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.
May 14, 1997 97-20
RECALLS AND FIELD CORRECTIONS: FOODS -- CLASS III ==========
_______________
PRODUCT Bear Mountain brand Honey in 5 pound jars. Recall #F-405-7.
CODE None.
MANUFACTURER C&W Farms, Dekalb, Mississippi. (Also known as
Jay's Honey and/or Pilgrim Farms.)
RECALLED BY Best Bargains, Inc., New Munster, Wisconsin, by
posting a sign and by letter on April 8, 1997.
Firm-initiated recall complete.
DISTRIBUTION Wisconsin and Illinois.
QUANTITY 63.33 cases were distributed.
REASON Product is labeled as pure honey but contains
approximately 70% undeclared syrup.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II
===========
_______________
PRODUCT Regular Strength Enteric Coated Aspirin Tablets, 325
mg, packaged in bottles of 100, 250, and 500, under the
following labels: Wal-Mart, Leader, K&B, Medic,
Eckerd, FDC.
Recall #D-171-7.
CODE The bulk lot codes assigned at Granutec's Largo, Florida
repacking facility were 6081552, 6102906, 6014875, 7016609,
7038752 and 7038755. Bulk Lot 6081552 was used in four
packaging orders filled in September and October 1996:
Wal-Mart (Equate brand) finished lot numbers 6091964 and
6103286, 250 count bottle; Leader finished lot number
6092229, 100 count bottle, and K&B finished lot number
6092137, 100 count bottle. The expiration for all finished
lot numbers is 6/98.
Bulk lot 6102906 was used in four packaging orders -
Wal-Mart (Equate brand) finished lot numbers 6103286, EXP
Date 6/98, 6103504, EXP 8/98 & 6114234, EXP Date 8/98, 250
count bottles and Medic lot number 6102919, EXP 6/98, 100
count bottle.
Bulk lot 6014875 was used in one packaging order - Wal-Mart
(Equate brand) finished lot number 6014914, EXP 12/97 in 100
count bottles. Bulk lot 7016609 was used in two packaging
orders - Eckerd finished lot number 6125554, EXP 8/98 in 500
count bottles and Wal-Mart (Equate brand) lot number
7016838, EXP 10/98 in 100 count bottles.
Bulk lot 7038752 was used in two packaging orders - FDC
finished lot number 7016194, EXP 1/99, 250 count bottles and
Wal-Mart (Equate brand) lots 7038767, EXP 1/99, 250 count
bottles and lot 7038809, EXP 1/99 in 100 count bottles.
Bulk lot 7038755 was used in one packaging order - Wal-Mart
(Equate brand) finished lot number 7038767, EXP 1/99 in 250
count bottles.
MANUFACTURER Granutec, Inc., Wilson, North Carolina.
RECALLED BY Manufacturer, by telephone on February 11, 1997,
followed by letter on February 13, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY Wal-Mart -- Lot #6091964: 25,536 units of 250 count
bottles; Lot #6103286: 24,864 units of 250 count
bottles; Lot #6103504: 18,000 units of 250 count
bottles; Lot #6114234: 20,448 units of 250 count
bottles; Lot #6014914: 33,696 units of 100 count
bottles; Lot Number 7016838: 33,408 units of 100 count
bottles; Lot Number 7038767: 35,376 units of 250 count
bottles; Lot Number 7038809: 24,624 units of 100 count
bottles; Lot Number 7038767; 35,376 units of 250 count
bottles
Leader -- Lot 6092229: 2,880 units of 100 count bottles
-2- K&B -- Lot #6092137: 2,880 units of 100 count bottles
Medic -- Lot #6102919: 1,440 units of 100 count bottles
Eckerd -- Lot #6125554: 4,752 units of 500 count bottles
FDC -- Lot #7016194; 1,440 units of 250 count bottles.
These lots were packaged in September and October 1996.
Firm estimates none remains on the market.
REASON Failing dissolution results in stability testing.
_______________
PRODUCT Miochol-E (Acetylcholine Chloride) Intraocular
Solution, 20 mg/2 ml vial, Rx, used in eye surgery.
Recall #D-174-7.
CODE LOT NO. EXP. DATE
U2280 12/97
U2280E 12/97
U22281 1/98
U2281D 1/98
U2285 1/98
U2285D 1/98
U2287 1/98
U2287D 1/98.
MANUFACTURER OMJ Pharmaceuticals, San German, Puerto Rico.
RECALLED BY Ciba Vision Ophthalmics (CVO), Duluth, Georgia, by
letter dated March 17, 1997. Firm-initiated
recall ongoing.
DISTRIBUTION Nationwide and Germany.
QUANTITY 56,448 units were distributed.
REASON Product failed pH specifications.
RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III ==========
_______________
PRODUCT Cleocin HCl 300 mg Capsules (Clindamycin Hydrochloride,
USP), packaged for unit dose administration in a carton
of 100 unit doses. Recall #D-170-7.
CODE Lot #66ARS EXP 6/30/00.
MANUFACTURER Pharmacia & Upjohn Company, Kalamazoo, Michigan.
RECALLED BY Manufacturer, by letter mailed during the week of
March 31, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Antigua.
QUANTITY 1,449 cartons containing 100 unit dose blisters were
distributed.
REASON Product labeled with the wrong expiration date
indicating one additional year of shelf life.
-3-_______________
PRODUCT SoloPak Hydralazine Hydrochloride Injection USP, 20
mg/ml, Rx antihypertensive SVP for intravenous or
intramuscular use.
Recall #D-172-7.
CODE Lot #960573 EXP 11/97.
MANUFACTURER SoloPak Pharmaceuticals, Inc., Elk Grove Village,
Illinois.
RECALLED BY Manufacturer, by letter dated April 16, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide.
QUANTITY 26,675 vials were distributed; firm estimated that 1
percent remained on market at time of recall
initiation.
REASON Product contains particulate matter.
_______________
PRODUCT Baclofen Tablets, USP, 20 mg, Rx muscle relaxant and
antispastic. Recall #D-173-7.
CODE Lot #3542-008.
MANUFACTURER Biocraft Laboratories, Inc., Elmwood Park, New
Jersey (responsible firm).
RECALLED BY Vangard Labs, Inc., Glasgow, Kentucky, by letter
April 2, 1997. Firm-initiated recall complete.
DISTRIBUTION Maine, New Jersey, Kentucky, North Carolina,
California.
QUANTITY 71 cartons were distributed.
REASON Product fails dissolution requirement.
RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II =======
_______________
PRODUCT Samplink Access Device, used during the blood donation
process to obtain a sample of the donors blood from the
bloodline.
Recall #B-560-7.
CODE Lot numbers: D8324H4 D8325H4 M8442M4
M8443M4 M8509P4 M8510P4 M8511P4 M8512P4
M8513P4 M8530P4 M8531P4 M8552A5 M8553A5
M8554A5 M8555A5 M8556A5 M8589B5 M8590B5
M8591B5 M8621B5 M8622C5 M8623C5 M8624C5
M8657C5 M8679D5 M8680D5 M8681D5 M8682D5
M8683D5 M8684E5 M8685E5 M8686E5 M8687E5
M8688E5 M8777F5 M8778F5 M8779F5 M8780G5
M8781G5 M8782G5 M9083P5 M9084P5 M9085P5
M9164A6 M9165A6 M9166B6 M9167B6 M9290C6
M9291C6.
MANUFACTURER Migada Ltd., Kiryat Shmona, Israel.
RECALLED BY Migada, Inc., Englewood Cliffs, New Jersey, by
letter on October 31, 1996. Firm-initiated recall
complete.
-4-DISTRIBUTION Nationwide.
QUANTITY 3,186,240 units were distributed.
REASON Upon removal of the vacuum tube from the Samplink
Access Device, the needle was pulling out of the
housing, leaving it exposed for potential needle
sticks.
_______________
PRODUCT (a) Red Blood Cells; (b) Platelets; (c) Recovered
Plasma. Recall #B-621/623-7.
CODE Unit #42K63478.
MANUFACTURER American Red Cross Blood Services, Cleveland,
Ohio.
RECALLED BY Manufacturer, by letter dated January 17, 1997.
Firm-initiated recall complete.
DISTRIBUTION Ohio, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose spouse
has hepatitis B.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS
II =========
_______________
PRODUCT Double-Up Breast Pump Kits (Powered).
Recall #Z-436-7.
CODE None.
MANUFACTURER The Natural Choice Company, Inc., Foster City,
California.
RECALLED BY Manufacturer, by memorandum on February 28, 1997,
followed by letter dated March 4, 1997. Firm-initiated recall ongoing.
DISTRIBUTION Virginia, Ohio, Alabama, Texas, Maryland, Florida,
Illinois, New Jersey, Washington state, Missouri,
Colorado.
QUANTITY 75 kits were distributed.
REASON The black corks used as milk contacting components are
not food grade and may contain Carbon Black.
Additionally, there is no cleared 510(k), premarket
notification, on file with the Food and Drug
Administration (FDA).
_______________
PRODUCT Deltec CADD Prizm VIP, Model No. 6100 Ambulatory
Infusion Pump, used to provide measured drug therapy
to patients in hospital or outpatient settings. Recall
#Z-481-7.
CODE All Lot Numbers.
MANUFACTURER SIMS Deltec, Inc., St. Paul, Minnesota.
RECALLED BY Manufacturer, by letter dated April 8, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide, Canada, United Kingdom.
QUANTITY 1,924 pumps were distributed.
-5-REASON A software error can result in an incorrect delivery
rate at the beginning of the taper down period and an
incorrect volume of fluid delivered during the taper
down period of the Total Parenteral Nutrition (TPN)
application program.
_______________
PRODUCT Autonomic Electronic Stimulator (AES) of the Gastro-Intestinal Tract and Mucous Membrane Patent #92009816.
Recall #Z-482-7.
CODE Model #1, Control Test P-6551-K.
MANUFACTURER AOOT "Zavod Komponent" Moscow, Russia.
RECALLED BY Kobee Company, Rutherford, New Jersey, by visit.
Firm initiated recall completed as of September
11, 1996.
DISTRIBUTION California, New Jersey, Russia, China, Japan,
Brazil.
QUANTITY 900 capsule-like objects were distributed.
REASON The device has been distributed without an approved
510k, PMA, or IDE.
_______________
PRODUCT NMC brand Naturalyte 9013 Acid Concentrate for
Bicarbonate Dialysis, a hemodialysis solution (Rx). Recall #Z-483-7.
CODE Catalog #08-9013-7, Lot #D6C064 EXP 3/98.
MANUFACTURER National Medical Care, Medical Products Division,
Delran, New Jersey.
RECALLED BY National Medical Care, Medical Products Division,
Rockleigh, New Jersey, by telephone on or about
August 8, 1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 967 cases (4 jugs per case) were distributed.
REASON The device is mislabeled as "9016 K-Free" meaning they
are potassium free when, in fact, it contains 2.0 mEq/L
Potassium.
_______________
PRODUCT Sterile and non-sterile cotton and rayon tipped
applicators:
Sterile Applicators:
(a) 3" Cotton Tip - Stock Nos. 20101, ST3-2WC; 20138,
ST6-1PC, 220371; 800901;
(b) 6" Cotton Tip - Stock Nos. 20139, ST6-1WC; 20140,
ST6-2PC; 20141, ST6-2WC; 220367; 220368; 220568, 220668,
MDS202000; MDS202055; 51627; IMST6-1WC; IMST6-2WC or 20131;
(c) 6" Rayon Tip - Stock Nos. 20188, ST6-1PR; 20190,
ST6-2WR; 220467; 5-6522; 5-6524;
Non-Sterile Applicators:
-6- (d) 3" Cotton Tip - Stock Nos. 20202, 3PC; 20203, 3WC;
220361, MDS202050; M000803; 45297; 0850107; IM3WC;
0504001-3;
(e) 6" Cotton Tip - Stock Nos. 20024, 6PC; 20225, 6WC;
20026, 6WC Plain; 20227, 6WC Plastic; 20228, 6WC/Large;
220362; MDS202054; MDS202055; MDS 202055Z; M00806; 32262;
0850123; 6PC WELCON; IM6WC; 0505001-6WC;
(f) 3" Rayon Tip - Stock No. 6-6521;
(g) 4" Rayon Tip - Stock No. 20272, Procto 50-8-4;
(h) 6" Rayon Tip - Stock No. 5-6520;
(i) 8" Rayon Tip - Stock Nos. 20270, Procto 100-8; 20271,
Procto 50-8;
(j) 16" Rayon Tip - Stock No. 20280 Procto 100-16; 20281
Procto 50-16.
Recall #Z-484/493-7.
CODE Ultra Sterile Cotton Tipped Applicators:
Reorder
Number Lot Number(s)
20101 6854, 6957, 7251
20139 69472
20140 61265, 7161
20141 68449, 68459, 68461, 68465, 69473,
611481, 611483, 612487, 612492,
7143, 7145, 71410, 72414, 72415
Ultra Sterile Rayon Tipped Applicators:
Reorder
Number Lot Number(s)
20185 68102, 612106
20190 68104
Ultra (non-sterile) Cotton Tipped Applicators
Reorder Lot Number(s)
20202 See Lot Numbers below
20203, 20024
20225, 20226
20227, 20228
Ultra Eight Inch Tipped Applicators
(non-sterile):
Reorder Number Lot Number(s)
20270, 20271 See lot numbers below
Ultra Sixteen Inch Tipped Applicators
(non-sterile):
Reorder Number Lot Number(s)
20280, 20281 See lot numbers below
Abco Sterile Cotton-Tipped Applicators:
Reorder Number Lot Number(s)
220367 69471
220368 68462, 610474, 611480,
611482, 612486, 612489,
612491, 7147, 72412
220668 7262
-7- Abco Non-sterile Cotton-Tipped Applicators:
Reorder Number Lot Number(s)
220361 See lot numbers below
220362
Imco Sterile Cotton-Tipped Applicators:
Reorder Number Lot Number(s)
IMST6-1WC 69467, 69468, 610730, 7146
IMST6-2WC 68463, 69470, 611478,
611479, 612488, 7142, 7148
Imco (non-sterile) Cotton-Tipped Applicators:
Reorder Number Lot Number(s)
IM3WC See lot numbers below
IM6WC
Rayswab Sterile packaged (rayon-tipped)
Applicators:
Reorder Number Lot Number(s)
5-6522 68103, 71101
5-6524 69105
Rayswab Non-Sterile Packaged (rayon-tipped)
Applicators:
Reorder Number Lot Number(s)
5-6521 See lot numbers below
5-6520
Medline Sterile 6" Cotton-Tipped Applicators:
Reorder Number Lot Number(s)
MDS 202000 68460, 68464, 68466,
69469, 610475, 610732,
610476, 611477, 611733,
611484, 612485, 612490,
7141, 7144, 7149, 72413,
72416
Medline Non-sterile 6" Cotton-Tipped
Applicators:
Reorder Number Lot Number(s)
MDS 202054 See lot numbers below
MDS 202055
MDS 202055Z
Medline Non-sterile 3" Cotton-Tipped
Applicators:
Reorder Number Lot Number(s)
MDS 202050 See lot numbers below
Medicom (non-sterile) Cotton Tip Applicators:
Reorder
Number Lot Number(s)
M000803 See Lot Numbers below
M000806
Moore Medical Corp. 6" Sterile Cotton-Tipped
Applicators:
Reorder
Number Lot Number(s)
51627 72411
-8- Moore Medical Corp. Non-sterile Cotton-Tipped
Applicators:
Reorder
Number Lot Number(s)
45297 See Lot Numbers below
32262
Patterson (non-sterile) Cotton-Tipped
Applicators:
Reorder
Number Lot Number(s)
0850107 See Lot Numbers below
0850123
Welcon (non-sterile) 6" Cotton-Tipped
Applicators - Plastic Stick:
Reorder
Number Lot Number(s)
6PCWELCON See Lot NumberS below
Zee Sterile Cotton-Tipped Applicators:
Reorder
Number Lot Number(s)
8009001 6955, 6956, 61258, 7252
Zee Non-sterile Cotton-Tipped Applicators:
Reorder
Number Lot Number(s)
0504001-3 See Lot Numbers below
0505001-6WC.
Non-sterile product lot numbers are:
621400 through 636599; 7100 through 7999
71000 through 75999; 700100 through 705999.
MANUFACTURER Banta Healthcare Products, Inc., Neenah,
Wisconsin.
RECALLED BY Manufacturer, by letter dated March 19, 1997.
Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and Canada.
QUANTITY 252,939,500 applicators were distributed; firm
estimated that 20 percent of product remained on market
at time of recall initiation.
REASON The cotton or rayon tips of the applicators may become
detached during use.
_______________
PRODUCT Miami J Collar Cervical Collar:
Product No. MJ-200;
Product No. MJR-200;
Product No. MJ-200L;
Product No. MJR-200L;
Product No. MJ-300;
Product No. MJR-300;
Product No. MJ-400;
Product No. MJR-400. Recall #Z- 494/501-7.
CODE None.
-9-MANUFACTURER The Jerome Group (Jerome Medical), Moorestown, New
Jersey.
RECALLED BY Manufacturer, by notices of December 21, 1997 and
July 30-31, 1996, and September 24, 1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 6,046 collars were distributed.
REASON The adhesive used to hold the velcro strips onto the
front of the cervical collar fails to adequately adhere
the velcro to the collar.
_______________
PRODUCT Adult Breathing Circuits with 40" Corrugated Hoses,
Part #R5041:
(a) Product No. 5031JXI0
(b) Product No. 5322AIMW
(c) Product No. 5320AMOS
(d) Product No. 5322AIMW
(e) Product No. 5322AIZ
(f) Product No. 5322FAIR
(g) Product No. 5330ACIZ
(h) Product No. 5030AMN
(i) Product No. 5133AEO7
(j) Product No. 51331ACEZ
(k) Product No. 6Q00X19X*
(l) Product No. 5030AE
* = Adult Breathing Circuit within a Supercircuit package.
Recall #Z-504/515-7.
CODE (a) Lot No. 229G; (b) Lot No. 229G;
(c) Lot No. 229H; (d) Lot No. 229H;
(e) Lot No. 229H; (f) Lot No. 229H;
(g) Lot No. 229H; (h) Lot No. 232G;
(i) Lot No. 232G; (j) Lot No. 232G;
(k) Lot No. 232G; (l) Lot No. 234G.
MANUFACTURER Vital Signs, Inc., Totowa, New Jersey.
RECALLED BY Manufacturer, by letter September 30, 1996. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 7,800 hoses were distributed; firm estimates none
remains on the market.
REASON The devices have pinholes in the 40" corrugated hose
which cause it to leak.
_______________
Product Passport Monitor with CO2 Capability, used to monitor
C02, respiration, temperature and non-invasive blood
pressure in a patient.
Recall #Z-516-7.
CODE Model Numbers: 0998-00-00095-61, 62, 63, 64, 66, 68,
70, 71, 72, 73, 74, 75, 76, B61, B62, B63, B64,
H61, H62, H63, H64, H70, H71, H72, N61, N62, N63, and
N64;
-10- Model Numbers: 0998-00-0126-61, 62, 63, 64, 73, 74, 75, 76,
N61, N62, N63, and N64.
MANUFACTURER Datascope Corporation, Paramus, New Jersey.
RECALLED BY Manufacturer, by letter August 2, 1996. Firm-initiated field correction complete.
DISTRIBUTION Nationwide and international.
QUANTITY 1,064 units were distributed.
REASON The CO2 circuit board assembly used in the Passport
Monitor has been found to experience intermittent
failure at start up.
_______________
PRODUCT Hemashield Microvel Double Velour Vascular Grafts, used
in the replacement or repair of arteries. Recall #Z-554/560-7.
CODE (a) Bifurcated - 40 cm of useful length
Product #085126 12mm x 6mm; Lot Nos. 106107, 226131, 596152
Product #085127 12mm x 7mm; Lot Nos. 126107, 206045,
236131, 306130
Product #085147 14 mm x 7mm; Lot Nos. 026108,
046130, 066130, 156015, 176138, 246131,
326064, 466059, 546024
Product #085148 14mm x 8mm; Lot No. 086106
Product #085168 16mm x 8mm; Lot Nos. 126073,
136073, 136094, 156073, 156094, 166073,
166094, 186094, 246129, 266129, 266130,
276108, 286108, 296108, 376093, 446108,
456108, 516137
Product #085169 16mm x 9mm; Lot Nos. 066139,
286110
Product #085189 18mm x 9mm; Lot Nos. 056110,
016111, 016113, 026115, 036111, 046110,
056110, 076131, 166134, 186138, 246106,
296045, 296131, 306045, 316130, 326110,
326129, 356110, 456059, 486108
Product #085180 18mm x 10mm; Lot Nos. 286073,
296073
Product #085201 20mm x 10mm; Lot Nos. 026109,
026153, 046017, 046111, 046131, 046153,
126060, 166109, 176109, 186109, 276137,
306073, 426131, 626152,
Product #085211 20mm x 11mm; Lot Nos. 076162,
286137
Product #085221 22mm x 11mm; Lot Nos. 366110,
486059
(b) Straight - 15 cm of useful length
Product #095106 6mm; Lot No. 106122
Product #095112 12mm; Lot Nos. 066057, 386128
Product #095114 14mm; Lot No. 096122
Product #096116 16mm; Lot Nos. 216029,
336139, 346136
-11- Product #095118 18mm; Lot Nos. 326010,
636114
Product #095120 20mm; Lot No. 075306, 366139
Product #095124 24mm; Lot Nos. 296158,
366136
(c) Straight - 30cm useful length
Product #095406 6mm; Lot Nos. 056115, 056136
Product #095408 8mm; Lot Nos. 416145
Product #095410 10mm; Lot No. 576131
Product #095412 12mm; Lot No. 116115
Product #095214 14mm; Lot No. 036057
Product #095216 16mm; Lot Nos. 096044,
206113, 216113, 526131, 726128
Product #095218 18mm Lot Nos. 116144,
126144, 136015, 146015, 375345, 546131, 646114
Product #095220 20mm; Lot Nos. 066017,
066159, 076115, 466139
Product #095222 22mm Lot No. 086115
Product #095224 24mm Lot Nos. 076017,
106115, 566131
(d) Straight - 40 cm useful length
Product #095306 6mm; Lot Nos. 046057, 046115,
266150
Product #095307 7mm; Lot Nos. 026057, 026137
(e) Straight - 60 cm useful length
Product #095208 8mm; Lot Nos. 136109, 146109,
186113 186157, 306010
Product #095210 10mm Lot No. 286099
(f) Straight - 100 cm useful length
Product #095507 7mm Lot No. 606131
(g) Axillo-Bifemoral - 100 cm with 60 cm side
branch
Product #095588 8mm right branch;
Lot No. 296065
Product #095589 8mm left branch;
Lot Nos. 136115, 626131.
MANUFACTURER Meadox Medicals, Inc., Oakland, New Jersey.
RECALLED BY Manufacturer, by letters on September 3 and 10,
1996. Firm-initiated recall ongoing.
DISTRIBUTION Nationwide and international.
QUANTITY 5,900 units were distributed.
REASON Devices may exhibit high porosity due to collagen
breakdown which could result in higher than expected
blood loss.
_______________
PRODUCT Pall Heat and Moisture Exchanger (HME) Filter with CO2
Monitoring Port, supplied with Flex Tubing and
Protective Cap, indicated for use with mechanically
ventilated patients to provide heat and humidity while
retaining bacterial/viral contaminants with greater
than 99.999% efficiency. Recall #Z-561-7.
-12-CODE Product #HME15-22M; Lot #531406.
MANUFACTURER Pall Biomedical, Inc., Fajardo, Puerto Rico
(finished device); Blow Molded Specialties,
Providence, Rhode Island (flex tube).
RECALLED BY Pall Biomedical Products Company, East Hills, New
York (distributor), by fax letter dated April 24,
1996. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, Indiana, Oklahoma, Florida,
New York.
QUANTITY 44 cases (50 units per case) were distributed.
REASON The flex tube had disconnected from the endotracheal
tube in several instances, some during anesthesia.
_______________
PRODUCT Sterile Burn Compress, 24" x 36" poly backed. Recall
#Z-562-7.
CODE Reorder #30108, Lot #DF0218.
MANUFACTURER McNeil Healthcare, Inc., Waterford, Connecticut.
RECALLED BY Manufacturer, by telephone on November 4, 1996.
Firm-initiated recall complete.
DISTRIBUTION Canada.
QUANTITY 24 cases (16 pouches per case) were distributed.
REASON The package seals were found to display voids, which
could compromise the sterility of the device.
RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III ========
_______________
PRODUCT Empi Dynex IV Dual Channel Transcutaneous Electric
Nerve Stimulator (TENS Device), indicated for the
symptomatic relief and management of chronic,
intractable pain, and as an adjunctive treatment in the
management of post-surgical and post-traumatic acute
pain problems. Recall #Z-502-7.
CODE 3115351 through 3115834
3115839 through 3115950
3115970, 3115980
3115988 through 3116060
3116069, 3116070
3116072 through 3116275.
MANUFACTURER Empi, Inc., Clear Lake, South Dakota.
RECALLED BY Empi, Inc., St. Paul, Minnesota, by letters dated
April 4, 7, or 8, 1997. Firm-initiated recall
ongoing.
DISTRIBUTION Nationwide, Australia, Canada, Spain.
QUANTITY 877 affected units were distributed.
-13-REASON The device to be adulterated in that the pulse rate and
pulse duration outputs do not match the mid-range
increments shown on the device labeling. The pulse
duration will be lower and the pulse rate will be
higher than indicated by the device dials.
_______________
PRODUCT Exeter Standard Size Hip Stem,
Catalog #0572-1-001. Recall #Z-503-7.
CODE Lot #U260264
MANUFACTURER Benoist Girard et Cie, Herouville Saint Clair,
France.
RECALLED BY Howmedica USA, Rutherford, New Jersey, by letter
dated September 24, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 5 units were distributed; firm estimated that 3 units
remained on market at time of recall initiation.
REASON The packages were incorrectly labeled on one of the two
outer labels as Jumbo instead of Standard.
_______________
PRODUCT Hall brand Long Surgical Burs 5092 Series, used in
orthopedic surgery. Recall #Z-531-7.
CODE Lot #00043870.
MANUFACTURER Linvatec, A Bristol-Myers Squibb Company, Largo,
Florida.
RECALLED BY Manufacturer, by letter on March 13, 1997. Firm-initiated recall complete.
DISTRIBUTION Pennsylvania, Iowa, Missouri, New York,
California, South Carolina, Minnesota, Indiana,
Tennessee.
QUANTITY 24 5-pack boxes were distributed.
REASON A lot was labeled as "Long Bur", when in fact they were
"Extra Long Bur".
_______________
PRODUCT Bartels FlexTrans Viral and Chlamydial Transport Media,
in-vitro diagnostic:
(a) Catalog No. B1029-90;
(b) Catalog No. B1029-90A;
(c) Catalog No. B1029-90B;
(d) Catalog No. B1029-90AM;
(e) Catalog No. B1029-90AY;
(f) Catalog No. B1029-90SS;
(g) Catalog No. B1029-90PS.
Recall #Z-532/538-7.
-14-CODE Lot #1064, EXP 12-20-96, Lot #1070,
EXP 1-26-97, Lot #1065, EXP 12-20-96,
Lot #1071, EXP 1-26-97, Lot #1066,
EXP 12-20-96, Lot #1072, EXP 1-26-97,
Lot #1067, EXP 12-20-96, Lot #1073,
EXP 1-26-97, Lot #1068, EXP 12- 6-96,
Lot #1074, EXP 2-29-97, Lot #1069,
EXP 1-26-97, Lot #1075, EXP 2-29-97,
Lot #1076, EXP 2-29-97, Lot #1077,
EXP 2-29-97, Lot #1078, EXP 2-29-97,
Lot #1079, EXP 2-29-97.
MANUFACTURER Viratest, San Antonio, Texas.
RECALLED BY Bartels, Inc., Issaquah, Washington, by letter
beginning November 27, 1996. Firm-initiated
recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 109,209 units were distributed.
REASON The media evaporated when stored at room temperature
which may lead to reduced recovery of viruses or
chlamydiae.
_______________
PRODUCT Clostridium Difficile Enzyme Immunoassay, in-vitro
diagnostic. Recall #Z-539-7.
CODE Catalog #B1029-69, Kit lot numbers: 1380, 1382, 1383, 1384;
strip lot #1264.
MANUFACTURER Bartels, Inc., Issaquah, Washington.
RECALLED BY Manufacturer, by fax beginning January 8, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 51 kits of lot 1380, 25 kits of lot 1382, 29 kits of
lot 1383, 4 kits of lot 1384, and all strips of lot
1264.
REASON The strips may give high optical density readings for
negative controls.
_______________
PRODUCT Respiratory Syncytial Viral Enzyme Immunoassay, in-vitro diagnostic.
Recall #Z-540-7.
CODE Catalog #B1029-420, Lot numbers 1067 EXP 9/18/96 and 1070
EXP 11/13/96.
MANUFACTURER Bartels, Inc., The Diagnostics Division of
Intracel Corporation, Issaquah, Washington.
RECALLED BY Manufacturer, by fax beginning February 2, 1996.
Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 21 kits of lot 1067 and 39 kits of lot 1070 were
distributed.
REASON The kit contained strips that may sporadically and at
random give high optical density readings.
-15-_______________
PRODUCT Cytomegalovirus IgG Enzyme Immunoassay, in-vitro
diagnostic. Recall #Z-541-7.
CODE Catalog #B1029-335, Lot #2033 EXP 11/96.
MANUFACTURER Gull Laboratories, Salt Lake City, Utah.
RECALLED BY Bartels, Inc., The Diagnostics Division of
Intracel Corporation, Issaquah, Washington, by fax
beginning June 10, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 25 kits were distributed.
REASON The kit contained (CMV) Cytomegalovirus IgM specimen
diluent was mislabeled as containing EBV IgM specimen
diluent.
_______________
PRODUCT Bartels PRIMA SystemTM Rubella IgG Enzyme Immunoassay,
in-vitro diagnostic.
Recall #Z-542-7.
CODE Catalog No. B1029-320, Lot #2042 EXP 4/97.
MANUFACTURER Gull Laboratories, Salt Lake City, Utah.
RECALLED BY Bartels, Inc., The Diagnostics Division of
Intracel Corporation, Issaquah, Washington, by fax
beginning October 15, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide.
QUANTITY 38 kits were distributed.
REASON The kit positive control serum was mislabeled as
reference serum.
_______________
PRODUCT Bartels PRIMA SystemTM HSV2 IgG EIA Kits, in-vitro
diagnostic. Recall #Z-543-7.
CODE Catalog No. B1029-350, Lot #2055 EXP 7/97.
MANUFACTURER Gull Laboratories, Salt Lake City, Utah.
RECALLED BY Bartels, Inc., The Diagnostics Division of
Intracel Corporation, Issaquah, Washington, by fax
beginning December 2, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 30 kits were distributed.
REASON The HSV2 IgG EIA Kits contained specimen diluent that
was labeled as HSV1 IgG specimen diluent.
_______________
PRODUCT Human Lung Fibroblast Cells MRC-5, in-vitro diagnostic.
Recall #Z-544-7.
CODE Catalog No. B1029-16B, Lot #V02543-V.
MANUFACTURER Bartels, Inc., The Diagnostics Division of
Intracel Corporation, Issaquah, Washington.
RECALLED BY Manufacturer, by telephone on December 3, 1996.
Firm-initiated recall complete.
-16-DISTRIBUTION Nationwide.
QUANTITY 203 vials were distributed.
REASON The Cell Culture Data Sheets supplied to the customers
did not include the correct lot number for MRC-5 Shell
Vials.
_______________
PRODUCT Human PRIMA SystemTM Cytomegalovirus IgM EIA Kit, in-vitro diagnostic. Recall #Z-545-7.
CODE Catalog No. B1029-335, Lot #2040.
MANUFACTURER Gull Laboratories, Salt Lake City, Utah.
RECALLED BY Bartels, Inc., The Diagnostics Division of
Intracel Corporation, Issaquah, Washington, by fax
on October 2, 1996. Firm-initiated recall
complete.
DISTRIBUTION Nationwide and international.
QUANTITY 62 kits were distributed.
REASON The kits may exhibit a decrease in the optical density
value of the positive control, which may invalidate
test runs.
_______________
PRODUCT Bartels Viral Respiratory Kit and Anti-RSV Antibody,
in-vitro diagnostic products:
(a) Viral Respiratory Kit, Catalog #B1029-86
(b) Anti-RSV Antibody, Catalog #1029-87G. Recall #Z-546/547-7.
CODE Lot numbers: (a) 1292 through 1298;
(b) 1047 and 1048.
MANUFACTURER Bartels, Inc., The Diagnostics Division of
Intracel Corporation, Issaquah, Washington.
RECALLED BY Manufacturer, by letter on March 14, 1995. Firm-initiated recall complete.
DISTRIBUTION Nationwide and international.
QUANTITY 263 units were distributed.
REASON The RSV IFA stains may have a greater level of
extracellular background fluorescent staining which can
result in increased difficulty in interpretation.
_______________
PRODUCT Human Foreskin (HF) Shell Vials, in-vitro diagnostic.
Recall #Z-548-7.
CODE Catalog No. B1029-2, Lot No. V02972-C.
MANUFACTURER Bartels, Inc., The Diagnostics Division of
Intracel Corporation, Issaquah, Washington.
RECALLED BY Manufacturer, by fax on February 24, 1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 96 units were distributed.
REASON The shell vials were contaminated with bacteria.
-17-_______________
PRODUCT Human Foreskin (HF) Culture Tubes, in-vitro diagnostic.
Recall #Z-549-7.
CODE Catalog No. B1029-1, Lot #1847-F.
MANUFACTURER Bartels, Inc., The Diagnostics Division of
Intracel Corporation, Issaquah, Washington.
RECALLED BY Manufacturer, by fax on February 24, 1997. Firm-initiated recall complete.
DISTRIBUTION Nationwide.
QUANTITY 415 units were distributed.
REASON The culture tubes were contaminated with fungus or
bacteria.
_______________
UPDATE EBV Viral Capsid Antigen IgM Elisa Test Kit, Recall #Z-470-7, which appeared in the May 7, 1997 Enforcement
Report should be corrected as follows:
MANUFACTURED/RECALLED BY: Clark Laboratories, Inc.,
Jamestown, New York.
DISTRIBUTION: Nationwide and International.
QUANTITY: 190 kits - domestic; and 166 kits -
International.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS II ===========
_______________
UPDATE Nutrena Super 20 Dairy Pellets (non-medicated),
which appeared in the April 16, 1997 Enforcement
Report should have been listed as Recall #V-033-7.
RECALLS AND FIELD CORRECTIONS: VETERINARY PRODUCTS -- CLASS III ==========
_______________
PRODUCT (a) Flavomycin 4 Type A Medicated Article
(bambermycin) (4 grams per pound)
(b) Flavomycin 10 Type A Medicated Article (bambermycin)
(10 grams per pound), used to increase weight gain and
to improve feed efficiency in broiler chickens.
Recall #V-035/036-7.
CODE Lot numbers: (a) A5034001 - A5348151
S6022001 - S6086074, A6058001 - A6295149
W6075001 - W6075017; (b) 06124001 - 06234019
05087001 - 06270044.
MANUFACTURER Merck AgVet, St. Louis, Missouri.
RECALLED BY Hoechst Roussel Vet, Somerville, New Jersey,
by letter on December 9, 1996. Firm-initiated
recall complete.
DISTRIBUTION Nationwide.
-18-QUANTITY 51,098 50-pound bags of Flavomycin 4 and 13,325 50-pound bags of Flavomycin 10 were distributed.
REASON Products failed the 24 month expiration date
stability testing. Flavomycin 4 was below 90-110%
of label claims and Flavomycin 10 was above 90-110%
of label claims.
-19-
END OF ENFORCEMENT REPORT FOR MAY 14, 1997. BLANK PAGES MAY FOLLOW.
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