FDA Enforcement Report For 12/17/97

[FDA]

_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._
_________________________________________________________________

December 17, 1997 97-51
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II ===========
_______________
PRODUCT Various Food Additives (artificial flavors):
(1) Monte Bianco Pistachio Cream, in 1 kg can
(2) Monte Bianco Lemon Syrup in glass bottles,
net content 100 cl.
(3) Monte Bianco Mint Syrup in glass bottles,
net content 100 cl.
(4) Monte Bianco Amerena (Cherry) Syrup in
glass bottles, net contents 100 cl.
(5) Monte Bianco Orange Syrup in glass bottles
100 cl.
(6) Monte Bianco Wild Strawberry Paste in
glass bottles, net weight 2 Kg.
(7) Monte Bianco Vanilla Expo paste
in metal cans, net weight 3 Kg.
(8) Perugina Pistachio Oro paste in metal
cans, net weight 6 Kg.
(9) Monte Bianco Rippy Kiwi in bottles,
net weight 1 Kg.
(10) Monte Bianco Rippy Strawberry in bottles
net weight 1 Kg.
(11) Monte Bianco Paste Banana in metal cans,
net weight 5 Kg.
(12) Monte Bianco Kiwi Paste in metal tins of
1.250 Kg. in a carton
(13) Monte Bianco Tropical Lime Paste in metal
tins of 1.250 Kg. in a carton
(14) Monte Bianco Salsa "Tropical Lime" in
metal tins, net weight 1.250 Kg., 6 tins
in a carton
(15) Monte Bianco Doppia Frutta Pear in metal
tins, net weight 1.250 Kg, 12 Tins in
a carton
(16) Monte Bianco Doppia Frutta Pear (new
label), net weight 3 Kg.
(17) Monte Bianco Cherry in Syrup (Amarena
Composta) in metal tins, 2 tins of 5 Kg.
in a carton
(18) Perugina Doppia Menta Paste in cans, net
weight 11 pounds 3/8 ounces.
Recall #F-008/025-8.
CODE Item #695, Monte Bianco Pistachio Crema
Item #770, Monte Bianco Lemon (Limone) syrup
Item #775, Monte Bianco Mint (Menta) syrup
Item #760, Monte Bianco Amarena syrup
Item #765, Monte Bianco Orange (Arancia) syrup
Item #803, Monte Bianco Wild Strawberry
(Fragolina di Bosco)
Item #535, Monte Bianco Vanilla Expo
Item #SMP755, Monte Bianco Rippy Kiwi
Item #SMP515, Monte Bianco Rippy Strawberry
Item #610, Monte Bianco Paste Banana
Item #740, Monte Bianco Paste Kiwi
Item #730, Monte Bianco Pasta Tropical Lime
Item #735, Monte Bianco Salsa Tropical Lime
Item #680, Monte Bianco Doppia Frutta Pear
Item #681, Monte Bianco Doppia Frutta Pear
(new)
Item #620, Monte Bianco Cherry in syrup
(Amarena composta)
Item #2416, Perugina Pistachio Oro
Item #0534, Perugina Pasta Doppia menta.
MANUFACTURER The manufacturer for the Montebianco products
is: Montebianco s.P.A., San Giuliano
Milanese, Milan, Italy
The manufacturer for the Perugina product is:
Perugina Sede Coperativa, San Sisto, Milan,
Italy.
RECALLED BY Colavita, USA, Linden, New Jersey
(distributor/importer), by letters on August
4 and 18, 1997, followed by telephone.
Firm-initiated recall ongoing.
DISTRIBUTION New York, New Jersey, Pennsylvania, California,
Nevada, Missouri, Texas, Ohio, Florida, Tennessee,
Washington state.
-2-
QUANTITY 3,150 units of the products were distributed.
REASON Products 1, 3, 4, 5, 6, 8, 9, 10, 12, 13, 14,
17 & 18 contain unapproved color additives.
Products 2, 3, 5, 7, 8, 9, 11, 12, 13, 14, 15
& 16 contain undeclared FD&C Yellow No. 5.
Products 7 & 14 contain undeclared FD&C
Yellow No. 6.

_______________
PRODUCT Chile Flavored Corn Stixs (Mexsnax Corn Churritos
de Maiz) 5 and 7 ounce sizes.
Recall #F-140-8.
CODE All codes 72297 or less.
MANUFACTURER Gonzales Fried Products, Dallas, Texas.
RECALLED BY Manufacturer, by letter on April 23, 1997.
Texas Department of Health initiated recall
complete.
DISTRIBUTION Texas, Kansas, Missouri.
QUANTITY 90,000 units were distributed.
REASON The product contains undeclared Yellow No. 5
and Yellow No. 6.

RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Happy Harvest Grade A Sweet Peas, in 15 ounce
cans. Recall #F-187-8.
CODE 7303*/ZF14K, where "*" = A, B, or C.
MANUFACTURER Nabisco Ltd. - Canada, Ontario, Canada.
RECALLED BY Aldi Inc., Batavia, Illinois, by electronic mail
message on November 19, 1997. Firm-initiated
recall complete.
DISTRIBUTION Ohio, Michigan, Pennsylvania, Indiana, Illinois,
Kentucky, West Virginia, New York, New Jersey,
Connecticut.
QUANTITY 10,289 cases (24 cans per case) were distributed.
REASON The product was contaminated with insect filth.

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I ============
_______________
PRODUCT OTC Skin-Cap Spray, Cream, and Shampoo
(Pyrithione Zinc), all sizes, all strengths:
a) Pyrithione Zinc Hair Shampoo, contained in a
white plastic bottle with a blue label, made in
Spain, and is packaged in a cardboard box with
blue bubbles printed on it. Boxes are packed 200
units to a case.

-3-

b) Pyrithione Zinc Topical Spray, contained in a
blue can with a white cap, packaged in a blue
cardboard box. Boxes are packed 200 units to a
case.
c) Pyrithione Zinc Topical Cream, contained in a
white plastic tube printed in blue and black, made
in Spain, the tubes are packed into a cardboard
box labeled similarly to the tube, but also with a
lot number and expiration date. The boxes are
packed 200 units to the case.
d) Skin Cap DISPLAY units which are promotional
displays given to distributors which contain each
of the above listed products to aid in the sales
of the product.
Recall #D-273/275-7.
CODE All codes and expiration dates.
MANUFACTURER Aerosols Preval, Complejo Industrial, Madrid,
Spain (contract manufacturer).
RECALLED BY Cheminova America, Miami, Florida
(importer/initial distributor), by fax on
September 4, 1997, and by mail on September 8,
1997. Firm-initiated recall ongoing. See also
FDA Statement dated August 8, 1997.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY Amount distributed is undetermined; firm estimated
that 19,916 units were in commerce at time of
recall initiation.
REASON Presence of undeclared clobetasol propionate
(corticosteroids).

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Fresh Frozen Plasma; d) Cryoprecipitated
AHF; e) Recovered Plasma.
Recall #B-158/162-8.
CODE Unit numbers: a) 29095-7127, 29094-0731
b) 29094-0731; c) 29094-0731
d) 29095-7127; e) 29095-7127.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated September 8, 1997, and by fax on
September 10, 1997. Firm-initiated recall
complete.
DISTRIBUTION Illinois and Switzerland.
QUANTITY a) 2 units; b-e) 1 unit of each component was
distributed.
REASON Blood products were collected from a donor who
had been deferred for a previous blood
exposure.

-4-
_______________
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
Recall #B-174/175-8.
CODE Unit numbers: 17030-0853, 17028-9687.
MANUFACTURER United Blood Services, McAllen, Texas.
RECALLED BY United Blood Services, Scottsdale, Arizona, by
letter dated September 8, 1997. Firm-initiated
recall complete.
DISTRIBUTION Tennessee, Texas, Florida, North Carolina.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor who had
been deferred for a previous blood exposure.

_______________
PRODUCT Human Tissue for Transplant:
a) Human Corneal Tissue; b) Whole Eye Globes.
Recall #B-224/225-8.
CODE All product harvested and distributed between the
date of the interim rule on Human Tissue Intended
for Transplantation (12/04/93) and the date the
firm received the final rule (04/30/97).
MANUFACTURER Utah Lions Eye Bank, Salt Lake City, Utah.
RECALLED BY Manufacturer, by letter dated November 3, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Utah and California.
QUANTITY a) 73 units; b) 2 units were distributed.
REASON Human Tissues for Transplant were collected from
donors who tested repeat reactive for HBsAg,
supplemental testing as negative.

_______________
PRODUCT Red Blood Cells. Recall #B-239-8.
CODE Unit #1825820.
MANUFACTURER Department of the Army, Dwight D. Eisenhower Army
Medical Center, Fort Gordon, Georgia.
RECALLED BY Manufacturer, by telephone on January 3, 1997.
Firm-initiated recall complete.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for the
hepatitis B surface antigen (HBsAg).

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-295/296-8.
CODE Unit numbers: a) LC20537 and LC21973;
b) LC21973.
MANUFACTURER The Blood Center of Central Iowa, Des Moines,
Iowa.
RECALLED BY Manufacturer, by letter dated July 2, 1997.
Firm-initiated recall complete.
-5-
DISTRIBUTION Iowa.
QUANTITY a) 2 units; b) 1 unit 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) Platelets.
Recall #B-297/298-8.
CODE Unit numbers: KW15804 and KW17145;
b) KW17145.
MANUFACTURER The Blood Center of Central Iowa,
Des Moines, Iowa.
RECALLED BY Manufacturer, by letter dated July 21, 1997.
Firm-initiated recall complete.
DISTRIBUTION Iowa.
QUANTITY a) 2 units; b) 1 unit 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) Platelets.
Recall #B-299/300-8.
CODE Unit numbers: a) KR91157, KR97113, KT81005
b) KR91157 and KR97113.
MANUFACTURER The Blood Center of Central Iowa,
Des Moines, Iowa.
RECALLED BY Manufacturer, by letter dated June 30, 1997.
Firm-initiated recall complete.
DISTRIBUTION Iowa and Colorado.
QUANTITY a) 3 units; b) 2 units were distributed.
REASON Blood products were collected from a donor who
traveled to an area considered endemic for
malaria.

_______________
PRODUCT Red Blood Cells. Recall #B-301-8.
CODE Unit numbers: KC95C215 and KC92716.
MANUFACTURER The Blood Center of Central Iowa,
Des Moines, Iowa.
RECALLED BY Manufacturer, by letter dated June 27, 1997, July
8 and 15, 1997, and September 19, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas and Massachusetts.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor
who traveled to an area considered endemic for
malaria.

_______________
PRODUCT Platelets. Recall #B-302-8.
CODE Unit #10534-5651.
-6-
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated October 7, 1997. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of whole
blood with an extended collection time.

_______________
PRODUCT Platelets. Recall #B-303-8.
CODE Unit #10533-1733.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on July 30, 1997. Firm-initiated recall
complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of whole
blood with an extended collection time.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-304/305-8.
CODE Unit #10522-3097.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on April 9, 1997. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
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 Platelets. Recall #B-306-8.
CODE Unit #10525-3787.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on February 25, 1997. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product was distributed after receipt of
post donation information reporting receipt of a
tattoo within 12 months of donation.

_______________
PRODUCT a) Red Blood Cells; b) Platelets
c) Cryoprecipitated AHF
d) Recovered Plasma. Recall #B-312/315-8.

-7-
CODE Unit numbers: a) FM88103 and GM25222
b) FM88103 and GM25222; c) FM88103
d) FM88103 and GM25222.
MANUFACTURER Lifeblood/Mid-South Regional Blood Center,
Memphis, Tennessee.
RECALLED BY Manufacturer, by letter dated February 14,
1996. Firm-initiated recall complete.
DISTRIBUTION Arizona, Tennessee, Florida.
QUANTITY a) 2 units; b) 2 units; c) 1 unit;
d) 2 units were distributed.
REASON Blood products were collected from a donor
taking the drug Proscar.

_______________
PRODUCT Red Blood Cells. Recall #B-322-8.
CODE Unit #21GK69747.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated October 10, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
reported travel to an area designated as endemic for
malaria.

_______________
PRODUCT Platelets, Pheresis. Recall #B-323-8.
CODE Unit #21-P69323.
MANUFACTURER American Red Cross, Portland, Oregon.
RECALLED BY Manufacturer, by letter dated July 24, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product had a platelet yield above the
acceptable limit.

_______________
PRODUCT Red Blood Cells. Recall #B-325-8.
CODE Unit numbers: 1624226, 1644612, 1645152.
MANUFACTURER Mississippi Blood Services, Inc., Jackson,
Mississippi.
RECALLED BY Manufacturer, by letter dated September 29, 1997.
Firm-initiated recall complete.
DISTRIBUTION Mississippi.
QUANTITY 3 units were distributed.
REASON Blood products were air contaminated during
leukodepletion.

_______________
PRODUCT Platelets, Pheresis (split product).
Recall #B-326-8.
CODE Unit #KZ41641.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
-8-
RECALLED BY Manufacturer, by telephone on February 18 or 20,
1997. Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended
expiration date.

_______________
PRODUCT a) Red Blood Cells
b) Platelets and Platelets, Pheresis
c) Fresh Frozen Plasma; d) Plasma
e) Cryoprecipitated AHF. Recall #B-328/332-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled.
MANUFACTURER Central Kentucky Blood Center, Lexington,
Kentucky.
RECALLED BY Manufacturer, by letters dated February 20 or 21,
1997. Firm-initiated recall complete.
DISTRIBUTION Kentucky, Florida, Texas, New Jersey, Illinois,
North Carolina, Massachusetts, Connecticut, Maine,
Arizona, Maryland, California.
QUANTITY Red Blood Cells, 574 units;
Platelets, 326 units
c) Platelets, expired, 18 units
Fresh Frozen Plasma, 150 units
Cryoprecipitated AHF, 69 units
Plasma, 6 units
Recovered Plasma, 55 units were distributed.
REASON Blood products were collected from donors
whose medical history screening was
incomplete.

_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Recovered Plasma. Recall #B-341/343-8.
CODE Unit #31LV00197.
MANUFACTURER American Red Cross Blood Services, Buffalo,
New York.
RECALLED BY Manufacturer, by letter dated January 3, 1996, and
by fax on January 16, 1996. Firm-initiated recall
complete.
DISTRIBUTION New York.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
received a tattoo within 12 months of donation.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
Recall #B-345/346-8.

-9-
CODE Unit #V32910.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
RECALLED BY Manufacturer, by letter dated October 9 or 14,
1997. Firm-initiated recall complete.
DISTRIBUTION Illinois and Indiana.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who
reported travel to an area designated as endemic
for malaria.

_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Recovered Plasma. Recall #B-348/350-8.
CODE Unit numbers: a) 49F95927 and 49W15371
b) 49W15371; c) 49F95927 and 49W15371.
MANUFACTURER American Red Cross Blood Services, Tulsa,
Oklahoma.
RECALLED BY Manufacturer, by letter dated August 21, 1997,
or September 25, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION California, Oklahoma, Texas.
QUANTITY a) 2 units; b) 1 unit; c) 2 units were
distributed.
REASON Blood products tested negative for the
antibody to the human immunodeficiency virus
type 1 (anti-HIV-1), but were collected from
a donor who previously tested repeatedly
reactive for anti-HIV-1, Western Blot
indeterminate.

_______________
PRODUCT Cryoprecipitated AHF. Recall #B-351-8.
CODE C63578, C63999, C64507, C64508, C64567,
C64608, C65021, C65049, C65069, C67017,
C67029, C67043, C67061, C67927, C68092,
C68095, C68633, C68634, C68645, C70564,
C70575, C70943, C71278, C71283, C73483,
C73496, C73499, C73500, C73504, C73735,
C73751, C73770, C73777, C73780, C74934,
C75889, C76041, C76205, C76213, C76214,
C76411, C77079, C77100, C77111, C78912,
C79269, C82986, C82993, C83275, C83278,
C83285, C83286, C83431, C83469, C83599,
C83604, C83621, C87556, C87558, C87559,
C87565, C87567, C87577, C87870, C89453,
C89462, C89463.
MANUFACTURER Regional Health Resources Center, Urbana,
Illinois.
RECALLED BY Manufacturer, by telephone and fax on August 14,
1997, followed by letter sent on August 29, 1997,
September 3 and 9, 1997. Firm-initiated recall
complete.
-10-
DISTRIBUTION Illinois and Ohio.
QUANTITY 67 units were distributed..
REASON Cryoprecipitated AHF was incorrectly processed.

_______________
PRODUCT Platelets, Pheresis. Recall #B-352-8.
CODE Unit #49407P.
MANUFACTURER Lane Memorial Blood Bank, Eugene, Oregon.
RECALLED BY Manufacturer, by letter dated October 30, 1996.
Firm-initiated recall complete.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product did not meet the minimum platelet
count specifications.

_______________
PRODUCT a) Red Blood Cells; b) Platelets;
c) Fresh Frozen Plasma. Recall #B-353/355-8.
CODE Unit #49N12007.
MANUFACTURER American Red Cross, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by telephone on September 4, 1997,
and by letter dated September 9, 1997.
Firm-initiated recall complete.
DISTRIBUTION Oklahoma and Texas.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking
the drug Proscar.

_______________
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma;
c) Platelets, for further manufacture.
Recall #B-356/358-8.
CODE Unit numbers: a) 49Q45069, 49X40893;
b) 49X40893; c) 49X40893.
MANUFACTURER American Red Cross, Tulsa, Oklahoma.
RECALLED BY Manufacturer, by telephone on September 23, 1997,
and by letter dated September 26, 1997.
Firm-initiated recall complete.
DISTRIBUTION Texas and Illinois.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit was distributed.
REASON Blood products were collected from a donor taking
the drug Methotrexate.

_______________
PRODUCT a) Red Blood Cells; b) Platelets.
c) Fresh Frozen Plasma.
Recall #B-359/361-8.
CODE Unit numbers: a) 24KJ23992, 24KJ26527, 24KJ27447; b) 24KJ26527;
c) 24KJ23992, 24KJ26527, 24KJ27447.

-11-
MANUFACTURER American Red Cross, Louisville, Kentucky.
RECALLED BY Manufacturer, by letter dated October 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Indiana, Kentucky, Maryland.
QUANTITY a) 3 units; b) 1 unit; c) 3 units were
distributed.
REASON Blood products were collected from donor
taking the drug, Amantadine.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======
_______________
PRODUCT Autologous Red Blood Cells.
Recall #B-238-8.
CODE Unit #KP42063.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on March 21, 1997.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product which confirmed positive for
syphilis was distributed without a biohazard
label.
______________
PRODUCT Source Plasma. Recall #B-240-8.
CODE Unit numbers: 79822800, 75471354, 75471767,
79885188.
MANUFACTURER Simi Biological Resources, Inc., doing
business as Muskogee Plasma Center, Muskogee,
Oklahoma.
RECALLED BY Manufacturer, by fax on September 12, 1997.
Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 4 units were distributed.
REASON Blood products were untested for syphilis.

_______________
PRODUCT Platelets, Pheresis. Recall #B-241-8.
CODE Unit numbers: R01481, R01483, R01487, R01488,
R01489, R01490, R01491, R01493, R01494, R01495,
R01496, R01497, R01498, LP00106, LP00109,
LP00110, LP00113.
MANUFACTURER Carolina-Georgia Blood Center, Greenville, South
Carolina.
RECALLED BY Manufacturer, by fax on April 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, Georgia, Illinois, North Carolina,
Utah.
QUANTITY 19 units (includes 2 split products) were
distributed.

-12-
REASON Unlicensed blood products were labeled with the
firm's license number and distributed interstate.

_______________
PRODUCT Source Plasma. Recall #B-270-8.
CODE Unit numbers: EUN660, EUN661, EUN662, EUN663,
EUN664, EUN665, EUN666, EUN667, EUN668,
EUN669.
MANUFACTURER Plasma Services of Scottsdale,
Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
letter dated April 28, 1995. Firm-initiated
recall complete.
DISTRIBUTION New Jersey, New York, Switzerland.
QUANTITY 10 units were distributed.
REASON Blood products may have been exposed to
unacceptable storage temperatures and were
not relabeled as Source Plasma, Salvaged.

_______________
PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated.
Recall #B-294-8.
CODE Units: 17FH52378 and 17FH52345.
MANUFACTURER American Red Cross Blood Services, St. Paul,
Minnesota.
RECALLED BY Manufacturer, by telephone on February 13, 1997.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin.
QUANTITY 2 units were distributed.
REASON Unlicensed blood product was distributed in
interstate commerce.

_______________
PRODUCT Red Blood Cells. Recall #B-307-8.
CODE Unit numbers: 10519-6422, 10519-6419, 10519-6423,
10519-4397, 10519-8880.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by
telephone on November 7, 1996. Firm-initiated
recall complete.
DISTRIBUTION Arizona.
QUANTITY 5 units were distributed.
REASON Blood products were shipped at an unacceptable
temperature were redistributed in error.

_______________
PRODUCT Reagent Red Blood Cells, Panel Two and Ficin Panel
TWO System. Recall #B-309-8.
CODE Lot #0708.
MANUFACTURER Gamma Biologicals, Inc., Houston, Texas.

-13-
RECALLED BY Manufacturer, by letter dated July 10, 1997,
followed by fax. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 813 vials (one lot).
REASON Supplemental Reagent No.9 Cell products were
labeled as positive for the Rh antigen D instead
of being negative.

_______________
PRODUCT a) Red Blood Cells; b) Whole Blood;
c) Platelets. Recall #B-318/320-8.
CODE a) Contact FDA, Center for Biologics Evaluation
and Research, Office of Compliance (301) 827-6220
for individual unit numbers recalled. First unit
listed: LY12197
b) Unit numbers: G34393, J00845, J00883, J02464,
J02512, J03157, J04533, J05461, J05613, J08668,
J08704, J08765, KC72792, KC78284, KC90843,
KC90961, KC94340, W27086, and W27209
c) LP04830, LP04844, P18365, P18749, LP04788,
P18991.
MANUFACTURER Lifeblood/Mid-South Regional Blood Center,
Memphis, Tennessee.
RECALLED BY Manufacturer, by letter mailed on January 6, 1997,
or February 14, 1996. Firm-initiated recall
complete.
DISTRIBUTION Alabama, Arkansas, Maryland, Mississippi,
Missouri.
QUANTITY a) 122 units; b) 19 units; c) 5 units were
distributed.
REASON Unlicensed blood products were distributed in
interstate commerce.

_______________
PRODUCT Fresh Frozen Plasma. Recall #B-321-8.
CODE Unit KZ42726.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
RECALLED BY Manufacturer, by telephone on or about May 16,
1997. Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who
received a tissue transplant (surgery) within a
year of donation.
_______________
PRODUCT Source Plasma. Recall #B-327-8.
CODE Contact FDA, Center for Biologics Evaluation and
Research, Office of Compliance (301) 827-6220 for
individual unit numbers recalled. First unit
listed: 0530121798.

-14-
MANUFACTURER North American Biologicals, Inc., Lexington,
Kentucky.
RECALLED BY Manufacturer, by letter dated August 5, 1997,
or September 18, 1997. Firm-initiated recall
complete.
DISTRIBUTION New York, North Carolina, New Jersey, France.
QUANTITY 536 units were distributed.
REASON Source Plasma was exposed to unacceptable storage
temperatures and not relabeled as Source Plasma,
Salvaged.

_______________
UPDATE Recall #B-1386-7, Red Blood Cells, Deglycerolized,
United Blood Services, Chicago, Illinois, which
appeared in the September 17, 1997, Enforcement
Report has been extended to include 65 additional
units. Contact FDA, Center for Biologics
Evaluation and Research, Office of Compliance
(301)827-6220 for individual unit numbers
recalled.

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II =========
_______________
PRODUCT NAG Brachyflex Catheter Implant Set:
a) Cook brand NAG Brachyflex Catheter Implant
Set, Reorder No. BFCS-6.0-30-DT-20
b) Cook brand NAG Brachyflex Catheter Implant
Set, Reorder No. BFCS-6.0-30-ST-20
c) Cook brand NAG Brachyflex Catheter Implant
Set, Reorder No. BFCS-6.0-30-STB-20
d) Cook brand NAG Brachyflex Catheter Implant
Set Reorder No. BFCS-6.0-50-STB-20.
Recall #Z-219/222-8.
CODE All Lot Numbers.
MANUFACTURER Cook, Inc, Bloomington, Indiana.
RECALLED BY Manufacturer, by letter dated July 11, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Arizona, Connecticut, Florida, Hawaii,
Indiana, Maine, Maryland, Minnesota, Ohio,
Pennsylvania, Utah, Canada, Denmark, Germany,
Japan, The Netherlands.
QUANTITY 289 sets were distributed.
REASON The catheters may break or separate during use.

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END OF ENFORCEMENT REPORT FOR DECEMBER 17, 1997. BLANK PAGES MAY FOLLOW.