FDA
Enforcement Report
The FDA Enforcement Report is published weekly by the Food and Drug
Administration,
U.S. Public Health Service, Department of Health and Human Services. It contains
information
on actions taken in connection with agency regulatory activities.
ENFORCE
05/03/1995
Recalls and Field Corrections: Foods -- Class III -- 05/03/1995
May 3, 1995 95-18
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III
========================
_______________
PRODUCT Morton Canning Pickling Salt, plain salt - nothing added, in
5 pound bags, for cooking, canning and pickling.
Recall #F-648-5.
CODE Lot #15H4HA.
MANUFACTURER Morton Salt, Grand Saline, Texas.
RECALLED BY Morton Salt Division, Morton International, Chicago,
Illinois, by telephone March 17, 1995. Firm-initiated
recall complete.
DISTRIBUTION Florida, Texas, Massachusetts, Pennsylvania, Maine, New
York, New Hampshire.
QUANTITY 429 bales (12 bags per bale) were distributed; firm
estimates none remains on the market.
REASON Product is contaminated with aluminum wires.
RECALLS AND FIELD CORRECTIONS: COSMETICS -- CLASS III
====================
_______________
PRODUCT Penecare Lotion, OTC skin moisturizing cosmetic product,
packaged in 8 ounce bottles may be sold individually or as a
part of a promo package. Recall #F-649-5.
CODE Lot #79679 for the individual 8 ounce bottles. The stock
number for pre-pack which could contain the recalled product
is 04408.
MANUFACTURER Packaging Advantages Corporation, Los Angeles, California.
RECALLED BY Penederm, Inc., Foster City, California, by letter on or
about March 31, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Approximately 14,700 bottles were distributed.
REASON Product is contaminated with Candida lipolytica.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
=========================
_______________
PRODUCT Neo-Synephrine Nasal decongestant Drops and NTZ Long-Acting
Nasal Decongestant Drops: (a) Pediatric Formula; (b) Mild
Formula; (c) Regular Formula; (d) Extra Strength Formula;
(e) NTZ Long-Acting Nasal Decongestant Drops.
Recall #D-118/122-5.
CODE Lot numbers: (a) B 200FA, B277 FF, B 309 FK, B324 FL, B 367
FP, B 201 HA, B 215 HA, B 284 HF, B 320 HJ, B 341 HJ, B 349
HK, B 379 HL, B 428 HP, B 204 JA, B 222 JB, B 293 JE, B 307
JH, B 307 JHA, B345 FN, B 410 JN, B 420 JP, KB 101, KD 135,
KE 149, KJ 171, KJ 171A, KL 165, KN 275, KP 305, KP 306, LA
005, LB 040, LC 120, LD 245, LE 300, LE 340;
(b) B202 FA, B 215 FA, B215 FAB, B 237 FCA, B 238 FC, B 251
FD, B 289 FH, B 299 FJ, B 335 FN, B 362 FP, B 212 HA, B 229
HB, B 229 HBA, B 237 HC, B 308 HF, B 317 HH, B 328 HJ, B 328
HJA, B 361 HJ, B 351 HK, B 386 HK, B 381 HLA, B 392 HN, B
205 JA, B 221 JB, B 253 JC, B 281 JD, B 294 JE, B 309 JH, B
347 JJ, B 347 JJB, B 348 JJ, B 367 JK, B 400 JL, B 406 JN, B
418 JN, B 213 KA, KB 102, KC 124, KD 133, KE 140, KH 164,
KJ 172, KL 175, KL 175 B, KP 375, LA 060, LA 350, LD 255,
LE 030, LE 290, (c) B 209 FA, B 246 FC, B249 FD, B 285 FF,
B 297 FJ, B 322 FL, B 332 FN, B 366 FP, B 217 HB, B 280 HF,
B 298 HH, B 331 HJA, B 375 HK, B 369 HL, B 398 HN, B 206 JA,
B 220 JB, B 236 JC, B 284 JD, B 296 JF, B 311 JH, B 348 JJ,
B 370 JK, B 411 JN, B 415 JP, B 212 KA, KB 107, KD 131,
KE 145, KE 146, KH 165, KJ 183, KN 280, KP 310, LA 090,
LC 135; (d) B 206 FA, B 213 FA, B 224 FAB, B 244 FBA,
B 263 FE, B 283 FF, B 291 FH, B 304 FJ, B 311 FK, B 311 FKA,
B 311 FKB, B 355 FL, B 353 FN, B 203 HA, B 205 HA, B 219 HB,
B 222 HB, B 239 HC, B 262 HD, B 270 HE, B 281 HF, B 301 HH,
B 303 HH, B 336 HJ, B 407 HK, B 370 HLA, B 382 HL, B 394 HN,
B 419 HP, B 203 JA, B 219 JB, B 240 JC, B 266 JD, B 285 JE,
B 297 JE, B 299 JE, B 315 JF, B 306 JH, B 349 JJ, B 369 JK,
B 369 JKA, B 394 JL, B 403 JN, B 419 JP, B 211 KA, B 216 KA;
KB 105, KB 108, KB 110, KC 122, KD 132, KD 136, KE 143,
KH 163, KJ 184, KK 120, KL 155, KL 160, KN 230, KN 255,
LA 395, LB 080, LB 100, LC 150, LC 150, LD 215, LE 295,
LE 365; (e) B 229 FC, B 210 HA, B 380 HL, B 371 JK, LB 035.
MANUFACTURER Nycomed Puerto Rico, Inc., formerly Sterling Health,
Barceloneta, Puerto Rico.
RECALLED BY Miles, Consumer Care Division, Parsippany, New Jersey, by
letter March 24, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
-2- REASON Some units are of varying superpotency based on evaporation
of liquid.
_______________
PRODUCT Cerose-DM Cough and Cold Formula, packaged in 4 ounce and in
1 pint bottles. Recall #D-127-5.
CODE Lot numbers: 3931145 EXP 10/95 (4 ounce)
3931146 EXP 10/95 (pint), 3931297 EXP 10/95 (4 ounce)
3940099 EXP 1/96 (4 ounce), 3940100 EXP 1/96 (pint),
3941020 EXP 10/96 (4 ounce), 3921021 EXP 10/96 (pint).
MANUFACTURER Wyeth Ayerst Laboratories, Rouses Point, New York.
RECALLED BY Wyeth Ayerst Laboratories, St. Davids, Pennsylvania, by
letter March 3, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 57,036 4-ounce bottles and 4,547 pint-bottles were
distributed.
REASON Incomplete warning statement regarding antihistamine
ingredient.
_______________
PRODUCT Pre-filled syringes marketed by SoloPak Medical Products
Inc.:
(a) SoloPak Heparin Lock Flush Solution, USP, Preservative
Free, 100 USP units/ml packaged in 1, 3 and 5 ml pre-filled
syringes; for maintenance of patency of intravenous
injection devices only, not to be used for anticoagulant
therapy:
(i) Catalog #10771: 1 ml Hy-Pod Syringe and 25G x 5/8"
needle, individually wrapped, 120 per carton
(ii) Catalog #10773: 3 ml Hy-Pod Syringe and 25G x 5/8"
needle, individually wrapped, 120 per carton
(iii) Catalog #10775: 5 ml Hy-Pod Syringe and 25G x 5/8"
needle, individually wrapped, 120 per carton
(iv) Catalog #10781: 1 ml Hy-Pod Syringe (needles not
included), individually wrapped, 120 per carton
(v) Catalog #10783: 3 ml Hy-Pod Syringe (needles not
included), individually wrapped, 120 per carton
(vi) Catalog #10785: 5 ml Hy-Pod Syringe (needles not
included), individually wrapped, 120 per carton
(vii) Catalog #11871: 1 ml Hy-Pod Syringe, contained in the
Lok-Pak-N Heparin Lock Flush Procedure Pack, 200 per case
(viii) Catalog #11873: 3 ml Hy-Pod Syringe, contained in the
Lok-Pak-N Heparin Lock Flush Procedure Pack, 200 per case
(ix) Catalog #11875: 5 ml Hy-Pod Syringe, contained in the
Lok-Pak-N Heparin Lock Flush Procedure Pack, 200 per case,
(x) Catalog #03702: 1 ml Hy-Pod Syringe, contained in the
Lok-Pak Heparin Lock Flush Procedure Pack, needle not
included, 200 per case
(xi) Catalog #03703: 3 ml Hy-Pod Syringe, contained in the
Lok-Pak Heparin Lock Flush Procedure Pack, needle not
included, 200 per case
-3- (xii) Catalog #03705: 5 ml Hy-Pod Syringe, contained in the
Lok-Pak Heparin Lock Flush Procedure Pack, needle not
included, 200 per case
(b) Sodium Chloride Injection, USP 0.9%, Preservative Free,
in 2 ml, 3 ml and 5 ml pre-filled syringes; for use as a
sterile isotonic vehicle for diluting or dissolving
compatible parenteral medications:
(i) Catalog #SP200: 2 ml Hy-Pod Syringe, 100 per tray, 5
trays per shipper (bulk pack)
(ii) Catalog #SP300: 3 ml Hy-Pod Syringe, 100 per tray, 5
trays per shipper (bulk pack)
(iii) Catalog #SP400: 5 ml Hy-Pod Syringe, 100 per tray, 5
trays per shipper (bulk pack)
(iv) Catalog #11272: 2 ml Hy-Pod Syringe and 25G x 5/8"
needle, individually wrapped, 120 per carton
(v) Catalog #11273: 3 ml Hy-Pod Syringe and 25G x 5/8"
needle, individually wrapped, 120 per carton
(vi) Catalog #11275: 5 ml Hy-Pod Syringe and 25G x 5/8"
needle, individually wrapped, 120 per carton
(vii) Catalog #11282: 2 ml Hy-Pod Syringe (needles not
included), individually wrapped, 120 per carton
(viii) Catalog #11283: 3 ml Hy-Pod Syringe (needles not
included), individually wrapped, 120 per carton
(ix) Catalog #11285: 5 ml Hy-Pod Syringe (needles not
included), individually wrapped, 120 per carton.
Recall #D-137/138-5.
CODE (a) Lot numbers 93Cxxx through 93Mxxx, 94Axxx through
94Jxxx, except lot 94J018; (b) Lot numbers 92Dxxx through
92Mxxx, 93Axxx through 93Mxxx, 94Axxx through 94Jxxx Where
the first two digits indicate the year of production, the
third digit indicates the month, JAN = A through DEC = M,
skipping "I", and the fourth through sixth digits indicate a
consecutive lot number for the month.
MANUFACTURER SoloPak Medical Products, Inc., Franklin Park, Illinois.
RECALLED BY SoloPak Medical Products, Inc., Elk Grove Village, Illinois,
by telephone beginning April 11, 1995. firm-initiated
recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 3,129,180 heparin syringes and 11,455 sodium chloride
syringes were distributed.
REASON Lack of assurance of sterility.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III
========================
_______________
PRODUCT Verapamil HCl Tablets, 80 mg packaged in bottles of 1000,
used for the treatment of angina, under the Mutual
Pharmaceutical label. Recall #D-128-5.
CODE Lot #2974 EXP 01 96.
MANUFACTURER Mutual Pharmaceutical Company, Philadelphia, Pennsylvania,
by letter March 14, 1995. Firm-initiated recall complete.
DISTRIBUTION Minnesota.
-4- QUANTITY 3 bottles were distributed; firm estimates none remains on
the market.
REASON Erroneous distribution and recovery of lot that was being
held because failed disintegration testing.
_______________
PRODUCT Propharma brand drug products:
(a) Flatulex Tablets, OTC, in 100 tablet bottles, for gas
release; (b) Spacol Tablets, Rx, in 100 tablet bottles,
an antispasmodic; (c) Urodol Caplets, Rx, in 100 tablet
bottles, urinary antiseptic; (d) Sernitas Tablets, OTC, in
60 tablet bottles, an antihistamine. Recall #D-129/132-5.
CODE Lot numbers: (a) 70D1240 EXP 4/97; (b) 70M1194 EXP 9/95;
(c) 70B1215 EXP 1/96; (d) 70C1221 EXP 2/97.
MANUFACTURER Wildflower Pharmacal Corporation, Mineola, New York.
RECALLED BY Propharma, Inc., Miami, Florida, by visit beginning March
27, 1995. Firm-initiated recall ongoing.
DISTRIBUTION Florida.
QUANTITY Firm estimates none remains on market.
REASON Subpotency.
_______________
PRODUCT (a) Corn Liquid, corn and callus remover, in 1/2 ounce fluid
ounce amber glass bottles, under the Clay Park label and the
following private labels: White Cross Improved Corn Liquid,
Thrifty Cornex, Treasury Corn & Callus Remover, Super D
Improved Corn Liquid Corn and Callus Remover, Select brand
Corn and Callus Remover, Schein Corn Liquid, Rugby Corn
Liquid, Rite Aid Improved Corn Liquid, Premier Cornex
Removal, OSCO Corn Liquid, CVS Liquid Corn & Callus Remover,
Big Discount Drugs Corn & Callus Remover;
(b) Wart Remover Liquid: Big B Discount Drugs Wart Remover
Solution, Brooks Liquid Wart Remover,
Peoples Wart Remover, Dr. Gaspari Verrumat, Fays Quality
Wart Liquid, Family Pharmacy Wart Liquid, Independent's
Choice Wart Remover Solution, Value Med Improved Wart
Liquid, Longs Wart Remover Solution, OSCO Wart Liquid, Phar-
Mor Wart Remover Solution, Wart Away Liquid made in the USA
for Qualitest, Revco Wart Liquid, Rite Aid Wart Liquid,Rugby
High Potency Wart Remover, Schein Wart Liquid, Select brand
High Potency Wart Remover Liquid, Super D High Potency Wart
Liquid, K & B High Potency Wart Remover Liquid, Treasury
Wart Remover Solution, Thrifty Wart Remover Solution, Top
Care Wart Liquid.
Recall #D-133/134-5.
CODE Batch numbers: (a) T933 EXP 4/95, T934 EXP 4/95, U200 EXP
5/95, U060 EXP 4/95, U201 EXP 5/95; (b) U000 EXP 4/95, U001
EXP 4/95, U059 EXP 4/95, U247 EXP 5/95, U248 EXP 5/95, U310
5/95, U311 EXP 5/95.
MANUFACTURER Clay Park Laboratories, Inc., Bronx, New York.
RECALLED BY Manufacturer, by letter April 17, 1995. Firm-initiated
recall ongoing.
-5- DISTRIBUTION (a) New York, Illinois, Tennessee, Texas, California,
Pennsylvania, Puerto Rico, West Indies, Virgin Islands,
Guyana, Hong Kong; (b) New York, Ohio, Kentucky, Virginia,
Missouri, Illinois, Pennsylvania, California, Alabama,
Tennessee, Connecticut, Indiana, Florida, Massachusetts,
Rhode Island, Hawaii, Puerto Rico, Kowloon.
QUANTITY (a) 46,133 bottles; (b) 95,683 bottles were distributed.
REASON Varying degrees of superpotency resulting from evaporation
of liquid.
_______________
PRODUCT Extendryl Syrup, root beer flavored, in 1 pint and 1 gallon
containers, Rx antihistamine-decongestant. Recall #D-135-5.
CODE Lot #4069471 EXP 6/96 and lower.
MANUFACTURER Fleming and Company, Fenton, Missouri.
RECALLED BY Manufacturer, by letter March 13, 1995. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
QUANTITY 122,127 pints and 141 gallons were distributed.
REASON Subpotency of the phenylephrine ingredient.
_______________
PRODUCT Isoniazid Tablets, USP 100 mg, in bottles of 180, an anti-
microbial agent used in the treatment of tuberculosis.
Recall #D-136-5.
CODE Lot #05965 EXP 12/2/95.
MANUFACTURER Barr Laboratories, Inc., Pomona, New York.
RECALLED BY Vangard Labs, Inc., Glasgow, Kentucky, by telephone April
14, 1995, followed by letter. Firm-initiated recall
complete.
DISTRIBUTION Idaho.
QUANTITY 319 bottles were distributed.
REASON Product does not meet dissolution specifications at the 48
and 60 month test intervals.
_______________
PRODUCT K-DUR 20's Extended Release Tablets (Potassium Chloride) 20
mEq, in bottles of 1000, Rx potassium supplement.
Recall #D-139-5.
CODE Lot #94167 EXP 11/96.
MANUFACTURER Schering-Plough Products, Inc., Las Piedras, Puerto Rico.
RECALLED BY Manufacturer, by letter April 18, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION Massachusetts, Maine, Maryland, California, Connecticut,
Florida, Rhode Island, New York, New Jersey, Pennsylvania,
Tennessee, Virginia, Puerto Rico.
QUANTITY 1,638 bottles were distributed; firm estimated that 350
bottles remained on market at time of recall initiation.
REASON Product bears incorrect expiration of Nov 1996 instead of
May 1996.
-6- RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
=====================
_______________
PRODUCT Human Plasma. Recall #B-246-5.
CODE Unit #N13529.
MANUFACTURER Biological Specialty Corporation, Colmar, Pennsylvania.
RECALLED BY Manufacturer, by letter August 1, 1994. Firm-initiated
recall complete.
DISTRIBUTION Canada.
QUANTITY 1 unit.
REASON Blood product, collected from a donor permanently deferred
in June 1992 for high risk behavior, was distributed.
_______________
PRODUCT Red Blood Cells. Recall #B-248-5.
CODE Unit #30H91308.
MANUFACTURER American National Red Cross (ARC), Ashley, Pennsylvania.
RECALLED BY Manufacturer, by letter February 2, 1994. Firm-initiated
recall complete.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit.
REASON Blood product which was collected from a donor who admitted
to traveling to an area designated as endemic for malaria,
was distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets. Recall #B-249/250-5.
CODE Unit numbers: (a) 15044-7010, 15044-7015, 15044-7016,
15044-7019, 15044-7021, 15044-7024; (b) 15044-7009, 15044-
7010, 15044-7011, 15044-7013, 15044-7014, 15044-7015, 15044-
7016, 15044-7017, 15044-7018, 15044-7019, 15044-7021, 15044-
7022, 15044-7023, 15044-7024.
MANUFACTURER United Blood Services, doing business as Blood Systems,
Inc., Lubbock, Texas.
RECALLED BY United Blood Services, doing business as Blood Systems,
Inc., Scottsdale, Arizona, by telephone May 4, 1994,
followed by letters May 5, 1994 and/or November 30, 1994.
Firm-initiated recall complete.
DISTRIBUTION California, Texas.
QUANTITY (a) 6 units; (b) 14 units.
REASON Blood products, in which the sterility of the collection
system was compromised, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-251/252-5.
CODE Unit #17P83615.
MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota.
RECALLED BY Manufacturer, by letter June 8, 1994. Firm-initiated recall
complete.
DISTRIBUTION Minnesota and Switzerland.
QUANTITY 1 unit of each component.
-7- 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 repeatedly
reactive for anti-HIV-1, were distributed.
_______________
PRODUCT (a) Red Blood Cells; (b) Recovered Plasma.
Recall #B-281/282-5.
CODE Unit #17GH78739, 17GH46389, 17GF06271, 17GH16453;
(b) 17GH78739, 17GH46389, 17GF06271.
MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota.
RECALLED BY Manufacturer, by letters dated August 26, 1994 and September
27, 1994. Firm-initiated recall complete.
DISTRIBUTION Minnesota, California, Washington, D.C.
QUANTITY (a) 4 units; (b) 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 repeatedly
reactive for anti-HIV-1, were distributed.
RECALLS AND FIELD CORRECTIONS -- BIOLOGICS -- CLASS III
===================
_______________
PRODUCT Platelets collected on 07/12/93. Recall #B-245-5.
CODE Unit numbers: 0170298, 0170305, 0170316, 0170303, 0170309,
0170318.
MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City,
Missouri.
RECALLED BY Manufacturer, by telephone July 20, 1993. Firm-initiated
recall complete.
DISTRIBUTION Kansas.
QUANTITY 6 units.
REASON Blood product(s), which were stored under unmonitored
temperature conditions, were distributed.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
=======================
_______________
PRODUCT Reinforced Treatment Catheters, used in the selectron of
LDR/MDR and HDR Radiation Therapy Units. Recall #Z-342-5.
CODE Batch #9-94, produced September 1994.
MANUFACTURER Nucletron International B.V., Vendendaal, The Netherlands.
RECALLED BY Nucletron Corporation, Columbia, Maryland, by letter on or
about November 23, 1994, followed by telephone. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, Mexico.
QUANTITY 14 units were distributed.
REASON The weld between the plastic and steel on the catheter was
determined to be incorrectly welded for the September 1994
batch.
-8- _______________
PRODUCT Orthopedic 2.9 mm Calibrated Twist Drill, Part #1731.
Recall #Z-600-5.
CODE Lot #E4443.
MANUFACTURER Ace Medical Company, Los Angeles, California.
RECALLED BY Manufacturer, by letter February 10, 1995. Firm-initiated
recall ongoing.
DISTRIBUTION California, Michigan, Texas, Japan, Austria.
QUANTITY 110 units were distributed.
REASON The depth calibrations are improperly marked, which may
result in the implantation of the wrong size bone screw.
_______________
PRODUCT Pulsoprobe 320 um Fiber, non-sterile, used with Pulsolith
Dye Laser Lithotripter, used in the treatment of calculi in
the bladder. Recall #Z-690-5.
CODE Lot No. Serial No.
93299 04253, 04251, 04274, 04245, 04273, 04236
04232, 04265, 04266, 04242, 04263, 04234
04275, 04231, 04268, 04237, 04238,
04250, 04254, 04243
93301 04058, 04073, 04053, 04028, 04045, 04038,
04264, 04256, 04057
94207 04180, 04218, 04198, 04199, 04216, 04203,
04206, 04224, 04221, 04182, 04197, 04194, 04225
N/A 04347, 01899
93075 01807, 01811
93267 01290, 01265, 01300, 01251, 01259, 01286,
01266, 01280, 01283, 01258, 01274, 01285, 01295
93272 04134, 04172, 04135, 04168, 04157, 04163, 04165
04162, 04138, 04130, 04152, 04137, 04170, 04132,
04159, 04131, 04171, 04154, 04167, 04151, 04129
04174, 04175, 04166, 04140, 04145, 04149, 04155
04146, 04173, 04164
93327 04060, 04055, 04050, 04064, 04071, 04059,
04044, 04068, 04032, 04065, 04072, 04048,
04054, 04051, 04043, 04075, 04034, 04046, 04047
04056, 04035, 04029, 04040, 04223, 04219, 04208
04185, 04191, 04077, 04204, 04042, 04183, 04226
04063, 04067, 04074, 04213, 04037, 04066, 04076
04069, 04220, 04052
N/A 04376, 04344, 04345, 04338.
MANUFACTURER Technomed Medical Systems, Vaux-en-Velin, France.
RECALLED BY EDAP/Technomed Group, Cambridge, Massachusetts, by letter
sent in September 1994. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 119 units were distributed.
REASON The probe may break in the ureter during treatment due to
changes in the fiber manufacturing process which resulted in
defective fibers.
-9- _______________
PRODUCT Endosonics'(a) VISION 3.5F Model 54700; (b) VISIONS F/X
Model 52700 Intravascular Ultrasound Imaging Catheters.
Recall #Z-691/695-5.
CODES There are approximately 2,386 individual, non-consecutive
serial numbers. Lot numbers are: 011694, 071194, 71194,
71894, 071894, 072594, 080194, 080894, 081594, 082294,
092994, 092094, 092694, 100394, 101094, 101794, 102494,
102894, 103194, 111494, 111794, 112894, 120694, 121294,
121994, 122694, 010995, 011695, 011795, 012495. Lots may or
may not contain both models of the recalled catheters.
MANUFACTURER Endosonics Corporation, Pleasanton, California.
RECALLED BY Endosonics Corporation, Rancho Cordova, California, by
telephone February 17, 1995, followed by letter February 18,
1995. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY (a) 531 units; (b) 1,438 units were distributed.
REASON The UV cone, a part on the catheters, could come loose when
the catheter is removed from the patient through a
hemostatic valve.
_______________
PRODUCT Emerson Uninterruptible Power Supply (UPS), Accupower Model
30/500VA, used to provide back-up power to complete a
radiation therapy treatment during an electrical outage.
Recall #Z-694-5.
CODES Serial Numbers:
100020 801270011 11000020020
100160021 801400011 11000060020
400800003 1000180020 11000070020
600080008 1000190020 11000080020
600270008 1000390021 108000450018
800030011 1100080020 110000030020
800290010 8001550011 110000240020
800400011 20400800003 110001000020
800490011 20600220008 600800470011
800560011 10800270017.
MANUFACTURER Omitron International, Inc., Houston, Texas.
RECALLED BY Manufacturer, by letter January 21, 1994. Firm-initiated
recall ongoing.
DISTRIBUTION Alabama, Arizona, California, Florida, Georgia, Illinois,
Louisiana, Maryland, Mississippi, North Carolina, New
Jersey, Pennsylvania, Tennessee, Texas, Washington D.C.,
Korea.
QUANTITY 29 units.
REASON A power failure of the UPS may go undetected during patient
treatment.
_______________
PRODUCT Simpson Coronary Atherocath-GTO with improved durable
cutting system: (a) GT)-50 5 FR; (b) GTO-60-09;
(c) GTO-70-09. Recall #Z-698/700-5.
-10- CODE Lot numbers: (a) 250102; (b) 250103; (c) 250101.
MANUFACTURER Devices for Vascular Intervention, Inc. (DVI), Temecula,
California.
RECALLED BY Manufacturer, by letter February 9, 1995. Firm-initiated
recall complete.
DISTRIBUTION California, Connecticut, Georgia, Maryland, North Carolina,
New York, Washington, D.C.
QUANTITY 54 units were distributed.
REASON There appears to be cutter misalignment and burrs in the
cutter window.
_______________
PRODUCT Coiled 60 Inch Low Pressure Extension Tubes, used to connect
the contrast dye reservoir to the patient's catheter on a CT
scanner. Recall #Z-717-5.
CODE Part #601195. All lots.
MANUFACTURER Surgimedics/Texas, Medical Products (TMP), Orrville, Ohio.
RECALLED BY Liebel-Flarsheim Company, Cincinnati, Ohio, by letters of
December 24, 27, 31, 1994, and January 3 and 4, 1995. Firm-
initiated recall ongoing.
DISTRIBUTION Nationwide, Puerto Rico.
QUANTITY The volume of each type of product distributed in 1994 is as
follows: for the Coiled 60 Inch Low Pressure Extension
Tubing, 500,000; for the CT Multipak - Syringe size 150 ml,
175,000; CT Multipak - Syringe size 260 ml: 81,000; CT
Multipak for Medrad CT Injectors - Syringe size 200 ml,
71,000; and for the Front Loading CT Multipak - Syringe size
200 ml, 127,000.
REASON Small fragments of plastic have been found in tubes used to
administer contrast material to patients for CT studies.
_______________
PRODUCT Sterile Triad Hydrophilic Wound Dressing, 2.5 ounce tubes,
Product #1964, used for the local management of pressure and
venous stasis ulcers, secreting dermal lesions/injuries,
superficial wounds, scrapes, first and second degree burns,
partial and full thickness wounds. Recall #Z-729-5.
CODE Lot #IM4Z.
MANUFACTURER Sween Corporation, N. Mankato, Minnesota.
RECALLED BY Manufacturer, by letter March 21, 1995. Firm-initiated
recall complete.
DISTRIBUTION Kentucky, Texas, Canada.
QUANTITY 180 tubes were distributed.
REASON A portion of the lot was not sterilized prior to
distribution.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II
===========
_______________
PRODUCT Lactated Ringers Sterile Solution, unit size 1000 ml.
Recall #V-030-5.
CODE Lot numbers: 3055, 3085, 3237.
-11- MANUFACTURER American Veterinary Products, Fort Collins, Colorado.
RECALLED BY Manufacturer, by letter November 29, 1994. Firm-initiated
recall complete.
DISTRIBUTION Arizona, Colorado, Illinois, Louisiana, Missouri, New
Mexico, New York, Texas, Washington State, Puerto Rico.
QUANTITY 3,684 units of lot 3055, 7,432 units of lot 3085,
7,380 units of lot 3237.
REASON pH is below specifications.
MEDICAL DEVICE SAFETY ALERT:
=============================================
_______________
PRODUCT Telectronics Pacing Systems:
(a) Telectronics Pacing Systems, single chamber (VVIR)
cardiac pulse generator, Model 1202:
(b) Telectronics Pacing Systems, single chamber (VVI)
cardiac pulse generator, Model 5281B;
(c) Telectronics Pacing Systems, single chamber (VVI)
cardiac pulse generator, Model 158B (never sold in United
States). Safety Alert #N-027/029-5.
CODE Various serial numbers.
MANUFACTURER Telectronics Pacing Systems, Miami Lakes, Florida.
ALERTED BY Telectronics Pacing Systems, TPLC, Inc., Englewood,
Colorado, by letter April 25, 1995.
DISTRIBUTION (a & b) Nationwide; (c) The United Kingdom.
QUANTITY (a) 159 units implanted, approximately 115 units remaining
implanted in the United States; (b) 75 units implanted,
approximately 58 units remaining implanted in the United
States; (c) 11 units were distributed in the United
Kingdom.
REASON These pacers may fail without warning and exhibit a sudden
no output condition due to loss of hermeticity and fluid
ingress as a result of a cracked ceramic feedthrough
assembly or a failed braze joint.
-12-
END OF ENFORCEMENT REPORT FOR MAY 3, 1995. BLANK PAGES MAY FOLLOW.
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