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
05/29/1996

ENFORCEMENT REPORT FOR 05/29/1996
^

May 29, 1996 96-22

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Mountain Man Nut & Fruit Co. Sesame Nut Mix,
packaged in 1 pound clear plastic bags.
Recall #F-566-6.
CODE None. All product lacking cashews and
soybeans in the ingredient statement.
MANUFACTURER Mountain Man Nut & Fruit Company, Parker,
Colorado.
RECALLED BY Manufacturer, by telephone beginning April 10,
1996, followed by letter, and by press release
on April 18, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 2,915 pounds were distributed.
REASON Product contains undeclared cashews and
soybeans.

RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS II =======
_______________
PRODUCT Various children's cologne and cologne gift
sets in 0.5 ounce bottles:
Product Code Product
(a) 20002.000.000 Barbie Comb/Mirror/Cologne
(b) 20003.000.000 Barbie Carded Cologne
(c) 20004.000.000 Barbie Carded Wing Rack
(d) 20005.000.000 Barbie Floorstand (Inc.
Fragrance Fun Set)
(e) 20006.000.000 Barbie Assorted Cosmetic
Rack
(f) 20010.000.000 Barbie Fragrance Fun Set
(g) 20010.000.101 Barbie Fragrance Fun Set
(h) 20041.000.000 Barbie Assortment
(i) 20079.000.000 Barbie Cologne Keepsake
(j) 21021.000.000 The Little Mermaid
Comb/Mirror/Cologne
(k) 21035.000.000 The Little Mermaid Carded
Cosmetic Rack
(l) 21045.000.000 The Little Mermaid
Fragrance Set
(m) 21045.000.101 The Little Mermaid
Fragrance Set
(n) 21073.000.000 The Little Mermaid
Assorted Cosmetic Sets
(o) 21073.100.000 The Little Mermaid Shelf
Tray Assortment
(p) 21080.000.000 The Little Mermaid Luau
Dress Up Set
(q) 21085.000.000 The Little Mermaid Prepack
(r) 23067.000.000 Fragrance Set Assortment
(s) 23068.000.000 Assorted Cosmetic Wing
Rack
(t) 23231.000.000 Girls Toiletry Floorstand
Recall #F-546/565-6.
CODE Those containing 0.5 ounce bottles of lot #
L138 cologne under "Barbie" or "The Little
Mermaid" label.
MANUFACTURER Chemaid Laboratories, Inc., Saddle Brook, New
Jersey (cologne).
RECALLED BY Tsumura International, Secaucus, New Jersey,
by letter on March 14, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 289,500 bottles were distributed; firm
estimated 20,000 bottles remained on market at
time of recall initiation.
REASON The cologne is contaminated with Pseudomonas
aeruginosa.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II ===========
_______________
PRODUCT Dilantin (Extended Phenytoin Sodium), USP, 30
mg, in bottles of 100, anticonvulsant.
Recall #D-142-6.
CODE Lot #27835L EXP 3/97.
MANUFACTURER Warner Lambert Company, Lititz, Pennsylvania.
RECALLED BY Manufacturer, by letter on May 6, 1996. Firm-
initiated recall ongoing.
-2-DISTRIBUTION Nationwide.
QUANTITY 28,397 bottles were distributed.
REASON Product does not meet dissolution
specifications.

_______________
PRODUCT Puritan Bennett (a) Carbon Dioxide, USP, 99%
in the following cylinder sizes: B, D, E, P,
F, M, G, T, and XL-45 refrigerated liquid
container;
(b) Carbon Dioxide 5%, Oxygen 95% Mixture in
the following cylinder sizes: E, G, and H.
Recall #D-143/144-6.
CODE (a) Carbon Dioxide, U.S.P., manufactured at
Linthicum Heights, MD (referred to as the
Baltimore Branch)
BATCH 54 BATCH 55 BATCH 56 BATCH 57
AA29D54 AB06D55 AB15D56 AB21D57
AA30D54 AB07D55 AB16D56 AB22D57
AA31D54 AB08D55 AB02D56 AB23D57
AB01D54 AB12D55 AB26D57
AB02D54 AB14D55

BATCH 58 BATCH 59 BATCH 60 BATCH 61
AB27D58 AC05D59 AC14D60 AC26D61
AB28D58 AC06D59 AC15D60 AC27D61
AB29D58 AC07D59 AC18D60 AC28D61
AC01D58 AC08D59 AC20D60 AC29D61
AC11D59 AC21D60 AD01D61
AC12D59 AC22D60 AD02D61
AC13D59 AC25D60

BATCH 62 BATCH 63 BATCH 64
AD03D62 AD11D63 AD17D64
AD04D62 AD12D63 AD18D64
AD05D62 AD15D63
AD08D62
AD09D62
AD10D62
Carbon Dioxide, U.S.P., manufactured in
Bellmawr, NJ (referred to as the Philadelphia
Branch)
BATCH 79
XD11D79
(b) Carbon Dioxide 5%, Oxygen 95% mixture,
manufactured at Linthicum Heights, MD. Carbon
dioxide used in mixtures is supplied to the
manufacturing system in cylinders and not
direct from the bulk supply. Therefore, the
following lot numbers of CO2/O2 mixture were
manufactured using cylinders from the listed
batches and not produced direct from the bulk
supply:
-3- BATCH 55 BATCH 59 BATCH 60 BATCH 62
AB09D62 AC19D64 AD04D66 AD08D67
AB21D62 AC19D65 AD17D68
AB23D63.
MANUFACTURERS Puritan-Bennett Corporation, a Subsidiary of
Nellcor Puritan Bennett Inc., Linthicum
Heights, Maryland;
Puritan-Bennett Corporation, a Subsidiary of
Nellcor Puritan Bennett Inc., Bellmawr, New
Jersey.
RECALLED BY Puritan-Bennett Corporation, a Subsidiary of
Nellcor Puritan Bennett Inc., Gas Products
Division, Overland Park, Kansas, by telephone
and visit beginning April 19, 1996, followed
by letter May 8-14, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Pennsylvania, Maryland, New Jersey,
Washington, D.C.
QUANTITY The Baltimore Branch distributed 1,253
cylinders or XL-45's CO2 between Philadelphia
1/29/96-4/19/96; Branch distributed 5
cylinders CO2 between 4/11-15/96.
The Baltimore Branch distributed 106 cylinders
of CO2/O2 mixture between 2/9/96-4/18/96.
REASON Presence of trace quantities of HCN (Hydrogen
Cyanide).

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Pharmics brand Polytinic, Rx diet supplement,
in bottles of 100. Recall #D-141-6.
CODE Lot #3053.
MANUFACTURER Gull Laboratories, Inc., doing business as
USANA, Inc., Murray, Utah.
RECALLED BY Pharmics, Inc., Salt Lake City, Utah, by
letter faxed beginning March 25, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Missouri, Utah, Idaho, Nevada, Colorado, Iowa,
Ohio, Florida, Wyoming.
QUANTITY 646 bottles were distributed; firm estimated
that less than 100 bottles remained on market
at time of recall initiation.
REASON Subpotency of the folic acid ingredient.

_______________
PRODUCT (a) Caffeine Tablets, manufactured for
Specialty Products Co., Inc., in white plastic
bottles; (b) Cough Suppressant liquid in 8
ounce clear plastic bottles, under Ion Labs
label. Recall #D-145/146-6.
CODE Lot numbers: (a) 400577 10-96;
(b) 500458-6-97.
-4-MANUFACTURER Ion Labs, Inc., Pinellas Park, Florida.
RECALLED BY Manufacturer, by telephone on March 18, 1996.
Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY (a) 2,300 bottles; (b) 468 bottles were
distributed.
REASON Caffeine product does not meet content
uniformity specifications. The Sorbutuss
product is subpotent.

_______________
PRODUCT Loxitane (Loxapine Succinate) Capsules, 25 mg,
in bottles of 100 and 1000, Rx antipsychotic
drug. Recall #D-147-6.
CODE Control numbers 342-351 (exp. date 09/97) and
374-435 (exp. date 01/99) were packaged in
bottles of 1000 capsules;
Control numbers 350-338 (exp. date 10/97),
360-359 (exp. date 11/97), 376-413 (exp. date
01/99) and 388-455 (exp. date 09/99) were
packaged in bottles of 100 capsules.
MANUFACTURER Wyeth-Ayerst/Lederle Laboratories, Inc., Pearl
River, New York.
RECALLED BY Whitehall Robins, Inc., Division of Wyeth-
Ayerst/Lederle Laboratories, Inc., Richmond,
Virginia, by letter on May 8, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and Australia.
QUANTITY 29,093 bottles were distributed.
REASON Potency not assured through expiration date.

_______________
PRODUCT Tricolan Antimicrobial Soap, in 32 ounce
bottles. Recall #D-148-6.
CODE Lot #019-96.
MANUFACTURER Perfecto Products Manufacturing, Inc.,
Atlanta, Georgia.
RECALLED BY Manufacturer, by telephone on April 8, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 1,365 bottles were distributed; firm estimated
that 30-40% of the lot remained on market at
time of recall initiation.
REASON Subpotency.

HUMAN TISSUES MANDATORY RECALLS =============================
_______________
PRODUCT Human Tissues for Transplant: Human Eye
Tissues. Recall #B-410-6.
CODE None.
MANUFACTURER Mid-South Eye Bank, Memphis, Tennessee.

-5-RECALLED BY Manufacturer, by letter dated January 23,
1996. Firm-initiated recall complete.
DISTRIBUTION Tennessee, Arkansas.
QUANTITY 112 shipments.
REASON Human tissues, not tested for HIV-2 were
distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Platelets, Pheresis. Recall #B-402-6.
CODE Unit #FF11472.
MANUFACTURER Irwin Memorial Blood Center, San Francisco,
California.
RECALLED BY Manufacturer, by letter dated January 11,
1994. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product was collected from a donor who
previously tested repeat reactive for HBsAg
and was not properly reentered.

_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-411/412-6.
CODE Unit numbers: (a) 40FG26902, 40FG27376,
40FG27688, 40FG27992; (b) 40FG27376.
MANUFACTURER American Red Cross Blood Services, Rock Falls,
Illinois.
RECALLED BY American Red Cross Blood Services, Peoria,
Illinois, by telephone on October 17, 1995,
followed by letter on October 24, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Illinois, Missouri, California, Tennessee.
QUANTITY (a) 4 units; (b) 1 unit.
REASON Blood products, collected from a donor who
travelled to an area designated as endemic to
malaria, were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-414-6.
CODE Unit #13FM00749.
MANUFACTURER American Red Cross, Detroit, Michigan.
RECALLED BY Manufacturer, by letter dated October 24,
1995. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASON Blood product, which was collected from a
donor with a medical history of hepatitis, was
distributed.

-6-_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma. Recall #B-415/417-6.
CODE Unit numbers: (a) 38N03281, 38M10808; (b)
38NO3281; (c) 38M10808.
MANUFACTURER American Red Cross, Fort Wayne, Indiana.
RECALLED BY Manufacturer, by letters dated November 21,
1995, February 2, 1996, and March 11, 1996.
Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY (a) 2 units; (b) 1 unit; (c) 1 unit.
REASON Blood products, which tested negative for all
infectious diseases, but were collected from a
donor who previously tested repeat reactive
for anti-HIV-1, and was never properly
reentered, were distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh
Frozen Plasma. Recall #B-418/420-6.
CODE Unit #13FL40372.
MANUFACTURER American Red Cross, Detroit, Michigan.
RECALLED BY Manufacturer, by letter dated October 26,
1995. Firm-initiated recall complete.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor taking
the drug, Proscar were distributed.

_______________
PRODUCT Source Plasma. Recall #B-421-6.
CODE Unit numbers: XM70573, XM75407, XM76739,
XM77060, XM77677, XM78015, XM81068, XM81661,
XM82218, XM83940, XM84260.
MANUFACTURER Community Bio-Resources, Inc., Grand Rapids,
Michigan.
RECALLED BY Manufacturer, by letter dated October 16,
1995. Firm-initiated recall complete.
DISTRIBUTION Austria.
QUANTITY 11 units.
REASON Blood products, which were collected from a
donor who reported his lips pierced, were
distributed.

_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c)
Recovered Plasma. Recall #B-422/424-6.
CODE Unit numbers: (a) C29773, C33026; (b) C29773,
C29913; (c) C29773, C29913, C33026.
MANUFACTURER Carlisle Hospital Blood Bank, Carlisle,
Pennsylvania.

-7-RECALLED BY Manufacturer, by letters dated August 21,
1995, September 11, 1995, and October 19,
1995. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY (a) 2 units; (b) 2 units; (c) 3 units.
REASON Blood products, collected from donors taking
the drug, Proscar were distributed.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT AS-1 Red Blood Cells. Recall #B-403-6.
CODE Unit #J86475.
MANUFACTURER Irwin Memorial Blood Center, San Francisco,
California.
RECALLED BY Manufacturer, by letter dated January 11,
1994. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product was shipped with an extended
expiration.

_______________
PRODUCT (a) AS-1 Red Blood Cells; (b) Platelets.
Recall #B-404/405-6.
CODE Unit #1371694.
MANUFACTURER LifeSource, Glenview, Illinois.
RECALLED BY Manufacturer, by telephone on September 29,
1995. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component.
REASON Blood products, collected from a donor who had
received a MMR vaccination, twenty-five days
prior to the donation, were distributed.

_______________
PRODUCT Red Blood Cells. Recall #B-426-6.
CODE Unit #17178-6918.
MANUFACTURER United Blood Service, McAllen, Texas.
RECALLED BY Blood Services, Inc., Scottsdale, Arizona, by
telephone on February 20, 1996. Firm-
initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit.
REASON Red Blood Cells, remained at room temperature
for an unknown amount of time, were
distributed.

-8-RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I ===========
_______________
PRODUCT Synthetic Serum Substitute, Catalog #99193, in
12 ml vials, designed for use as a tissue
culture protein supplement. Recall #Z-709-6.
CODE Lot #9919350921 EXP 9/96.
MANUFACTURER Irvine Scientific Sales Company, Inc., Santa
Ana, California.
RECALLED BY Manufacturer, by letter dated December 14,
1995. Firm-initiated recall complete.
DISTRIBUTION Alabama, California, Connecticut, Florida,
Hawaii, Illinois, Massachusetts, Missouri, New
Jersey, Nevada, New York, Ohio, Pennsylvania,
Tennessee, Texas, Washington state, Japan.
QUANTITY 1,669 vials were distributed.
REASON The device is contaminated with Penicillium
sp. mold. The device labeling does not meet
the labeling requirements for in vitro
diagnostic devices in 21 CFR 809.10.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II ==========
_______________
PRODUCT Harvey Vapo-Steril Solution, a sterilizing
compound for use with Harvey Chemiclave
sterilizers, for sterilizing dental and
surgical instruments. Recall #Z-725-6.
CODE Lot numbers: 2794, 2395, 2595.
MANUFACTURER MDT Biologics Company, Rancho Dominguez,
California.
RECALLED BY Manufacturer, by letter on February 1, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, New Zealand, Taiwan.
QUANTITY 82,606 bottles were distributed.
REASON The product may not adequately sterilize since
an active ingredient, formaldehyde, was found
to be less than declared in some lots, and
some bottles in one lot contained no
formaldehyde at all.

_______________
PRODUCT Transducer Protector in Custom Sterile Trays,
a component of a sterile custom tray
identified with the user's name and a unique
work order number:
(a) Dualex Transducer Protector;
(b) Dualex Plus Transducer Protector;
(c) Dualex Ultra Transducer Protector.
Recall #Z-761/763-6.
CODE The above devices are contained in the
following NMC Item Numbers (Catalog Nos.):
NMC-97-1030-00, NMC-97-4030-00,

-9- NMC-97-0650-00, NMC-97-7910-00,
NMC-97-9370-00, NMC-97-7870,
NMC-97-0010-00, NMC-97-0240-00,
NMC-97-8030-00, NMC-97-9806-00,
NMC-97-0480-00, NMC-97-0570-00,
NMC-97-9041-00, NMC-97-4360-00,
NMC-97-7380-00, NMC-97-9820-00,
NMC-97-0650-01, NMC-97-0710-00,
NMC-97-0371-00, NMC-97-4422-00,
NMC-97-8235-00, NMC-0250-00,
NMC-97-0380-00, NMC-97-0400-00,
NMC-97-0520-00, NMC-97-0580-00,
NMC-97-4841-00, NMC-97-4361-00,
NMC-97-4952-00, NMC-97-0500-00,
NMC-97-8200-00, NMC-97-0720-00,
NMC-97-0410-00, NMC-97-7761-00,
NMC-97-8350-00, NMC-97-0430-00,
NMC-97-0390-00, NMC-97-0460-00,
NMC-97-0530-00, NMC-97-0601-00,
NMC-97-4850-00, NMC-97-4453-00,
NMC-97-7831-00, NMC-97-0500-01,
NMC-97-9942-00, NMC-97-0730-00,
NMC-97-0420-00, NMC-97-8163-00,
NMC-97-0270-00, NMC-97-0420-00,
NMC-97-8163-00, NMC-97-0270-00,
NMC-97-0440-00, NMC-97-0260-00,
NMC-97-0470-00, NMC-97-0560-00,
NMC-97-0360-00, NMC-97-5000-00.
MANUFACTURER Millipore Corporation, Bedford, Massachusetts
(transducers).
RECALLED BY Sterile Design, Division of Maxxim Medical,
Clearwater, Florida, by letter dated February
21, 1995. Firm-initiated recall ongoing.
DISTRIBUTION New Jersey.
QUANTITY 490,578 custom kits were distributed.
REASON The transducer protectors may exhibit air
leakage at the female luer lock connection to
the male luer of the hemodialysis machine
under normal operating conditions.

_______________
PRODUCT BactiCard Neisseria, a test kit for use in the
rapid, presumptive identification of
pathogenic Neisseria species isolated from
primary culture of clinical specimens on
selective media. Recall #Z-779-6.
CODE Catalog #21-110, Lot #5502, EXP 2/28/96.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on July 28 & 31,
1995. Firm-initiated recall complete.

-10-DISTRIBUTION California, Oklahoma, Michigan, Virginia,
Georgia, Wisconsin, Vermont, Tennessee,
Minnesota, South Carolina, Ohio, Missouri,
Maryland, Florida, New Mexico, Louisiana, New
York, Illinois, Rhode Island.
QUANTITY 84 units were distributed.
REASON The tests resulted in a positive GLUT reaction
with Neisseria gonorrhoeae. The expected
reaction should be negative. As a result
Neisseria gonorrhoeae isolate would be
misidentified as a false negative.

_______________
PRODUCT Orthopedic Bone Screws with Cancellous or
Cortical Thread Designs:
(a) Cortical Locking Screw, All Lengths, Part
No. 1020-XX;
(b) Cancellous Locking Screw, All Lengths,
Part No. 1030-XX;
(c) 5.5 mm Cortical Screw, All Lengths, Part
No. 1515-XX;
(d) 4.8 mm Cannulated Lag Screw, All Lengths,
Part No. 1717-XX;
(e) 4.5 mm Cortical Bone Screw, All Lengths,
Part No. 14022-XX;
(f) Cannulated Hip Screw, All Lengths, Part
No. 14088-XX;
(g) S.C.F.E. Screw, All Lengths, Part No.
14188-XX;
(h) 8.0 mm Cannulated Cancellous Screw, 24 mm
Thread, All Lengths, Part No. 14192-XX;
(i) 6.5 mm Cannulated Cancellous Lag Screw, 22
mm Thread, All Lengths, Part No. 14196-XX;
(j) 6.5 mm Cannulated Cancellous Lag Screw, 40
mm Thread, All Lengths, Part No. 14197-XX;
(k) Cannulated Cortical Bone Screw, All
Lengths, Part No. 14200-XX;
(l) 5.0 mm Cannulated Cancellous Lag Screw,
All Lengths, Part No. 14225-XX;
(m) Cannulated Cortical Lag Screw, All
Lengths, Part No. 14250-XX;
(n) 4.0 mm Solid Cancellous Screw, Full
Thread, All Lengths, Part No. 14369-XX;
(o) 4.0 mm Cannulated Cancellous Bone Screw,
16 mm Thread, All Lengths, Part No. 14370-XX;
(p) 4.0 mm Cannulated Cancellous Bone Screw,
32 mm Thread, All Lengths, Part No. 14372-XX;
(q) 3.5 mm Cannulated Cortical Bone Screw, All
Lengths, Part No. 14375-XX;
(r) 3.5 mm Cortical Bone Screw, All Lengths,
Part No. 14377-XX. Recall #Z-791/808-6.

-11-CODE All lot numbers of the devices listed above
distributed from September 1, 1994 to April 6,
1996.
MANUFACTURER Ace Medical Company, El Segundo, California.
RECALLED BY Manufacturer, by notice titled "urgent
notification" on June 20, 1995. Firm-
initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY Approximately 105,195 bone screws were
distributed; firm estimates none of the
misbranded product remains on the market
REASON The device labels did not contain the
following required Warning Statement:
"WARNING: This device is not approved for
screw attachment or fixation to the posterior
elements (pedicles) of the cervical, thoracic,
or lumbar spine."

_______________
PRODUCT Stryker Rugged Ambulance Cot Models 6060 and
6070, for ambulance loading/unloading.
Recall #Z-809/810-6.
CODE Serial numbers: 960339013, 960339016,
960339017, 960339020 through 96339031,
960339042 through 96339099, 960339300 through
96339325, and 960339336.
MANUFACTURER Stryker Medical, Division of Stryker
Corporation, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by telephone between April 2 and
15, 1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 99 cots.
REASON The siderail mounting holes on the outer
support rail were drilled incorrectly. This
defect could result in a decrease in the
fatigue strength of the cot and collapse and
cause more injury to patient.

_______________
PRODUCT SeraChem Plus Clinical Chemistry Control Serum
(Bovine), Unassayed Level II, intended for
monitoring the precision of assays for
digoxin, theophylline, phenobarbital,
phenytoin, gentamicin, and tobramycin.
Recall #Z-815-6.
CODE Catalog #3161-84, Lot #N0543560 EXP 6/96.
MANUFACTURER Instrumentation Laboratory Company,
Orangeburg, New York.
RECALLED BY Instrumentation Laboratory Company (ILC),
Lexington, Massachusetts, by telephone on
September 25-26, 1996. Firm-initiated recall
complete.

-12-DISTRIBUTION Pennsylvania, Kentucky, Tennessee, Florida,
Washington state, Oregon, Montana, Texas,
California, Idaho, Michigan, Missouri,
Connecticut, Wisconsin.
QUANTITY Approximately 1,051 units were distributed.
REASON The reconstituted control serum had turbidity
and a drop in calcium, creatine and other
analytes.

_______________
PRODUCT Hip Prosthesis Stem:
(a) Apollo Hip Non Porous Stem, Size 2,
Catalog Number 7370-00-02,
(b) Natural Hip Non Porous CoCr Stem, Size 1,
Catalog Number 7352-35-001,
(c) Natural Hip Porous Collarless Stem, Size 2
Left, Catalog Number 7354-01-102.
Recall #Z-816/818-6.
CODE Lot numbers: (a) 1236826; (b) 1235461 and
1235464; (c) 1234318.
MANUFACTURER Intermedics Orthopedics, Inc. (IOI), Austin,
Texas.
RECALLED BY Manufacturer, by telephone on April 17, 1996.
Firm-initiated recall complete.
DISTRIBUTION Missouri, Ohio, Pennsylvania, South Dakota,
Tennessee.
QUANTITY 19 units were distributed; firm estimates none
remains on the market.
REASON The devices were mislabeled.

_______________
PRODUCT Disposable Steri-Shield Togas, used during
surgical procedures in order to help protect
the wearer against contamination and/or
exposure to body fluids and microorganisms:
(a) Part No. 400-410 Toga, Pullover, Regular;
(b) Part No. 400-420 Toga, Pullover, Large;
(c) Part No. 400-430 Toga, Pullover, Extra
Large;
(d) Part No. 400-412 Toga, Pullover, Regular;
(e) Part No. 400-422 Toga, Pullover, Large;
(f) Part No. 400-432 Toga, Pullover, Extra
Large;
(g) Part No. 400-510 Toga, Zipper, Regular;
(h) Part No. 400-520 Toga, Zipper, Large;
(i) Part No. 400-530 Toga, Zipper, Extra
Large;
(j) Part No. 400-512 Toga, Zipper, Regular;
(k) Part No. 400-522 Toga, Zipper, Large;
(l) Part No. 400-532 Toga, Zipper, Extra
Large. Recall #Z-819/830-6.
CODE All lots bearing a lot number ending in
"-1-S".
-13-MANUFACTURER BioMedical Devices, Irvine, California.
RECALLED BY Stryker Instruments, Division of Stryker
Corporation, Kalamazoo, Michigan, by letter
issued on or about April 16, 1996. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 79,530 togas were distributed.
REASON The sterility of the devices have been
compromised due to loss of package integrity.

_______________
PRODUCT ECG Pre Amp PC Board Assembly for the ECG
Option of the Siemens Gamma Camera System.
Recall #Z-831-6.
CODE Assembly #820824270. All boards shipped on or
after November 22, 1995.
MANUFACTURER Solectron Technology, Inc., Charlotte, North
Carolina (board).
RECALLED BY Siemens Medical Systems, Inc., Nuclear
Medicine Group, Hoffman Estates, Illinois, by
letter dated April 9, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 67 units were distributed.
REASON The circuit board exceeds the maximum leakage
current safety requirement for patient
connected devices.

_______________
PRODUCT 7200 Series Microprocessor Ventilators,
indicated for delivery of gas to patients
dependent on artificial respiration:
(a) Model No. 7200ae shipped domestically;
(b) Model No. 7200e shipped internationally;
(c) Model No. 7200sp shipped internationally.
Recall #Z-832/834-6.
CODE 8,402 ventilators each with its own unique
nonsequential serial number.
MANUFACTURER Nellcor Puritan Bennett (NPB), Carlsbad,
California.
RECALLED BY Manufacturer, by letter October 2, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 8,402 ventilators were distributed.
REASON Ventilators can enter the SVO State (Stopped
Ventilating) when they are first turned on due
to defective software.

_______________
PRODUCT Power Wheelchairs marketed under the following
brand names:
(a) Ranger X Power Wheelchair;

-14- (b) Ranger II Power Wheelchair;
(c) Arrow Power Wheelchair;
(d) Arrow XT Power Wheelchair;
(e) Jaguar Power Wheelchair;
(f) Power 9000 Action Cat.
Recall #Z-835/840-6.
CODE All codes beginning with 93K through 94C and
followed by any five digit combination.
MANUFACTURER Invacare Corporation, Elyria, Ohio
(wheelchairs); Gould Electronics, Mexico
(component).
RECALLED BY Invacare Corporation, Elyria, Ohio, by letter
dated November 22, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 4,761 chairs were distributed.
REASON A wire harness connecting the battery to the
controller contains a fuse holder that may
cause the wheelchair to lose power due to a
faulty soldering weld.

_______________
PRODUCT Laser Systems, used as optical oscillators for
highly specialized laboratory applications:
(a) Model KerBBQS-EAFB Laser System;
(b) Model CYLF-KTP1 Optical Parametric
Oscillator (OPO). Recall #Z-850/851-6.
CODE None.
MANUFACTURER Schwartz Electro-Optics, Inc., Orlando,
Florida.
RECALLED BY Manufacturer. FDA approved the firm's
corrective action plan on May 3, 1996. Firm-
initiated field correction ongoing.
DISTRIBUTION Southeast and Southwest region of the United
States.
QUANTITY 1 unit each.
REASON The laser systems were found to be in
noncompliance with 21 CFR 1010.2 and 1010.3,
1040.10(f),(g), and (h)(1) in that they failed
to have identification, certification, warning
logotype, aperture labels, and labels for
defeatably interlocked protective housings.
The products also failed to incorporate beam
attenuators, emission indicators, and
defeatable safety interlocks. There was no
user information provided with the products.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Urea Broth for AFB, 1.5 ml tubed media, for
in-vitro diagnostic use. Recall #Z-769-6.
CODE Catalog #06-5222, Lot #5504 EXP 8/31/96.
-15-MANUFACTURER Remel Limited Partnership, Lexena, Kansas.
RECALLED BY Manufacturer, by telephone on November 7-8,
1995. Firm-initiated recall complete.
DISTRIBUTION California, Virginia, Connecticut, Wisconsin,
Michigan, Pennsylvania, Arkansas, Kansas, New
York, Florida, Ohio, Indiana, Puerto Rico.
QUANTITY 540 units were distributed; firm estimates
none remains on the market.
REASON The broth was pink in color while being stored
in refrigeration at 2-8 centigrade compared to
another lot that was yellow.

_______________
PRODUCT Phenol Red Broth with 1% Sucrose, tubed media,
for in-vitro diagnostic use. Recall #Z-770-6.
CODE Catalog #06-2432, Lot #5503 EXP 10/31/96.
MANUFACTURER Remel Limited Partnership, Lexena, Kansas.
RECALLED BY Manufacturer, by telephone on February 7,
1996. Firm-initiated recall complete.
DISTRIBUTION Ohio, California, Nebraska, Illinois, New
York, Missouri.
QUANTITY 260 units were distributed; firm estimates
none remains on the market.
REASON The product appeared as a semi-solid that was
light pink in color. The expected appearance
of the product is as a broth that is
orange-red in color.

_______________
PRODUCT Mueller Hinton Agar with 4% NaCL with 6 mcg/ml
Oxacillin, plated media, for in-vitro
diagnostic use. Recall #Z-773-6.
CODE Catalog #01-626, Lot #3542 EXP 10/27/94.
MANUFACTURER Remel Limited Partnership, Lexena, Kansas.
RECALLED BY Manufacturer, by telephone on October 4-6,
1995. Firm-initiated recall complete.
DISTRIBUTION Texas, Ohio, Georgia, Florida, Colorado,
California, Virginia, Connecticut, Wisconsin,
Kansas.
QUANTITY Approximately 2,030 units were distributed;
firm estimates none remains on the market.
REASON The device does not support growth, including
growth of the positive control organism S.
Aureu.

_______________
PRODUCT Cystine Heart Agar without Blood, 20 ml tubed
media, for in-vitro diagnostic use.
Recall #Z-774-6.
CODE Catalog #09-308, Lot #5502 EXP 2/28/96.
MANUFACTURER Remel Limited Partnership, Lexena, Kansas.
RECALLED BY Manufacturer, by telephone on November 7,
1995. Firm-initiated recall complete.
-16-DISTRIBUTION Kansas, Oklahoma.
QUANTITY 40 units were distributed.
REASON The device was made with Heart Infusion broth
instead of Heart Infusion Agar causing it to
be liquid instead of a solid.

_______________
PRODUCT Glycerol Buffered Saline, for in-vitro
diagnostic use in qualitative procedures for
the preservation of enteric pathogens and the
transportation of fecal specimens to the
laboratory:
(a) Glycerol Buffered Saline, Fecal Transport
System, 15ml vials, packaged 12 vials per box
Product/Catalog No. 21-650;
(b) Cary Blair w/ Indicator, Glycerol Buffered
Saline, Fecal Transport System, 15ml vials,
packaged 6 vials per box. Product/Catalog No.
21-611. Recall #Z-775/776-6.
CODE Lot 4542.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on January 23,
1996. Firm-initiated recall complete.
DISTRIBUTION Nebraska, Indiana, Oklahoma.
QUANTITY (a) 39 boxes; (b) 2 boxes were distributed.
REASON The devices contained black particles within
the saline solution. The black particles were
actually fungi contamination.

_______________
PRODUCT Buffered CYE with CCVC (Charcoal Yeast Extract
Agar with Cycloheximide, Cephalothin,
Vancomycin, and Colistin), for in-vitro
diagnostic use. Recall #Z-777-6.
CODE Catalog No. 01-344, Lot #5510 EXP 11/29/95.
MANUFACTURER Remel Limited Partnership, Lenexa, Kansas.
RECALLED BY Manufacturer, by telephone on October 9, 1995.
Firm-initiated recall complete.
DISTRIBUTION Illinois, New York.
QUANTITY 70 units were distributed.
REASON The BCYE with CCVC was inadvertently released
into distribution with poor growth of
Legionella pheumophila.

_______________
PRODUCT SureCaltm 1 Calibrator, for use in the
calibration of the IL Phoenixtm
Chemistry/Eletrolyte Analyzer, for in-vitro
diagnostic use. Recall #Z-780-6.
CODE Catalog #33365, Lot #N0553652 EXP 4/96.
MANUFACTURER Instrumentation Laboratory Company,
Orangeburg, New York.
-17-RECALLED BY Instrumentation Laboratory Company (ILC),
Lexington, Massachusetts, by letter dated
October 23, 1995, followed by telephone on
October 24 & 25, 1995. Firm-initiated recall
complete.
DISTRIBUTION New York, New Jersey, North Carolina, South
Carolina, Mississippi, Florida, Minnesota,
Missouri.
QUANTITY Approximately 103 cartons (12 5-ml bottles)
were distributed.
REASON Chloride channel for the IL Phoenix Analyzer
would not calibrate, or the Chloride
recoveries were high for patient values.

_______________
PRODUCT Cutter Perfourm Light C.D. Vinyl Polysiloxane
Impression Material Type 1, Low Viscosity Kit,
intended as a dental impression material for
professional use by dentists.
Recall #Z-787-6.
CODE Catalog #35044, Kit Lot #041614, Catalyst Lot
#041563.
MANUFACTURER Heraeus Kulzer GmbH & Company, Kg, Dormagen,
Germany.
RECALLED BY Heraeus Kulzer, Inc., South Bend, Indiana, by
letter dated April 3, 1996. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 1,327 kits were distributed.
REASON The device fails to set within the specified
time frame.

_______________
PRODUCT ReferrIL B Calibrator and IL Test TCO2
Reagent: (a) ReferrIL B Calibrators, Catalog
No. 35262,(b) IL Test TCO2 Reagent, Catalog
No. 182548. Products used in combination are
intended for the in-vitro diagnostic
determination of TC02 Reagent in human serum.
Recall #Z-811/812-6.
CODE Lot numbers: (a) N1041015, N0153605,
N1054504; (b) N0554298, N0554299.
MANUFACTURER (a) Instrumentation Laboratory Company,
Orangeburg, New York; (b) Medical Analysis
Systems, Inc., Camarillo, California.
RECALLED BY Instrumentation Laboratory Co., Lexington,
Massachusetts, by letter on March 11, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 2,046 units of ReferrIL B and
502 units of TC02 reagent (Monarch) were
distributed.

-18-REASON The TCO2 recoveries were lower than labeled on
the Monarch system using a new liquid form of
reagents.

_______________
PRODUCT SeraChem Assayed Control Sera for Monitoring
the ILab 500, ILab 900, ILab 1800, Monarch,
and Phoenix Chemistry Systems
and the IL 943 Flame Photometer:
(a) Level 1, Catalog No. 181624-12,
(b) Level 2, Catalog No. 181625-12.
Recall #Z-813/814-6.
CODE Lot numbers: (a) I1230549; (b) I1230550.
MANUFACTURER Instrumentation Laboratory Company,
Orangeburg, New York.
RECALLED BY Instrumentation Laboratory Company, Lexington,
Massachusetts, by letter dated November 22,
1995. Firm-initiated recall complete.
DISTRIBUTION New York, New Jersey, Massachusetts, Florida,
Wisconsin, California, Maryland, Virginia,
Arkansas, Oklahoma.
QUANTITY Approximately 21 (12 5-ml vials) packages were
distributed.
REASON The label inserts had the incorrect amylase
and triglyceride values.

_______________
PRODUCT Dade Protein C Clotting Assay Kit, in-vitro
diagnostic product used for the quantitative
determination of the anticoagulant activity of
protein C in plasma. Recall #Z-846-6.
CODE Catalog #B4233-70, Lot #KPC-17M.
MANUFACTURER Dade International, Inc., Miami, Florida.
RECALLED BY Manufacturer, by letter dated February 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Texas, Maryland, Wisconsin, Illinois,
Kentucky, Michigan, Ohio, California,
Australia.
QUANTITY 82 kits were distributed.
REASON The kit was packaged using Actin Activated
Cephaloplastin Reagent, which has been found
to perform outside its specifications. This
APTT reagent generates long coagulation times
when used with control material and patient
specimen.

_______________
PRODUCT Isolab's HemoCard S and A&S Kits, in-vitro
diagnostic test kits for the detection of
hemoglobin variants (Hb A & S) or (Hb S).
(a) Code No. HC-1000; (b) Code No. HC-2030;
(c) Code No. HC-2000. Recall #Z-847/849-6.

-19-CODE Lot numbers: (a) 510080, 512110;
(b) 510084; (c) 510084.
MANUFACTURER Isolab, Inc., Akron, Ohio.
RECALLED BY Manufacturer, by letter on April 15, 1996.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Belgium, Israel,
Portugal, Canada, England.
QUANTITY 186 kits were distributed.
REASON The signal for Hb A and Hb S has weakened and
may produce a negative signal on a positive
control or patient sample prior to the kits'
expiration date. The absence of a strong
positive signal when running the recommended
controls could result in a misdiagnosis of any
test performed with these kits.

_______________
UPDATE Recall #Z-728-6, Stratus brand CK-MB
Fluorometric Enzyme Immunoassay, which
appeared in the May 22, 1996 Enforcement
Report should read:
REASON: The lot numbers for the calibrator
components "E" and "F" are incorrect on the
box label.

MEDICAL DEVICE SAFETY ALERTS: ===============================
_______________
PRODUCT Fresenius Hemodialysis Machines, 2008 Series:
(a) A2008 Dialysis System (models 2008C and
2008D); (b) A1008D Dialysis System (not sold
in U.S.); (c) A2008 Expansion Model (not sold
in U.S.); (d) A2008E Dialysis System (model
2008E); (e) 3008/FDS08 Dialysis System (model
2008H). Safety Alert #N-015/019-6.
CODE All serial numbers.
MANUFACTURER Fresenius USA, Inc., Walnut Creek, California.
ALERTED BY Manufacturer, by letter dated December 26,
1995.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 25,000 units were distributed.
REASON The heaters have been found to have pit
corrosion problems, resulting in cracks
sufficient to cause the ground fault
interrupter (GFI) to trip. This may be due to
bleach used to clean the machine when it is
not always sufficiently rinsed out after use.

-20-

END OF ENFORCEMENT REPORT FOR MAY 29, 1996. BLANK PAGES MAY
FOLLOW.

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