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
05/15/1996

ENFORCEMENT REPORT FOR 05/15/1996

May 15, 1996 96-20

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Animal Crackers and Animal Grahams:
(a) Animal Crackers in 11 oz. boxes (Royal
Crest, Funanimals, and Jungle Jammers brands)
(b) Animal Grahams in 1 oz. bags
(c) Animal Crackers in 15 lb. bulk cases
(Danish Delight brand). Recall #F-524/526-6.
CODE Lot numbers:
Royal Crest brand Animal Crackers: 11116P,
11126P, 11136P, 11166P, 11686P, 11706P,
11716P, 12116P, 12126P, 12516P, 12616P,
12806P, 12816P, 12936P
Funanimals brand Animal Crackers: 12516P and
12616P
Jungle Jammers brand Animal Crackers:
17FEB96AP, 18FEB96AP, 24FEB96AP, 25FEB96AP,
18APR96AP, 16APR96AP, 06MAY96AP, 27MAY96AP,
28MAY96AP, 29MAY96AP, 15JUN96AP, 17JUL96AP,
05AUG96AP, 06AUG96AP
Animal Grahams: 20MAR96AP, 25MAR96AP,
28MAR96AP, 29MAR96AP, 01APR96AP, 03APR96AP,
04APR96AP, 07APR96AP, 09APR96AP, 10APR96AP,
11APR96AP, 14APR96AP, 15APR96AP, 16APR96AP,
20AUG96AP, 21AUG96AP, 22AUG96AP, 26AUG96AP,
09SEP96AP, 10SEP96AP, 11SEP96AP, 12SEP96AP,
19SEP96AP, 20SEP96AP, 22SEP96AP, 23SEP96AP,
24SEP96AP
Danish Delight brand Animal Crackers:
06JUL96AP, and 27JUL96AP.
MANUFACTURER Imperial Baking Company, St. Louis, Missouri.
RECALLED BY Consolidated Biscuit Company, McComb, Ohio, by
press release issued on March 13, 1996,
followed by letter March 14, 1996. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY (a) 27,000 cases (12 boxes per case); (b)
4,394 cases (150 bags per case); (c) 270 cases
were distributed.
REASON Products contain undeclared egg whites.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Hydrox Fresh Moment Alcohol Free Mouthwash in
2, 4, and 32 fluid ounce bottles:
(a) Mouthwash, yellow formulation, under
"Hydrox Fresh Moment Alcohol Free" label
(b) Mouthwash, blue formulation, under "Hydrox
Fresh Moment Alcohol Free" and "Medline
Mouthwash (Non-Alcoholic)" labels.
Recall #F-503/504-6.
CODE All lots produced between August 31, 1995 and
January 26, 1996, lot numbers 10026 through
10410.
MANUFACTURER Hydrox Chemical Company, Elgin, Illinois.
RECALLED BY Manufacturer, by telephone on February 2, 22,
23, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 98,212.5 gallons were distributed; firm
estimated that 3,000 gallons remained on
market at time of recall initiation.
REASON Products are contaminated with Pseudomonas
cepacia.

_______________
PRODUCT Ceramicware from various manufacturers:
(a) Small, green, ribbed compote
(b) Pasta bowls, confetti pattern, multi
colored
(c) Le Cirque ("The Circus") theme dessert
plates, six different designs

-2- (d) Olive green, footed bowls, 7" diameter
(e) Dit-Dash Cachepot (pitcher).
Recall #F-509/513-6.
CODE None.
MANUFACTURERS Ceramiche Estensi s.p.a. (doing business as:
Este CE), Italy; Susan Eslick Custom Ceramics,
San Francisco, California; Manufacture de
Luneville, Paris, France; Square One, Tampa,
Florida; Jill Rosenwald Ceramic Designs,
Somerville, Massachusetts.
RECALLED BY Gump's, Inc., San Francisco, California, by
letters mailed on or about September 18, 1995.
Firm-initiated recall complete.
DISTRIBUTION Illinois, California, Florida, Texas,
Delaware, Oregon.
QUANTITY Firm estimates none remains on the market.
REASON Products contained excessive levels of
leachable lead.

_______________
PRODUCT Various flavored carbonated soft drinks:
(a) Orange India in 11.27 fluid ounce aluminum
cans and 2.0 Liters, plastic bottles
(b) China Sonny in 11.27 fluid ounce aluminum
cans; (c) Sunny Isles in 11.27 fluid ounce
aluminum cans. Recall #F-516/518-6.
CODE Lot numbers - 50495, 60595, 62295, 80495,
91995, 92295, 101395, 110795, 122795, 32595.
MANUFACTURER Cerveceria India, Inc., Mayaguez, Puerto Rico.
RECALLED BY Manufacturer, by visit. Firm-initiated recall
complete.
DISTRIBUTION Puerto Rico.
QUANTITY 4,858 cases (24 cans per case) and 11,492
cases (6 bottles per case) were distributed.
REASON Products contain undeclared FD&C Yellow No. 5
but are labeled as containing FD&C Yellow
No. 6.

_______________
PRODUCT Ice Cream and Sherbet sold in pints, half
gallon and 3-gallon tubs:
(a) Mint Chocolate Chip; (b) Pistachio; (c)
Orange Sherbet; (d) Vanilla; (e) French
Vanilla. Recall #F-519/523-6.
CODE There are no lot numbers used on the 1 pint
and 1/2 gallon containers. Three-gallon tubs
with lot numbers of C31 or lower are subject
to recall.
MANUFACTURER Purity Ice Cream Company, Ithaca, New York.
RECALLED BY Manufacturer, by letter dated April 4, 1996.
Firm-initiated recall complete.
DISTRIBUTION New York, Vermont.

-3-QUANTITY 1,979 3-gallon tubs; 22,641 1/2 gallon
containers; 6,832 pint containers were
distributed. All in-house product has been
corrected.
REASON Product contained undeclared FD&C Yellow
No. 5.

_______________
PRODUCT Wallabeans, peach flavored, jellybean type
confection, in 10 ounce boxes.
Recall #F-505-6.
CODE None. All misbranded product.
MANUFACTURER Marich Confectionery Company, Watsonville,
California.
RECALLED BY Manufacturer, by letter dated November 16 and
20, 1995. Firm-initiated recall complete.
DISTRIBUTION Georgia, New York, California.
QUANTITY 6 cases were distributed.
REASON Product contained undeclared FD&C Yellow
No. 5.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Wallabeans, jellybean type confection, in 10
ounce boxes:
(a) Wild Cherry Flavored; (b) Licorice
Flavored. Recall #F-506/507-6.
CODE None. All misbranded product.
MANUFACTURER Marich Confectionery Company, Watsonville,
California.
RECALLED BY Manufacturer, by letter dated November 16 and
20, 1995. Firm-initiated recall complete.
DISTRIBUTION Georgia, New York, California.
QUANTITY (a) 20 cases; (b) 9 cases were distributed.
REASON The wild cherry flavor contains undeclared
FD&C Red No. 40; and the licorice flavor is
labeled with the name and ingredient statement
for the peach flavor product.

_______________
PRODUCT Processed (cooked) Backfin Crabmeat.
Recall #F-508-6.
CODE 2/28/96 Backfin.
MANUFACTURER NED Enterprises, Inc., doing business as Gulf
Crab Company, Des Allemands, Louisiana.
RECALLED BY Manufacturer, by telephone and
letter/facsimile on March 5, 1996. Firm-
initiated recall complete.
DISTRIBUTION Louisiana.
QUANTITY 120 pounds were distributed.
REASON Product is contaminated with E. coli.

-4-RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS III ======
_______________
PRODUCT Styling and sculpting gel:
(a) White Rain Styling Gel, net weight 5
ounces; (b) White Rain Exotics Sculpting Gel,
net weight 5 ounces. Recall #F-514/515-6.
CODE (a) Shipper code 8351V; (b) Shipper code
5509V.
MANUFACTURER The Gillette Company, Andover, Massachusetts.
RECALLED BY The Gillette Company, Boston, Massachusetts,
by telephone on April 18, 1996, followed by
letter. Firm-initiated recall ongoing.
DISTRIBUTION Illinois, New York, North Dakota, Ohio, Iowa,
California.
QUANTITY (a) 2,000 cases; (b) 34 cases were
distributed.
REASON The products are packaged in containers with
the incorrect ingredient statement.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Medline Epi-Clenz Instant Antiseptic Hand
Cleanser, an OTC liquid for handwashing to
decrease bacteria on the skin.
Recall #D-136-6.
CODE Lot #5354A.
MANUFACTURER Polychem Corporation, New Haven, Connecticut.
RECALLED BY Medline Industries, Inc., Mundelein, Illinois,
by letter dated April 20, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 297 cases were distributed; firm estimated
that 25 percent of product remained on market
at time of recall initiation.
REASON Some bottles were mislabeled as TLC Mouth
Rinse.

_______________
PRODUCT CO2 Compressed Gas. Recall #D-137-6.
CODE Lot numbers: 0940031396 1440041596
1040032196 0541031596 1040032596
0541040296 1240040396 1340040896
MANUFACTURER MG Industries, Inc., Malvern, Pennsylvania.
RECALLED BY Manufacturer, by letter April 23, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Pennsylvania, Maryland, West Virginia,
Virginia, Tennessee, Kentucky, Georgia, North
Carolina, New Jersey, Bermuda.
QUANTITY Undetermined.
REASON Presence of trace quantities of HCN (hydrogen
cyanide).

-5-_______________
PRODUCT Carbon Dioxide USP, 50 pound and 7 pound
cylinder capacity. Recall #D-138-6.
CODE Lot numbers beginning with the prefix "CLT" or
"CFX" and have "96" as the fifth and sixth
numerals in the numeric portion of the lot
number.
MANUFACTURER Sunox, Inc., Charlotte, North Carolina
(repacker).
RECALLED BY Repacker, by letter sent on May 2, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION North Carolina, Virginia.
QUANTITY Approximately 1,200 cylinders (50 pound
capacity) and 159 cylinders (7 pound capacity)
were produced.
REASON Presence of trace quantities of HCN (hydrogen
cyanide).

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Cytarabine Injection 20 mg/ml -- 1000mg/50ml;
Cytarabine Injection 20 mg/ml -- 100mg/5ml, Rx
drug for IV or subcutaneous use.
Recall #D-133-6.
CODE Lot # EXP Date.
5201994 07/97
5211994 11/97
5201979 07/97
5211979 11/97
5221979 11/97.
MANUFACTURER Faulding Pharmaceutical Company, David Bull
Laboratories, Mulgrave, Victoria 3170,
Australia.
RECALLED BY Faulding Pharmaceutical Company (Purepac),
Elizabeth, New Jersey (responsible firm), by
letter dated March 8, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 32,400 bottles were distributed; firm
estimated that 50-60 percent of product
remained on market at time of recall
initiation.
REASON Particulate matter formation (Calcium and
Silicate).

_______________
PRODUCT Barre-National (a) Bromanate Elixir in 4 ounce
bottles, OTC decongestant/antihistamine, under
the Albertsons and Janet Lee labels;

-6- (b) Tussex Cough Syrup, in 4 ounce bottles,
OTC cough syrup, cough suppressant, nasal
decongestant, expectorant, under the Moore and
Major labels. Recall D-134/135-6.
CODE (a) Lot VJ3443, EXP 8/22/96 and VF3262, EXP
7/21/96; (b) Lot RF4329, EXP 6/13/97 and
RP3864, EXP 3/8/97.
MANUFACTURER Barre-National, Inc., Baltimore, Maryland.
RECALLED BY Manufacturer, by letter sent on April 26,
1996. Firm-initiated recall ongoing.
DISTRIBUTION California, Connecticut, Florida, Michigan,
Texas.
QUANTITY Firm estimates none remains on the market.
REASON Product labeling not in accord with OTC
monograph (missing warning statement).

_______________
UPDATE Recall #D-036-6, SoloPak Sodium Chloride
Injection USP, 0.9% which appeared in the
December 13, 1995 Enforcement Report has been
extended as follows: 5 ml vials: lot numbers
950330, 950741, 951033, 950330, 950741,
951033; 10 ml vials: lot numbers 940923,
940960, 940973B, 941043, 941143, 950162,
950438, 950643, 950646, 950723, 950746,
950805, 950805B, 950834, 950917, 951053,
951056.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Platelets. Recall #B-393-6.
CODE Unit #29133-2740.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on February 12,
1996. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, prepared from a unit of Whole
Blood designated as a "difficult" collection,
was distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Red Blood Cells. Recall #B-366-6.
CODE Unit numbers: 29132-9813, 29133-3453.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone on February 8,
1996, followed by letter dated February 14,
1996. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 2 units.
-7-REASON Red Blood Cells, stored at room temperature
for an unknown amount of time, were
distributed.

_______________
PRODUCT Recovered Plasma. Recall #B-395-6.
CODE Unit #40GH09296.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by letter dated October 30,
1995. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, corresponding to a unit of Red
Blood Cells implicated in a febrile
transfusion reaction, was distributed.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT Sterile Intravenous Administration IV Sets
with 1.2 Micron Air Eliminating Filter and
Injection Sites: (a) Catalog No. CC1385-
Clave Needle Free Extension Set with 1.2
Micron Air Eliminating Filter and Clave
Injection Site;
(b) Catalog No. NF1385- Safeline Extension Set
with 1.2 Micron Air Eliminating Filter and
Injection Site;
(c) Catalog No. NF3155- 15 Drops/ml Safeline
Horizon Pump Primary Additive IV Set with 1.2
Micron Filter and 3 Injection Sites;
(d) Catalog No. V1716- 15 Drops/ml Vented IV
Set with 1.2 Micron Filter and Injection Site;
(e) Catalog No. V5812- Add-On Set with 1.2
Micron Air Eliminating Filter and Injection
Site; (f) Catalog No. V7112- Intelligent Pump
Primary Additive IV Set with 1.2 Micron
Filter; (g) Catalog No. V7412- 15 Drops/ml
Horizon Pump Primary Additive IV Set with 1.2
Micron Filter and 3 Injection Sites.
Recall #Z-640/646-6.
CODE All lot numbers where the first 2 digits are
F3, F4, or F5.
MANUFACTURER McGaw of Puerto Rico, Inc., Sabana Grande,
Puerto Rico.
RECALLED BY McGaw, Inc., Irvine, California, by letter on
January 19, 1996; firm estimated that little,
if any, product remained on market at time of
recall initiation. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Canada.

-8-QUANTITY 21,145 cases (895,324 units) were distributed.
REASON An inadequate bond/design may cause
tube/filter separation, resulting in leakage.

_______________
PRODUCT TanFit 24 Suntanning Bed. Recall #Z-724-6.
CODE Serial Numbers: 00800002-00800009,
00800010-00800016, 00800018-00800027,
00800032-00800044.
MANUFACTURER Puretan International/Asterisk, Inc., Dallas,
Texas.
RECALLED BY Manufacturer, by letter November 14, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 38 units.
REASON Eighteen (18) gauge wire was used in the
timers in lieu of 12 gauge which caused the
timers to shut the lamps off prematurely.

_______________
PRODUCT Lumin Laparoscopic Uterine Manipulator
Injector, Catalog #MIS-100, used for
manipulation of the uterus during diagnostic
and surgical procedures. Recall #Z-727-6.
CODE Lot numbers 60283-1 and 60283-2.
MANUFACTURER Utah Medical Products, Inc., Midvale, Utah.
RECALLED BY Manufacturer, by letter on March 25, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Arizona, California, Indiana, Kansas, Maine,
Michigan, Tennessee, Texas, Virginia, and
international.
QUANTITY 305 units were distributed.
REASON The sterility of the device may be compromised
due to loss of package integrity.

_______________
PRODUCT Puritan Bennett 7200 Series Ventilators,
indicated for delivery of gas to patients
dependent on artificial respiration:
(a) Model No. 7200 shipped domestically;
(b) Model No. 7200e shipped domestically;
(c) Model No. 7200ae shipped domestically;
(d) Model No. 7200e shipped internationally
(e) Model No. 7200spe shipped internationally.
Recall #Z-742/746-6.
CODE 2,987 ventilators, each with its own unique,
non-sequential serial number.
MANUFACTURER Nellcor Puritan Bennett (NPB), Carlsbad,
California.
RECALLED BY Manufacturer, by letter dated October 2, 1995.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.

-9-QUANTITY 2,987 units were distributed.
REASON Device contains a defective pressure
transducer, causing it to stop ventilation at
set parameters.

_______________
PRODUCT BioStar Strep A OIA Test, intended for in-
vitro diagnostic use as an aid in the
diagnosis of group A streptococcal
pharyngitis: (a) Catalog No. GAS30 for the 30
Test Kits; (b) Catalog No. GAS100 for the 100
Test Kits. Recall #Z-748/749-6.
CODE Lot numbers: (a) 45031, 45198, 46141, 47133,
48034, 48105/7, 49229, 49238, 50060/1, 51013,
51054; (b) 44097, 45008, 45032, 45065, 46032,
46011, 46140, 46230, 47021/9, 48100/4, 48189,
48206, 49082/4, 49227/8, 50001, 50058/9,
50177, 50259, 51051/3, 51147/8.
MANUFACTURER BioStar, Inc., Boulder, Colorado.
RECALLED BY Manufacturer, by letter April 18, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Firm estimates 125,000 test devices or
approximately 1,250 100-test kits were
distributed.
REASON The test kits may produce false positive
results when performed at the maximum assay
times stated in the package insert.

_______________
PRODUCT Action Cat brand Power Scooter, Three-Wheeled
Wheel Chair: (a) Cat Traditional; (b) Cat
Aviation. Recall #Z-750/751-6.
CODE (a) All Serial Numbers Beginning With 95F-95L;
(b) All Serial Numbers Beginning With 96A.
MANUFACTURER Invacare Corporation, Elyria, Ohio.
RECALLED BY Manufacturer, by letter dated January 19,
1996. Firm-initiated field correction
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 671 scooters were distributed.
REASON The brake key (pin) which connects the motor
shaft to the scooter brake may slide out of
position causing the brake to become non-
functional.

_______________
PRODUCT Uroview Diagnostic Imaging Systems.
Recall #Z-752/753-6.
CODE Uroview Model 2000 and Uroview Model 2500.
MANUFACTURER OEC Medical Systems, Salt Lake City, Utah.

-10-RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan November 24, 1993.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 61 units.
REASON The devices were found to be in noncompliance
with 21 CFR 1032(a) and 21 CFR
1020.32(b)(2)(I) in that the x-ray system will
produce x-rays without a primary protective
barrier and the system's x-ray field will
exceed the visible area of the image receptor.

_______________
PRODUCT Model 9400 Mobile Fluoroscopy Imaging System.
Recall #Z-754-6.
CODE None.
MANUFACTURER OEC Medical Systems, Salt Lake City, Utah.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan November 17, 1993.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 767 units.
REASON The device was found to be in noncompliance
with 21 CFR 1032(c) in that wires in the x-ray
control may cause an accidental radiation
occurrence (ARO) resulting in the x-ray unit.

_______________
PRODUCT Aruba Suntanning Bed. Recall #Z-755-6.
CODE Serial numbers 400327 through 400719.
MANUFACTURER Puretan International/Asterisk, Inc., Dallas,
Texas.
RECALLED BY Manufacturer, by sending replacement knobs
with instructions on May 16, 1994. Firm-
initiated field correction complete.
DISTRIBUTION Nationwide and Canada.
QUANTITY 368 units were distributed.
REASON The shaft on timer was too short and this
caused the knob of the timer to jam when the
temperature increased and expanded the plastic
canopy of the device.

_______________
PRODUCT Ophthalas 532 Laser System, used in ophthalmic
surgery. Recall #Z-756-6.
CODE Model 532.
MANUFACTURER Alcon Laboratories, Inc., Irvine, California.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan May 2, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 848 units.

-11-REASON The device was defective within 21 CFR
1003.2(h)(2) in that the system might
inadvertently experience a power jump during
treatment.

_______________
PRODUCT Tri-Rolls brand Power Scooter, a three-wheeled
wheelchair. Recall #Z-757-6.
CODE Codes prior to 93K.
MANUFACTURER Invacare Corporation, Elyria, Ohio.
RECALLED BY Manufacturer, by letter dated February 21,
1994. Firm-initiated correction complete.
DISTRIBUTION Nationwide.
QUANTITY 5,631 scooters were distributed.
REASON Under severe use or heavy abuse tiller spring
that turns the tiller throttle can break
and/or slip off, due to a metal burr, causing
the scooter to remain in drive unless the
drive control is manually moved into neutral
position.

_______________
PRODUCT Hydromat Hydrovalve and Tubing Set for
laparoscopic suction and irrigation:
(a) Hydromat Hydrovalve & Tubing Set, Catalog
#263101-61, Series 1 Set;
(b) Hydromat Hydrovalve & Tubing Set, Catalog
#263104-61, Series 4 Set.
Recall #Z-764/765-6.
CODE Lot Numbers: (a) 1-082695; (b) 4-082695.
MANUFACTURER Infinity Extrusion and Engineering, Inc.,
Santa Clara, California.
RECALLED BY Karl Storz Endoscopy, Culver City, California,
by letter sent on January 30, 1996. Firm-
initiated recall complete.
DISTRIBUTION California, Colorado, Florida, Georgia,
Kentucky, Massachusetts, Maryland, New York,
Ohio, Oklahoma, Pennsylvania, South Carolina,
Texas, Virginia, Washington state, West
Virginia.
QUANTITY 720 sets were distributed.
REASON Device sterility may be compromised due to a
defective packaging seal.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Sentinel-Seal Autotransfusion Chest Drainage
System (CDU), Catalog #8888-571489, a sterile,
single use, prescription device.
Recall #Z-581-6.
CODE Lot #94C305X, 94C293X, 94D045X.

-12-MANUFACTURER Sherwood Medical Company, Commerce, Texas.
RECALLED BY Manufacturer, by visit beginning on October
12, 1994. Firm-initiated recall complete.
DISTRIBUTION Belgium, France, Greece, Italy, Spain.
QUANTITY 2,680 units were distributed.
REASON Device is subject to air leak which may occur
between the patient connection site and the
chest drainage system collection chamber.

_______________
PRODUCT Baxter Myelogram Tray, containing an 18 gauge
x 3-1/2" Spinal Needle with Stylet and Nine-
Holed Aspiration Needle, used to obtain spinal
fluid samples and removal of oil-based
contrast media during myelograms.
Recall #Z-726-6.
CODE Catalog #4320, lot #L6B082.
MANUFACTURER Baxter Healthcare Corporation, Mannford,
Oklahoma.
RECALLED BY Baxter Healthcare Corporation, McGaw Park,
Illinois, by letter dated April 19, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 470 cases were distributed; firm estimated
that 50 percent of product remained on market
at time of recall initiation.
REASON The aspiration cannula may not fit inside the
spinal needle as intended.

MEDICAL DEVICE SAFETY ALERTS: ==============================
_______________
PRODUCT Schneider Wallstent Esophageal Prosthesis,
used to keep the esophagus of a patient open
when there are strictures or fistulas
resulting from cancer:
(a) Model E38-2040-95, 40mm long;
(b) Model E38-2060-95, 60mm long;
(c) Model E38-2090-95, 90mm long.
Safety Alert #N-012/014-6.
CODE All lots.
MANUFACTURER Schneider (USA), Inc., Minneapolis, Minnesota.
ALERTED BY Manufacturer, by letter March 21, 1996.
DISTRIBUTION Nationwide, Argentina, Australia, Canada, Hong
Kong.
QUANTITY 4,577 prostheses were distributed.

-13-REASON There is a possibility of increased risk of
perforation and bleeding in patients who have
received or will receive radiation therapy
following stent placement, and to those
patients with hiatal hernia and/or gastric
prolapse into the esophageal area for stents
implanted near the gastroesophageal junction.

-14-

END OF ENFORCEMENT REPORT FOR MAY 15, 1996. BLANK PAGES MAY FOLLOW.

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