AUGUST 2002
WEEK ENDING AUGUST 3
PRODUCT CryoValve Allograft - Heart valve.
CODE Serial No. 6773739, Model No. PV00.
RECALLING FIRM/MANUFACTURER Cryolife, Inc. Kennesaw, GA
REASON Aortic valve donor was associated with alleged case
of Endocarditis.
VOLUME OF PRODUCT IN COMMERCE One valve.
DISTRIBUTION CA.
PRODUCT LTV Series Ventilators
CODE LTV 1000, LTV 950 and LTV 800 Series Ventilator
Serial numbers affected are:
A03816-A03840
C03168-C03197
D01006-D01010,
D01013, D01015, D01021, D01022.
RECALLING FIRM/MANUFACTURER Pulmonetic Systems, Inc.,
Colton, CA
REASON EMI shield short circuits units, potential for fire.
VOLUME OF PRODUCT IN COMMERCE 64.
DISTRIBUTION PA, OH, FL, NC, GA, PA, WA, CA and to Canada,
Japan, and Taiwan.
PRODUCT Ct Tri Pak Sterile disposable syringe kits.
CODE Catalog number CTP-200-FLS. Lot numbers 29764,
29765, and 29766.
RECALLING FIRM/MANUFACTURER Medrad, Inc., Indianola, PA
REASON May exceed endotoxin specification limits
VOLUME OF PRODUCT IN COMMERCE 41650 kits
DISTRIBUTION Nationwide and Sultanate of Oman, Korea,
Taiwan and BR.
PRODUCT Intera 1.0T and 1.5T MR Systems Magnetic Resonance
Systems are indicated for use as diagnostic devices that display the internal
structure and/or function of the head, body or extremeties. The coils are used
to obtain optimal imaging.
CODE Software version R7.1.2 and higher
RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc.,
Bothell, WA
Manufacturer: Philips Medical Systems Nederland B.V.
Netherlands
REASON Higher than expected current in the insulation of
the coil cable.
VOLUME OF PRODUCT IN COMMERCE 3.
DISTRIBUTION FL and WA.
PRODUCT STAAR Surgical UV Absorbing Posterior Chamber
Intraocular Lens, Model - AQ5010V
CODE Serial Numbers: 3033515, 3040022, 3040026, 3523618,
3523692, 3033498, 3033542, 3040615, 3040616, 3033529, 3523628, 3178667,
3033540,
3431112,
3431109, 3040666, 3050410, 3178655, 3431093, 3037418, 3040623, 3432070,
3034695, 3432088, 3174470, 3044717, 3413510, 3431119,
3040647,
3044721, 3151535, 3151546, 3174464, 3040621, 3408081, 3033508, 3151441,
3151513, 3040646, 3040655, 3033570, 3033571, 3037477,
3040031,
3151439, 3040037, 3040046, 3040067, 3037476, 3432064, 3033555, 3033556,
3413514, 3178643, 3178644, 3050437, 3040614, 3037434,
3033520,
3040638, 3431111, 3523208, 3040051, 3040033, 3040049, 3432083, 3151437,
3431095, 3431116, 3040054, 3431108, 3037485, 3033573,
3432075,
3033561, 3037456, 3037457, 3033568, 3033569, 3050440, 3151536, 3037435,
3037442, 3033538, 3151438, 3432069, 3523186, 3040613,
3033521,
3523187, 3523188, 3523701, 3040060, 3037464, 3037465, 3174458, 3431106,
3523207, 3523197, 3037492, 3432067, 3034699, 3151443,
3033541,
3033550, 3040610, 3040624, 3040637, 3174453, 3523604, 3523210, 3033511,
3432066, 3040038, 3432598, 3523679, 3033576, 3033577,
3151528,
3178647, 3523195, 3040612, 3033500, 3033501, 3040035, 3408082, 3523695,
3033516, 3431094, 3432618, 3523696, 3034704, 3040620,
3033533,
3033539, 3523213, 3432089, 3432065, 3432597, 3523621, 3040651, 3040660,
3033527, 3431113, 3040639, 3040640, 3432609, 3432610,
3408087,
3432074, 3037470, 3040619, 3040635, 3040063, 3432603, 3040052.
RECALLING FIRM/MANUFACTURER Staar Surgical Co. Monrovia,
CA
REASON Mislabeled as to diopter.
VOLUME OF PRODUCT IN COMMERCE 156.
DISTRIBUTION Nationwide and Puerto Rico and the Dominican
Republic.
PRODUCT Ela/Angeion Lyra Model 2020, 2021, and 2022
Implantable Cardioverter Defibrillators.
CODE All of the defibrillators are involved, and all of
these units have been implanted. The
devices are no longer in distribution. The last implant occurred on August 18,
2000.
RECALLING FIRM/MANUFACTURER Recalling Firm: Angeion Corporation, St. Paul, MN.
Manufacturer: Ela-Angeion, Plymouth, MN
REASON The devices could stop providing therapy due to
premature battery depletion.
VOLUME OF PRODUCT IN COMMERCE 494.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Dyonics Direct View and Video Arthroscopes 4.0 mm as
follows:
a)
Part Number: 3622R, Video Arthroscope, 4mm x 30 degree, Repair;
b) Part
Number: 3622S, Video Arthroscope, 4mm x 30 degree, Service;
c)
Part Number: 3626R, Arthroscope, 4mm x 30 degree, Repair;
d)
Part Number: 3626S, Arthroscope, 4mm x 30 degree, Service. Replacement;
e)
Part Number: 4125S, Arthroscope, 4mm x 30 degree, Service Replacement
CODE a) Serial Number: HD208005
b)
Serial Numbers: HD207995, HD208006, HD208009, HD208740, HD207981
c)
Serial Number: HD208802
d)
Serial Numbers: HD207980, HD207984, HD207997, HD208008, HD208721, HD208731,
HD208790, HD208760, HD208761,HD208762, HD208771, HD208780, HD208772, HD208779,
HD208788, HD208789, HD209557, HD209559, HD209576, HD209589, HD209603 HD207988
HD208751
e)
Serial Numbers: HD207986, HD208749, HD209577
RECALLING FIRM/MANUFACTURER Smith & Nephew, Inc.
Andover, MA
REASON Arthroscopes may be missing weld and contamination
may penetrate resulting in inadequate sterilization.
VOLUME OF PRODUCT IN COMMERCE 33.
DISTRIBUTION Nationwide and Australia, Mexico and the
United Kingdom.
PRODUCT Stryker brand TPS U2 drill for use with the Stryker
Total Performance System.
CODE Model 5100-100-000 drills built or repaired, and
model 5100-100-900 drills with motor repairs made, from 3/7/02 to 3/26/02.
RECALLING FIRM/MANUFACTURER Stryker Corporation, Stryker
Instruments Division, Kalamazoo, MI
REASON Possible shock hazard.
VOLUME OF PRODUCT IN COMMERCE 84 drills.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Surgeons Vest
CODE Lot Numbers 1020250, 1020320, 1020370, 1020380,
1020530.
RECALLING FIRM/MANUFACTURER Precept Medical Products,
Inc. Arden, NC
REASON Incomplete seal on packaging.
VOLUME OF PRODUCT IN COMMERCE 187 cases/30 per case or
5,610 units.
DISTRIBUTION Nationwide.
PRODUCT SONOLINE Antares, Diagnostic Ultrasound System. The SONOLINE Antares is a high-resolution,
digital, broadband diagnostic ultrasound imaging system. It supports the following diagnostic
applications: abdominal, OB/GYN, small parts, musculoskeletal, vascular, and
urology.
CODE Units with software version 1.0 or 1.1.
RECALLING FIRM/MANUFACTURER Semens Medical Systems,
Inc., Issaquah, WA
REASON Software anomalies that affect measurement and
calculation data.
VOLUME OF PRODUCT IN COMMERCE 260 units.
DISTRIBUTION Nationwide.
PRODUCT Kimberly-Clark Multifunction Electrodes, R2 Pads,
Self-adhesive Pre-gelled low impedance electrodes. Manufactured by Ballard
Medical Products
CODE Catalog No. 3200-1715. Lot Numbers: 144766, 145094,
146041, 146042, 146636, 147350, 147352, 149095, 149096, 149885, 149886, 149887,
150667, 150668, 150669, 151605, 151987, 151988, 152848, 153541, 153592, 153671,
153878, 155327, 155928, 155929, 156742, 156743, 157681, 157682, 158661, 159261,
160052, 160053, 160061, 160062, 161079, 161080
RECALLING FIRM/MANUFACTURER Ballard Medical Products,
Draper, UTREASON Unit
label incorrectly identifies the pads as radiolucent.
VOLUME OF PRODUCT IN COMMERCE 88,518 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT ISPAN, Sulfur Hexafluoride (SF6) and Perfluoropane
(C3F8) Liquified Gas under Pressure, for intraocular use.
Cylinder
series LD2, LD1, and LD.
CODE Device Catalog Number 8065-7971-01 Alcon Customer
Lot Information:
Transfill
Lot # Quantity Released Size
021519 41 LD2
021605 42 LD2
021606 42 LD1
021812 42 LD2
022002 42 LD2
022119 7 LD2
022310 42 LD1
022403 34 LD1
023401 30 LD
023518 42 LD2
023519 42 LD2
023520 42 LD2
023521 41 LD2
024403 40 LD2
024404 23 LD
024505 42 LD2
024515 42 LD2
024917 38 LD2
024918 42 LD2
025006 28 LD2
025020 42 LD2
025103 41 LD2
025114 40 LD2
025126 35 LD1
025210 32 LD
025220 12 LD1
025620 25 LD2
025843 28 LD1
026221 33 LD
026222 34 LD
026318 6 LD
029809 33 LD
031323 9 LD
034605 42 LD1
034619 14 LD1
034708 27 LD
108005 42 LD2
108038 42 LD2
108101 27 LD2
108102 41 LD2
108223 7 LD
110806 24 LD
110917 27 LD1
112225 35 LD2
112401 30 LD1
114321 42 LD2
114322 23 LD2
116525 26 LD2
116311 34 LD
117934 34 LD1
120708 42 LD2
120709 42 LD2
120815 22 LD2
120818 31 LD1
121318 32 LD
124002 39 LD2
126423 19 LD2
126424 42 LD2
126425 42 LD2
126426 28 LD1
129010 42 LD2
129028 40 LD2
129108 28 LD2
129502 33 LD1
Escalon
Customer Lot Information:
Transfill
Lot # Quantity Released Size
021504 41 LD1
021616 42 LD1
021738 41 LD1
022433 16 LD1
025802 42 LD1
025807 42 LD1
025924 42 LD1
025902 42 LD1
025903 42 LD1
025904 42 LD1
026201 42 LD1
026202 41 LD1
034103 42 LD1
034104 30 LD1
101019 17 LD1
101020 15 LD1
101127 28 LD1
101133 14 LD1
108504 22 LD1
108711 28 LD1
112914 33 LD1
115001 42 LD1
121319 41 LD1.
RECALLING FIRM/MANUFACTURER Scott Medical Products,
Plumsteadville, PA
REASON Post-operative warning against use of nitrous oxide
gas before intraocular gas has dissipated from the eye.
VOLUME OF PRODUCT IN COMMERCE 2900 cylinders/ 2nd
notification: 4205 cylinders.
DISTRIBUTION Nationwide.
PRODUCT Baxter Ipump Pain Management System infusion pump,
product codes 2L3107 and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL.
CODE Product codes 2L3107 and 2L3107R, all serial
numbers.
RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter
Healthcare Corp., Round Lake, IL.
Manufacturer:
Baxter Healthcare Pte. Ltd., Singapore, SG.
REASON Software anomaly allows access to change
prescription or program bolus without security.
VOLUME OF PRODUCT IN COMMERCE 9,927 pumps.
DISTRIBUTION Nationwide.
PRODUCT Boston Scientific/Medi-Tech Dual Lumen Vaxcel PICC
(Peripherally Inserted Central Catheter) as follows:
Catalog
Number Product Description
a)
45-413 VAXCEL 5F DUAL LUMEN
PICC;
b)
45-426 VAXCEL 6F DUAL
LUMEN PICC;
c)
45-445 PICC
VAXCEL 5F DL/CLAMPABLE/60CM WIRE/OB;
d)
45-446 PICC
VAXCEL 6F DL/CLAMPABLE/60CM WIRE/OB
CODE
Lot
Numbers
a)
628022A, 626091AR, 604101AR; b) 611032B, 618032B; c) 628022B, 611032C; d)
611032C
RECALLING FIRM/MANUFACTURER Recalling Firm: Boston
Scientific Corp./Medi-Tech, Watertown, MA
Manufacturer:
Medsource Technologies LLC, Navajoa, Sonora.
REASON Catheter Extension tube detached from hub upon being
flexed.
VOLUME OF PRODUCT IN COMMERCE 5,214.
DISTRIBUTION Nationwide.
PRODUCT Vaxcel Single Lumen Peripherally Inserted Central
Catheter (PICC) as follows:
Catalogue
Number Description
a)
45-430 4F SL/Clamp/130 cm PICC;
b)
45-432 5F
SL/Clamp/130 cm PICC.
CODE Lot Number a) 605121A, 608111B; b) 628081A.
RECALLING FIRM/MANUFACTURER Recalling Firm: Boston
Scientific Corp.Medi-Tech, Natick, MA
Manufacturer:
Medsource Technologies LLC, Navajoa, Sonora.
REASON Guidewire is incorrectly coiled in protective hoop
with luer fitting at wrong end.
VOLUME OF PRODUCT IN COMMERCE 1112 units.
DISTRIBUTION Nationwide and Canada.
PRODUCT
a)
Model IM2 Licox Bolt System, Double
Lumen
b)
Model IM3 Licox Bolt System, Triple Lumen
c)
Model IM2.S Complete Licox Probe Kit,
Double Lumen
d)
Model IM3.S Complete Licox Probe Kit,
Triple Lumen
e)
Model Im3.ST Complete Licox Probe Kit
with Temperature Probe, Triple Lumen
CODE a) Lots 050301A, 290301A, 120501, 151200, 160101A;
b)
Lots 261101, 271101, 151200, 050301A, 290301B, 31101,181001, 040101A, 140401,
150601, 120501, 51001, 260101A,290301A, 160601;
c)
Lots 02449, 02649, 02751, 02883, 02539, 02680, 02780, 02889, 02604, 02731,
02813, 02920;
d)
Lots 02441, 02748;
e)
Lots 02416, 02478, 02550, 02666, 02722, 02765, 02778, 02829, 02847, 02890,
02419, 02508, 02561, 02696, 02747, 02766, 02789, 02838, 02856, 02900, 02432,
02522, 02620, 051001,02755, 02773, 02796, 02842, 02879, 02904.
RECALLING FIRM/MANUFACTURER Integra Neuro Care LLC, San
Diego, CA
REASON Catheter/ bolt incompatibilty may result in
erroneous intracranial pressure measurements.
VOLUME OF PRODUCT IN COMMERCE 388 bolts.
DISTRIBUTION Nationwide.
PRODUCT Camino Intracranial Pressure Monitoring Catheter
with Licox IMC Bolt Fitting. Model
110-4L.
CODE All lots.
RECALLING FIRM/MANUFACTURER Integra Neurocare LLC, San
Diego, CA
REASON Catheter collapse may result in erroneously high
pressure readings.
VOLUME OF PRODUCT IN COMMERCE 44 estimated in
distribution.
DISTRIBUTION Nationwide.
PRODUCT GE Signa .5T, 1.0T, and 1.5T MR/I Extremity coils.
CODE All serial numbers are affected.
RECALLING FIRM/MANUFACTURER General Electric Medical
Systems, Waukesha, WI
REASON Extremity coil pads could catch on fire and burn
patient.
VOLUME OF PRODUCT IN COMMERCE 2573 devices.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Ti cann Troch Fixation Nail (Trochanteric Fixation Nail).
The responsible firm on the label is Synthes USA, Monument, CO.
CODE 456.315S, lot 4381555 expiration date March 19, 2011
456.318S,
lot 4381514 expiration date March 19, 2011.
RECALLING FIRM/MANUFACTURER Recalling Firm: Synthes (USA), Paoli, PA.
Manufacturer: Synthes (USA), Monument, CO.
REASON Manufactured outside design specification.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION AZ, CO, FL, MO, MS, OR, PA and TX.
PRODUCT Choice A.B. (aberation blocking) Daily wear soft
(hydrophilic) contact lens. The product
is packaged in trial and multipacks.
CODE Lot No. 0620, 1016, 1009, 0912, 0924, 0925, 0926,
1025, 1004, 0926, 1015, 0829, 0912, 1023, 0912, 0921, 0717, 0916, 10620, 11025,
10823, 10730.
RECALLING FIRM/MANUFACTURER Recalling Firm: Ciba Vision Corp., Duluth, GA.
Manufacturer: Specialty Ultravision, St. Hubert, Quebec,
Canada.
REASON The polymer was undercured, lens may appear cloudy.
VOLUME OF PRODUCT IN COMMERCE 781 units.
DISTRIBUTION Nationwide.
PRODUCT a)Cardiac/ Peritoneal Catheter, Standard Barium
Impregnated, 90cm Catalog No. 43103;
b)
Peritoneal Catheter, Open end with wall slits, Standard, Barium impregnated, 90 cm, Catalog No.
43522.
CODE a)Catalog Number 43103, Product lots Y1953 and
Y1954; b)Catalog Number 43522, Product lots Y1955 and Y1956.
The
first catalog number product and lots are contained in the second catalog
number product and lots packaging and labeling.
RECALLING FIRM/MANUFACTURER Medtronic Neurosurgery,
Goleta, CA
REASON Product Mix-up/ Substitution/ Mislabeling.
VOLUME OF PRODUCT IN COMMERCE 219.
DISTRIBUTION Nationwide and Canada, Australia and Korea.
PRODUCT Bone Stack
Calcium Sulfate
CODE Catalog No.
6184-5-050; 6184-5-100; 6184-5-200; 6184-3-200; 6184-3-400.
Lot
Code: 95181; 95799A; 95799; 95905A; 95803; 958051; 95805; 958061; 95806.
RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica
Osteonics Corp., Allendale, NJ.
Manufacturer:
Stryker Howmedica Osteonics Limerick, Ireland.
REASON Volume of pellets is less than listed on the
labeling.
VOLUME OF PRODUCT IN COMMERCE 193 units.
DISTRIBUTION Nationwide.
PRODUCT Hemashield Gold Woven Double Velour 4-Branch
Vascular Graft in 28 and 30mm sizes.
Catalog Number 175928 and 175930.
CODE For the 28mm size: Lot 4019302RW For the 30mm size: Lot 3743489RW.
RECALLING FIRM/MANUFACTURER Boston Scientific
Corp./Medi-Tech Wayne, NJ
REASON 28 and 30mm sizes were mislabeled.
VOLUME OF PRODUCT IN COMMERCE 17 -- 28mm size; 17 -- 30mm
size.
DISTRIBUTION Nationwide.
WEEK ENDING AUGUST 10
PRODUCT 1.5T MR Systems with software version R7.1.2 and
higher: Magnetic Resonance Systems are indicated for use as diagnostic devices
that produce transverse, sagital, coronal and oblique cross-sectional images,
spectroscopic images and/or spectra based upon 1H and 31P metabolites, and that
display the internal structure and/or function of the head, body or
extremeties. These images and/or
spectra, when interpreted by a trained physician, yeild information that may
assist in diagnosis. The coils are used
to obtain optimal imaging.
CODE Release 6.
RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc.,
Bothell, WA.
Manufacturer: Philips Medical Systems, Nederland B.V.
Netherlands.
REASON Higher than expected current in the insulation of
the coil cable.
VOLUME OF PRODUCT IN COMMERCE 3.
DISTRIBUTION FL and WA.
WEEK
ENDING AUGUST 17
PRODUCT CAPTIA Syphilis G ELISA Test
Kit For in vitro diagnostic use. Packed in kits of 96 determinations and kits
of 960 determinations.
CODE Lot numbers:
K00841, Exp. 14 JAN 03
K00842, Exp. 14 JAN 03
K00839, Exp. 14 JAN 03
K00838, Exp. 14 JAN 03
(these may be suffixed by a
letter)
Product codes:
800-925, 96 tests per kit
801-030, 960 tests per kit
801-032, 96 tests per kit
801-033, 960 tests per kit.
RECALLING
FIRM/MANUFACTURER Trinity Biotech plc Co., Wicklow, Ireland
REASON Potential false negative
results.
VOLUME OF
PRODUCT IN COMMERCE 292 units.
DISTRIBUTION
CA,
FL, MN, NJ, and PA.
PRODUCT a)Calcium reagent for
Hitachi Modular P analyzer, catalog no. 1730240.
b)Calcium reagent for
Hitachi Modular P and D analyzers, catalog nos. 1929780 and 1929798.
c)Calcium reagent for
Hitachi Modular D analyzer, catalog nos. 1929801 and 1929828
d)Calcium reagent for
Hitachi Model 704, 717, 902, 904, 911, 912 and 914 analyzers, catalog no.
1489216.
e)Calcium reagent for
Hitachi Model 717, 904, 911, 912 and 914 analyzers, catalog no. 1125621.
f)Calcium reagent for
Hitachi Model 736, 737 and 747 analyzers, catalog nos. 1127551 and 1127560.
g)Calcium reagent for
Hitachi Model 747-400 analyzers, catalog nos. 1554352 and 1554352.
h)Cobas INTEGRA 400, 700,
and 800 calcium reagent, Art 0763128; catalog no. 2055716.
CODE All lots.
RECALLING
FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN, by letter dated
4/10/02. Firm initiated recall is
complete.
REASON MRI contrast media
interferes with calcium test results.
VOLUME OF
PRODUCT IN COMMERCE 2,867 analyzers.
DISTRIBUTION
Nationwide.
PRODUCT e.soft software version 2.0
used on all E.CAM Emission Imaging Computed Tomography Systems with e.soft A or
e.soft A/P nuclear medicine workstations.
CODE e.soft software version 2.0
installed on e.soft A and e.soft A/P workstations.
RECALLING
FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Hoffman Estates, IL
REASON Incorrect image time stored
for static images resulting in incorrect results.
VOLUME OF
PRODUCT IN COMMERCE 346 units.
DISTRIBUTION
Nationwide
and Internationally.
PRODUCT OEC MiniView 6800 Mobile
C-arm X-ray system.
CODE OEC MiniView 6800 Mobile
C-arm. 369 units within the Serial Number range 86-0009 thru 86-0798.
RECALLING
FIRM/MANUFACTURER GE OEC Medical Systems, Inc., Salt Lake City, UT
REASON Unit may become unbalanced
and tip when the C-arm assembly is extended.
VOLUME OF
PRODUCT IN COMMERCE 369.
DISTRIBUTION
Nationwide
and Internationally.
PRODUCT CODE BLUE, PEDI BLUE, and
BABY BLUE line of manual resuscitators.
CODE Model Numbers: 72054, 7500,
7500JACK, 7500K, 75045, 7505, 7505E, 7505EK, 7505EK9, 7505K, 7550, 7550A,
7550E, 7550EK, 7550K, 7550K9, 7550T9, 7552, 7552K, 7800, 7800JACK, 7800R,
7800R79, 7803, 7803R, 7830, 7830R, 7830T9, 7834, 7834A, 7840, 7868R, 78689,
7900, 7900JACK, 7900R, 7900R79, 7900T, 7902, 7902R, 7910, 7910A, 7910R, 7920,
7920C, 7920P9, 7920R, 7920S, 7920T, 7921, 7921AT9, 7921CNPT, 7921CP, 7921OSHU,
7921R, 7921S, 7921T, 79249.
Lot Numbers: All lot codes
beginning with "D" and "E" 001 through 365 and those beginning
with "F" and "H" 001 through 106.
RECALLING
FIRM/MANUFACTURER Vital Signs, Inc., Totowa, NJ
REASON Failures due to air/oxygen
leakage.
VOLUME OF
PRODUCT IN COMMERCE 227,580.
DISTRIBUTION
Nationwide
and Internationally.
PRODUCT Disposable Bipolar Cable,
sterile, 12 foot, packaged in pouch, under the Q2 MEDICAL label, 10 pouches per
case.
CODE Lot Number 108932 Part Number 20-1102.
RECALLING
FIRM/MANUFACTURER Olsen Medical, Louisville, KY
REASON Device may not be sterile
due to packaging defect.
VOLUME OF
PRODUCT IN COMMERCE 2,650 units.
DISTRIBUTION
NM,
WA, VA, MI, NY, PA, TX, OK and TN.
PRODUCT MedComp Custom Dialysis
Trays/Kits. The trays/kits are prep trays that do not contain a catheter. The
trays/kits contain Wyeth's Heparin 1000 units/ml 1 ml dosette vial.
CODE Catalog Number Tray #614JR
Lot Number M001070;
Catalog Number Tray #322 Lot
Number M001520;
Catalog Number Tray #500 Lot
Number M002000;
Catalog Number Tray #119 Lot
Number M002370;
Catalog Number Tray #273 Lot
Number M005780;
Catalog Number Tray #328 Lot
Number M008600;
Catalog Number Tray #119 Lot
Number M010740;
Catalog Number Tray #163 Lot
Number M012680;
Catalog Number Tray #119 Lot
Number M013230;
Catalog Number Tray #322 Lot
Number M015930;
Catalog Number Tray #119 Lot
Number M016860;
Catalog Number Tray #293 Lot
Number M017120;
Catalog Number Tray #163 Lot
Number M017520;
Catalog Number Tray #614JR
Lot Number M017980;
Catalog Number Tray #163 Lot
Number M018350;
Catalog Number Tray #328 Lot
Number M020250;
Catalog Number Tray #163 Lot
Number M020260;
Catalog Number Tray #498 Lot
Number M021920;
Catalog Number Tray #163 Lot
Number M024150;
Catalog Number Tray #163 Lot
Number M029170;
Catalog Number Tray #500 Lot
Number M032740;
Catalog Number Tray #273 Lot
Number M033590;
Catalog Number Tray #163 Lot
Number M034030;
Catalog Number Tray #328 Lot
Number M034060;
Catalog Number Tray #163 Lot
Number M034250;
Catalog Number Tray #3 Lot
Number M036190;
Catalog Number Tray #293 Lot
Number M038260;
Catalog Number Tray #293 Lot
Number M040950;
Catalog Number Tray #273 Lot
Number M041850;
Catalog Number Tray #322 Lot
Number M043130;
Catalog Number Tray #328 Lot
Number M043250;
Catalog Number Tray #119 Lot
Number M043290;
Catalog Number Tray #163 Lot
Number M048640;
Catalog Number Tray #163 Lot
Number M048920;
Catalog Number Tray #328 Lot
Number M050000;
Catalog Number Tray #322 Lot
Number M102130;
Catalog Number Tray #614JR
Lot Number M102410;
Catalog Number Tray #498 Lot
Number M103380;
Catalog Number Tray #163 Lot
Number M103970;
Catalog Number Tray #273 Lot
Number M104390;
Catalog Number Tray #163 Lot
Number M104830;
Catalog Number Tray #328 Lot
Number M104860;
Catalog Number Tray #614JR
Lot Number M106730;
Catalog Number Tray #163 Lot
Number M106990;
Catalog Number Tray #273 Lot
Number M107000;
Catalog Number Tray #119 Lot
Number M109850;
Catalog Number Tray #163 Lot
Number M110040;
Catalog Number Tray #498 Lot
Number M112450;
Catalog Number Tray #328 Lot
Number M112540;
Catalog Number Tray #328A
Lot Number M112550;
Catalog Number Tray #163 Lot
Number M113410;
Catalog Number Tray #163 Lot
Number M114760;
Catalog Number Tray #293 Lot
Number M115060;
Catalog Number Tray #328 Lot
Number M115280;
Catalog Number Tray #163 Lot
Number M116370;
Catalog Number Tray #163 Lot
Number M117960;
Catalog Number Tray #614JR
Lot Number M118960;
Catalog Number Tray #163 Lot
Number M119060;
Catalog Number Tray #500 Lot
Number M121830;
Catalog Number Tray #163 Lot
Number M123930;
Catalog Number Tray #163 Lot
Number M124410;
Catalog Number Tray #119 Lot
Number M130080;
Catalog Number Tray #273 Lot
Number M134880;
Catalog Number Tray #163 Lot
Number M136380;
Catalog Number Tray #293 Lot
Number M137480;
Catalog Number Tray #273 Lot
Number M138600;
Catalog Number Tray #498 Lot
Number M138610;
Catalog Number Tray #328 Lot
Number M140100;
Catalog Number Tray #322 Lot
Number M140110;
Catalog Number Tray #322 Lot
Number M142350;
Catalog Number Tray #119 Lot
Number M142720;
Catalog Number Tray #328 Lot
Number M143950;
Catalog Number Tray #273 Lot
Number M147330;
Catalog Number Tray #328 Lot
Number M200500;
Catalog Number Tray #163 Lot
Number M201940;
Catalog Number Tray #293 Lot
Number M203590;
Catalog Number Tray #163 Lot
Number M203760;
Catalog Number Tray #328B
Lot Number M209330;
Catalog Number Tray #273 Lot
Number M209420;
Catalog Number Tray #273 Lot
Number M210220;
Catalog Number Tray #163 Lot
Number M215100;
Catalog Number Tray #163 Lot
Number M920280;
Catalog Number Tray #500 Lot
Number M920290;
Catalog Number Tray #163 Lot
Number M921220;
Catalog Number Tray #119 Lot
Number M923420;
Catalog Number Tray #163 Lot
Number M927630;
Catalog Number Tray #273 Lot
Number M928300;
Catalog Number Tray #322 Lot
Number M928900;
Catalog Number Tray #163 Lot
Number M929440;
Catalog Number Tray #119 Lot
Number M929460;
Catalog Number Tray #328 Lot
Number M929480;
Catalog Number Tray #163 Lot
Number M931940;
Catalog Number Tray #163 Lot
Number M935350;
Catalog Number Tray #163 Lot
Number M935590;
Catalog Number Tray #498 Lot
Number M937630;
Catalog Number Tray #163 Lot
Number M940560;
Catalog Number Tray #328 Lot
Number M940570;
Catalog Number Tray #163 Lot
Number M941880;
Catalog Number Tray #163 Lot
Number M944170;
Catalog Number Tray #163 Lot
Number M944180.
RECALLING
FIRM/MANUFACTURER Medical Components, Inc., Harleysville, PA
REASON Kits contain recalled
Heparin.
VOLUME OF
PRODUCT IN COMMERCE 8603 kits.
DISTRIBUTION
Nationwide.
PRODUCT Terumo(tm) Hypodermic
Syringes, sterile, bulk packed in plastic thermo-formed "Pharmacy
Trays", heat sealed with Tyvek lidstock. 10 syringes per tray, 12 trays
per case.
CODE Catalog #SS30LT, Lot #CE15.
exp 2007-03.
RECALLING
FIRM/MANUFACTURER Terumo Medical Corp., Elkton, MD
REASON Hypodermic Syringe packaging
defect could compromise sterility.
VOLUME OF
PRODUCT IN COMMERCE 2040 syringes.
DISTRIBUTION
MO and
Canada.
PRODUCT CrossSail (brand) Coronary
Dilatation Catheter, 3.0 x 20 mm. Common name: Coronary Dilatation Catheter
CODE Part number 1005270-20 Lot number 2010952.
RECALLING
FIRM/MANUFACTURER Guidant Corp., Temecula, CA
REASON Inadequate bond joint.
VOLUME OF
PRODUCT IN COMMERCE 145.
DISTRIBUTION
Nationwide.
PRODUCT Logix-CM Compounder
Software.
CODE Catalog #2M8400, Logix-CM
software version 1.0.2.
RECALLING
FIRM/MANUFACTURER Baxter Healthcare Corp., Round Lake, IL
REASON Software allows ingredient
concentration errors during compounding.
VOLUME OF
PRODUCT IN COMMERCE 4 units.
DISTRIBUTION
NC,
UT, AZ and WI.
PRODUCT Kimberly-Clark Ballard TRACH
CARE* Closed Suction System for Pediatrics. Tracheobronchial suction catheter.
CODE Catalog No. 1910, Lot
159541.
RECALLING
FIRM/MANUFACTURER Ballard Medical Products, Draper, UT
REASON Product is unusable as
assembled due to an incorrect component (elbow).
VOLUME OF
PRODUCT IN COMMERCE 61 cases (1220 units).
DISTRIBUTION
Nationwide
and Canada.
PRODUCT a) AxSYM B12 Reagent Pack
(Dual Pack), list 3C79-20; b) IMx B12 Reagent Pack, list 2200-20. 100 test kits
CODE a) Lots 84411M100,
89273M300, 89274M300, 89275M300,
89470M200; b) Lots 75782M200, 75998M200.
RECALLING
FIRM/MANUFACTURER Abbott Laboratories, Inc., Abbott Park, IL
REASON Precision problem - controls
out of range.
VOLUME OF
PRODUCT IN COMMERCE 5,826 kits.
DISTRIBUTION
Internationally.
PRODUCT a) LifeScan brand ONETOUCH
Ultra Blood Glucose Meter; b) LifeScan Brand InDuo Blood Glucose Meter.
CODE All serial numbers.
RECALLING
FIRM/MANUFACTURER Recalling Firm: LifeScan, Inc., Milpitas, CA.
Manufacturer: Inverness
Medical Ltd., United Kingdom.
REASON Products may encounter
display problem: "Er 4" message.
VOLUME OF
PRODUCT IN COMMERCE 2,080,000 units.
DISTRIBUTION
Nationwide
and Internationally.
PRODUCT ENDOPATH Non-Bladed
Obturator Trocar with Smooth Sleeve, size 5mm, length 100mm, handled. The
handled obturator trocar and the smooth sleeve components are packaged,
dissasembled, as a set in a single labeled package. The devices are packaged as
6 sets per unit box. Each of the components can also be purchased separately by
end-users.
CODE Packaging Lot number:
P4PP4J The catalog number: 35HL.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Ethicon
Endo-Surgery, Inc., Cincinnati, OH.
Manufacturer: Ethicon Endo-Surgery, Inc., Ciudad Juarez
Chihuahua, Mexico.
REASON The packaged device is
missing the trocar sleeve component.
VOLUME OF
PRODUCT IN COMMERCE 171 units (1026 components).
DISTRIBUTION
Nationwide.
PRODUCT Gambro Renal Products Acid
Concentrate for Bicarbonate Dialysate AC-2412-4 Date of Mfg. DEC 01 EXP DATE:
DEC 03.
CODE Lot G1L034.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Gambro Renal Products, Daytona Beach, FL.
Manufacturer: Di-Chem
Concentrates, Inc., Lewisberry, PA.
REASON Incorrect ingredient
concentrations on labeling.
VOLUME OF
PRODUCT IN COMMERCE 41/ 4 gallon cases.
DISTRIBUTION
VI,
PA, MA and NYK.
PRODUCT PW-41 Microplate Washer.
Washer automatically washes microtiter plates.
Product is labeled in part "***Bio-Rad, Redmond, WA***".
CODE Serial #s KBOL001 - KBOL005,
KBOL011 - KBOL020.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Bio-Rad Laboratories, Redmond, WA.
Manufacturer: Adil
Instruments, SA Strasbourh Schiltigheim, France.
REASON FIRMWARE ERROR - time base rate
for calculating soaking time & method interval.
VOLUME OF
PRODUCT IN COMMERCE 9.
DISTRIBUTION
FL,
KS, OH, PA, PR, SC, TX, and WI.
PRODUCT Multiplace Hyperbaric
Chamber Systems.
CODE The following Multiplace Chamber
Serial Numbers are involved: 97028C, 98091B, 98091A, 99005A, 99005B, 97028C,
97028B, 95068.
RECALLING
FIRM/MANUFACTURER Tampa Hyperbaric Enterprise Inc., Tampa, FL
REASON Various potential chamber
component failures.
VOLUME OF
PRODUCT IN COMMERCE 8.
DISTRIBUTION
AZ,
MA, WV, FL, CA, AND VA.
PRODUCT Kallestad Hep-2 12 well, 48
Test Kit Kallestad Hep-2 12 well, 60 Test Kit Product is for the detection and
semi-quantitation of human autoantibodies.
Product is labeled in part "***Bio-Rad Laboratories Diagnostics
Group ** Redmond, WA***" or "Sanofi Diagnostics Pasteur". (Bio-Rad was previously Sanofi Diagnostics
Pasteur).
CODE Lot #s 908849, 908866.
RECALLING
FIRM/MANUFACTURER Bio-Rad Laboratories, Redmond, WA
REASON Incorrect temperature
storage information provided on outer label.
VOLUME OF
PRODUCT IN COMMERCE Lot #908849 - 214; lot #908866
- 139.
DISTRIBUTION
Nationwide.
PRODUCT CT-SMAC Agar Plates, Catalog
number G129.
CODE Lot 2175.
RECALLING
FIRM/MANUFACTURER Hardy Diagnostics, Santa Maria, CA
REASON Fails to grow bacteria
according to specifications and labeling.
VOLUME OF
PRODUCT IN COMMERCE 620.
DISTRIBUTION
AR,
CA, IL and WY.
PRODUCT IRISpec1 Microscopic
Calibrator/Control for Flow and Focus Determination. Catalog Number 475-0001.
Product is used in IRIS
Urinalysis Workstations adn Models 900/939UDx Urine Pathology Systems.
CODE Lot No. 126-2002-001. Exp
Date 11/2002.
RECALLING
FIRM/MANUFACTURER Intl. Remote Imaging Systems, Chatsworth, CA
REASON Does not meet labeled
specification.
VOLUME OF
PRODUCT IN COMMERCE 319.
DISTRIBUTION
Nationwide
and England.
PRODUCT VITROS Immunodiagnostics
Products: Anemia Controls. In vitro diagnostic use. CAT #161 9360.
CODE Lot Numbers:
90, Exp. 26 June 2002**
100, Exp. 19 August 2002
110, Exp. 7 November 2002
**Although Lot 90 appears to
be stable, its formulation was similar to Lots 100 and 110. Without understanding the root cause of the
problem, Lot 90 was included in this action.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Ortho-Clinical Diagnostics, Inc., Rochester, NY
Manufacturer: Ortho-Clinical
Diagnostics, Inc., Cardiff.
REASON Folate is not stable
resulting in negatively biased QC results.
VOLUME OF
PRODUCT IN COMMERCE Domestic - 694 units /
International - 586 units.
DISTRIBUTION
Nationwide
and Internationally.
WEEK ENDING AUGUST 24
PRODUCT
a) Ulnar Implant, standard stem, Sizes 1 thru 4. Catalog numbers UHA-S1 thru
UHA-S4;
b) Ulnar Implant, stem, 20mm collar, Sizes 1 thru 4. Catalog numbers UHA-S120
thru UHA-S420.
CODE Lot numbers US0001
thru US0054 for stand alone device Distal Ulnar Stem with extended collar. It
is included in a Kit called an "Ulnar Head Kit" Catalog No. UHA-KIT.
Which is also under recall. Kit contains 4 head sizes, 4 stem sizes with
regular collars and 4 stem sizes with extended collars. Additionally, as a
precaution, firm is recalling the following Catalog Numbers: UHA-S1 thru UHA-S4
which are four sizes of Distal Ulnar Stems. UHA-S120, UHA-S220, UHA-S320,
UHA-S420 which are four sizes of Distal Ulnar Stem with extended collar.
RECALLING FIRM/MANUFACTURER Avanta
Orthopaedics, Inc., San Diego, CA.
REASON Sterility,
extended collar stems break through peel pouch.
VOLUME OF PRODUCT IN COMMERCE 252.
DISTRIBUTION KY and
Internationally.
PRODUCT
Baxter Basal/Bolus Infusor, 0.5 x 2mL/hr, a portable elastomeric infusion
system; 6 units per case.
CODE Product code
2C1955KJ, lot 00N040, Exp. Dec 31 2005.
RECALLING FIRM/MANUFACTURER Recalling
Firm: Baxter Healthcare Corp., Round Lake, IL.
Manufacturer: Baxter Healthcare Corp., Irvine, CA.
REASON Possible
overinfusion.
VOLUME OF PRODUCT IN COMMERCE 2502
units.
DISTRIBUTION PA, Japan
and South Africa.
PRODUCT
Celsite ST 301 P Implantable Port Catheter. The device is a 6.5F polyurethane
implantable catheter. The catheter is primarily used for sub-clavian
implantation.
CODE Product Codes
CVS200KP and CVS250KP.
RECALLING FIRM/MANUFACTURER Recalling
Firm: B. Braun Medical, Inc., Allentown, PA.
Manufacturer: Braun, Aesculap, France.
REASON Fractures.
VOLUME OF PRODUCT IN COMMERCE141
units.
DISTRIBUTION AL, CA,
FL, MD, NM, VA, and WA.
PRODUCT
XT75410 Opti-Plast XT PTA Balloon Dilation Catheter; XT100410 Opti-Plast XT PTA Balloon Dilation Catheter;
XT120410 Opti-Plast XT PTA Balloon Dilation Catheter
CODE Not lot specific.
RECALLING FIRM/MANUFACTURER C.
R. Bard, Inc./Bard Peripheral Technologies, Covington, GA
REASON Product was distributed without 510(k) clearance.
VOLUME OF PRODUCT IN COMMERCE 5
units.
DISTRIBUTION LA, OK
and TN.
PRODUCT
Streptozyme, Hemagglutination slide test.
CODE Product Code:
45D4 Lot Number 0224501 Exp. 6/03.
RECALLING FIRM/MANUFACTURER Recalling
Firm: Wample Laboratories, Div. of Medpointe Healthcare, Inc., Cranbury, NJ.
Manufacturer: J&S Medical Associates, Inc., Framingham, MA.
REASON Weak
sensitivity, may result in weak positives going undetected.
VOLUME OF PRODUCT IN COMMERCE 74.
DISTRIBUTION Nationwide.
PRODUCT
Dimension(R) Xpand software revision 6.0.1 and 6.1 (Clinical Chemistry
Analyzer).
CODE Xpand software
revision 6.0.1 and 6.1.
RECALLING FIRM/MANUFACTURER Recalling
Firm: Dade Behring, Inc., Newark, DE.
Manufacturer: Dade Behring, Inc., Brookfield, CT.
REASON The sample
probe does not accurately track the fluid level.
VOLUME OF PRODUCT IN COMMERCE 261.
DISTRIBUTION Nationwide.
PRODUCT
TwistOR Bone Cement Mixer.
CODE Catalog No.
CM-MD-3100 Lot No. AA0131 Exp. Date July 2002.
RECALLING FIRM/MANUFACTURER Immedica,
Inc., Chatham, NJ
REASON Non sterile box sent to hospital.
VOLUME OF PRODUCT IN COMMERCE 4
units.
DISTRIBUTION CT and
IL.
PRODUCT
Fabius Anesthesia Machine. The device is exported only in accordance with FFDCA
section 801(e)(1).
CODE Catalog number
4115300.
RECALLING FIRM/MANUFACTURER Recalling
Firm: Drager Medizintechnik Gmbh Luebeck.
Manufacturer: Drager Medical, Telford, PA.
REASON Ground wire too
short.
VOLUME OF PRODUCT IN COMMERCE 1879
units.
DISTRIBUTION Nationwide.
PRODUCT
Softchrome brand In-Office Tint System, Complete System
CODE All codes,
including (Red dye lot nos. F0122, B0002;
Brown dye lot nos. L9916, B0027, D0130).
RECALLING FIRM/MANUFACTURER Softchrome,
Inc., San Ramon, CA
REASON Devices use unlisted dyes used in a tinting kit for
contact lenses.
VOLUME OF PRODUCT IN COMMERCE 123
units.
DISTRIBUTION Nationwide
and Internationally.
PRODUCT
Bio-Rad Chlamydia Blocking Assay; Bio-Rad Chlamydia Microplate EIA - 96 Tests;
Bio-Rad
Chlamydia Microplate EIA - 192 Tests.
CODE Lot #s 909468,
910235, 912578, 909681, 906620, 912400, 910620, 912579, 911794, 909469, 910236.
RECALLING FIRM/MANUFACTURER Bio-Rad
Laboratories, Redmond, WA.
REASON Incorrect
product information regarding discarding out of range control.
VOLUME OF PRODUCT IN COMMERCE 2095.
DISTRIBUTION Nationwide
and Germany, Italy, France and Portugal.
PRODUCT
Acid Concentrate for Bicarbonate Dialysate AC-2403-4 Manufactured For Gambro
Use with Gambro BP-002 Bicarbonate products. One Gallon.
CODE Lot G0G084.
RECALLING FIRM/MANUFACTURER Recalling
Firm: Gambro Healthcare, Daytona Beach, FL.
Manufacturer: Di-Chem Concentrates, Inc., Lewisberry, PA.
REASON Incorrect expiration
date of 4/00.
VOLUME OF PRODUCT IN COMMERCE 1,150
cases.
DISTRIBUTION Nationwide.
PRODUCT
Kallestad Anti-La (SSB) Microplate EIA Kit labeled in part "Kallestad
Anti-La (SS-B) EIA ** Sanofi Diagnostics Pasteur ** Chaska, MN **".
CODE Lot #192, expiration
10/12/01.
RECALLING FIRM/MANUFACTURER Recalling
Firm: Bio-Rad Laboratoaries, Redmond, WA.
Manufacturer: Axis-Shield Diagnostics, Ltd., Dundee, Scotland, United Kingdom.
REASON Ratio range on
label of positive control instead of concentration range.
VOLUME OF PRODUCT IN COMMERCE 27.
DISTRIBUTION FL, OH,
TN, TX, WA, and WI.
PRODUCT
501-1 One Sheet 12" x 12" x .015 Sil-Tec Sheeting a Class VI USP
Medical Grade Silicone Rubber Latex-Free Reinforced and 501-3 One Sheet
12" x 12" x .020 Sil-Tec Sheeting a Class VI USP Medical Grade
Silicone Rubber Latex-Free Reinforced.
CODE Lot 1-041189.
RECALLING FIRM/MANUFACTURER Technical
Products, Inc. of Georgia, USA, Decatur, GA
REASON Product labeled Reinforced was not reinforced.
VOLUME OF PRODUCT IN COMMERCE 7
units.
DISTRIBUTION CO, IL,
NM, TX and UT.
PRODUCT
Niagara TRS Thermal Retention System, 2 Liter, Catalog No. 008075-901.
CODE Serial Numbers
N02A023, N02A024, N02A025, N02A026, and N02A027.
RECALLING FIRM/MANUFACTURER ACMI
Corporation, Racine, WI
REASON The product is a 2 liter system but is misidentified
on the device label as a 3 liter system. This might result in the user
attempting to use a 3 liter fluid bag in the 2 liter system.
VOLUME OF PRODUCT IN COMMERCE 5
divices.
DISTRIBUTION SD, MO,
LA and WI.
PRODUCT
Brand Name: ADVIA Centaur(R) Analyzer
CODE All serial
numbers distributed with Model/Part Number 572561, along with all existing
software versions from 2.1 to 2.5.
RECALLING FIRM/MANUFACTURER Recalling
Firm: Bayer Corporation, Business Group Diagnostics, Tarrytown, NY.
Manufacturer: Bayer Diagnostics Manufacturing Limited, Swords County, Dublin.
REASON Software
programming error.
VOLUME OF PRODUCT IN COMMERCE 2275
units.
DISTRIBUTION Nationwide
and Internationally.
PRODUCT CryoValve Heart Valve Allograft.
CODE Serial No. 7746517, Model No. AV00.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA
REASON Findings of transitional cell cancer in donors
bladder.
VOLUME OF PRODUCT IN COMMERCE 1 valve.
DISTRIBUTION PA.
PRODUCT Bio-Rad brand MICROMAT II HEMOGLOBIN HbA1c Test
Cartridge (for use in MICROMAT II HEMOGLOBIN HbA1c Test Instrument) Catalog No.
280-0008.
CODE Catalog No.: 280-0008
Lot
#: Exp. Dates:
050K28 5/29/02
050K29 6/1/02
050K31 7/13/02
050K32 7/13/02
050K33 7/23/02
050K34 8/2/02
050K35 8/10/02
050K36 8/30/02
050K37 9/19/02
050K38 10/1/02
050K39 10/5/02.
RECALLING FIRM/MANUFACTURER Recalling Firm: Bio-Rad Laboratories, Inc., Hercules, CA
Manufacturer:
Provalis Diagnostics, New Tech Square, Deeside, Flintshire CH5 2NT, United
Kingdom.
REASON Product stored at temperatures outside
manufacturer’s specifications.
VOLUME OF PRODUCT IN COMMERCE Total of 4119 affected lots
were distributed. Lot # 050K28: 402, Lot #050K29: 158,Lot #050K31: 193, Lot
#050K32: 15, Lot #050K33: 103, Lot #050K34: 559, Lot #050K35: 167, Lot #050K36:
851, Lot #050K37: 90, Lot #050K38: 864, Lot #050K39: 717.
DISTRIBUTION Nationwide.
PRODUCT TransFx Bar to Bar Clamp (or Rod to Rod Clamp),
11mm.
CODE Catalog (Part) No.00-4452-010-11 Lot No’s: 70189400,
70193300, 70197800, and 70200400.
RECALLING FIRM/MANUFACTURER Immedica, Inc., Chatham, NJ
REASON Product failure due to broken screw.
VOLUME OF PRODUCT IN COMMERCE 604 Units.
DISTRIBUTION IN.
PRODUCT Acuson brand Aspen® Diagnostic Ultrasound System
with various versions of software.
CODE Catalog No: 8247888, 8261531, 8247887, 8253683. The
transducers which are the subject of this action are as follows:
13L5;
4C1; 4V2c; C3; C7; EC7; EV7; EVC8; L582; V4c; V5; V7
RECALLING FIRM/MANUFACTURER Acuson Corp., Mountain View,
CA
REASON Certain components of the system (transducers) have
the potential to reach a temperature which is above the allowable limit.
VOLUME OF PRODUCT IN COMMERCE Approx. 3500.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Acuson Sequoia® Diagnostic Ultrasound System with
various versions of software.
CODE Catlog No: 8246951 (Model C256); Catlog No: 8245876
(Model 512).
RECALLING FIRM/MANUFACTURER Acuson Corp., Mountain View,
CA
REASON Transducers have the potential to reach a
temperature above the allowable limit.
VOLUME OF PRODUCT IN COMMERCE 6650.
DISTRIBUTION Nationwide and Internationally.
PRODUCT a) Stryker Bertec Acute Care Bed Model 3000, half
length side rails, 80" electric AC powered adjustable bed, model series
FL13E80, U.S. order number 32501000000;
b)
Stryker Bertec Acute Care Bed Model 3000, half length side rails, 84"
electric AC powered adjustable bed, model series
c)
Stryker Bertec Acute Care Bed 3000, half length side rails, 72" manual
adjustable hospital bed, model series FL13M72, U.S. order number
32503000000;
d)
Stryker Bertec Acute Care Bed Model 3000, half length side rails, 78"
manual adjustable hospital bed, model series FL13M78, U.S. order
number 9999999305;
e)
Stryker Bertec Acute Care Bed Model 3000, half length side rails, 84"
manual adjustable hospital bed, model series FL13M84, U.S. order
number 32504000000.
CODE Serial numbers A71194 through A78105.
RECALLING FIRM/MANUFACTURER Recalling Firm: Stryker Corp., Stryker Medical Division
Kalamazoo, MI
Manufacturer: Styker Bertec Medical Inc., L'Islet
(Quebec), Canada.
REASON Side rails may unlock and drop.
VOLUME OF PRODUCT IN COMMERCE 442.
DISTRIBUTION Nationwide and Puerto Rico.
PRODUCT a) Centurion brand 1.45 cm circ. bells &
inserts, sterile, single use. Product CR145;
b)
Centurion brand CIRCLAMP with 1.45 cm bell & insert, latex free,
sterile. Product CR245;
c)
Centurion brand CHS circumcision tray with 1.45 clamp, sterile. Product
CIT2940;
d)
Centurion brand circumcision tray with 1.45 clamp, latex-free, sterile. Product CIT3370.
CODE a) lots 02252, 11121 and 03051; b) lots 05132,
03252, 03182, 02182, 10151, 09101, 08131, 04301, 06111, 07091, 04231, 04271 and
03191;
c)
lot 510011; d) lots 512171, 502042, 502252, 503252 and 504222.
RECALLING FIRM/MANUFACTURER Tri-State Hospital Supply
Corp., Howell, MI
REASON Clamping procedure may fail due to cracks in the
bell.
VOLUME OF PRODUCT IN COMMERCE 2,006.
DISTRIBUTION Nationwide.
PRODUCT Deflectable Circular Mapping Lasso Catheter.
CODE Device product code: D7-L10-12-RT Part Number:
D-1220-05-S All lots.
RECALLING FIRM/MANUFACTURER Biosense Webster, Inc.,
Irwindale, CA
REASON Perforation on soft tip of the LASSO catheter.
VOLUME OF PRODUCT IN COMMERCE Not specified.
DISTRIBUTION Nationwide and Internationally.
PRODUCT In Line NebTee with Valve Aerosol Tee Connector.
CODE Lot numbers 20021 and 21021.
RECALLING FIRM/MANUFACTURER Hudson Respiratory Care,
Inc., Temecula, CA
REASON Assembly defect.
VOLUME OF PRODUCT IN COMMERCE 879 units.
DISTRIBUTION Nationwide.
PRODUCT Medusa software, DiaSorin Part 15794, for an OMNI
(automated microtiter plate) Instrument used for the ETI-HA-IGMK Plus Enzyme Immunoasay
for the Detection of IgM Antibody to Hepatitis A Virus in Human Serum or
Plasma.
CODE Medusa software, DiaSorin Part 15794.
RECALLING FIRM/MANUFACTURER Diasorin Inc., Stillwater,
MN.
REASON As a result of a software error, the cut-off for the
ETI-HA-IGMK Plus kit would be incorrectly calculated, potentially causing false
negative results to be reported.
VOLUME OF PRODUCT IN COMMERCE Six laboratories had the
defective software.
DISTRIBUTION FL, KS, NY and TX.
PRODUCT CLARION brand Cochlear Implant Guide.
CODE All product codes.
RECALLING FIRM/MANUFACTURER Advanced Bionics Corp.,
Sylmar, CA
REASON Firm is recalling due to association of implant
guide with meningitis cases.
VOLUME OF PRODUCT IN COMMERCE Not disclosed.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Model 500A Hyperbaric Ventilator.
CODE Serial numbers: 270, 493, 400, 9, 527, 570, 75, 227,
495, 563, 160, 215, 126, 121, 10, 507, 25, 218, 101, 230, 104, 80, 481, 145,
87, 132, 286,
567,
62, 91, 512, 479, 271, 118, 119, 97, 86, 421, 194, 211, 298, 548, 549, 551,
552, 553, 554, 555, 556, 557, 558, 559, 560, 561, 562, 564, 566, 550, 565.
RECALLING FIRM/MANUFACTURER Sechrist Industries, Inc.,
Anaheim, CA
REASON Complaint of malfunction of hyperbaric ventilator.
VOLUME OF PRODUCT IN COMMERCE 59.
DISTRIBUTION Nationwide, Austrialia, Brazil, Japan and
Taiwan.
PRODUCT Accu Chek Inform blood glucose monitoring system.
CODE All units that have ever displayed a temperature
icon in conjunction with patient use.
RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corporation, Indianapolis,
IN
Manufacturer: 0 Roche Diagnostics, Mannheim, Germany.
REASON May give erroneous results if the temperature icon
has ever been displayed with use.
VOLUME OF PRODUCT IN COMMERCE 15,452.
DISTRIBUTION Nationwide.
PRODUCT Spectro Ferritin MT Substrate reagent for Spectro
Ferritin MT assay.
CODE Substrate code of 210081.
RECALLING FIRM/MANUFACTURER Ramco Laboratories, Inc.,
Houston, TX.
REASON Calibrating reagents may degrade and cause the
calibration curve to become skewed.
VOLUME OF PRODUCT IN COMMERCE 35 kits.
DISTRIBUTION NY, IA, MI, NJ, PA and Switzerland.
PRODUCT Choice A.B. (aberrtion blocking) Daily Wear Soft
(hydrophilic) Contact Lens. The product
is packaged in multipacks.
CODE Lot 0313 and 0905.
RECALLING FIRM/MANUFACTURER Recalling Firm: Ciba Vision Corp., Duluth, GA
Manufacturer: Specialty Ultravision, St. Hubert, Quebec,
Canada.
REASON Labeling problem.
VOLUME OF PRODUCT IN COMMERCE 50 units.
DISTRIBUTION CA, MA, MO, OR and Canada.
PRODUCT a) Kallestad HEp-2 12 well slides; b) Kallestad
HEp-2 12 well, 60 Test Kit; c) Kallestad HEp-2 12 well, 240 Test Kit.
CODE a) Catalog #30470, Lot #910927 and 910929; b)
Catalog #30471, Lot #908855; c) Catalog #30472, Lot #911821.
RECALLING FIRM/MANUFACTURER Bio-Rad Laboratories,
Redmond, WA
REASON Reactivity issues may cause low titered positive
samples to not be detected.
VOLUME OF PRODUCT IN COMMERCE a) Lot #910927 - 2989, lot #910929 – 13380; b) Lot
#908855 – 190; c) Lot #911821 - 499.
DISTRIBUTION Nationwide and Internationally.
PRODUCT a) Architect Prolactin Calibrator Kit, list number
6C27-01, 2 - 4 mL bottles of calibrators per box;
b)
Architect Prolactin Control Kit, list number 6C27-10, 3 - 8 mL bottles of
controls per box.
CODE a) lots 76916M300 and 84229M100; b) lot 76926M300.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc.,
Abbott Park, IL
REASON The concentration of prolactin decreased by 20%.
VOLUME OF PRODUCT IN COMMERCE 1512 kits.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Abbott Bilirubin Calibrator Cat No 01E66-01.
CODE Lot 79131M200.
RECALLING FIRM/MANUFACTURER Recalling Firm: Abbott Laboratories, Inc., South Pasadena,
CA
Manufacturer: Medical Analysis Systems, Inc., Camarillo, CA.
REASON Calibration set values misprinted on labeling,
affects neonatal values.
VOLUME OF PRODUCT IN COMMERCE 426.
DISTRIBUTION Nationwide and Internationally.
The
Food and Drug Administration (FDA) announced that Abbott Laboratories, Inc.,
has initiated a worldwide recall of 32 laboratory kits used to diagnose
gonorrhea. The kits have been shown to be unreliable because they may give
false negative results. These test kits were distributed to hospitals and
laboratories from Jan. 11 to June 24 2002.
Gonorrhea
is a serious, highly contagious sexually transmitted disease that affects both
men and women. Women primarily suffer severe consequences from infection that
is not detected and treated. Untreated gonorrhea in women can cause pelvic
inflammatory disease that can lead to sterility. In pregnant women, infection
can potentially cause abortion, premature delivery, or infection in the baby.
If undetected and untreated in men, it can cause an infection of the urethra
that makes urination painful and difficult. In both sexes, infection can spread
through the bloodstream and infect the joints, skin, bones, tendons and other
parts of the body.
People
who have had a negative gonorrhea test since Jan. 11 may wish to ask their
physician if they should be re-tested for gonorrhea.
Abbott
notified its customers (clinical laboratories) to discontinue use of all test
kits and to destroy any remaining product. Abbott also advised the laboratories
to contact the health care providers served by their facility and have them
determine if their patients need to be re-tested. The physician should offer a
re-test to the patients whose test results were negative and who were not
already treated. Repeat testing should be performed on a fresh specimen and not
on retained specimens. Abbott Labs will reimburse expenses associated with
repeat testing.
Abbott
voluntarily recalled 32 lots of its gonorrhea test kits after learning through
routine internal testing that certain lots did not meet specifications and, as
a result, could report positive test results as negative. Upon further testing,
Abbott determined that only 16 of these 32 lots did not meet internal release
criteria. Abbott is continuing to investigate the cause of the problem. The 16
lots that failed to meet specification when tested by Abbott are: 84073M400;
84075M400; 84142M300; 84146M300; 85487M200; 87007M400; 87103M400; 87243M100;
87377M200; 87899M200; 87905M200; 88097M300; 88105M300; 88107M300; 88439M200;
and 88439M201. Patients who received a negative test result with test kits from
these lots may need to be re-tested. Approximately 750,000 tests are affected.
Consumers or laboratories with questions can contact
Abbott Laboratories at 1-800-527-1869. Physicians with questions on this recall
should contact Abbott Laboratories at 1-866-233-0471.