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.

July 16, 1997 97-29

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS I ============
_______________
PRODUCT Various chocolate candy:
a) Assorted Chocolates, 18 ounces
b) Assorted Chocolates, 12 ounces
c) Assorted Chocolates, 6 ounces
d) Coconut Cream Eggs, 8 ounces, 16 ounces, 2 pounds, 5
pounds
e) Butter Cream Eggs, 8 ounces, 16 ounces, 2 pounds, 5
pounds
f) Chocolate Fudge Eggs, 8 ounces, 16 ounces, 2 pounds, 5
pounds Recall #F-495/500-7.
CODE (These are Macy's product identification codes. There are
NO manufacturing codes):
(1) "Macy's Traditional American Chocolates", 18 ounces,
coded: EGO601
(2) "Macy's" Assorted Chocolates, 12 ounces, coded EGO603
(3) "Macy's" Assorted Chocolates, 6 ounces, coded EGO602
(4) Coconut Cream Eggs, 8 ounces, coded EGO604
16 ounces, coded EGO605, 2 pounds, coded,
EGO606, 5 pounds, coded EGO607
(5) Butter Cream Eggs, 8 ounces, coded EGO604
16 ounces, coded EGO605, 2 pounds, coded
EGO606, 5 pounds, coded EGO607
(6) Chocolate Fudge Eggs, 8 ounces, coded
EGO604, 16 ounces, coded EGO605
(No 2 pounds or 5 pounds sized eggs of this type were sold.)
MANUFACTURER Bayard-Prete Candy Company, Inc., Pennsauken, New
Jersey.
RECALLED BY Manufacturer, by letters on March 5 and 13, 1997,
and by press release on March 10, 1997. Firm-initiated recall ongoing.
DISTRIBUTION New Jersey, Georgia, New York, Connecticut,
Massachusetts, Rhode Island, Pennsylvania,
Delaware, Virginia, Florida, Louisiana.
QUANTITY Amount distributed:
(1) Macy's Traditional American Chocolates:
18 oz, 792 units (12X66cs)
(2) Macy's 6 ounces assorted chocolates:
480 units (24X20cs)
(3) Macy's 12 oz assorted chocolates:
98 units (14X7 cs)
(4) Coconut Cream Eggs:
8 ounces : 1104 eggs (24X46 cs)
16 ounces : 960 eggs (12X80 cs)
2 pounds : 12 eggs (4X3 cs)
5 pounds : 4 eggs (2X2 cs)
(5) Butter Cream Eggs:
8 ounces : 960 eggs (24X40 cs)
16 ounces : 480 eggs (12X40 cs)
2 pounds : 12 eggs (4X3 cs)
5 pounds : 4 eggs (2X2 cs)
(6) Chocolate Fudge Eggs:
8 ounces : 480 eggs (24X20 cs)
16 ounces : 144 eggs (12X12 cs).
REASON The products did not bear full ingredient statements
and contained the following undeclared ingredients that
could elicit reactions in sensitive individuals:
a) brazil nuts, cashews, walnuts, peanuts, peanut butter,
egg albumen, whole milk, almonds, and sulfites
b) and c) peanuts, peanut butter, egg albumen, whole milk,
and sulfites
d) egg albumen, whole milk, FD&C Yellow 6, and sulfites
e), and f) egg albumen, whole milk, and FD&C Yellow 6.

_______________
PRODUCT Sarabeth's Kitchen's Peach-Apricot Preserves, in 9
ounce and 18 ounce glass jars.
Recall #F-501-7.
-2-CODE All codes/lots manufactured prior to 12/11/96.
MANUFACTURER S.B.K. Preserves, Inc., doing business as
Sarabeth's Kitchen, New York, New York.
RECALLED BY Manufacturer, by letter on April 18, 1997, and by
press release. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined. Firm estimates little if any product
remain on the market.
REASON Product contains undeclared sulfites.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Turkish Delight Akide Candy, in 12 ounce rigid tubs, a
hard candy. Recall #F-488-7.
CODE None. All product containing the unapproved color additive
Ponceau 4R.
MANUFACTURER Capaloglu Vokosu, Istanbul, Turkey.
RECALLED BY EFE, Inc., Brooklyn, New York, by letter on
January 21, 1997. Completed recall resulted from
sample analysis and followup by the New York State
Department of Agriculture and Markets.
DISTRIBUTION New York and Georgia.
QUANTITY 18 containers were distributed. Firm estimated that
little, if any product remain on market.
REASON Product contained the unapproved color additive Ponceau
4R.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Minute Maid Berry Juice in 64 ounce gable-top
cartons. Recall #F-492-7.
CODE Container: JUN 18 LEY XXXX and JUN 19 LEY XXXX - Shipping
Case: XXXX LEY JUN18 W12774C BERRY PUNCH 2739 and XXXX LEY
JUN19 W12774D BERRY PUNCH 2739.
MANUFACTURER Cutrale Citrus Juices USA, Leesburg, Florida.
RECALLED BY The Minute Maid Company, Houston, Texas, by hand
held computers on May 16, 1997, and by visits on
May 16 and 22, 1997. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 6,668 cases were distributed.
REASON The product is adulterated due to the presence of
CS-400, a hi-strength, chelated liquid alkali system
used for circulation cleaning throughout the food
industry.

-3-_______________
PRODUCT Sarabeth's Kitchen Preserves, in 9 ounce and 18 ounce
glass jars: a) orange-Apricot Marmalade; b)
Apricadabra; c) Lemon-Pear Butter. Recall #F-502/504-7.
CODE (a&b) All codes/lots manufactured prior to 12/11/96; c) All
codes/lots manufactured prior to 4/4/97.
MANUFACTURER S.B.K. Preserves, Inc., doing business as
Sarabeth's Kitchen, New York, New York.
RECALLED BY Manufacturer, by letter sent on April 18, 1997,
and by press release. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined. Firm estimated little if any product
remain on market.
REASON Products contain undeclared sulfites.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Liquefied Carbon Dioxide, Bulk.
Recall #F-491-7.
CODE Production dates involved are 02/03/97 - 02/17/97. No
production codes are used with the product. Production is
continuous and storage of the finished product is commingled
within the bulk storage system used. Any product shipped to
customers constitutes a mix of residual carbon dioxide
produced on that date as well as all previous dates.
MANUFACTURER Praxair, Inc., Loudon, Tennessee.
RECALLED BY Manufacturer, by telephone and letter beginning on
February 18, 1997, and ending February 26, 1997.
Firm-initiated field correction complete.
DISTRIBUTION Tennessee, Kentucky, Florida, Virginia,
Pennsylvania, New York.
QUANTITY Undetermined.
REASON Product was contaminated with low levels of carbonyl
sulfide.

_______________
PRODUCT Sarabeth's Kitchen Blood Orange Marmalade, in 9 ounce
and 18 ounce glass jars.
Recall #F-505-7.
CODE All codes/lots manufactured prior to April 4, 1997. Firm-initiated recall ongoing.
MANUFACTURER S.B.K. Preserves, Inc., doing business as
Sarabeth's Kitchen, New York, New York.
RECALLED BY Manufacturer, by letter sent on April 18, 1997,
and by press release. Firm-initiated recall
ongoing.
-4-DISTRIBUTION Nationwide.
QUANTITY Undetermined. Firm estimates little if any product
remain on the market.
REASON Product contains undeclared sulfites.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS
III ==========
_______________
PRODUCT Lithobid (Lithium Carbonate extended release tablets,
300 mg, packaged in bottles of 100 and 1000, Rx used
for the treatment of depression and bipolar disease.
Recall #D-217-7.
CODE Lot numbers: 86864 (100s) and 86848 (1000s).
MANUFACTURER Solvay Pharmaceuticals, Baudett, Minnesota.
RECALLED BY Solvay Pharmaceuticals, Marietta, Georgia, by
telephone on April 17, 1997 and by letter on May
23, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 13,917 100-tablet bottles and 1,432 1000-tablet bottles
were distributed.
REASON Dissolution failure (stability).

_______________
PRODUCT Phenylhistine Expectorant, Antitussive- Decongestant
Expectorant, each 5 ml contains: Codeine Phosphate (10
mg.), Pseudoephedrine Hydrochloride (30 mg.),
Guaifenesin (100 mg.) and Alcohol (7.5%) in bottles of
4 fluid ounces and 16 fluid ounces, packaged under the
Vintage and Qualitest labels.
Recall #D-223-7.
CODE Lot No. 012J6, EXP 10/98 (Qualitest/Vintage), 012J6A,
012J6B, 012J6C, 012J6D, 012J6E.
MANUFACTURER Vintage Pharmaceuticals, Inc., Huntsville,
Alabama.
RECALLED BY Manufacturer, by telephone followed by letter
dated May 9, 1997. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 8,149 4-fluid ounce bottles and 5,766 16-fluid ounce
bottles were distributed.
REASON Product lacks stability for the Codeine Phosphate
ingredient with the six (6) month assay falling below
specification (subpotent).

_______________
PRODUCT Sterile Saline 0.9%, For Irrigation purposes only, 110
mL, in prefilled graduates, Rx.
Recall #D-224-7.

-5-CODE Catalog No. 5501: 4 lot numbers: 7775, 7804, 7806, 7813;
Catalog No. 5501R: 3 lots numbers: 7805, 7807, 7814.
Expiration Date 7/99 for the above 7 lots.
MANUFACTURER Intermed/Allstate, A Division of Urohealth
Systems, Inc., Sparta, New Jersey.
RECALLED BY Manufacturer, by fax on or about September 12,
1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 2,386 cases (84,192 vials) were distributed.
REASON Labeling error -- Some units of sterile saline were
labeled as sterile water.

_______________
PRODUCT Lithium Carbonate Tablets, USP, 300 mg, packaged in
bottles of 100, Rx prescribed as remedial and/or
maintenance drug therapy for the treatment of
individuals diagnosed with manic episodes
characterizing Bipolar Disorders. Recall #D-225-7.
CODE Lot #961458 EXP 6/1/98.
MANUFACTURER Roxane Laboratories, Inc., Columbus, Ohio.
RECALLED BY Manufacturer, by letter on June 16, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 9,455 bottles were distributed; firm estimated that 20%
of product remained on market at time of recall
initiation.
REASON Product fails dissolution specification (stability).

_______________
PRODUCT Histalet Forte Tablets, antihistamine-decongestant(Phenylpropanolamine HCl 50 mg/Pyrilamine
Maleate 25 mg/Phenylephrine HCl 10 mg/Chlorpheniramine
Maleate 4 mg), packaged in 20, 100 and 250 tablet
bottles.
Recall #D-226-7.
CODE Lot numbers: F960551A - 250 tablet bottles
F960551B - 100 tablet bottles
X960778A - 20 tablet bottles **
X960778B - 250 tablet bottles
X960778C - 100 tablet bottles
**repackaged into bottles of 100's.
MANUFACTURER Mikart, Inc., Atlanta, Georgia.
RECALLED BY Manufacturer, by letter on May 20, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Arizona, California, Florida,
Massachusetts, Maryland, Missouri, Mississippi,
North Carolina, New Jersey, Ohio, Oklahoma, Texas.

-6-QUANTITY Lot F960551A - 376 bottles were shipped
Lot F960551B - 3727 bottles were shipped
Lot X960778A - 9919 bottles were shipped
Lot X960778B - 259 bottles were shipped
Lot X960778C - 2160 bottles were shipped.
REASON Product failed content uniformity (validation).

_______________
PRODUCT 1% Lidocaine HCl Injection, USP, 10 mg/ml, 50 ml
multiple dose vials held in shelf packs of 25 vials, Rx
SVP for production of local or regional anesthesia.
Recall #D-227-7.
CODE Lot #23-198-DK.
MANUFACTURER Abbott Laboratories, Rocky Mount, North Carolina.
RECALLED BY Abbott Laboratories, Hospital Products Division,
Abbott Park, Illinois, by letter dated June 26,
1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and The Netherlands.
QUANTITY 180,250 vials were distributed; firm estimated that 20%
of product remained on the market at time of recall
initiation.
REASON Mispackaged -- Correctly labeled 2% vial packaged in 1%
labeled shelf pack.

________________
PRODUCT Acetaminophen Tablets, 325 mg, OTC analgesic, in 100
tablet plastic bottles.
Recall #D-229-7.
CODE Lot #100166 EXP 4/98.
MANUFACTURER AAA Pharmaceutical, Inc., Paulsboro, New Jersey.
RECALLED BY Manufacturer, by telephone and fax on March 28,
1997. Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 649 bottles were distributed; firm estimates none
remains on the market.
REASON Labeling -- Incorrect lot number.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Corneal Tissues for Transplant: Corneal Human Tissue.
Recall #B-750-7.
CODE Donor numbers: 93-4437/8, 93-4441/4, 93-4449, 93-4451,
93-4453/6, 93-4463, 93-4465/6, 93-4469/70, 93-4473/6,
93-4479, 93-4483/90, 93-4493/8, 93-4501/2, 93-4507, 93-4509,
93-4511/3, 93-4515/6, 93-4520, 93-4523/32,

-7- 93-4537/40, 93-4543/4, 93-4546, 93-4549/52, 93-4557/62,
93-4567/70, 93-4572, 93-4577/82 and unit numbers
94-0021/0022, 96-1563/1564.
MANUFACTURER Lions Eye Bank of Texas, Baylor College of
Medicine, Houston, Texas.
RECALLED BY Manufacturer, by letter dated April 8, 1997.
Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY All recalled product has been transplanted and none
remains in stock.
REASON Human Tissues for Transplant which: Were not tested
for HIV-2; Donor's corneas tested repeat reactive for
anti-HIV-1/2; One donor's blood may have been
hemodiluted during viral marker testing.

_______________
PRODUCT Platelets. Recall #B-880-7.
CODE Unit #16LR10733.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
RECALLED BY Manufacturer, by letter dated May 20, 1997. Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of Whole Blood
with an extended collection time.

_______________
PRODUCT Platelets, Pheresis. Recall #B-993-7.
CODE Unit #4501025.
MANUFACTURER Carter Blood Center, Fort Worth, Texas.
RECALLED BY Manufacturer, by telephone on May 28, 1997. Firm-initiated recall complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration
date.

_______________
PRODUCT Red Blood Cells. Recall #B-1000-7.
CODE Unit #LH02831.
MANUFACTURER Irwin Memorial Blood Centers, San Francisco,
California.
RECALLED BY Manufacturer, by letter dated February 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with an
unacceptable hematocrit.

-8-_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1002/1003-7.
CODE Unit #1293480.
MANUFACTURER Central Kentucky Blood Center, Lexington,
Kentucky.
RECALLED BY Manufacturer, by letter dated December 12, 1996.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who traveled
to an area considered endemic for malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-1004-7.
CODE Unit #11316-1302.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on May 5, 1997. Firm-initiated recall
complete.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled
to an area considered endemic for malaria.

_______________
PRODUCT Platelets. Recall #B-1005-7.
CODE Unit #5025918.
MANUFACTURER Lorain County Blood Bank, Inc., Elyria, Ohio.
RECALLED BY Manufacturer, by telephone on September 27, 1996.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled
to an area considered endemic for malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-1006-7.
CODE Unit #732277.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by letter dated February 18, 1997.
Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled
to an area considered endemic for malaria.

-9-_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1007/1008-7.
CODE Unit numbers: 5010831, 5014851, 5027455.
MANUFACTURER Lorain County Blood Bank, Inc., Elyria, Ohio.
RECALLED BY Manufacturer, by telephone on January 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio.
QUANTITY 3 units of each component were distributed.
REASON Blood products were collected from a donor who traveled
to an area considered endemic for malaria.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1009/1010-7.
CODE Unit #2004042.
MANUFACTURER Lorain County Blood Bank, Inc., Elyria, Ohio.
RECALLED BY Manufacturer, by telephone on October 8, 1996, and
by letter dated November 25, 1996. Firm-initiated
recall complete.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who traveled
to an area considered endemic for malaria.

_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma.
Recall #B-1011/1012-7.
CODE Unit #M90301.
MANUFACTURER Topeka Blood Bank, Inc., doing business as Kansas
Blood Services, Topeka, Kansas.
RECALLED BY Manufacturer, by telephone on March 28, 1996.
Firm-initiated recall complete.
DISTRIBUTION Missouri and Kansas.
QUANTITY 1 unit of each component was distributed.
REASON Blood products with an elevated ALT result were labeled
as negative.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1016/1017-7.
CODE Unit #11314-6490.
MANUFACTURER United Blood Services, El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on May 5, 1997. Firm-initiated recall
complete.
DISTRIBUTION Texas and New Mexico.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were prepared from a unit of Whole Blood
designated as overweight.

-10-_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-1018/1019-7.
CODE Unit numbers: a) 1258143; b) 1258143 and 1273695.
MANUFACTURER Central Kentucky Blood Center, Lexington,
Kentucky.
RECALLED BY Manufacturer, by telephone on December 16 and 23,
1996. Firm-initiated recall complete.
DISTRIBUTION Kentucky.
QUANTITY a) 1 unit; b) 2 units were distributed.
REASON Blood products were collected from a donor who traveled
to an area considered endemic for malaria.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1029/1030-7.
CODE Unit #42H98740.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated May 27, 1997. Firm-initiated recall complete.
DISTRIBUTION Ohio and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who was
taking the drug Proscar.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1031/1032-7.
CODE Unit #42G02452.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letters dated December 23 and 18,
1996. Firm-initiated recall complete.
DISTRIBUTION Ohio and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who was
taking the drug Zovirax.

_______________
PRODUCT Platelets. Recall #B-1033-7.
CODE Unit #49F97919.
MANUFACTURER American Red Cross Blood Services, Waco, Texas.
RECALLED BY American Red Cross Blood Services, Tulsa,
Oklahoma, by telephone on May 2, 1997, followed by
letter dated May 5, 1997. Firm-initiated recall
complete.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.

-11-REASON Blood product corresponded to a unit of Red Blood Cells
that was reported as clotted.

_______________
UPDATE Recall #B-886/888-7, Red Blood Cells; Platelets;
Plasma, which appeared in the June 11, 1997 Enforcement
Report is being rescinded. Information included in
this recall is identified as Recall #B-616/618-6.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma. Recall #B-997/999-7.
CODE Unit #24KK71562.
MANUFACTURER American Red Cross Blood Services, Louisville,
Kentucky.
RECALLED BY Manufacturer, by letter dated April 11, 1997.
Firm-initiated recall complete.
DISTRIBUTION Kentucky and Indiana.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking an
experimental CMV vaccine.

_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-1021/1022-7.
CODE Unit numbers: a) 1007028, 1018619, 1018623; b) 1005271,
1007028.
MANUFACTURER Community Blood Center, Dayton, Ohio.
RECALLED BY Manufacturer, by letter dated February 25, 1997 or
April 1, 1997, and March 18, 1997, and April 28,
1997. Firm-initiated recall complete.
DISTRIBUTION Ohio and California.
QUANTITY a) 3 units; b) 2 units were distributed.
REASON Blood products were collected in expired collection
bags.

_______________
PRODUCT Red Blood Cells. Recall #B-1037-7.
CODE Unit numbers: 40GV09619, 40GV09620, 40GV09621, 40GV09622,
40GV09623, 40GV09624, 40GV09625, 40GV09626, 40GV09627,
40GV09628, 40GV09629, 40GV09630, 40GV09631, 40GV09632,
40GV09633, 40GV09634, 40GV09635, 40GV09636, 40GV09637,
40GV09639.
MANUFACTURER American Red Cross Blood Services, Peoria,
Illinois.
RECALLED BY Manufacturer, by telephone on June 2, 1997, and by
letter dated June 13, 1997. Firm-initiated recall
complete.
-12-DISTRIBUTION Illinois, Missouri, Tennessee, California,
Pennsylvania.
QUANTITY 20 units were distributed.
REASON Blood products were stored at an unacceptable
temperature.

_______________
UPDATE Recall #B-781/782-7, Streptokinase Kabikinase, a
sterile purified preparation of bacterial protein
elaborated by group C B-hemolytic streptococci, which
appeared in the June 4, 1997, Enforcement Report is
being updated as follows:
a) Streptokinase Kabikinase 250,000 IU, lot 14476A51; b)
Streptokinase Kabikinase 1,500,000IU, lot 14304A51.
Additional information from the firm indicates portions of
these lots were labeled MANUFACTURED BY: Kabi Pharm., Inc.,
Uppsala, Sweden DISTRIBUTED BY: Kabi Pharm., Inc.,
Pischataway, New Jersey.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =========
_______________
PRODUCT Microaire Pulse Lavage Tube Sets and Pulse Lavage Hip
Sets, used with the Pulse Lavage Handpiece 4740-000, a
precision instrument for debriding bone surfaces as
well as cleansing trauma and other soft tissue wounds.
Recall #Z-705/708-7.
CODE Product Number Lot Number
a) 4740-060 129624156
4740-060 019724464
4740-060 029725355
b) 4740-061 119623581
4740-061 119623582
4740-061 119623583
4740-061 019724833
4740-061 029724834
4740-061 029725487, 039725776
c) 4740-062 119623858
4740-062 129623048
4740-062 129624155
4740-062 129624395
4740-062 019724465
4740-062 039725707
d) 5600-70 DePuy Lot N0. R98AK4000
DePUY Product MicroAire Lot No. 019724466.
MANUFACTURER Microaire Surgical Instruments, Charlottesville,
Virginia.
RECALLED BY Manufacturer, by letters dated April 15 and 28,
1997. Firm-initiated recall ongoing.
-13-DISTRIBUTION Nationwide and international.
QUANTITY 1,389 tubing set units and 197 hip set units were
distributed.
REASON The devices are subject to separation at the joint
between the nose connection and the pump body of the
product which could result in the nozzle falling into
the surgical field.

_______________
PRODUCT Anesthesia Gas Sampling Tee Connector, Part No. 92002,
and Anesthesia Circuits which Contain the Gas Sampling
Tee Connector:
a) Ohmeda brand Gas Sampling Straight Tee (Plastic);
b) SpaceLabs Medical brand TRU-LINK DISPOSABLE ANESTHETIC
AGENT SAMPLE LINE WITH GAS SAMPLING TEE for use with 90518
Multigas Analyzer;
c) SpaceLabs Medical brand TRU-LINK DISPOSABLE ANESTHETIC
AGENT SAMPLE LINE WITH GAS SAMPLING TEE for use with 90518
Multigas Analyzer;
d) Gibeck brand Gas Sampling
e) Gibeck brand Gas Sampling
f) Gibeck brand Mass Spec Straight Tee
g) Gibeck brand Gas Sampling Tee
h) Gibeck brand Adult Anesthesia Breathing Circuit
i) Gibeck brand Pediatric Anesthesia Breathing Circuit
j) Gibeck brand Adult Anesthesia Breathing Circuit
k) Gibeck brand Gas Sampling Tee with Luer
l) Gibeck brand Pediatric Anesthesia Breathing Circuit
m) Gibeck brand Adult Anesthesia Breathing Circuit
n) Gibeck brand Mass Spec Tee w/Cap Put Label (Criticare)
o) Gibeck brand Gas Sampling Tee & Cap Put Label (Datex).
Recall #Z-711/725-7.
CODE a) Product No. 6027-0000-019; Lot No. M027794.
b) Product 015-0312-00; Lot No. M027658.
c) Product No. 015-0313-00; Lot No. M027659.
d) Product No. 126213-BQW; Lot No. M028791.
e) Product No. 12820, Lot Nos. M029039, P003583, and
P003612.
f) Product No. 12820B; Lot No. M027901.
g) Product No. 12820-150, Lot Nos. MO28219 and M028360.
h) Product No. 16303-742; Lot Nos. C033964, C034071,
C034157, and C034247.
i) Product No. 16511-742; Lot No. C034073.
j) Product No. 173232-BPG; Lot No. C033735.
-14- k) Product 24432; Lot No. M028809.
l) Product 304-0002-710; Lots No. C034015 and C034262.
m) Product No.304-0001-724; Lot Nos. C034229, C034032, and
C034401.
n) Product No. 41439B001; Lot No. M027488.
o) Product No. 73385; Lot No. M028990.
MANUFACTURER Gibeck, Inc., Indianapolis, Indiana.
RECALLED BY Manufacturer, by letter on April 21, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 53,800 connectors were distributed.
REASON The gas sampling tee connector was observed to be
partially occluded by a thin molded membrane inside the
connector.

_______________
UPDATE Recall #Z-452/453-7, Sonoline Prima and Versa Pro
Ultrasound Systems with Enhanced OB Calculation Package
Option, which appeared in the May 7, 1997 Enforcement
Report has been extended to include the firms issuance
of a second letter alerting users of additional
software errors (erroneous onscreen growth curve
information).

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END OF ENFORCEMENT REPORT FOR JULY 16, 1997. BLANK PAGES MAY FOLLOW.

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End of Enforcement Report for