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
08/26/1992
RECALLS AND FIELD CORRECTIONS: August 26, 1992
FOODS -- CLASS III
92-35
PRODUCT (a) Cooked IQF Shrimp;
(b) Raw IQF Shrimp;
(c) Breaded Shrimp. Recall #F-483/485-2.
CODE 182 2N or less.
MANUFACTURER The New England Shrimp Company, Ayer, Massachusetts.
RECALLED BY Manufacturer, by July 27, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada.
QUANTITY 359,864 cases were distributed.
REASON Product contains saccharin which is not permitted in these
products.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
PRODUCT Lortab 7.5/500 Tablets CIII, an Rx analgesic drug,
Recall #D-459-2.
CODE 920156B EXP 1/94.
MANUFACTURER Mikart, Inc., Atlanta, Georgia.
RECALLED BY Whitby Pharmaceuticals, Inc., Richmond, Virginia (responsible
firm), by fax August 4, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 4,304 100-tablet unit dose packages.
REASON A carton labeled as 5 mg Lortab contained correctly labeled
unit dose 7.5 mg Lortab.
PRODUCT Major Pharmaceutical brand Dimaphen S.A. Tablets, in 1,000
tablet bottles, an Rx drug indicated for relief of coughs and
upper respiratory symptoms. Recall #D-460-2.
CODE Lot #6018-115 EXP 8/93.
MANUFACTURER Pioneer Pharmaceuticals, Inc., Irvington, New Jersey.
RECALLED BY Manufacturer, by telephone June 1, 1992, followed by letter
June 2, 1992 and FAX June 3, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Florida.
QUANTITY 5 bottles were distributed; firm estimates none remain on the
market.
REASON Bottles labeled as Dimaphen Tablets contained Carisoprodol
Tablets.
PRODUCT Kanamycin Sulfate Injection USP, an Rx injectable antibiotic
for IM or IV use:
(a) Pediatric Kanamycin Sulfate Injection USP, equivalent to 75
mg Kanamycin per 2 ml, in 2 ml vial;
(b) Kanamycin Sulfate Injection USP, equivalent to 500 mg
Kanamycin per 2 ml, in 2 ml vials;
(c) Kanamycin Sulfate Injection USP, equivalent to 1 g
Kanamycin Sulfate Injection USP, equivalent to 1 g Kanamycin
per 3 ml, in 3 ml vials. Recall #D-462/464-2.
CODE Catalog Numbers Lot numbers:
(a) 06502 910531 EXP 11/92;
(b) 06402 910225 EXP 8/92, 910411 EXP 10/92, 910614
EXP 12/92, 910908 EXP 3/93, 911226 EXP 6/93,
920224 EXP 8/93;
(c) 06305 910339 EXP 9/92, 910451 EXP 10/92, 910625
EXP 12/92, 910737 EXP 1/93, 910839 EXP 2/93,
910913 EXP 3/93, 911012 EXP 4/93, 920106
EXP 7/93, 920249 EXP 8/93.
MANUFACTURER Smith & Nephew Solopak, Elk Grove Village, Illinois.
RECALLED BY Manufacturer, by letter August 11, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 9,040 vials; (b) 95,060 vials; (c) 224,910 vials were
distributed, firm estimates 35,000 remain on market.
REASON Subpotency.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
PRODUCT Aluminum Hydroxide Gel, an OTC product used for temporary
relief of heartburn, sour stomach, and/or acid indigestion, in
-2-
16 ounce, 12 ounce and 128 ounce bottles, under the
Barre-National, Barre, Bioline, Goldline, Major, Moore and
Baxter labels. Recall #D-457-2.
CODE All lots.
MANUFACTURER Barre National, Inc., Baltimore, Maryland.
RECALLED BY Manufacturer, by letter July 27, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 339,031 tablets were distributed; firm estimates 22,828 tablets
remain on the market.
REASON Product does not meet stability specifications.
PRODUCT Isoproterenol HCl Inhalation Aerosol USP, in 15 ml aerosol
bottles, an Rx product for the relief of bronchospasm
associated with acute and chronic asthma and reversible
bronchospasm which may be associated with chronic bronchitis or
emphysema, under the Barre, Goldline, Major, Schein, Rugby, and
H.L. Moore label. Recall #D-458-2.
CODE Lot numbers: 13159 EXP 3/93, 02075 EXP 4/93, 03841 EXP 11/93,
13567 EXP 8/94.
MANUFACTURER Barre National, Inc., Baltimore, Maryland.
RECALLED BY Manufacturer, by letter July 27, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY 173,946 bottles were distributed; firm estimates 24,385 bottles
remain on the market.
REASON Presence of a precipitate.
PRODUCT Taro brand Desoximetasone Cream, USP 0.05%, in 60 gram tubes,
an Rx epidermal. Recall #D-461-2.
CODE Lot numbers 2C23, 2C24, 2C25.
MANUFACTURER Taro Pharmaceuticals, Inc., Downsview, Ontario, Canada.
RECALLED BY Taro Pharmaceuticals U.S.A., Inc., Hawthorne, New York, by
letter July 28, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 7,504 tubes were distributed.
REASON Potency not assured through expiration date.
PRODUCT Vitafol (Hemovite), in 16 ounce bottles, a Rx drug used for the
prevention of Vitamin B-12, Vitamin B-6, and iron
deficiencies. Recall #D-465-2.
CODE Lot numbers: 02070 EXP 2/93, 13473 EXP 4/93.
MANUFACTURER Barre National, Inc., Baltimore, Maryland.
RECALLED BY Manufacturer, by telephone July 27, 1992. Firm-initiated
recall ongoing.
DISTRIBUTION New Jersey.
QUANTITY 8,073 bottles were distributed.
REASON Product does not meet stability specification for the folic
acid ingredient.
-3-
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Fresh Frozen Plasma.
Recall #B-343/345-2.
CODE Unit numbers: (a) 64843, 67267, 69152; (b) 64843, 67267;
(c) 67267, 69152, 64843.
MANUFACTURER Metropolitan Washington Blood Banks, Inc., Silver Spring,
Maryland.
RECALLED BY Manufacturer, by letter February 13, 1992. Firm-initiated
recall complete.
DISTRIBUTION Washington, D.C., Maryland, Texas, Massachusetts.
QUANTITY (a) 3 units; (b) 2 units; (c) 3 units.
REASON Blood products, collected from a donor who previously tested
repeatedly reactive for the antibody to the human
immunodeficiency virus type 1 (anti-HIV-1) were distributed.
PRODUCT Recovered Plasma. Recall #B-355-2.
CODE Unit #92-0213.
MANUFACTURER Hunterdon Medical Center Blood Bank, Flemington, New Jersey.
RECALLED BY Manufacturer, by telephone March 2 and 3, 1992. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania, Florida.
QUANTITY 1 unit.
REASON Blood product, improperly tested for hepatitis B surface
antigen (HBsAg), was distributed.
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Platelets;
(d) Cryoprecipitated AHF; (e) Fresh Frozen Plasma;
(f) Red Blood Cells for Further Manufacture;
(g) Platelets for further manufacture;
(h) Recovered Plasma. Recall B-378/385-2.
CODE Unit numbers: (a) 41KT85455;
(b) 41FC93128, 41FC93888, 41FC94005, 41FE50884, 41FE82489,
41FF66870, 41FF69983, 41FG80765, 41FH92567, 41FH93522,
41FR11435, 41FX11044, 41GQ16159, 41KT87363;
(c) 41FC93128, 41FC93888, 41FC94005, 41FE82489, 41FF66870,
41FF69983, 41FH92567, 41FH93522, 41FR11435, 41GQ16260;
(d) 41KT87363;
(e) 41FC93128, 41FC93888, 41FE82489, 41FF66870, 41FG80765,
41FH92567, 41FR11435, 41GQ16159;
(f) 41GQ16260, 41LE75012, 41LF57999;
(g) 41FE50884;
(h) 41FC94005, 41FE50884, 41FF69983, 41FH93522, 41FX11044,
41GQ16260, 41LE75012, 41LF57999.
MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama.
RECALLED BY Manufacturer, by telephone between April 2, 1992 and letters
dated April 30, 1992, and May 5, 6, and 13, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Alabama, California, Illinois, Switzerland.
QUANTITY (a) 1 unit; (b) 14 units; (c) 10 units; (d) 1 unit;
(e) 8 units; (f) 3 units; (g) 1 unit; (h) 8 units.
-4-
REASON Blood products, which tested negative for all required viral
markers, but were collected from donors who previously either:
1) tested repeatedly reactive for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1); or 2) reported
histories of hepatitis or jaundice, were distributed.
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Red Blood Cells
Leukocytes Removed; (d) Platelets; (e) Platelets Pheresis; (f)
Fresh Frozen Plasma; (g) Cryoprecipitated AHF; (h) Recovered
Plasma. Recall #B-389/396-2.
CODE DS3233, DV4558, F2487, F5438, F6650, F7211, F7599, F9561,
F9596, G1646, G1752, G2374, G2718, G3717, G5379, G7846, G9718,
M1568, M3704, M3885, M5898, M5978, M6306, M7740, M7770;
(b) DS1659, DS7194, DS7228, DS8029, DS8167, DS9188, F1719,
F3333, F3631, F3646, F3836, F4367, F6221, F8153, F8465, F9872,
F9880, G2797, G4012, G4227, G5000, G5827, G6125, G9225, G935,
H6911, M0004, M1198, M1342, M1406, M14081, M1510, M1587,
M16402, M2256, M3110, M3149, M3519, M3835, M3881, M3930, M4477,
M4507, M4638, M5096, M5540, M5734, M5950, M6436, M6881, M7181,
M7639, M8498, M8553, M879, M9028, M9533;
(c) M8819, M9507;
(d) DS7228, DS8029, DS8167, DS9188, DV4558, F1719, F2487,
F3631, F3646, F3836, F4367, F5438, F6221, F6650, F7211, F7599,
F8153, F8465, F9561, F9596, F9872, F9880, G1646, G1752, G2718,
G2797, G3717, G3722, G4012, G4227, G5000, G5379, G5827, G6125,
G7846, G9225, G935, H6911, M0004, M1198, M1406, M14081, M1568,
M1587, M16402, M3704, M3835, M3930, M4507, M5096, M5734, M5898,
M5978, M6306, M6881, M7770, M8494, M8553, M9507, M9533;
(e) PH1246;
(f) DS7228, F1719, G2797, M4477, M4507, M9507, M9533;
(g) DS7194, DS8121, F3333, M1510, M2256, M3110, M3149, M4638,
M5540, M6436, M7181, M879, M8819, M9028;
(h) DS1659, DS7194, DS8029, DS8121, DS8167, DS9188, F3333,
F3631, F3646, F3836, F4367, F6221, F8153, F8465, F9872, F9880,
G3722, G4012, G5000, G5827, G6125, G9225, G935, H6911, M0004,
M1198, M1342, M1406, M1510, M1587, M16402, M2256, M3110, M3149,
M3519, M3835, M3881, M3930, M4638, M5096, M547, M5540, M5734,
M5950, M6436, M6881, M7181, M7639, M8498, M8553, M879, M8819,
M9028.
MANUFACTURER Spokane & Inland Empire Blood Bank, Spokane, Washington.
RECALLED BY Manufacturer, by letter dated between January and May 1992,
followed by telephone. Firm-initiated recall ongoing.
DISTRIBUTION Washington state, Idaho, California, Missouri, North Carolina,
Florida.
QUANTITY (a) 25 units; (b) 57 units; (c) 2 units; (d) 60 units; (e) 1
unit; (f) 7 units; (g) 14 units; (h) 53 units.
REASON Blood products, which tested non-reactive for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1) but were
collected from donors who previously tested repeatedly reactive
for anti-HIV-1, were distributed.
-5-
PRODUCT (a) Whole Blood; (b) Red blood Cells; (c) Platelets; (d)
Cryoprecipitated AHF; (e) Fresh Frozen Plasma; (f) Red Blood
Cells For Further Manufacture; (g) Platelets For Further
Manufacture; (h) Recovered Plasma. Recall #F-403/410-2.
CODE Unit numbers: (a) 5005903;
(b) 1179399, 1185088, 1196010, 1241471, 1241494, 1241496,
1256581, 1269617, 1321557, 1321592, 1321602, 1343532, 1403500,
1408904, 1603066, 1623132, 1624390, 1628854, 1633595, 1633646,
1633664, 1648145, 1654476, 1675509, 1701139, 1701740, 1813336,
2015118, 2024309, 2042752, 2044451, 3144293, 5006146, 5006725,
5007337, 5007592 5007970, 5008502, 5009139, 5009527, 5010042,
5010806, 5010928, 5011210, 5011842, 5013152, 7008003, 7009296,
7010464, 7125076, 7157148, 7232083, 7234206, 7234209, 7234220,
7236898, 7265614, 7320918, 7335516, 7503135, 7505242, 8502589;
(c) 1179399, 1185088, 1241471, 124196, 1257416, 1321557,
1321592, 1321602, 1343532, 1403500, 1408904, 1603066, 1624390,
1628854, 1633595, 1633646, 1633664, 1648145, 1654476, 1701139,
1701740, 1813336, 2042752, 3144293, 5010806, 5010928, 5011210,
5011842, 5013152, 7008003, 7009296, 7010464, 7125076, 7157148,
7232083, 7236898, 7265614, 7320918, 7335516, 7503135, 8502589;
(d) 1196010, 1269617, 1654476, 7234220;
(e) 1179399, 1241471, 1241496, 1256581, 1343532, 1403500,
1408904, 1603066, 1623132, 1624390, 1628854, 1648145, 1701139,
2024309, 2026421, 2042752, 2044451, 3144293, 5010928, 5013152,
7008003, 7157148, 7232083, 7320918, 7503135.
(f) 2026421; (g) 2044451;
(h) 1185088, 1196010, 1269617, 1321557, 1321592, 1321602,
1633646, 1633664, 1654476, 1675509, 1701740, 1813336, 2015118,
5006146, 5006725, 5007337, 5007592, 5007970, 5008502, 5008979,
5009139, 5009527, 5010042, 5010806, 5011210, 5011842, 7009296,
7010464, 7125076, 7234206, 7234209, 7234220, 7236898, 7265614,
7335516, 7505242, 8502589.
MANUFACTURER Lifesource, Glenview, Illinois.
RECALLED BY Manufacturer, by letters of 6/13/91, 7/8/91, 7/11/91, 7/12/91,
7/16/91, 9/30/91, 1/8/92, 5/27,28/92, and 6/4,5/92.
Firm-initiated recall ongoing.
DISTRIBUTION Illinois, Florida, Arizona, California, Pennsylvania,
Washington, D.C., Switzerland.
QUANTITY (a) 1 unit; (b) 61 units; (c) 41 units; (d) 4 units; (e) 25
units; (f) 1 unit; (g) 1 unit; (h) 37 units.
REASON Blood products, which tested negative for the antibody to human
immunodeficiency virus type 1 (anti-HIV-1), but were collected
from donors who previously tested repeatedly reactive for
anti-HIV-1, were distributed.
PRODUCT Platelets. Recall #B-416-2.
CODE Unit #29-101-5436.
MANUFACTURER United Blood Services, Chicago, Illinois.
RECALLED BY Manufacturer, by telephone April 7, 1992. Firm-initiated
recall complete.
-6-
DISTRIBUTION Illinois.
QUANTITY 1 unit.
REASON Blood product, which tested positive for syphilis by the Rapid
Plasma Reagin (RPR) assay, was distributed.
PRODUCT Source Plasma. Recall #B-417-2.
CODE Unit #11774075.
MANUFACTURER Premier BioResources, Inc., Huntington, West Virginia.
RECALLED BY Consignee contacted firm by telephone May 18, 1992.
Manufacturer requested that the consignee destroy the unit in a
letter dated May 27, 1992. Firm-initiated recall complete.
DISTRIBUTION California.
QUANTITY 1 unit.
REASON Source Plasma, which tested repeatedly reactive for the
antibody to hepatitis C virus encoded antigen (anti-HCV), was
distributed.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III
PRODUCT Whole Blood. Recall #B-387-2.
CODE Unit #KP09473.
MANUFACTURER Richmond Metropolitan Blood Services, Richmond, Virginia.
RECALLED BY Consignee notified firm by telephone February 24, 1992.
Firm-initiated recall complete.
DISTRIBUTION Virginia.
QUANTITY 1 unit.
REASON Blood product labeled with an incorrect expiration date was
distributed.
PRODUCT (a) Whole Blood; (b) Red Blood Cells; (c) Platelets; (d) Fresh
Frozen Plasma; (e) Cryoprecipitated AHF; (f) Recovered Plasma.
Recall #B-397/402-2.
CODE Unit numbers: (a) DS2041, DS9198, F2152, F3702, F4217, F5088,
F5766, F6950, F9099, F9300, F9468, G3864, G4255, M6417, M7555,
M6347, M9012, M913;
(b) B1274, DS1826, DS1826, DS3005, DS307, DS311, DS3119, DS408,
DS4200, DS447, DS4820, DS6793, DS7039, DS7109, DS884, DS9295,
F3454, F3691, F5246, F5527, F7092, F712, F8354, F8831, F8908,
F9061, G1135, G1926, G2277, G2403, G3452, G3760, G5271, G5466,
G1926, G2277, G2403, G3452, G3760, G5271, G5466, G5868, G7655,
G7972, G9022, G9732, G9867, H4887, H5701, H6838, H8831, J2252,
J3370, K15707, K4276, K6407, K8673, K0857, M11671, M1219,
M1222, M1335, M1904, M2080, M2146, M2409, M2568, M2648, M2941,
M3152, M3660, M3802, M3808, M4524, M4559, M5204, M6216, M6454,
M7155, M7488, M7724, M7810, M8245, M8631, M9189, M9398;
(c) B1274, DS1826, DS2041, DS3005, DS307, DS311, DS3119, DS408,
DS4200, DS447, DS4820, DS6793, DS7039, DS7109, DS9295, F2152,
F3454, F3691, F3702, F4217, F5246, F5527, F5766, F7092, F8354,
F8831, F8908, F9300, F9468, G1135, G1926, G2277, G2403, G3452,
-7-
G3760, G3864, G4255, G5271, G5466, G7972, G9867, H4887, H5701,
H6838, H8831, J2252, J3370, K15707K4276, K6407, K8673, M0857,
M11671, M1335, M2080, M2146, M2409, M2568, M2941, M3660, M3802,
M3808, M6347, M6417, M7488, M7555, M8245, M8591, M9012, M913;
(d) B1274, DS1826, DS311, DS3119, DS4200, DS7109, F3454, G5271,
H4887, K15707, M22671, M1335, M2146, M2409, M2941;
(e) DS884, F712, G5868, G9732, M1219, M1222, M3153, M4524,
M5204, M6216, M6454, M7155, M7724, M7810, M8631, M9398;
(f) DS3005, DS307, DS408, DS447, DS4820, DS6793, DS7039, DS884,
DS9209, DS9295, F3691, F5246, F5527, F7092, F712, F8354, F8831,
F8908, G1135, G1926, G2277, G2403, G3452, G3760, G5466, G5868,
G7655, G7972, G9022, G9732, G9867, H5701, H6838, H8831, J2252,
J3370, K4276, K6407, K8673, M0857, M1219, M1222, M1904, M2080,
M2568, M2648, M3153, M3660, M3802, M3808, M4524, M4559, M6216,
M6454, M7155, M7488, M7724, M7810, M8245, M8631, M9189, M9398.
MANUFACTURER Spokane & Inland Empire Blood Bank, Spokane, Washington.
RECALLED BY Manufacturer, by letter dated between January and May 1992,
followed by telephone. Firm-initiated recall ongoing.
DISTRIBUTION Washington state, Idaho, California, Missouri, North Carolina,
Florida.
QUANTITY (a) 18 units; (b) 78 units; (c) 70 units; (d) 15 units; (e) 16
units; (f) 62 units.
REASON Blood products, which tested non-reactive for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1) but were
collected from donors who previously tested repeatedly reactive
for anti-HIV-1, were distributed.
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Cryoprecipitated AHF;
(d) Fresh Frozen Plasma; (e) Recovered Plasma.
Recall #B-411/415-2.
CODE Unit numbers: (a) 1016185, 1017782, 1038208, 1051724, 1241494,
1681850; (b) 1016185, 1017782, 1038208, 1051724, 1681850; (c)
1017782; (d) 1241494; (e) 1016185, 1017782, 1038208, 1051724,
1681850.
MANUFACTURER Lifesource, Glenview, Illinois.
RECALLED BY Manufacturer, by letters 6/13/91, 7/8/91, 7/11/91, 7/12/91,
7/16/91, 9/30/91, 1/8/92, 5/27, 28/92, 6/4, 5/92.
Firm-initiated recall ongoing.
DISTRIBUTION Washington, D.C., California, Arizona, Pennsylvania,
Switzerland.
QUANTITY (a) 6 units; (b) 5 units; (c) 1 unit; (d) 1 unit; (e) 5 units.
REASON Blood products, which tested non-reactive for the antibody to
the human immunodeficiency virus type 1 (anti-HIV-1) but were
collected from donors who previously tested repeatedly reactive
for anti-HIV-1, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS I
PRODUCT Kendall Continuous Spinal Catheter Kits and Trays:
(a) Cospan tray with 22 GA Quinke Needle, Product #5423;
(b) Cospan Kit with 22 GA Quinke Needle, Product #5422;
-8-
(c) Cospan Tray with 22 GA Sprotte Needle, Product #5429;
(d) Cospan Kit with 22 GA Sprotte Needle, Product #5428.
Recall #Z-691/694-2.
CODE All lots.
MANUFACTURER Med-West, Division of Kendall Company, Salt Lake City, Utah.
RECALLED BY Kendall Healthcare Products Company, Mansfield, Massachusetts,
by letter May 14, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 35,775 kits were distributed; firm estimates 500 (drug free
kits) and 1,000 trays containing drugs remain on the market.
REASON Products have been implicated with the incidence of cauda
equina syndrome and other adverse performance.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
PRODUCT Hewlette Packard Software Version N.3 used in Sonos 1000
Ultrasound Imaging System, models 77025A, Sonos 1500 Ultrasound
Imaging System model 77035A, Sonos OR Ultrasound Imaging System
model 77049A:
(a) Sonos 1000 Ultrasound Imaging System Models 77025A & 77030A;
(b) Sonos 1500 Ultrasound Imaging System Model 77035A;
(c) Sonos OR Ultrasound Imaging System Model 77040A.
Recall #Z-1192/1194-2.
CODE All machines with N Point 3 Version Software..
MANUFACTURER Hewlett Packard Company, Imaging Systems, Andover,
Massachusetts.
RECALLED BY Manufacturer, by letter April 28, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Europe, Far East.
QUANTITY 174 units were distributed.
REASON Device may cause an artifact and the release of excessive
ultrasound (Isppa) and mechanical index.
PRODUCT Posterior Intraocular Lenses. Recall #Z-1196.
CODE All serial numbers of Model #PL52A-OUV which were part of batch
number 266 with a labeled expiration date of 2/94 and a labeled
A-constant value of 116.4.
MANUFACTURER DGR, Inc., St. Petersburg, Florida.
RECALLED BY Manufacturer, by telephone March 17-18, 1992. Firm-initiated
recall complete.
DISTRIBUTION Louisiana, Hawaii, Tennessee.
QUANTITY 49 incorrectly labeled devices were distributed; firm estimates
none remains on the market.
REASON The lenses were incorrectly labeled with an incorrect
A-constant value. The product was labeled as having an
A-constant value of 116.4; the correct value of the lenses is
118.0.
PRODUCT Kodak MIN-R H Film, 18 x 24 cm size. Recall #Z-1199-2.
CODE Emulsion identification numbers: 227-019, 227-020, 227-021.
227-046, 227-047, 227-048, 228-034, 228-045, 229-012, 229-013,
229-014, 229-015, 229-016, 231-012, 231-013, 231-014, 231-021,
-9-
231-039, 231-040, 231-041, 231-052, 232-012, 232-013, 233-012,
233-014, 233-015, 233-016, 234-013, 234-019, 234-020, 234-021,
234-023, 234-030, 234-039, 234-041, 234-043, 234-044, 234-045,
234-046, 234-047, 234-048, 235-011, 235-012, 235-013, 235-014,
235-015, 235-016, 235-017, 235-018, 235-019, 235-020, 235-021,
235-023, 235-024, 235-025, 235-026, 235-027, 235-028, 235-029,
235-031, 235-032, 235-033, 235-035, 235-039, 235-040, 235-041,
235-042, 235-043, 235-044, 235-045, 235-046, 235-047, 235-048,
235-049, 235-050, 235-051, 235-052, 235-053, 235-054, 235-055,
235-056, 235-057, 235-059, 236-011, 236-012, 236-013, 236-014,
236-015, 236-016, 237-039, 237-040, 237-041, 237-042, 237-043,
237-044, 237-045, 237-046, 237-047, 238-012, 238-013, 238-014,
239-011, 239-012, 239-013, 239-014, 239-016, 239-017, 239-047,
239-048, 239-049, 239-050, 239-052, 239-053, 241-011, 241-012,
241-013, 241-014, 241-015, 241-016, 242-011, 242-012, 242-013,
242-014, 242-015, 242-016, 242-017, 242-019, 242-020, 242-021,
242-022, 242-023, 242-024, 242-025, 242-026, 242-030, 242-031,
242-032, 242-033, 242-034, 242-035, 242-036, 242-037, 242-038,
242-039, 242-040, 242-041, 242-043, 242-044, 242-045, 242-048,
242-052, 242-054, 242-055, 242-056, 242-057, 242-058, 242-059,
242-060, 242-061, 242-066, 243-011, 243-012, 243-013, 243-016,
244-011, 244-012, 244-013, 244-014, 244-015, 244-016, 244-019,
244-020, 244-021, 244-022, 244-023, 244-024, 244-027, 244-028,
244-029, 244-030, 244-031, 244-032, 244-034, 244-035, 244-038,
244-040, 244-041, 244-042, 245-011, 245-012, 245-013, 245-014,
245-016, 246-011, 246-012, 246-013, 246-014, 246-015, 246-016,
246-017, 246-019, 246-023, 246-025, 247-013, 247-014, 247-015.
The products are also coded with a 24 month expiration date.
Therefore, the film involved in the recall would have
expiration dates ranging from January 1994 to May 1994.
MANUFACTURER Kodak Canada, Inc., Toronto, Canada.
RECALLED BY Eastman Kodak, Health Sciences Division, Rochester, New York,
by letter June 18, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Europe, The Carribbean.
QUANTITY 45,838 boxes (100 units per box) were distributed.
REASON The film was oversized and did not fit properly into the
cassettes which can cause poor quality of x-ray image,
resulting in need for repeat procedures.
PRODUCT Stereotaxic 60 Cobalt Gamma System Leksell Gamma System, Model
23016. Recall #Z-1200-2.
CODE All units.
MANUFACTURER Elekta Instruments, Sweden.
RECALLED BY Elekta Instruments, Inc., Tucker, Georgia, by telephone and
letter March 10, 1992. Firm-initiated recall ongoing.
DISTRIBUTION California, Georgia, Illinois, Kentucky, Maryland, Minnesota,
Pennsylvania, Rhode Island, Texas, Virginia.
QUANTITY 11 units were distributed.
REASON Two radiation beams can exit the radiation unit without primary
beam attenuation when the shielding door is open.
-10-
PRODUCT CritiCath Thermodilution Catheters, diagnostic devices intended
to be used in the critical care environment:
(a) Model SP5107H; (b) SP5107HS; (c) Model SP5507H;
(d) Model SP5507HS; (e) Model SP5527H; (f) Model SP5537H.
Recall #Z-1201/1206-2.
CODE The following are the last 3 sequential numbers for all
recalled lots beginning with 91JUL: 822, 824, 826, 836, 837,
839, 842, 844, 846, 848, 850, 852, 856, 858. The following
recalled lot numbers all begin with 91AUG: 801, 803, 805, 807,
808, 811, 814, 818, 820, 822, 824, 830, 832, 834, 835, 836,
839, 843, 846, 848, 852, 853, 857, 862, 863, 866, 870. The
following lot numbers all begin with 91SEP: 801, 803, 805,
807, 808, 811, 814, 819, 824, 826, 827, 830, 831, 832, 832,
834, 835, 839, 842, 843, 845, 846, 850, 853. The following lot
numbers all begin with 91OCT: 802, 824, 838, 845. The
following lot numbers all begin with 91NOV: 805, 806. The
product has a 2 year expiration date.
MANUFACTURER Viggo-Spectramed, Singapore.
RECALLED BY Viggo-Spectramed, Oxnard, California, by letter June 30, 1992.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico, Europe, Thailand, Philippines, South
Korea, Japan, Canada, Bahamas, Mexico.
QUANTITY 48,546 units were distributed; firm estimates 27,000 units
remain on the market.
REASON Some of the balloons of certain lot numbers fail to inflate or
lose gas (air) after inflation.
PRODUCT Resonex Model RX-4000 Magnetic Imaging System.
Recall #Z-1207-2.
CODE P1R, P2 through P9, P11 through P14, P16 through P31, P33
through P43. Codes P10, P15 and P32 were not used by the firm.
MANUFACTURER Resonex, Inc., Sunnyvale, California.
RECALLED BY Manufacturer, by letter June 11, 1991, followed by visit.
Firm-initiated field correction complete.
DISTRIBUTION Nationwide, Korea, Poland, Sweden.
QUANTITY 40 units were distributed.
REASON The patient couch speed increased to excessive levels while the
patient was on the couch.
PRODUCT Advantx LC Cardiac System and Advantx LC/LP Cardiac Biplane
System Positioners, for surgical C-Arm fluoroscopic x-ray
systems typically used in cardiac catheterization labs, Model
numbers 46-279781P2, 46-279781P3, 45559753, 45560345, 45258560,
45259685, 45258540. Recall #Z-1208/1209-2.
CODE All serial numbers of most of the models are affected. The
affected serial numbers of model 45559753 units are limited to
those through 83610. The affected serial numbers of Model
45560345 units are limited to those through 89247.
MANUFACTURER General Electric Company, Inc., Waukesha, Wisconsin. Some were
also manufactured by General Electric CGR, Buc, France.
-11-
RECALLED BY General Electric Company, Inc., Waukesha, Wisconsin, by sending
field modification instructions on or about June 8, 1992.
Firm-initiated field correction ongoing.
DISTRIBUTION Nationwide, International.
QUANTITY 235 units were distributed.
REASON The positioners were moving without commands or continued to
move after the enable switch had been released.
PRODUCT Escort 100 Series Portable Patient Monitors. Recall #Z-1211-2.
CODE Serial numbers are within the range from 1001 through 9645.
Not all units within this range are affected. Linked Escorts
are not affected.
MANUFACTURER Medical Data Electronics, Arleta, California.
RECALLED BY Manufacturer, by telephone beginning on or about July 13, 1992,
followed by letter July 15, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, South Africa, Australia.
QUANTITY 440 units were distributed.
REASON The audio alarm may fail to alarm when a lead to a patient
fails.
PRODUCT Sterile Hex Handle Grooved-Tip Sucker, used whenever a
surgical procedure requires a hand held instrument to clear
the operative field of blood or other fluids. Recall #Z-1218-2.
CODE Catalog #201135-000, Lot #204798, exp. date 2/10/92.
MANUFACTURER Surgimedics/TMP, The Woodlands, Texas.
RECALLED BY Manufacturer, by letter April 28, 1992. Firm-initiated recall
complete.
DISTRIBUTION Texas, Pennsylvania.
QUANTITY 150 units were distributed, firm estimates none remain on
market.
REASON Some of the units were found to have unsealed pouches which
could compromise the sterility of the device.
PRODUCT Basix Inflation Syringes, Catalog #BX3000 and Catalog BX3001.
Recall #Z-1220/1221-2.
CODE Lot #081696.
MANUFACTURER Merit Medical Systems, Inc., Salt Lake City, Utah.
RECALLED BY Manufacturer, by telephone July 8, 1992. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,925 units were distributed; firm estimates none remains on
the market.
REASON There may be adhesive partially obscuring the orifice to the
pressure gauge, thereby causing a slower than expected gauge
response to pressure changes.
-12-
PRODUCT Liquid Oxygen Systems, intended for use by patients with
respiratory problems: (a) Companion 550 Liquid Oxygen System,
Product #778051 (b) Mark 7 Liquid Oxygen System, Product
#778171. Recall #Z-1222/1223-2.
CODE Serial numbers: 92012339, 91100707, 91100903, 91100716,
91100714, 91100713, 91100720, 91100909, 91100725, 91100702,
91100717, 91100729, 91100708, 91100907, 91100905, 91100705,
91100704, 91100732, 91100728, 91100904, 91100901, 91030811,
92030974, 91112013, 91100906, 91100738, 91031816, 91030807,
91030812. All serial numbers are Companion 550 units.
MANUFACTURER Puritan-Bennett Corporation, Cryogenic Equipment Division,
Indianapolis, Indiana.
RECALLED BY Manufacturer, by telephone April 14-27, 1992. Firm-initiated
recall complete.
DISTRIBUTION Florida, Kansas, Colorado, Indiana, Canada.
QUANTITY 29 units were distributed.
REASON There is a possibility for a leak to occur at the flow
indicator in the top of the units. This leak has the potential
to create a frostbite hazard and/or minor injuries.
UPDATE LDS 1700 Series Adult Heated Anesthesia Circuits, Recall
#Z-1162/1191-2, which appeared in the August 19, 1992
Enforcement Report should read:
REASON: Device may have loose crimps on the terminals of the
circuit wires which may cause the circuit not to heat.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III
PRODUCT Thromboquik - Thrombin Reagent, an in-vitro diagnostic reagent
intended for use in thrombin time determinations.
Recall #Z-1213-2.
CODE Product #35515, Lot numbers: 101774 EXP 11/92, 101963 EXP
3/93, 101964 EXP 4/93, 102223 EXP 7/93, 102224 EXP 10/93.
MANUFACTURER Organon Teknika Corporation, Durham, North Carolina.
RECALLED BY Manufacturer, by letter April 9, 1992. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Canada, Colombia, Ecuador, Mexico.
QUANTITY 5,264 unit packages were distributed. 603 were reworked to
include the insert addendum prior to shipment.
REASON The reconstituted stability of the recalled product was less
than the two weeks indicated in the package insert.
-13-
PRODUCT (a) PKU Test Agar Base, Catalog #20818; (b) PKU Test Kit,
Catalog numbers 21110 and 21111, for use in the Guthrie
modified bacterial-inhibition assay procedure for screening
newborn infants for phenylketonuria. Recall #Z-1214/1215-2.
CODE Lot numbers: (a) D2EGZW, E2EHCQ, I2EHUN, J2EHYI, A3EIND,
B3EINO, B3EITJ, C3EIUQ, E3EJCJ; (b) L0HFDT, G1HFFS, L1HFIE,
HIHFGA, H1HFHI, H1HFGU, H1HFHT, L1HFJK, L1HFKB, L1HGLE, L1HFMH,
L1HFKM, L1HFMF.
MANUFACTURER Becton Dickinson Microbiology Systems, Cockeysville, Maryland.
RECALLED BY Manufacturer, by letter July 11, 1991. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide.
QUANTITY (a) 143 units; (b) 286 and 947 units were distributed; firm
estimates none remains on the market.
REASON Devices exhibited reduced growth and unacceptable zone sizes.
PRODUCT Nobelpharma Titanium Fixture, 3.75 x 15 mm, a sterile
endosseous implant for jawbone anchored teeth or bridgework in
Nobelpharma's Branemark System. Recall #Z-1216-2.
CODE On ampule: Heat sterilized 12/13/88, use before 12-13-93,
Batch #52-0049-06. On Peel package: 88 DEC L 03, Expiry date
93 Dec.
MANUFACTURER Nobelpharma AB, Gothenburg, Sweden.
RECALLED BY Nobelpharma USA, Inc., Chicago, Illinois, by telephone
September 13-14, 1989, followed by letters dated September 12,
1989. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 111 implants were distributed; firm estimates none remains on
the market.
REASON Packaging labeled as a 3.75 x 15 mm implant may actually
contain a 3.75 x 7 mm DCA 002 implant.
PRODUCT Nobelpharma Titanium Fixture, 3.75 x 10 mm, a sterile
endosseous implant for jawbone anchored teeth or bridgework in
Nobelpharma's Branemark System. Recall #Z-1217-2.
CODE On ampule: Heat Sterilized APRIL 1991, Use Before APRIL 1996,
Batch no. 505178. On peel package: 91 May E01, Expiry date 96
May.
MANUFACTURER Nobelpharma AB, Gothenburg, Sweden.
RECALLED BY Nobelpharma USA, Inc., Chicago, Illinois, by telephone April
28, 1992, followed by letter sent during the first week of May
1992. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 200 implants were distributed; firm estimates 30 remain on the
market.
REASON Packaging labeled as a 3.75 x 10 mm implant may actually
contain a 3.75 x 13 mm SDCA 018 implant.
-14-
RECALLS AND FIELD CORRECTIONS: VETERINARY -- CLASS II
PRODUCT (a) Penicillin G Procaine Aqueous Suspension 100 ml vials -
37,497 vials labeled as follows:
Hanford's Penicillin G Procaine;
Durvet Pen-Aqueous Penicillin G Procaine;
Aquacillin Vedco Penicillin G Procaine;
(b) Polyflex (sterile Ampicillin) in 25 gram bottles under the
Ft. Dodge Laboratories label. Recall #V-048/049-2.
CODE (a) Lot H1397, EXP OCT 91
(b) Lot H1477, EXP NOV 1 93.
MANUFACTURER G.C. Hanford Manufacturing. Company, Syracuse, New York.
RECALLED BY Manufacturer, by telephone July 28, 1992, followed by letter
July 29, 1992. Firm-initiated recall ongoing.
DISTRIBUTION Iowa, Missouri.
QUANTITY (a) 37,497 vials (b) 2,436 vials were distributed.
REASON Lack of assurance of sterility.
PRODUCT Renasept, in 1,000 tablet bottles, a Rx veterinary used for
treatment of urinary tract infections in cats and dogs.
Recall #V-050-2.
CODE Lot numbers: 10733 EXP 5/93, 10435 EXP 2/93.
MANUFACTURER Manufacturing Chemists, Inc., Indianapolis, Indiana.
RECALLED BY The Butler Company, Dublin, Ohio, by telephone May 28, 1992,
followed by letter May 29, 1992. Firm-initiated recall ongoing.
DISTRIBUTION States east of the Mississippi, and in Texas, Louisiana,
Alabama, Missouri.
QUANTITY 557 bottles were distributed.
REASON Product is an unapproved new animal drug.
-15-
END OF ENFORCEMENT REPORT FOR AUGUST 26, 1992. BLANK PAGES MAY
FOLLOW.
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