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;