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
06/21/1995
ENFORCEMENT REPORT FOR 06 21 95
June 21, 1995 95-25
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS II
=========================
PRODUCT Danish Bakery Larsens Prune Twist, in 12 ounce packages.
Recall #F-671-5.
CODE 5-10-95 stamped on top of package.
MANUFACTURER Larsen Brothers Danish Bakery, Lynnwood, Washington.
RECALLED BY Manufacturer, by telephone on or about May 12, 1995. Firm-
initiated recall complete.
DISTRIBUTION Washington state.
QUANTITY 17 packages were distributed.
REASON Product contains undeclared almonds.
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
PRODUCT Evon R/S Granulated Peanuts, roasted, salted peanut
granules, in 40 pound bulk poly-lined cardboard cases.
Recall #F-655-5.
CODE MAR 28 1995.
MANUFACTURER John B. Sanfilippo & Son, Inc., Elk Grove Village, Illinois.
RECALLED BY Manufacturer, by telephone April 28, 1995, followed by
letter May 1, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Wisconsin, Illinois, Michigan, Texas.
QUANTITY 73 cases were distributed; firm estimated that 20 percent of
the product remained on market at time of recall initiation.
REASON The peanuts are contaminated with glass and sunflower seeds.
_______________
PRODUCT Flavorite Chunk Light Tuna in Water, in 6-1/8 ounce cans.
Recall #F-667-5.
CODE SCC/AC3DP/2871C.
MANUFACTURER Songkla Canning Ltd., Ampher Muang Songkla, Thailand.
RECALLED BY Preferred Products, Inc., Chaska, Minnesota, by memorandum
March 30, 1995. Firm-initiated recall complete.
DISTRIBUTION Washington state, Alaska, California, Montana, Oregon.
QUANTITY 403 cases (48 cans per case) were distributed.
REASON Decomposition.
HUMAN TISSUE MANDATORY RECALLS:
==========================================
PRODUCT Human Tissue from Cadaveric Donors, indicated for human
transplant. Recall #B-385-5.
CODE Donor numbers: LA93-16, LA93-65, LA93-72, LA93-73, LA93-81,
LA94-01, LA94-03, LA94-10, LA94-14, LA94-17, LA94-18, LA94-
19, LA94-22, LA94-36, LA94-44, LA94-49, LA94-55, LA94-56,
LA94-60, LA94-68, LA95-02.
MANUFACTURER Life Alaska, Inc., Anchorage, Alaska.
RECALLED BY Manufacturer, by telephone December 16, 1994, and by letter
December 20, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Alaska.
QUANTITY Approximately 63 pieces.
REASON Human tissue from cadaveric donors was distributed which
lacked adequate documentation about the donors' relevant
medical history related to risk factors for, or clinical
evidence of, hepatitis B, hepatitis C, or human
immunodeficiency virus (HIV) infection.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Platelets, Expired;
(d) Recovered Plasma. Recall #B-283/286-5.
CODE Unit numbers: (a) N9625, N7539, N4763, P3618, P8644, P6049,
R7862, R0813, S0062, S1214, S2144, S5323, S5906, S6930,
S6947, S7666, S8108, S9844, T00017, T00163; (b) N9625,
N7539, P3618, P6049, S0062, S1214, S2144, S6947, S7666,
T00163; (c) S5323, S5906, S8108, S9844; (d) N9625, N7539,
N4763, P3618, P8644, P6049, R7862, R0813, S0062, S1214,
S2144, S5323, S5906, S6930, S6947, S7666, S8108, S9844,
T00017, T00163.
MANUFACTURER Southeast Iowa Blood Center, Ottumwa, Iowa.
RECALLED BY Manufacturer, by letter December 8, 1993. Firm-initiated
recall complete.
DISTRIBUTION Iowa, Illinois, New York, California, Tennessee,
Pennsylvania, Missouri.
QUANTITY (a) 20 units; (b) 10 units; (c) 4 units; (d) 20 units.
REASON Blood products, which tested negative for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1) but
were collected from donors who had previously tested
repeatedly reactive for anti-HIV-1, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-287/288-5.
CODE Unit numbers 03LW04564, 03LW05599.
MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia.
RECALLED BY Manufacturer, by letter May 27, 1994. Firm-initiated recall
complete.
DISTRIBUTION Georgia.
QUANTITY 2 units of each component.
REASON Blood products, collected from a donor currently taking the
drug Proscar, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Platelets, Pheresis;
(d) Cryoprecipitated AHF; (e) Recovered Plasma.
Recall #B-290/294-5.
CODE Unit numbers: (a) E09973, V95162, W25388, W25389, W25390,
W25391, W25393; (b) W25388, W25390, W25391; (c) Q01299; (d)
E09973; (e) V95162, W25388, W25389, W25390, W25391, W25393.
MANUFACTURER Central California, Blood Center, Fresno, California.
RECALLED BY Manufacturer, by letter November 23, 1994. Firm-initiated
recall complete.
DISTRIBUTION California.
QUANTITY (a) 7 units; (b) 3 units; (c) 1 unit; (d) 1 unit; (e) 6
units.
REASON Blood products, which were untested for syphilis, were
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered Plasma.
Recall #B-295/297-5.
CODE Unit numbers: (a) 10N01414, 10F10360, 10F03886; (b)
10N01414, 10F10360; (c) 10N01414, 10F10360, 10F03886.
MANUFACTURER American National Red Cross, Springfield, Missouri.
RECALLED BY Manufacturer, by letters dated January 7 and 13, 1994.
Firm-initiated recall complete.
DISTRIBUTION Missouri, California.
QUANTITY (a) 3 units; (b) 2 units; (c) 3 units.
REASON Blood products, which 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, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma;
(d) Cryoprecipitated AHF; (e) Red Blood Cells; (f) Platelets
For Further Manufacture; (g) Recovered Plasma.
Recall #B-298/304-5.
CODE Unit numbers: (a) 01G09681, 01G48187, 01GG07306, 01H02657,
01H40310, 01H58821, 01H79868, 01K30121, 01K42385, 01K52677,
01K55590, 01K65621, 01K74101, 01KH03093, 01KH17602,
01KK00876, 01KK07960, 01KK09847, 01KK11439, 01KV05457,
01X22028, 01X31804, 01X38660, 01X43372, 01X50243, O1X97881;
(b) 01G09681, 01GG07306, 01K30121, 01K42385, 01K55590,
01K74101, 01KH03093, 01KK11439, 01X31804, 01X38660,
01X43372, 01X50243, 01X97881; (c) 01H79868, 01X43372,
01KK00876, 01KK07960; (d) 01G48187, 01K03158; (e) 01K03158;
(f) 01H58821, 01H79868, 01H02657, 01K52677, 01KK00876,
01KK07960, 01KK09847, 01KH17602; (g) 01G09681, 01G48187,
01GG07306, 01H02657, 01H40310, 01H58821, 01K03158, 01K30121,
01K42385, 01K52677, 01K55590, 01K65621, 01K74101, 01KH03093,
01KH17602, 01KK09847, 01KK11439, 01KV05457, 01X22028,
01X31804, 01X38660, 01X50243, 01X97881.
MANUFACTURER American National Red Cross (ARC) Rochester, New York.
RECALLED BY Manufacturer, by letters dated August 1, 5, 1994, or
September 2, 1994. Firm-initiated recall ongoing.
DISTRIBUTION New York, Florida, California, Switzerland.
QUANTITY (a) 26 units; (b) 13 units; (c) 3 units; (d) 2 units; (e) 1
unit; (f) 8 units; (g) 23 units.
REASON Blood products, which 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, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma.
Recall #B-316/318-5.
CODE Unit #03GF09863.
MANUFACTURER American National Red Cross (ARC), Atlanta, Georgia.
RECALLED BY Manufacturer, by letters dated September 12 and 13, 1994.
Firm-initiated recall complete.
DISTRIBUTION Georgia.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor with a
medical history of hepatitis, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated
AHF; (d) Recovered Plasma; (e) Red Blood Cells,
Deglycerolized. Recall #B-319/323-5.
CODE Unit numbers: (a-d) 31E00891; (e) 31KW03686, 31KT07553.
MANUFACTURER American Red Cross Blood Services, Buffalo, New York.
RECALLED BY Manufacturer, by letters August 1, 2, and 9, 1994. Firm-
initiated recall complete.
DISTRIBUTION New York, Oklahoma, Switzerland.
QUANTITY (a-d) 1 unit of each component; (e) 2 units.
REASON Blood products which tested negative for antibody to the
hepatitis C virus encoded antigen (anti-HCV), but were
collected from a donor who previously tested repeatedly
reactive for anti-HCV, or were deglycerolized using outdated
12% sodium chloride, were distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-324-5.
CODE Unit #7825059, 7825354.
MANUFACTURER Department of the Air Force, Shaw Air Force Base, South
Carolina.
RECALLED BY Manufacturer, by memorandum dated August 6, 1993, and by
message sent December 1993. Firm-initiated recall complete.
DISTRIBUTION International.
QUANTITY 2 units.
REASON Blood products, collected from ineligible donors due to
histories of blood transfusion or ear piercing, were
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Fresh Frozen Plasma; (c) Recovered
Plasma. Recall #B-329/331-5.
CODE Unit numbers: (a) 4650464, 4937732, 5710749, 6912332,
6912254, 6939791; (b) 5710749; (c) 6939791.
MANUFACTURER Bloodcare, Dallas, Texas.
RECALLED BY Manufacturer, by letter August 19, 1994, and by fax August
25, 1994. Firm-initiated recall complete.
DISTRIBUTION Texas, California.
QUANTITY (a) 6 units; (b) 1 unit; (c) 1 unit.
REASON Blood products, corresponding to platelets contaminated with
Streptococcus constellatus/milleri, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Cryoprecipitated AHF.
Recall #B-332/333-5.
CODE Unit #C27429.
MANUFACTURER Regional Health Resources Center, Urbana, Illinois.
RECALLED BY Manufacturer, by telephone September 23, 1994, followed by
letter September 28, 1994. Firm-initiated recall complete.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component.
REASON Blood products, which tested repeatedly reactive for the
antibody to the hepatitis B core antigen (anti-HBc), were
distributed.
_______________
PRODUCT Source Plasma. Recall #B-335-5.
CODE Unit #32218527.
MANUFACTURER Bio-Blood Components, Inc., Hammond, Indiana.
RECALLED BY Manufacturer, by telephone November 18, 1993. Firm-
initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for the
antibody to the human immunodeficiency virus type 1 (anti-
HIV-1, was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-361/362-5.
CODE Unit #30FF03809.
MANUFACTURER American National Red Cross, Ashley, Pennsylvania.
RECALLED BY Manufacturer, by letter October 1, 1993. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit of each component.
REASON Blood products, which were collected from a donor with a
medical history of hepatitis, were distributed.
_______________
PRODUCT Antibody for the Human T-Lymphotropic Virus Type 1 ELISA
Test Kits. Recall #B-384-5.
CODE Lot #105T5169.
MANUFACTURER Cambridge Biotech Corporation, Rockville, Maryland.
RECALLED BY Cambridge Biotech Corporation, Worcester, Massachusetts, by
letters dated March 23 and 24, 1995. Firm-initiated recall
complete.
DISTRIBUTION New Jersey.
QUANTITY 25 kits.
REASON Antibody to the human T-lymphotropic virus type 1 (anti-
HTLV-1) test kits, which contained incorrect supplemental
product inserts, were distributed.
_______________
PRODUCT Platelets. Recall #B-386-5.
CODE Unit #2434429.
MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis,
Indiana.
RECALLED BY Manufacturer, by telephone October 2, 1992, followed by
letter February 9, 1993. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 1 unit.
REASON Blood product, which tested repeatedly reactive for the
antibody to the hepatitis B core antigen (anti-HBc), was
distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-387/388-5.
CODE Unit #2946177.
MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis,
Indiana.
RECALLED BY Manufacturer, by telephone and letter August 23, 1993,
August 23, 1993. Firm-initiated recall complete.
DISTRIBUTION New Jersey and Indiana.
QUANTITY 1 unit of each component.
REASON Blood products which tested initially reactive for syphilis,
were distributed for transfusion.
_______________
PRODUCT Platelets. Recall #B-401-5.
CODE Unit numbers: 3164381, 3164383, 3164386.
MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis,
Indiana.
RECALLED BY Manufacturer, by telephone February 8, 1994, followed by
letter March 9, 1994. Firm-initiated recall complete.
DISTRIBUTION Indiana.
QUANTITY 3 units.
REASON Blood products, which were manufactured from whole blood
that was shipped at unacceptable temperatures, were
distributed.
_______________
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Recovered Plasma.
Recall #B-402/404-5.
CODE Unit numbers: (a) 1123758, 1131368; (b) 2083415, 4061961,
2096837; (c) 2083415, 4061961, 2096837.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, by letters dated May 12, 13, and 25, 1994.
Firm-initiated recall complete.
DISTRIBUTION Missouri, Kansas, Tennessee, Massachusetts.
QUANTITY (a) 2 units; (b) 3 units; (c) 3 units.
REASON Blood products, which tested negative for antibody to human
immunodeficiency virus type 1 (anti-HIV-1), but were
collected from a donor who previously tested Western blot
indeterminate, were distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
====================
PRODUCT Recovered Plasma. Recall #B-305-5.
CODE Unit #09G77435.
MANUFACTURER American National Red cross (ARC), Omaha, Nebraska.
RECALLED BY Manufacturer, by facsimile October 1, 1992. Firm-initiated
recall complete.
DISTRIBUTION Switzerland.
QUANTITY 1 unit.
REASON Blood product, corresponding to platelets contaminated with
Escherichia coli, was distributed.
_______________
PRODUCT Blood products distributed from units collected between May
3, 1993, and May 16, 1994, and corresponding to the
following inclusive whole blood numbers: 18E39562-18E54461,
18M89957-18M95344, 18N31902-18N37348, 18P17937-18P19902,
18Q30019-18Q47473, 18R29164-18R43210, 18S24950-18S25268,
18W48169-18W65734, 18X44769-18X60442, 18Y45419-18Y61317,
18Z46225-18Z62617, 18FE00001-18FE06273, 18FC28880-18FC45676,
18FF00001-18FF00086, 18FG00001-18FG00028.
Recall #B-306-5.
CODE All codes produced between May 3, 1993, and May 16, 1994.
MANUFACTURER American National Red Cross (ARC), Lansing, Michigan.
RECALLED BY Manufacturer, by letter November 2, 1994. Firm-initiated
recall complete. See also FDA talk paper T94-52, November
3, 1994.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 94,171 units were distributed.
REASON Blood products, which may have tested weakly reactive in the
Macro-Vue Rapid Plasma Reagin (RPR) Test, and interpreted as
non-reactive, contrary to the manufacturer's directions,
were distributed.
_______________
PRODUCT (a) Whole Blood (CPDA-1; (b) Red Blood Cells; (c) Platelets;
(d) Platelets, Pheresis. Recall #B-325/328-5.
CODE Unit numbers: (a) 3145714, 3145717; (b) 3145704, 3145711,
3145716; (c) 3145708, 3145716, 3256103, 3256106; (d)
3145705.
MANUFACTURER Louisiana Blood Center, Monroe, Louisiana.
RECALLED BY Louisiana Blood Center, Shreveport, Louisiana, by telephone
June 14, 1993. Firm-initiated recall complete.
DISTRIBUTION Louisiana.
QUANTITY (a) 2 units; (b) 3 units; (c) 4 units; (d) 1 unit.
REASON Blood products, which were improperly tested for the
antibody to the human immunodeficiency virus type 1/2 (anti-
HIV-1/2), were distributed.
_______________
PRODUCT Fresh Frozen Plasma. Recall #B-334-5.
CODE Unit numbers: 38FM59265, 38FM59268, 38FM59274, 38FM59281,
38FM59289, 38FM59290.
MANUFACTURER American National Red Cross, Fort Wayne, Indiana.
RECALLED BY Manufacturer, by telephone August 14, 1992. Firm-initialed
recall complete.
DISTRIBUTION Indiana.
QUANTITY 6 units.
REASON Blood products, which were labeled with an incorrect
expiration date, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets, Pheresis.
Recall #B-363/364-5.
CODE Unit numbers: (a) L95568; (b) K03513, K03514.
MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, Iowa.
RECALLED BY Manufacturer, by telephone, facsimile, and letter dated
August 25, 1994 and by letter of September 9, 1994. Firm-
initiated recall complete.
DISTRIBUTION New York, Pennsylvania.
QUANTITY (a) 1 unit; (b) 2 units.
REASON Blood products, which were improperly tested for the
antibody to the human immunodeficiency virus types 1 and 2
(anti-HIV-1/2), were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets;; n(c) Fresh Frozen
Plasma; (d) Recovered Plasma. Recall #B-377/380-5.
CODE 373 unit numbers.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
RECALLED BY Manufacturer, by letters between February 4 and 9, 1994,
March 25, 1994. Firm-initiated recall ongoing.
DISTRIBUTION Michigan, Massachusetts.
QUANTITY 373 units.
REASON Blood products were distributed for which syphilis test
results were incorrectly interpreted as negative when one of
the positive controls in the test run was invalid.
_______________
PRODUCT Recovered Plasma. Recall #B-389-5.
CODE Unit 2946177.
MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis,
Indiana.
RECALLED BY Manufacturer, by letter August 20, 1993, followed by letter.
Firm-initiated recall complete.
DISTRIBUTION New Jersey.
QUANTITY 1 unit.
REASON Blood product, which tested initially reactive for syphilis,
was distributed for further manufacture.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
PRODUCT Servo Ventilator 300, Product Number 6079391 E3380E.
Recall #Z-751-5.
CODE All serial numbers.
MANUFACTURER Siemens-Elema AB, Life Support Systems Division, Solna,
Sweden.
RECALLED BY Siemens Medical Systems (SMS), Inc., Danvers, Massachusetts,
by letters of March 30, 1994, June 30, 1994, and November 1,
1994, followed by telephone. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 300 units were distributed.
REASON In the event of both a capacitor failure and a failure of
the 24 volt supply, then the possibility exists that the
ventilator may become inoperable without activation of its
alarms.
_______________
PRODUCT Invacare Pediatric Flowmeter Accessory, Model IRCPF16, used
to reduce the amount of oxygen to the patient to levels
substantially less than the normal output of a concentrator.
Recall #Z-752-5.
CODE All serial numbers that begin with prefix "94-".
MANUFACTURER Mobilite Corporation, Sanford, Florida.
RECALLED BY Manufacturer, by letter December 2, 1994. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 274 units were distributed.
REASON The wrong tubing connecting the flowmeter to the humidifier
bottle adapter was assembled at the time of manufacture
which has resulted in a loss of oxygen flow to a patient.
_______________
PRODUCT RAHD Oncology Products treatment planning system radiation
therapy computer software version 1.95 used in the following
systems: (a) Model 5000B; (b) Model 5000C, (c) Model 5000D.
Recall #Z-818/820-5.
CODE Planning systems containing Software Version 1.95.
MANUFACTURER Electronic Services Mart, Inc., Ferguson, Missouri.
RECALLED BY Manufacturer, by telephone April 4, 1995, followed by fax.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide.
QUANTITY 44 systems containing Version 1.95 software were
distributed.
REASON Under certain circumstances, the computer will not adjust
the final beam distribution to account for contributions of
other beams to the total dosage delivered to the patient.
_______________
PRODUCT Transducer Protectors, used as an in-line protective device
for pressure monitors in hemodialysis systems:
(a) Dualex Transducer Protector - Catalog No. SLGV S25 XS;
(b) Dualex Plus Transducer Protectors -
Catalog No. SLFG 025 PS; Catalog No. SLGV S25 PS;
Catalog No. SLFG 025 PQ; Catalog No. SLGV S25 PQ;
Catalog No. SLFG 025 PB; Catalog No. SLGV S25 PB;
(c) Dualex Ultra Transducer Protectors -
Catalog No. SLFG 025 US; Catalog No. SLGV S25 US;
Catalog No. SLFG 025 UB; - Catalog No. SLGV S25 UB.
Recall #Z-823/825-5.
CODE Catalog Numbers Lot numbers:
(a) SLVG S25 XS H4MM02765, H4PM03325,
(b) SLFG 025 PQ H4DM01745, H4DM01817, H4DM01830,
H4DM01889, H4DM01896, H4DM01944,
H4DM01950, H4DM01953, HK4M02655,
H4KM02730, H4MM02808, H4MM02855,
H4NM03054, H4NM03100, H4NM03156, H4NM03170
SLFG 025 PB H4EM02001, H4EM02014, H4EM02034,
H4EM02088, H4EM02104, H4HM02302,
H4JM02395, H4JM02405, H4JM02460,
H4PM03389, H4JM02481, H4KM02585,
H4KM02610, H4KM02669, H4MM02763,
H4MM02817, H4NM03017, H4NM03044,
H4NM03118, H4NM03204, H4PM03214,
H4PM03340, H4PM03389
SLGV S25 PQ H4KM02722, H4MM02828, H4NM03019,
SLVG S25 PB HK4M02653, H4MM01872, H4SM03417
(c) SLFG 025 UB H4DM01720, H4DM01814, H4HM02149,
H4HM02223, H4HM02225, H4KM02498,
H4MM02764, H4MM02962
SLGV S25 UB H4KM02783, HNM02987, H4PM03257
SLGV S25 US H4KM02725, H4NM03018
SLFG 025 US H4KM02724.
MANUFACTURER Millipore Cidra, Inc., Cidra, Puerto Rico.
RECALLED BY Millipore Corporation, Bedford, Massachusetts, by letter
February 21, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, England, Canada, Australia.
QUANTITY 8,215,700 were distributed domestically and .5 million units
were distributed internationally.
REASON The device may exhibit air leakage when connected to the
hemodialysis machine under operating conditions.
_______________
PRODUCT Mallinckrodt Medical Radiology Catheters sold individually
and in kits: (a) 4 French Radiology Catheters in individual
packages; (b) Angiography Kits Containing 4 French Radiology
Catheters with different accessory components.
Recall #Z-826/827-5.
CODE (a) SKU
Product) Recorder Lot Numbers
Numbers Numbers
1391-16 1391-16 MN24340, MN24690
1391-17 1391-17 MN24070, MN24330, MN24500, MN24700
1391-44 1391-44 MN24110, MN24460
1391-54 1391-54 MN24320
1391-58 1391-58 MN24510
1391-A5 1391-A5 MN24430
1623-01 1623-01 MN24160
1623-13 1623-13 MN24130, MN24300, MN24590
1623-20 1623-20 MN24250
1623-23 1623-23 MN24420
1623-28 1623-28 MN24260
1623-36 1623-36 MN24240
1623-53 1623-53 MN24550
1623-74 1623-74 MN24440
1623-75 1623-75 MN24280
1623-76 1623-76 MN24290
5420-50 5420-51 M181610
5420-60 5420-61 M180690, M182770, M189980
5513-10 5513-13 M189690
5539-P0 5539-P1 M175560, M177150, M177620, M178260,
M179630, M180720, M181640, M182790,
M185110, M187300, M188750, M190950,
M193110, M193370
5539-R0 5539-R1 M177160, M178270, M178280, M179640,
M180730, M181650, M182800, M185120,
M185820, M187930, M190010
5539-S0 5539-S1 M186940, M190020, M910710
5546-P0 5546-P1 M177670, M179680, M181700, M185130,
M187350, M187990, MA10054
5546-R0 5546-R1 M186730, M192150
5563-N2 5563-N3 M183970, M185140, M188810
5563-P2 5563-P3 M180780, M187370, M191040
5564-K2 5564-K3 M180800, M185890, M190110, M192800
5564-L2 5564-L3 M180810, M188030, M190120
5564-M2 5564-M3 M179710, M188040
5565-L2 5565-L3 M185150
5566-L2 5566-L3 M190140
5566-M2 5566-M3 M193150
5567-22 5567-23 M179770
5569-42 5569-43 M188850
5570-B2 5570-B3 M182920, M187850, M190170
5571-32 5571-32 MN24530
6635-22 6635-23 M181790, M182950, M188890
6654-XO 6654-X3 179800, M181800, M182960,
M185970, M185980, M187450,
M188100, M188900, M190210,
M191130, M192260
8822-22 8822-23 M181070, M186140, M188340, M192480
8823-22 8823-23 M189220
(b) SKU
(Product) Recorder Lot Numbers
Numbers Numbers
0287-30 0287-30 M185050
0290-30 0290-30 M185290
1110-30 1110-30 M185300
1168-70 1168-70 M176350, M193310
1168-80 1168-80 M183990
1168-90 1168-90 M187100, M190860
1172-70 1172-70 M176360
6615-C0 6615-C0 M186750.
MANUFACTURER Mallinckrodt Medical, Inc., Angleton, Texas.
RECALLED BY Manufacturer, by letters of December 22, 1994, January 30,
1995, followed by telephone. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 30,690 catheters were distributed.
REASON Possible tip separation.
_______________
PRODUCT Percupump 1A CT Injection System, a low pressure contrast
media injector intended only for the administration of
nonionic and ionic compounds in conjunction with computed
tomography (CT) Scanning of the body. Recall #Z-842-5.
CODE 1338-1345, 1347-1350, 1352-1368, 1370-1373, 1375-1381, 1395,
1397, 1403, 1405, 1413, 1415.
MANUFACTURER E-Z-EM, Inc., Westbury, New York.
RECALLED BY Manufacturer, by letter March 9, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide, The Netherlands, United Kingdom, Ireland, Hong
Kong, Argentina, Singapore.
QUANTITY 47 units were distributed.
REASON The injector's pigtail cable did not meet the necessary
requirements for the life expectancy of the device; the
ribbon cable in the pigtail, which proved to not be flexible
enough to withstand the bending force on the cable, would
fail under excessive bending, causing the unit to stop
functioning or increase its injection rate to the maximum
rate of 5 cc per second.
_______________
PRODUCT Bionex Latex Examination Gloves, powder free, non-sterile,
ambidextrous, 100 gloves per box, manufactured for Boston
Medical Corporation, in the following sizes:
(a) Reorder #6210 - Petite; (b) Reorder #6211 - Small; (c)
Reorder #6212 - Medium; (d) Reorder #6213 - Large; (e)
Reorder #6216 - Unisize. Recall #Z-843-5.
CODE All lots labeled Made in China.
MANUFACTURER Chung Ye Industries, Ltd., Causeway Bay, Hong Kong (buyer).
RECALLED BY Baxter Healthcare Corporation, McGaw Park, Illinois
(distributor), by letter dated May 1, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 5,558 cases were distributed; firm estimated that 20 percent
of the product remained on market at time of recall
initiation.
REASON The gloves have deteriorated, are brittle, discolored and
are subject to spontaneous ignition.
_______________
PRODUCT Centrysystem 3 Blood Tubing Sets. Recall #Z-844-5.
CODE Catalog #003410-510, Lot #04A15353.
MANUFACTURER Cobe Renal Care, Inc., Lakewood, Colorado.
RECALLED BY Manufacturer, by telephone May 2 and 3, 1995, followed by
letter. Firm-initiated recall ongoing.
DISTRIBUTION New Jersey, Minnesota, California, Virginia, Rhode Island,
Tennessee.
QUANTITY 105 cases (1,575 units) were distributed.
REASON Device may exhibit air leakage when connected to the
hemodialysis machine during priming.
_______________
PRODUCT Centrysystem 2 Blood Tubing Sets. Recall #Z-845-5.
CODE Catalog Numbers Lot Numbers
018440-500 11Z3317,11Z3318, 11Z3319, 03A3307,
03A3308, 03A3310
018455-500 12Z3315, 03A3320, 03A3321, 03A3322,
03A3323, 03A3324, 03A3325, 03A3326,
03A3327.
MANUFACTURER Cobe Renal Care, Inc., Lakewood, Colorado.
RECALLED BY Manufacturer, by sending recall package on May 1, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Belgium, Australia, Puerto Rico, Hong Kong.
QUANTITY 809 cases (15 units per case) of Catalog #018440-500, and
939 cases (15 units per case) of Catalog #018455-500 were
distributed.
REASON The device may exhibit air leakage when connected to the
hemodialysis machine during priming.
_______________
PRODUCT Baxter ImmunoScan (ASO) Latex Kit, an in-vitro diagnostic
rapid slide test for the qualitative and semi-qualitative
measurement of antistreptolysin O (ASO) in human serum or
plasma. Recall #Z-846-5.
CODE Lot #074K03 EXP 8/95.
MANUFACTURER Wampole Labs, Cranbury, New Jersey (kit);
J&S Medical Associates, Inc., Natick, Massachusetts (latex
reagent).
RECALLED BY Baxter Healthcare Corporation, McGaw Park, Illinois, by
letters dated April 20, 1995. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 1,038 test kits were distributed; firm estimated that 25
percent of the product remained on market at time of recall
initiation.
REASON There is a potential for false negative results.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
======================
PRODUCT Plaque Control 3000 Plaque Removal Instrument:
(a) Model PC-3000W; (b) Model PC-3000W(P).
Recall #Z-854/855-5.
CODE Serial numbers: (a) 94EZ53, 94GZ53, 94JZ53, 94KZ53, 94LZ53,
94MZ53, 95AZ53; (b) 94KZ93, 95AZ93.
MANUFACTURER Teledyne Water Pik, Fort Collins.
RECALLED BY Manufacturer, by press release May 18, 1995, followed by
letter and telephone. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 77,561 units were distributed.
REASON The device's battery charger base emits a loud popping
noise, carbon soot, odor and/or smoke, which may result in a
fire hazard.
_______________
UPDATE First Choice Regent Strips for the Glucometer 3 (G3) Blood
Glucose Meter, manufactured by Polymer Technology
International, Issaquah, Washington, which appeared in the
January 11, 1995 Enforcement Report, has been extended to
include the following additional lots:
Z-202-5 - Catalog No. 91060, Lot Nos.: F18063, F18067,
F18068, F18069, F18085, F18088, F18097,
F18099, F18100, F18101, F18111, F18113,
F18114, F18119, F18120, F18121, F18122,
F18123, F18124, F18132, F18156;
Z-203-5 - Catalog No. 91061, Lot Nos.: F18058, F18059,
F18067, F18084, F18085, F18088, F18097,
F18099, F18100, F18101, F18111, F18114,
F18115, F18119, F18121, F18122, F18123,
F18124, F18132;
Z-204-5 - Catalog No 91065, Lot Nos.: F18084, F18099,
F18100, F18113, F18115, F18116, F18132.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
PRODUCT Dilantin (extended Phyentoin sodium capsules) Kapseals, 100
mg, veterinary. Recall #V-032-5.
CODE 05354FB EXP 4/96, 01563FA EXP 6/95.
MANUFACTURER Warner Lambert Company, Fajardo, Puerto Rico.
RECALLED BY Parke-Davis, Division of Warner Lambert Company, Morris
Plain, New Jersey, by letter mailed April 18 and 27, 1995.
Firm-initiated recall ongoing.
DISTRIBUTION Iowa.
QUANTITY Undetermined.
REASON Product does not meet dissolution specifications through the
expiration date.
-15-
####
END OF ENFORCEMENT REPORT FOR JUNE 21, 1995. BLANK PAGES MAY FOLLOW.