2620, 300-2782, 300-3050, 300-3902, 300-4349, 300-4856, 300-5616, 321-0134, 321-0436, 321-2456, 321-4277, 321-4907, 321-7307;

-6- (b) 300-4267, 300-4279, 300-4810, 300-4528, 300-4832, 300-5436,
300-5625, 300-5636, 300-5714, 300-5734; (c) 152-9633, 300-2782,
300-4279, 300-4528, 300-4922, 300-5636, 300-5714, 300-5734; (d)
152-9633, 214-6277, 321-2456, 321-4277, 321-4907, 321-7307.
MANUFACTURER Sylvan N. Goldman Center, Doing business as Oklahoma Blood
Institute, Oklahoma City, Oklahoma.
RECALLED BY Manufacturer, by fax on September 3-5, 1996, followed by letter
dated February 24, 1997. Firm-initiated recall complete.
DISTRIBUTION Oklahoma, Massachusetts, Rhode Island, Texas, Switzerland.
QUANTITY (a) 17 units; (b) 10 units; (c) 8 units; (d) 6 units were distributed
REASON Blood products were mistakenly collected from permanent deferred
donors and inappropriately released.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma. Recall
#B-690/692-7.
CODE Unit #1890155.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by letter dated March 10, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component.
REASON Blood products were collected from a donor who reported a history
of cancer.

_______________
PRODUCT Red Blood Cells. Recall #B-694-7.
CODE Unit #9746022.
MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center,
Cincinnati, Ohio.
RECALLED BY Manufacturer, by letter dated November 20, 1996. Firm-initiated
recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported emigrating
from an area considered endemic for malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-695-7.
CODE Unit #21GF94751.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
RECALLED BY Manufacturer, by telephone on January 23, 1997. Firm-initiated
recall complete.
DISTRIBUTION Washington state.
-7-QUANTITY 1 unit was distributed.
REASON Blood product had a satellite bag attached in a manner that could
compromise the sterility of the product.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma. Recall
#B-696/698-7.
CODE Unit #8406414.
MANUFACTURER Community Blood Centers of South Florida, Inc., Lauderhill, Florida.
RECALLED BY Manufacturer, by fax or by telephone on February 13, 1995. Firm-initiated recall complete.
DISTRIBUTION Florida, New York, Massachusetts.
QUANTITY 1 unit of each component.
REASON Blood products tested negative for the antibody to the human
immunodeficiency virus type 2 (anti-HIV-2), but was collected from
a donor who previously tested initially reactive for anti-HIV-2.

_______________
PRODUCT (a) Red Blood Cells; (b) Red Blood Cells - Leukocytes Reduced; (c)
Platelets; (d) Fresh Frozen Plasma. Recall #B-699/702-7.
CODE Unit numbers: (a) 8472505, 8472511, 8472517, 8472552; (b)
8472484; (c) 8472484, 8472505, 8472511, 8472517, 8472552; (d)
8472484, 8472505, 8472511, 8472517, 8472552.
MANUFACTURER Community Blood Centers of South Florida, Inc., Lauderhill, Florida.
RECALLED BY Manufacturer, by fax or telephone between May 23-26, 1995. Firm-initiated recall complete.
DISTRIBUTION Florida and New York.
QUANTITY (a) 4 units; (b) 1 unit; (c) 5 units; (d) 5 units were distributed.
REASON Blood products, corresponding to Platelets which were contaminated
with a gram negative bacteria suspected to be Serratia marcescens,
were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Red Blood Cells. Recall #B-458-7.
CODE Unit #3551326.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by telephone on February 21, 1997. Firm-initiated
recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.

-8-REASON Blood product was labeled with an extended expiration date.

_______________
PRODUCT (a) Coulter HIV-1 p24 Antigen Neutralization Kit; (b) Coulter
HIV-1 p24 Antigen Assay; (c) Coulter HIV-1 p24 Antigen ELISA
Test System.
Recall #B-564/566-7.
CODE All lots,
MANUFACTURER Coulter Corporation, Miami, Florida.
RECALLED BY Manufacturer, by letter February 10, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 25,187 kits were distributed.
REASON The reconstituted Positive Antigen Reagent product may not remain
stable over the period indicated in the product labeling.

_______________
PRODUCT Red Blood Cells. Recall #B-641-7.
CODE Unit #2669075.
MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas.
RECALLED BY Manufacturer, by fax on February 15, 1995. Firm-initiated recall
complete.
DISTRIBUTION Texas and Florida.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for the antibody to the hepatitis C
virus encoded antigen (anti-HCV), but was collected from a donor
who previously tested repeatedly reactive for the anti-HCV.

_______________
PRODUCT Blood Transfer Bag (150 ml Quad Set with attached 600 ml bag).
Recall #B-664-7.
CODE Catalog #T3605, Lot #954045.
MANUFACTURER CharterMed, Inc., Lakewood, New Jersey.
RECALLED BY Manufacturer, by telephone followed by letter on December 29,
1995. Firm-initiated recall complete.
DISTRIBUTION Indiana, New York, Virginia.
QUANTITY 1,848 units were distributed.
REASON Improper assembly of blood collection bags resulted in unrestricted
blood flow into the wrong blood bag.

_______________
PRODUCT Red Blood Cells. Recall #B-693-7.
CODE Unit numbers: 53Y64165, 53LN09976, 53LN09977, 53F08187,
53F08186.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
-9-RECALLED BY Manufacturer, by telephone on July 26, 1996. Firm-initiated recall
complete.
DISTRIBUTION Maryland.
QUANTITY 5 units were distributed.
REASON Blood products were labeled with an extended expiration date.

_______________
PRODUCT Red Blood Cells, Irradiated. Recall #B-717-7.
CODE Unit 29442-3339.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by letter dated March 4, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product was held at an unacceptable temperature and was
released for distribution.

_______________
PRODUCT Platelets, Pheresis. Recall #B-719-7.
CODE Unit numbers: LP11046-P51, LP11046-P52, LP11049-P51,
LP11049-P52, LP11052-P51, LP11052-P52, LP11058-P52,
LP11064-P52, LP11068-P51, LP11068-P52.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
RECALLED BY Manufacturer, by telephone on September 9, 1996. Firm-initiated
recall complete.
DISTRIBUTION Missouri.
QUANTITY 10 units.
REASON Unlicensed blood products were distributed, labeled with the firm's
license number.

_______________
PRODUCT Platelets, Pheresis. Recall #B-720-7.
CODE Unit #03FH05603.
MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone on December 16, 1996. Firm-initiated
recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product was stored at an unacceptable temperature.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets.
Recall #B-723/724-7.
CODE Unit #9316269.
MANUFACTURER Florida Blood Services, Inc., St. Petersburg, Florida.
RECALLED BY Manufacturer, by telephone/orally on May 9, 1996. Firm-initiated
recall complete.
-10-DISTRIBUTION Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the antibody to the hepatitis B
core antigen (anti-HBc), but were collected from a donor who
previously tested repeatedly reactive for anti-HBc.

_______________
PRODUCT Fraction IV-1 Paste (Plasma Fraction Intermediate). Recall #B-744-7.
CODE Lot #963002.
MANUFACTURER V.I. Technologies, Inc. (VITEX), also konwn as Melville
Biologicals, Inc., Melville, New York.
RECALLED BY Manufacturer, by telephone on August 23, 1996, followed by letter
on March 25, 1997. Firm-initiated recall ongoing.
DISTRIBUTION North Carolina.
QUANTITY 42.1kg was distributed.
REASON Fractionated products with detectable levels of ethylene glycol were
distributed.

.RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =========
_______________
PRODUCT Vacutainer brand Lok-on Needle Disposal Container, designed to
lock the needle and needle holder onto the container.
Recall #Z-462-7.
CODE Catalog #366223, involve Lot #'s 5H602, 5H603, 5J604, 5J605,
5J606, 5K600, 5L600, 5L601, 5L602, 5M600, 6A600, 6A601,
6A602, 6C600, 6C601, 6D602, 6D603, 6E600, 6E601, 6F601.
MANUFACTURER Becton Dickinson Vacutainer Systems, Sumter, South Carolina.
RECALLED BY Becton Dickinson Vacutainer Systems, Franklin Lakes, New Jersey,
by letters on October 21 and 31, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 58,350 units were distributed.
REASON The device to be adulterated in that some of the containers have been
manufactured with a defective needle removal device (blue insert)
which may break, causing the needle holder to permanently lock to
the container.

_______________
PRODUCT BMW Clampless Valved Venous Catheters:
(a) Clampless Valved Catheter-Tunneled
(CVC-T ) Catalog Nos.: CVC421 CO, CVC421 1K, CVC661
CO,CVC661 1K, CVC961 CO, CVC961 1K;

-11- (b) Clampless Valved-PICC (CV-PIC) Catalog Nos.: PIC401 1K,
PIC501 1K;
(c) Clampless Valved Midline-Catheter (CV-MLC) Catalog
Number: MLC401 1K.
Recall #Z-466/468-7.
CODE All lots.
MANUFACTURER BMW Medical Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by letter on April 2, 1997, followed by fax on April 8,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, California, Colorado, Indiana, New Jersey, Massachusetts,
Maryland, Michigan, Missouri, Pennsylvania, South Carolina, Texas,
Washington state.
QUANTITY 53 cases (10 units per case) were distributed.
REASON The catheters have potentially defective molded female hubs which
can result in a crack developing after repeated cleaning with alcohol.

_______________
PRODUCT Diagnostic X-Ray System - CompuGen Systems, used for general
purpose radiography:
(a) Model No. WWG0301 X-Ray Control Console;
(b) Model No. WWG0302 Power Unit;
(c) Model No. WWG0303 High Voltage Generator;
(d) Model No. WWG0310 Under/Over Power Unit;
(e) Model No. WWG4001 X-Ray Control Console;
(f) Model No. WWG4002 Power Unit;
(g) Model No. WWG4003 High Voltage Generator;
(h) Model No. WWG4010 Under/Over Power Unit;
(i) Model No. WWG0351 X-Ray Control (50 hz);
(j) Model No. WWG0352 Power Unit (50 hz);
(k) Model No. WWG0350 Under/Over Power Unit (50 hz);
(l) Model No. WWG4051 X-Ray Control Console (50 hz);
(m) Model No. WWG4052 Power Unit (50 hz);
(n) Model No. WWG4050 Under/Over Power Unit (50 hz). Recall
#Z-517/530-7.
CODE See Model numbers above.
MANUFACTURER Wuestec Medical, Inc., Mobile, Alabama.
RECALLED BY Manufacturer. FDA approved the firm's corrective action plan on
May 9, 1997. Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY All units manufactured prior to March 26, 1996.

-12-REASON The diagnostic x-ray devices were found noncompliant with 21 CFR
1010.2 AND 1010.3 of the Federal Performance Standard for
Diagnostic X-Ray System and Their Major Components. Some of
the devices were improperly identified and certified to the diagnostic
x-ray standard.

_______________
PRODUCT Mobile Radiographic Systems, intended for portable use in making
film radiographs in a hospital environment:
(a) Lorad Model RT 125 OEM, Serial Nos. 38001-380068;
(b) Philips Model X-Ray 2000, Serial Nos.
1500496001-1500397027;
(c) Philips PRACTIX 2000;
(d) Bennet HMX (High Frequency Mobile Radiographic System),
Model HMX-5, Serial Nos. 94-37-001 through 96-37-467.
Recall #Z-550/553-7.
CODE Devices manufactured prior to October 1996. (See serial numbers
above).
MANUFACTURER Lorad Corporation, Danbury, Connecticut.
RECALLED BY Manufacturer, by letter on April 14, 1997. Firm-initiated field
correction ongoing.
DISTRIBUTION Nationwide.
QUANTITY 70 Lorad RT 125 units; 491 Philips-200/PRACXTIX units; and 22
Bennet HMX-5 units were distributed.
REASON The radiographic units may be subject to unanticipated movement.

_______________
PRODUCT Vitros Hb DT Slides, used to measure the concentration of
hemoglobin in blood.
Recall #Z-563-7.
CODE Vitros Hb DT Slides, Catalog No. 125 1453,
GEN 75 - All lots starting with 2175-00052-xxxx,
GEN 76 - All lots starting with 2176-00056-xxxx;
GEN 77 - All lots starting with 2177-00057-xxxx.
MANUFACTURER Johnson & Johnson Clinical Diagnostics, Inc., Rochester, New York.
RECALLED BY Manufacturer, by letter dated March 31, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 23,520 boxes (25 slides per box) were distributed.

-13-REASON The hemoglobin results were biased to the reference method.

_______________
PRODUCT Kendall Curity Spinal Anesthesia Tray, sterile, Reorder #4761.
Recall #Z-566-7.
CODE Lot #AD8372KG.
MANUFACTURER Especialidades Medicas Kenmex, Tiajuana, Mexico.
RECALLED BY Kendall Healthcare Products Company, Mansfield, Massachusetts, by
telephone on April 7, 1997, followed by letter dated April 8, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Alabama, California, Georgia, Mississippi.
QUANTITY 310 units were distributed.
REASON The tray contained Xylocaine MPF 5% with Glucose 7.5%, 2 ML
instead of Bupivacaine Hydrochloride 0.75 with Dextrose 8.25%,
2ML.

_______________
PRODUCT Sentry Medical Products Heparin-Bonded Polyurethane Umbilical
Vessel Catheters and Trays with Catheters:
(a) 3.5 F Heparin-Bonded Polyurethane Catheter, Reorder Nos.
15000350 and MC0040;
(b) 5.0 F Heparin-Bonded Polyurethane Catheter, Reorder Nos.
1500500 and MC00050;
(c) Insertion Tray with Catheter (3.5 F), Reorder Nos. 1502350 and
MT00010;
(d) Insertion Tray with Catheter (5.0 F), Reorder Nos. 1502500 and
MT00020.
Recall #Z-567/570-7.
CODE Sentry LTP Sentry LTP
p/n p/n lot # lot #
1500350 MC0040 056649 904641
056413 904640
055544 904478
056695 904764
1500500 MC00050 055554 904697
055553 904731
055559 904765
057396 904826
1502350 MT00010 055550 904639
055549 904636
055525 904444
056764 904698
056414 904763
1502500 MT00020 055555 904699
055556 904724
055556 904725
055560 904761
057213 904829.
-14-MANUFACTURER Kendall Sheridan, Argle, New York.
RECALLED BY Ludlow Technical Products, Chicopee, Massachusetts, by telephone
on April 15, 1997, followed by letter issued April 24, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 245 cases were distributed.
REASON The lumens of the catheters are occluded by Benzalkonium Heparin
Coating and cannot flush correctly.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Comfortec Disposable pH Probes, used for monitoring pH levels in
the esophagus.
Recall #Z-571-7.
CODE Catalog numbers: NIS, NID5, NID10, NID15, NID21, IIS, IID5,
IID10, IID15, IID21.
Lot numbers: 1996 Lots: 601, 602, 603, 604, 605, 606, 607, 608,
609, 610, 611, 612.
1997 Lots: 701, 702, 703, 704.
MANUFACTURER Alpine Biomed Corporation, Santa Ana, California.
RECALLED BY Sandhill Scientific, Inc., Highlands Ranch, Colorado, by letter sent on
April 29, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 400-500 probes remained at customer locations
at time of recall initiation.
REASON A precipitate may form on the probe connector leads and break the
signal path between the probe and the data logger, resulting in loss of
signal.

_______________
PRODUCT All-in-One Laparoscopic Hand Control,
Catalog #0055. Recall #Z-582-7.
CODE Lot #2400.
MANUFACTURER MegaDyne Medical Products, Inc., Draper, Utah.
RECALLED BY Manufacturer, by fax on August 19, 1996, followed by letter on
August 20, 1996. Firm-initiated recall complete.
DISTRIBUTION California, Colorado, Florida, Georgia, Kentucky, Louisiana,
Massachusetts, Minnesota, Missouri, Montana, Ohio, Pennsylvania,
Texas, Virginia, and international.
QUANTITY 825 units were distributed.

-15-REASON Device was distributed and labeled as "E-Z CLEAN 2.5" BLADE
ELECTRODE FOR ALL-IN-ONE HANDLE, Catalog No. 0066",
instead of the correct identification, "ALL-IN-ONE
LAPAROSCOPIC HAND CONTROL, Catalog No. 0055".

RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III ==========
_______________
PRODUCT Vigortone VigorGlo 22 CTC Milk Replacer Medicated,
(chlortetracycline) for aid in the prevention of bacterial calf diarrhea.
Recall #V-038-7.
CODE Lot numbers: 7B06H15, 7B06H14, 7B13H08, 7B20H10, 7B28H11,
7C07H09, 7C10H02-06, 7C11H09, 7C13H14, 7C24H50.
MANUFACTURER Milk Specialties Company, Dundee, Illinois.
RECALLED BY Manufacturer, by telephone on April 4 and 8, 1997. Firm-initiated
recall complete.
DISTRIBUTION Iowa, Nebraska, Ohio.
QUANTITY 1,867 50-pound bags were distributed.
REASON Product was mislabeled -- 1,500 bags were mislabeled to contain 150
g/ton chlortetracycline instead of 20 g/ton chlortetracycline.

MEDICAL DEVICE SAFETY ALERTS: ==============================
_______________
PRODUCT 3M Sarns Sternal Saw II System, used during chest surgery. Safety
Alert #N-014-7.
CODE Part #98-0702-0597-0.
MANUFACTURER 3M Health Care, Ann Arbor, Michigan.
ALERTED BY Manufacturer, by letter of April 24, 1997.
DISTRIBUTION Nationwide and international.
QUANTITY Undetermined.
REASON Use of Komet Medical's KM-278 and KM-278N blades are not to be
used with the 3M Starns Sternal Saw II System, because they are not
suitable replacement for the 3M Sarns 5589 and 5755 blades, as
specified by Komet Medical. These blades do not fit into the chuck
properly and may not stay attached to the saw and be expelled during
use.

-16-

END OF ENFORCEMENT REPORT FOR MAY 21, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for