AUGUST 2003
WEEK ENDING AUGUST 2
PRODUCT
a) Portex Uncuffed Nasal Tracheal Tubes, Ivory 5mm x 25cm Reference Number:
100/105/050.
b) Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 3mm x 17cm Reference
Number: 100/111/030.
c) Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 3.5mm x 19cm
Reference Number: 100/111/035.
d) Portex Uncuffed Oral/Nasal Tracheal Tubes, Siliconised 8mm x 33cm Reference
Number: 100/111/080.
e) Portex Uncuffed Oral Tracheal Tubes, Siliconised 6mm x 19cm Reference
Number: 100/126/060.
f)
Portex Uncuffed Oral/Nasal Tracheal Tube, Murphy Eye Clear 3.5mm x 19cm
Reference Number: 100/127/035.
g) Portex Uncuffed Oral/Nasal Tracheal Tubes, Murphy Eye Siliconised 5mm x 25cm
Reference Number: 100/141/050.
h) Portex Tracheal Tube Profile Soft-Seal Cuff, Ivory Nasal 5mm x 25cm
Reference Number: 100/179/050.
i) Portex Profile Soft-Seal Cuff Oral/Nasal Tracheal Tube, Clear Murphy Eye 8
mm x 33cm Reference Number: 100/199/080.
CODE
a) Lot number: 161614;
b) Lot number: 161633;
c) Lot number: 161638;
d) Lot number: 161652;
e) Lot number: 161669;
f) Lot number: 161671;
g) Lot number: 161705;
h) Lot number: 153163;
i) Lot numbers: 153011, 153007;
RECALLING FIRM/MANUFACTURER Portex Ltd., Hythe, Kent, GB.
REASON Tracheal tubes may be non-sterile.
VOLUME OF PRODUCT IN COMMERCE 2,580 units.
DISTRIBUTION Nationwide.
PRODUCT Zoll M Series External Defibrillator.
CODE
Serial
Numbers: T02137097-T03C45238.
RECALLING FIRM/MANUFACTURER Zoll Medical Corporation, Burlington, MA.
REASON Defibrillator may fail to charge or hold its charge above
energies of 75 joules.
VOLUME OF PRODUCT IN COMMERCE 8,142 units.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT MagNA Pure LC Instrument; Catalog number 2236931.
CODE All units with software version 3.0.
RECALLING FIRM/MANUFACTURER Roche Diagnostics, Corp., Indianapolis, IN.
REASON Potential for false negative patient results with software
version 3.0.
VOLUME OF PRODUCT IN COMMERCE 17.
DISTRIBUTION Nationwide.
PRODUCT Drill bits used in ENDOTINE Forehead( 3.5 and 3.0, Catalog
Number: CFD-010-4203 and CFD-010-4303.
CODE Lot numbers: 00085, and 00092.
RECALLING FIRM/MANUFACTURER Coapt Systems, Inc., Palo Alto, CA.
REASON During use, the device has a potential for unacceptable deep hole
in the cranium which can cause patient injury.
VOLUME OF PRODUCT IN COMMERCE 275 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT EDI VueCath Endoscopic Spinal System. Catalog Number: S002.
CODE Lot/Serial Nos: F10021, F10017, F10012, F10018, F10025, F10019,
F10020, F10014, F10023, F10022, F10001, F10000, F10024, F10007, F10008, F00005,
F10003, F10016, F10015, F10002, F10027.
RECALLING FIRM/MANUFACTURER EBI, L.P., Parsippany, NJ.
REASON Non sterile device is labeled sterile.
VOLUME OF PRODUCT IN COMMERCE 39.
DISTRIBUTION Nationwide.
PRODUCT Misys Laboratory System.
CODE Versions 5.2, 5.23, and 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ.
REASON Software anomally. Results with a global flag failure that
autofile without review can cause abnormal results being communicated without
associated abnormal disignations.
VOLUME OF PRODUCT IN COMMERCE 467.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT Sanarus Visica( Treatment System (disposable), Model/Product
Code: VP-0500 (single).
CODE Lot # C030404.
RECALLING FIRM/MANUFACTURER Sanarus Medical, Inc., Pleasanton, CA.
REASON Corrosion in stainless steel device shaft that allows Argon gas
to escape from device during a cryoablation procedure.
VOLUME OF PRODUCT IN COMMERCE 41 units.
DISTRIBUTION Nationwide.
PRODUCT
a) Pulsar Max II Multiprogrammable Pacemaker, Model 1180.
b) Pulsar Max II Multiprogrammable Pacemaker, Model 1181.
c) Discovery II Multiprogrammable Pacemaker, Model 0481.
d) Discovery II Multiprogrammable Pacemaker, Model 0981.
e) Discovery II Multiprogrammable Pacemaker, Model 1184.
f) Discovery II Multiprogrammable Pacemaker, Model 1283.
g) Discovery II Multiprogrammable Pacemaker, Model 1284.
h) Discovery II Multiprogrammable Pacemaker, Model 1286.
i) Discovery II Multiprogrammable Pacemaker, Model 1280.
CODE
a) Serial numbers 110685, 110687, 110688, 110706, 110708, 110709, 110710,
110711, 110712, 110713, 110714, and 110715;
b) Serial number 811798;
c) Serial number 105497;
d) Serial numbers 206555, 206557, 206558, 206559, 206560, 206561, 206562,
206525, 206526, 206527, 206528, and 206529;
e) Serial numbers 319492, 319493, 319494, 319495, 319496, 319497, 319498,
319499, 319500, 319501, 319502, 319503, 319505, 319506, and 319507;
f) Serial numbers 639293, 639295, and 639296;
g) Serial numbers 721824, 721825, 721826, 721827, 721828, 721829, 721830,
721831, 721832, 721833,721834, 721835, 721836, 721837, 721838, 721839, 721840,
721841, 721843, 721908, 721909, 721910, 721911, 721912, 721913, 721914, 721915,
721916, 721917, 721918, 721919, 721920, 721921, 721922, 721923, 721924, 721926,
721927, 721928, 721929, 721930, 721931, 721932, 721933, 721934, 721935, 721936,
721937, 721938, and 721939;
h) Serial numbers 908813, 908814, 908817, 908819, 908820;
i) Serial numbers 547737, 547738, 547739, 547740, 547741, 547742, 547744,
547745, 547746, 547747, 547748, 547749, 547751, 547753, 547754, and 547964.
RECALLING FIRM/MANUFACTURER Guidant Corp-Cpi Division, St Paul, MN.
REASON Some of the pacemakers may fail to pace due to an inadequately
soldered electrical connection at an integrated circuit.
VOLUME OF PRODUCT IN COMMERCE 115 pacemakers.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT MSI-EpiDermGlu (Iso-Butyl 2 Cyanoacrylate) tissue adhesive for
soft tissue approximation; 0.22 cc plastic squeeze tubes packaged in a
Tyvek/PPE pouch with paper label, 10 units per case.
CODE
All lots.
RECALLING FIRM/MANUFACTURER Recall Firm: Elite Medical Group,
Bloomington, IL.
Manufacturer: Medisav Services, Inc., Ontario L3S 1Y7, Canada. FDA
initiated recall is ongoing.
REASON The liquid tissue adhesive was marketed with FDA pre-market
clearance.
VOLUME OF PRODUCT IN COMMERCE 129 cases.
DISTRIBUTION IL, TN, KN, KY, MD, and MO.
PRODUCT
a) Vail Enclosed Bed System, model 1000.
b) Vail Enclosed Bed System, model 2000.
CODE All serial numbers affected.
RECALLING FIRM/MANUFACTURER Vail Products, Inc., Toledo, OH.
REASON Patients may become entrapped between the bottom side rail and
mattress.
VOLUME OF PRODUCT IN COMMERCE 1,899 units.
DISTRIBUTION Nationwide, Canada, and Saudi Arabia.
PRODUCT
a)
Hill-Rom Newborn bassinet, model P247.
b) Hill-Rom Newborn bassinet, model P248.
CODE All units distributed from November 2000 through April 2003.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN.
REASON The caster/wheel may come off of the bassinet, causing the
bassinet to tip.
VOLUME OF PRODUCT IN COMMERCE 2,901.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT Magic View 1000U, version VE40A. Digital Image Communication
System.
CODE Part number 7502003.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc.,
Malvern, PA.
REASON Software issue. New examinations may not be saved properly and
the examination may be lost.
VOLUME OF PRODUCT IN COMMERCE 49 units.
DISTRIBUTION Nationwide.
PRODUCT
a) Fibered Platinum Coil, 0.035 Type, 4 mm x 30 mm. Catalog no. 372403.
b) Fibered Platinum Coil, 0.035 Type, 9 mm x 60 mm. Catalog no. 372906.
CODE
a) Lot number: 5473831;
b) Lot number: 5472234.
RECALLING FIRM/MANUFACTURER Boston Scientific Corporation, Natick, MA.
REASON Product's Outer box label may not match pouch label: a 4 mm x 30
mm coil may be labeled as a 9 mm x 60 mm or vice versa.
VOLUME OF PRODUCT IN COMMERCE 60 units.
DISTRIBUTION Japan, Italy, France, Turkey, Israel, Finland.
PRODUCT 9 French Super Arrow-Flex Percutaneous Sheath Introducer Kit
with Arrowg and Blue Antimicrobial Surface Sheath. Catalog numbers AK-07903-AG,
SI-07903-AG, JM-07903-AG, and CI-07903-AG.
CODE Not indicated.
RECALLING FIRM/MANUFACTURER Arrow International, Inc., Reading, PA.
REASON Separation of sheath.
VOLUME OF PRODUCT IN COMMERCE 13,442 units.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT AMO PhacoFlex II Model SI40NB, Intraocular Lenses.
CODE 1011620109 1303290109 1011680109 1309920109 1038960109 1330610110
1039310109 1391120107 1077970111 1391590107 1077990111 1391930107 1104820203
1414530107 1123300203 1430530112 1149800001 1441910105 1162800105 1454360107
1167400105 1454380107 1168730109 1459930105 1189090109 1484520108 1191330109
1484570112 1191500109 1484650108 1192830105 1486950107 1192940105 1501090108
1207160105 1690550106 1213960109 1690810106 1214020109 1780720106 1215950109
1780740106 1216120109 1781220106 1224570111 1781340106 1227610105 1785280202
1232610109 1846620106 1232680109 1896320106 1232760109 1896330106 1237660109
1896420106 1237880109 1974109910 1276430109 9909772334 1010640212 1012010212 1012040212
1286460208 1299700208 1299760208 1299770208 1324100211 1324110211 1324530211
1384980211 1392500211 1408400211 1419200208 1445720211 1663700211 1670870211
1670890211 1672080211 1703760211 1721900211 1797030210 1956470211 1963580210
1990660211 1991080211 1993620211 1993660211 2121580206 2121690206
Known Implanted Lenses 1704120211 1990690211.
RECALLING FIRM/MANUFACTURER Allergan Medical Optics Inc., Santa Ana, CA.
REASON Post operative complaints of cloudiness in the intraocular
lenses.
VOLUME OF PRODUCT IN COMMERCE 98.
DISTRIBUTION Brazil.
PRODUCT Roche/Hitachi Tina-quant RF II; catalog # 3004902.
CODE All lots.
RECALLING FIRM/MANUFACTURER Roche Diagnostics Corp., Indianapolis, IN.
REASON Test results may exhibit a positive bias when plasma samples are
used for the assay.
VOLUME OF PRODUCT IN COMMERCE 480.
DISTRIBUTION Nationwide.
PRODUCT Rheumatoid Factor ELISA Test Kit. Labeled under the following
names:
a) Sigma Diagnostics, Inc, Saint Louis, MO. Product Number 507-B;
b) Zeus Scientific, Inc., Branchburg, NJ. Product Number 2Z921M.
CODE
a) Lot Number: 090K6499 Expiration Date: 5-31-2002;
b) Lot Number: 00010446 Expiration Date: 06-09-2002.
RECALLING FIRM/MANUFACTURER Zeus Scientific Inc., Branchburg, NJ.
REASON Calibrator C not meeting its optical density specification.
VOLUME OF PRODUCT IN COMMERCE 505.
DISTRIBUTION Nationwide.
PRODUCT Cathcor/LX/Desktop, System, X-Ray, Angiographic.
CODE
Serial
Numbers: 01029, 01033, 01034, 01062, 01108, 01110, 01121, 01125, 02048.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc.
REASON Incorrect CTR values are found when used with ODBC interface, and
may result in misdiagnosis.
VOLUME OF PRODUCT IN COMMERCE 9.
DISTRIBUTION Nationwide.
PRODUCT Stryker Advanced Cement Mixing System Bowl and 180 Gram Cement
Cartridge with Break-Away Femoral Nozzle for use with Stryker high vacuum
cement injection system, 6 pack; part 0306-563-000.
CODE Lot 03030232.
RECALLING FIRM/MANUFACTURER Stryker Instruments, Instruments Div.,
Kalamazoo, MI.
REASON Non-sterilized product sold as sterile.
VOLUME OF PRODUCT IN COMMERCE 440.
DISTRIBUTION Nationwide, Canada, Italy, Japan, and United Kingdom.
PRODUCT Custom Sterile Surgical Procedure Packs. The product packaging consists
of a vented polybag with a label insert inside the polybag.
a) Sterile Minor Extremity Pack, Catalog SOP11MEMMD, order 101449.
b) Sterile Major Abdominal Pack, Catalog SBA21MAHVJ, order 101491.
c) Sterile General Local Tray, Catalog SBA11GLMMD, order 101466.
d) Sterile Laparotomy Pack, Catalog SBA61MJSFH, order 101438.
e) Sterile General Surgery Pack, Catalog SBA35GSMOG, order 101467.
CODE
a) Mfg date 5/20/03, Exp date 11/01/04;
b) Mfg date 5/22/03, Exp date 1/01/05;
c) Mfg date 5/20/03, Exp date 1/01/05;
d) Mfg date 5/21/03;
e) Mfg date 5/21/03.
RECALLING FIRM/MANUFACTURER
Cardinal Health, McGaw Park, IL.
REASON The kits labeled as sterile were stolen in transit to the
sterilizer and have not been sterilized.
VOLUME OF PRODUCT IN COMMERCE 1,242 packs.
DISTRIBUTION NJ, TN, MO, and MN.
PRODUCT Quest Myocardial Protection System (MPS) Arrest/Additive
Cassettes.
a) Catalog Number: 5001102;
b) Catalog Number: 5001104;
Lots manufactured but not distributed:
c) Catalog Number: 6001101;
d) Catalog Number: 7001102.
CODE
a) Lot numbers: 20823.R10, 20853.S01, and 20863.S04;
b) Lot Number: 20706.S09;
c) Lot Number: 20639.R10;
d) Lot Number: 20638.R10.
RECALLING FIRM/MANUFACTURER Quest Medical, Inc., Allen, TX.
REASON Cassettes leak causing a delay of administration of cardioplegia
solutions to the heart during open heart surgery.
VOLUME OF PRODUCT IN COMMERCE 2,158 devices.
DISTRIBUTION Nationwide, Japan, and Canada.
PRODUCT CryoValve, Synegraft Pulmonary Valve & Conduit.
CODE Serial #7925364, Model #SGPV00.
RECALLING FIRM/MANUFACTURER Cryolife, Inc. Kennesaw, GA.
REASON Human tissue for transplantation, which was associated with a
donor whose pre-processing culture detected microorganisms was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
a) ProVision Hytrel Elastomer Hood, product 5431-05-000.
b) ProVision Hytrel Universal Hood/Gown, product 5431-31-000.
c) ProVision Barrier Universal Hood/Gown, product 5431-33-000.
d) ProVision Disposable Hood, product 5431-50-000.
CODE All products manufactured between February 1, 2002 and June 17,
2003 that does not have a green square on the label above the CE mark. Product
bearing the green square on the label has been 100% inspected and is not under
recall.
RECALLING FIRM/MANUFACTURER Depuy Orthopaedics, Inc. Warsaw, IN.
REASON Lack of assurance of sterility, due to the possibility of an
incomplete package seal.
VOLUME OF PRODUCT IN COMMERCE 168,528.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT MagNA Pure LC Instrument, Catalog number 2236931.
CODE All systems using software version 3.0.
RECALLING FIRM/MANUFACTURER Roche Diagnostics, Corp., Indianapolis, IN.
REASON A software bug in version 3.0 may result in prolonged mixing
time, evaporation of elution volume and biased sample results for various
protocols.
VOLUME OF PRODUCT IN COMMERCE 17.
DISTRIBUTION Nationwide, and Canada.
PRODUCT
a) Positive Touch (TM) TEXTURED POWDER-FREE LATEX EXAM GLOVES, Large. Reorder
No. 8843. Single Use Only. Qty. 100 Per Box (50 pairs), 1000 Per Case.
b) Positive Touch (TM) SMOOTH POWDER-FREE LATEX EXAM GLOVES, Large. Reorder No.
8878. Single Use Only. Qty. 100 Per Box (50 pairs), 1000 Per Case.
CODE All lots distributed between May 28, 2003 and July 9, 2003,
including Lot # 4E02A021.
RECALLING FIRM/MANUFACTURER Henry Schein, Inc., Melville, NY.
REASON FDA's analysis revealed defects (holes) in the latex gloves.
VOLUME OF PRODUCT IN COMMERCE 96 cases.
DISTRIBUTION Nationwide.
PRODUCT AxSYM AFP Reagent Pack, list 7A48-22 (100 test kit), 7A48-21
(French label), and AxSYM Cancer Assay Disk, list 3D50-02 (Version 2.0),
3D50-03 (Version 3.0), and 3D50-04 (Version 4.0).
CODE All lots of AFP list 7A48-22 and 7A48-21 used with all lots of
AxSYM Cancer Assay Disk list 3D50-02, 3D50-03 and 3D50-04 with AFP Assay File
version 2.00.200, when used with AxSYM System Software Versions 3.00 and
higher.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD, Abbott Park,
IL.
REASON AFP results obtained when using the 1:101 automated dilution
protocol showed an overestimation of AFP of up to 30.5%.
VOLUME OF PRODUCT IN COMMERCE 23,000 kits.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT
a) SurgASSIST System. Circular Stapler DLU 29 mm, product code CS29.
b) SurgASSIST System. Circular Stapler DLU 33 mm, product code CS33.
CODE
a) Lot numbers DS-000036, DS-000043, DS-000047, DS-000049, DS-000052,
DS-000055, DS-000057, DS-000061, DS-000064, DS-000072, DS-000073, DS-000077,
DS-000078, DS-000082, DS-000084, DS-000085, DS-000086, DS-000090, DS-000095, DS-000099,
DS-000117, DS-000118, DS-000119, DS-000126, DS-000132, DS-000133, DS-000135,
DS-000138, DS-000140, DS-000141, DS-000145, LC-000022, LC-000023, LC-000024,
LC-000030, LC-000044, LC-000052, LC-000053, LC-000055, LC-000056, LC-000061,
LC-000066, LC-000068, and LC-000074;
b) Lot numbers DS-000122, DS-000123, DS-000127, DS-000134, DS-000139,
DS-000142, DS-000146, and DS-000148.
RECALLING FIRM/MANUFACTURER Power Medical Interventions, New Hope, PA.
REASON Latching mechanism failure.
VOLUME OF PRODUCT IN COMMERCE 4,978 units.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT
a) Active Electrode Monitoring System. EM2 NC AEM Monitor (NON-COM).Catalog
Number EM2 NC.
b) Active Electrode Monitoring System. EM2+A NC AEM Monitor (NON-COM). Catalog
Number EM2+A NC.
CODE All serial numbers.
RECALLING FIRM/MANUFACTURER Encision, Inc., Boulder, CO.
REASON Use of NC versions of AEM monitor presents burn hazard when used
with single pad and capacitively coupled patient return electrodes.
VOLUME OF PRODUCT IN COMMERCE 27 units.
DISTRIBUTION CA, IL, KS, OH, OK, PA, TN, Canada, and Italy.
PRODUCT LMA-Unique Laryngeal
Mask Airway Size 4, Catalog No. 12140, and Catalog No. 12150.
CODE Lots FH041202 and FJ021202.
RECALLING FIRM/MANUFACTURER LMA
North America Inc., San Diego, CA.
REASON Sterility cannot be assured.
VOLUME OF PRODUCT IN COMMERCE 2,579.
DISTRIBUTION Nationwide.
PRODUCT Medex 2000 Series Syringe Infusion Pumps.
The 2001 series is a general use pump, 2001E is for German use, 2001G is for
use in the UK, 2001T is for use in
Taiwan, 2010iK is for use in Korea, (the pumps with different languages have
different syringes than those used in the U.S.), 001H has a different power
cord connector,
"VX" in the suffix means it is an evaluation pump, "NFHU"
is not for human use; used in test labs for testing purposes, 2010 has an
anesthesia mode built into the software, "ZE" are returned because of
outdated software. They are refurbished or up graded and re-distributed,
2010i has an anesthesia mode and library mode for programming.
CODE
Series # 2001, 2201E, 2001G, 2001H, 2001VX, 2001HZE, 2001NFHU, 2001T, 2010,
2010E, 2010H, 2010HVX, 2010HZE, 2010i, 2010ik, 2010iVX, 2010iZE.
RECALLING FIRM/MANUFACTURER Medex, Inc., Duluth, GA.
REASON Inadequate warning label as pertains to use of the pump in
conjunction with Extracorporeal Membrane Oxygenation (ECMO) procedures.
VOLUME OF PRODUCT IN COMMERCE 59,938 units.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT
a) ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250.
b) ASAP Channel Cut Biopsy System, 15 gauge Reference Number: 1390.
c) ASAP Channel Cut Biopsy System, 18 gauge Reference Number: 1394.
CODE
a) 4104836 4145036 4211323 4290090 4370503 4405122 4445839 4461241 4569317
4666229 4916051 5022356 5120746 5133248 5251508 5288530;
b) 4097154 4126946 4145035 4158456 4193792 4212753 4221510 4231545 4256164
4262043 4258584 4282986 4313907 4323261 4349628 4375687 4392520 4405118 4408527
4414677 4425997 4464404 4464403 4468969 4494611 4528589 4537936 4550692 4557360
4562655 4579693 4583642 4625634 4628069 4639625 4652811 4689625 4701139 4701138
4727026 4742360 4764119 4764122 4774555 4788365 4823397 4830419 4845754 4900789
4910488 4915451 4935096 4963935 4963936 4983393 4992627 5007857 5019451 5022419
5038639 5065152 5121437 5129514
5140440 5155296 5158742 5169243 5173373 5182914 5186852 5205601 5223778 5227258
5238638 5246424 5251510 5269078 5288531 5301576 5320588 5371233 5427428 5440613
5473223 5501877 5505775 5511863 5547602;
c) 4105648 4113988 4162641 4193798 4206664 4231542 4266299 4290089 4297846
4339339 4363204 4387477 4401411 4414613 4472494 4494612
4506626 4528577 4555320 4591333 4611363 4646473 4671080 4732694 4776718 4792615
4814439 4916050 4923749 4940371 4955250 5000456
5025458 5048339 5071211 5086862 5153158 5190439 5226638 5280768 5313310 5340135
5343856 5347420 5374497 5388620 5395693 5446265.
RECALLING FIRM/MANUFACTURER Boston Scientific Corporation, Natick, MA.
REASON Sterility of the device may be compromised due to a lack of
package integrity.
VOLUME OF PRODUCT IN COMMERCE 12,990 units.
DISTRIBUTION Nationwide.
PRODUCT
a) Servo Controlled Oxygen System for Ohmeda's Medical Giraffe OmniBed;
b) Ohmeda's Medical Girraffe Incubators. .
CODE
a) Giraffe OmniBeds (w/Servo O2 option): HEDF50041 - HEDF50076 HDGE50562 -
HDGE50567, HDGF54039, HDGF54153 - HDGF54155
HDGF54165 - HDGF54167;
b) Giraffe Incubators (w/Servo O2 option): HDHE50160-HDHE50161,
HDHF50023-HDHF50024, HDHF50105, HDHF50109, HDHF50114, HDHF50227-HDHF50245,
HDHF50278, HDHF50302, HDHF50304, HDHF50306, HDHF50309, HDHF50327-HDHF50328,
HDHF50333-HDHF50343, HDHF53070, HDHF54046, HDHF54122, HDHF54131-HDHF54133,
HDHF54135, HDHF54143-HDHF54145, HDHF54152-HDHF54155.
RECALLING FIRM/MANUFACTURER Ohmedia Medical, A division of Datex-Ohmeda,
Inc., Laurel, MD.
REASON Medical device malfunction affecting instrument's calibration and
alarm systems.
VOLUME OF PRODUCT IN COMMERCE 157 units.
DISTRIBUTION Internationally.
PRODUCT Lo-Profile Fenestrated Tracheostomy
Tube, Cuffed and Fenestrated Tube I.D.9.0mm Catalog Number: 593090.
CODE Lot Number: 905486 EXP: 2004-05.
RECALLING FIRM/MANUFACTURER Portex, Inc., Keene, NH.
REASON Mislabeled: Tracheostomy
tube was not fenestrated as specified on the label.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION CA, GA, KA, MO.
PRODUCT
a) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size
47-90 microns, 1 cc; order number PVA-50.
b) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size
90-180 microns, 1 cc; order number PVA-100.
c)
Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size 180-300
microns, 1 cc; order number PVA-200.
d) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size
300-500 microns, 1 cc; order number PVA-300.
e) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size
500-710 microns, 1 cc; order number PVA-500.
f) Cook Polyvinyl Alcohol Foam (PVA) Embolization Particles, particle size
710-1000 microns, 1 cc; order number PVA-700.
CODE All units distributed from February 24, 2003 through June 26, 2003.
RECALLING FIRM/MANUFACTURER Cook, Inc., Bloomington, IN.
REASON Vial contains less product than is declared on the label.
VOLUME OF PRODUCT IN COMMERCE 4,179.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
a) Ventra Percutaneous Intravenous Catheter Repair Kit for Luer Connector
Segments and Single-Lumen Catheters, Reorder Number
21-0105.
b)
Ventra Percutaneous Intravenous Catheter Repair Kit for 9 French Dual-Lumen
External Catheter Segment, Reorder Number 21-0106.
c) Ventra Percutaneous Intravenous Catheter Repair Kit for 11 French
Triple-Lumen External Catheter Segment,
Reorder
Number 21-0107.
CODE
a) Lot numbers M20689, 90299, 85047;
b) Lot numbers M20690, 95310;
c) Lot numbers M20691, 95311.
RECALLING FIRM/MANUFACTURER Deltec, Inc, St. Paul, MN.
REASON Silicone adhesive in kits used to repair damaged catheters does
not set (cure) properly and remains in a tacky state.
VOLUME OF PRODUCT IN COMMERCE 86 kits.
DISTRIBUTION CA, IL, KS, MI, MN, MO, PA, and TX.
PRODUCT
a) Cyto-Stat/Coulter Clone B6-RD, Part number 6604426.
b) Coulter Clone B6-FITC Reagent.
CODE
a) Lot numbers 737312, 737313, 737314, 737315;
b) Lots 735512F, 735513F and 735514FR.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Diminished expression on B-Cell populations when drawn in EDTA
tubes, which may lead to inaccurate interpretation of phenotype results.
VOLUME OF PRODUCT IN COMMERCE 1,053 kits.
DISTRIBUTION Nationwide and Canada.
PRODUCT PHS, Tubular Stockinette Cotton, 6'x 48', 8'x 72', 4'x 60' and
4'x 48' Double Ply, 6'x 72', 4'x 48' and 6'x 48' Single Ply and 4' x 4 YDS, 6'
x 4 YDS and 3'x 4YDS, 1/pk 25 pk/cs.
CODE Lot #250512, Item #489150, 489230, 489267, 489305, 489310, 489347,
489433, 489374, 489412, 489427 and 499448. Lot #250514, Item #489150, 489230
and 489273.
RECALLING FIRM/MANUFACTURER Rx Textiles, Inc., Monroe, NC.
REASON Product may not be sterile.
VOLUME OF PRODUCT IN COMMERCE 141 cases 25 pk/cs.
DISTRIBUTION CA, and NV.
PRODUCT Guidant Multi-Link Zeta Coronary Stent System.
CODE 3050632 3060432 3060251 3051952 3052251 3060331 3051231 3051951
3052752 3052031 3051931 3050651 3052752 3060531 3060451 3050751 3052251 3051951
3050931 3050632 3052032 3060251 3051531 3053051 3051634 3051632 3053051 3051531
3052952 3051552 3050931 3052852 3060431 3060432 3050751 3052131 3051532 3052031
3051631 3050251 3043051 3050931 3051531 3051451 3052851 3051551 3051531
3041031.
RECALLING FIRM/MANUFACTURER Guidant Corporation ACS, Temecula, CA.
REASON Potential loss of package sterility.
VOLUME OF PRODUCT IN COMMERCE Not provided.
DISTRIBUTION China.
PRODUCT "Alcon Ladarwave Custom Cornea Wavefront System"
Aberrometer software Version 7.91.
CODE Serial Numbers: LWN1002Z LWN1003Z LWN1010Z LWN1011Z LWN1013Z
LWN1023Z LWN1025Z LWN1035Z LWN1040Z LWN1440Z LWN1513Z LWN1522Z LWN1626Z
LWN1629Z LWN1647Z LWN1748Z LWN1796Z LWN1805Z LWN1817Z LWN1820Z LWN1821Z
LWN1822Z LWN1823Z LWN1843Z LWN1846Z LWN1944Z LWN1945Z LWN1946Z LWN1947Z
LWN1949Z LWN1950Z LWN1952Z LWN1953Z LWN1954Z LWN1955Z LWN1956Z LWN1957Z
LWN1958Z LWN1959Z LWN1961Z LWN2187Z LWN2188Z LWN2189Z LWN2190Z LWN2191Z
LWN2192Z LWN2193Z LWN2194Z LWN2197Z LWN2198Z LWN2199Z LWN2200Z LWN2262Z
LWN2263Z LWN2264Z LWN2265Z LWN2267Z LWN2268Z LWN2269Z LWN2270Z LWN2271Z
LWN2272Z LWN2273Z LWN2276Z LWN2277Z LWN2278Z LWN2279Z LWN2280Z LWN2342Z
LWN2343Z LWN2344Z LWN2345Z LWN2346Z LWN2347Z LWN2348Z LWN2349Z LWN2350Z
LWN2351Z LWN2352Z LWN2353Z LWN2355Z LWN2356Z LWN2357Z LWN2403S LWN2404S
LWN2405S LWN2406S LWN2414Z LWN2415Z LWN2416Z LWN2417Z LWN2420Z LWN2421Z
LWN2427S LWN2428S LWN2464Z LWN2465Z LWN2466Z LWN2467Z LWN2468Z LWN2469Z
LWN2470Z LWN2471Z LWN2472Z LWN2473Z LWN2475Z LWN2476Z LWN2477Z LWN2478Z
LWN1609Z LWN1951Z.
RECALLING FIRM/MANUFACTURER Alcon Laboratories, Inc., Orlando, FL.
REASON Software error could, under specific circumstances, allow the
patient's centration images and data to be stored incorrectly.
VOLUME OF PRODUCT IN COMMERCE 157.
DISTRIBUTION Nationwide
PRODUCT
a) Kimberly-Clark/Ballard TRACH-CARE*MAC (Multi Access Catheter) for Neonates.
b) Kimberly-Clark / Ballard TRACH-CARE*MAC (Multi Access Catheter) for
Neonates.
c) Kimberly-Clark / Ballard TRACH-CARE*MAC (Multi Access Catheter) for
Neonates.
d) Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for
Neonates.
e) Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for
Neonates.
f) Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter) for
Neonates. For international distribution only.
g) Kimberly-Clark / Ballard TRACH-CARE* MAC (Multi Access Catheter)
for Neonates. For distribution to Germany only.
CODE
a) Catalog No: 1900, Lot Numbers:211006, 211830, 213674;
b) Catalog No: 1920, Lot Numbers: 212812, 215498;
c) Catalog No: 1925, Lot Numbers: 215499, 218054;
d) Catalog No: 1930, Lot Numbers: 212853, 213673, 213675, 217882;
e) Catalog No: 1935, Lot Numbers: 212811;
f) Catalog No: 1900IN, Lot Numbers: 210293, 210296;
g) Catalog No: 7001G, 7002G, 7003G. Lot numbers 217642, 215497, 217640.
RECALLING FIRM/MANUFACTURER Ballard Medical Products, Draper, UT.
REASON Incorrect plug was included in the multi access catheter pkg.
When inserted in the "Y" it may disengage, allowing a leak of
ventilator gases.
VOLUME OF PRODUCT IN COMMERCE 5,285 units.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT Misys Laboratory System.
CODE Version 5.3 and up to 5.3.2 with Anatomic Pathology Module.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ.
REASON Software anomaly allows patient reports to contain incomplete
data used for Anatomic Pathology Module.
VOLUME OF PRODUCT IN COMMERCE 315.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT Misys Laboratory System.
CODE Version 5.3.
RECALLING FIRM/MANUFACTURERMisys Healthcare System, Tucson, AZ.
REASON Patient files become mixed up due to a software defect.
VOLUME OF PRODUCT IN COMMERCE 1.
DISTRIBUTION NY.
PRODUCT Cytomegalovirus (CMV) IgG ELISA Test System, In-Vitro Diagnostic.
CODE Product Number 9Z9501G, Lot Number: 03022371, exp. 2004-July;
03022392 exp. 2004-July; 03022472 exp. 2004-July.
RECALLING FIRM/MANUFACTURER Recalling Firm: Zeus Scientific, Inc.,
Branchburn, NJ.
Manufacturing Firm: Zeus Scientific, Inc., Raritan, NJ.
REASON The Calibrator included within the kit may be losing reactivity.
VOLUME OF PRODUCT IN COMMERCE 270 kits.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT Rubella IgM ELISA Test Kit. It is an enzyme-linked
immunoabosorbent assay designed for the qualitative detection of IgM antibodies
to Rubella virus in human serum.
CODE Product Number: 514-B (Sigma Diagnostics) Lot Numbers: 020K6491
Exp. 10-02-2001; 090K6483, Exp. 5-31-2002.
RECALLING FIRM/MANUFACTURER Zeus Scientific, Inc., Branchburg, NJ.
REASON The high positive control/low positive standard ratio recovering
too low.
VOLUME OF PRODUCT IN COMMERCE 205.
DISTRIBUTION MO.
PRODUCT Foundation Knee System, non-porous Femur Size 8, Right.
CODE Lot numbers 811761, 815241, 815251, 817891, 834781, 835291, 838201,
850611.
RECALLING FIRM/MANUFACTURER Encore Medical, LP, Austin, TX.
REASON Product container was labeled incorrectly indicating left femur
instead of right.
VOLUME OF PRODUCT IN COMMERCE 14 units.
DISTRIBUTION PA, TX, MA, FL, NV, AZ, France, and Saudi Arabia.
PRODUCT
a) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm / 1.5 cm /90 cm
(balloon width/balloon
length/catheter length), Reference Catalog Number 37915-4015.
b) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm,
Reference Catalog Number 37915-4020.
c) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/90 cm,
Reference Catalog Number 37915-4515.
d) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 2.0 cm/90 cm,
Reference Catalog Number 37915-5020.
e) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/90 cm,
Reference Catalog Number 37915-6015.
f) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5 mm/ 2.0 cm/90 cm,
Reference Catalog Number 37915-6520.
g) Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 1.5 cm/90 cm,
Reference Catalog Number 37915-7015.
h) Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/90 cm,
Reference Catalog Number 37915-7020.
i) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 1.5 cm/150 cm,
Reference Catalog Number 37916-4015.
j) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 2.0 cm/150 cm,
Reference Catalog Number 37916-4020.
k) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/150 cm,
Reference Catalog Number 37916-4515.
l) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/150 cm,
Reference Catalog Number 37916-4515.
m) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 1.5 cm/150 cm,
Reference Catalog Number 37916-5015.
n) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.5 mm/ 2.0 cm/150 cm,
Reference Catalog Number 37916-5520.
o) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/150 cm,
Reference Catalog Number 37916-6015.
p) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5 mm/ 1.5 cm/150 cm,
Reference Catalog Number 37916-6515.
q) Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/150 cm,
Reference Catalog Number 37916-7020.
r) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/150 cm,
Reference Catalog Number 38950-5020.
s) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/150 cm,
Reference Catalog Number 38950-6020.
t) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/1.5 cm/90 cm,
Reference Catalog Number 38990-4015, Product Number H7493791540150.
u) Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm,
Reference Catalog Number 38990-4020.
v) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/1.5 cm/90 cm,
Reference Catalog Number 38990-5015.
w) Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/90 cm,
Reference Catalog Number 38990-5020.
x) Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/90 cm,
Reference Catalog Number 38990-6020.
y) Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/2.0 cm/90 cm,
Reference Catalog Number 38990-7020.
CODE
a) Lot numbers 5490976, 5530109, and 5564475;
b) Lot numbers 5462665, 5486700, 5509423, 5570097, 5580887, 5591636, and
5592100;
c) Lot number 5491423;
d) Lot numbers 5458926, 5459705, 5462880, 5464053, 5523106, 5570556, 5576584,
and 5581120;
e) Lot numbers 5486922 and 5625627;
f) Lot number 5138299;
g) Lot numbers 5491707 and 5563990;
h) Lot numbers 5487644, 5514945, 5524567, 5531394, 5560048, 5571045, and
5581781;
i) Lot number 5493302;
j) Lot numbers 5463361, 5463825, 5467755, 5591116, and 5592367;
k) Lot number 5523632;
l) Lot numbers 5470240 and 5493444;
m) Lot number 5464221;
n) Lot number 5463435;
o) Lot number 5515405;
p) Lot number 5493691;
q) Lot numbers 5463705 and 5464511;
r) Lot number 5554279;
s) Lot numbers 5470562, 5536519, 5543449, and 5554623.
t) Lot number 5562834;
u) Lot numbers 5531084 and 5543317;
v) Lot number 5455553;
w) Lot numbers 5519448, 5519891, 5537795, and 5551411;
x) Lot numbers 5455345, 5536214, 5551137, 5563785, and 5620006;
y) Lot numbers 5490680, 5540265, and 5584469.
RECALLING FIRM/MANUFACTURER Boston Scientific Scimed, Maple Grove, MN.
REASON Some of the product pouches have holes in the seals.
VOLUME OF PRODUCT IN COMMERCE 751 catheters.
DISTRIBUTION Nationwide.
PRODUCT
a) Radionics Disposable Grounding Plate.
b) Radionics Cool-tip RF Electrode Kit, containing DGP-HP single-use grounding
pads.
CODE
a) Catalog Number DGP-HP;
b) Catalog Numbers: CT-1020, CT-1030, CT-1510, CT-1520, CT-1530, CT-2020,
CT-2030, CT-2530, CTC-1025, CTC-1525, CTC-2025.
RECALLING FIRM/MANUFACTURER Valleylab, Inc., Boulder, CO.
REASON Pads may have a thin plastic film covering the conductive gel
surface underneath the normal printed cover, causing non-adherence and possible
burn.
VOLUME OF PRODUCT IN COMMERCE 25,000 pads.
DISTRIBUTION Nationwide, and Internationally.
PRODUCT Boston Scientific Scimed Monorail Express 2 Coronary Stent
System, 3.5 mm x 32 mm, Catalog number 35050-3235.
CODE Lot 5570485.
RECALLING FIRM/MANUFACTURER Boston Scientific Scimed, Maple Grove, MN.
REASON There is an increased potential for broken struts of the stents.
VOLUME OF PRODUCT IN COMMERCE 17 stent systems.
DISTRIBUTION Nationwide.
PRODUCT Intralase FS Laser System. Laser Keratome.
CODE All codes.
RECALLING FIRM/MANUFACTURER Intralase Corp., Irvine, CA.
REASON Gantry moves toward patient when 'Home' button is used after
procedure.
VOLUME OF PRODUCT IN COMMERCE 70.
DISTRIBUTION Nationwide and Japan.
PRODUCT Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests
per kit, Catalog Numbers: 620096 and 9Z9501G.
CODE Lot Numbers: #03022371 and #03022472. All lots Exp. Date: 2004-07.
RECALLING FIRM/MANUFACTURER Meridian Bioscience, Inc., Cincinnati, OH.
REASON The low Positive Standard kit component is losing potency that
may result in false positive test results.
VOLUME OF PRODUCT IN COMMERCE 43 kits.
DISTRIBUTION CA, UT, NY, MD, KY and Belgium.
PRODUCT Easy Web.
CODE Site number: Z1776, 86233, 86264, 83198, 86944, 85075, 85077,
85083, 85071, 85067, 10377, 85048, 86026, X1676, 83675, 86025, 87131, 87158,
82683, 84027, 84087, 84359, 86007, 84405, 85453, 83917, 85189, 83961.
RECALLING FIRM/MANUFACTURER Philips Medical Systems, Bothell, WA.
REASON Potential for incorrect body part information.
VOLUME OF PRODUCT IN COMMERCE 28.
DISTRIBUTION Nationwide.
PRODUCT Architect Processing Module, List number 8C89-01.
CODE All units.
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc, Irving, CA.
REASON Under specific conditions, the system can allow an incorrect
sample ID to be assigned to another sample in a different carrier.
VOLUME OF PRODUCT IN COMMERCE 787 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Barrier Hip Sheet with Side Pockets.
CODE Product Code 0202 Lot numbers 03149759 and 03165584. Product Code
0204 Lot numbers 030305, 030321, and 03165583. Product Code 9202 Lot numbers
250203, 03205562, and 03255432.
RECALLING FIRM/MANUFACTURER Molnlycke Health Care, Inc., Newton, PA.
REASON Pouch may tear which could result in contamination of sterile field.
VOLUME OF PRODUCT IN COMMERCE 2,714 units.
DISTRIBUTION Nationwide and Internationally.
PRODUCT IRMA SL Blood Analysis System CC pH, pCO2, p)O2, Hct, Na+, K+,
iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges
in a box.
CODE The lot on the boxes of the product is ALHCB (this is the correct
lot) and is incorrectly printed as ALOHC on the packages of the recalled
disposable cartridges.
RECALLING FIRM/MANUFACTURER Diametrics Medical, Inc. Roseville, MN.
REASON An incorrect lot designation, when entered into the blood
analysis device, causes the device to give an error message and not operate.
VOLUME OF PRODUCT IN COMMERCE 103 boxes of 25 cartridges per box.
DISTRIBUTION Nationwide.
PRODUCT Blood Agar Plates, 5%.
CODE Lot number A-10-3155A.
RECALLING FIRM/MANUFACTURER Hardy Media, Inc. Dba Hardy Diag., Santa
Maria, CA.
REASON Customers complained of bacterial contamination.
VOLUME OF PRODUCT IN COMMERCE 11,250 plates.
DISTRIBUTION Nationwide.
PRODUCT Synchron LX Systems Primary Tube Sample Template ( a piece of
"labeling" for use with the Synchron LX 20 and LX 20 Pro systems),
Part Number: 967178.
CODE No range of serial numbers apply.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc. Brea, CA.
REASON Dead volume on sight gauge for the Synchron LX 20 Pro Systems not
stated, which may result in instrument error.
VOLUME OF PRODUCT IN COMMERCE 502.
DISTRIBUTION Nationwide and Canada.
PRODUCT Prosorba Protein A Immunoadsorption Column.
CODE Lot #PNC001A.
RECALLING FIRM/MANUFACTURER Fresenius Hemocare, Inc., Redmond, WA.
REASON No package insert.
VOLUME OF PRODUCT IN COMMERCE 19 cases/6 columns each.
DISTRIBUTION AZ, CA, MI, MN, MO, PA, TN, TX, and VA.
PRODUCT
a) MR Systems.
b) Leonardo Workstations with software version 2022A/B, 2003A.
c) Leonardo Workstations with software versions prior to 2022A.
CODE
a) Upgrade Harmony Syngo MR, model 7106714 K2200, Serial # 10501 through 10587.Harmony
Syngo MR, model 7104693 K2200, Serial # 11001
through 11172. Upgrade Symphony Syngo MR, model 7106557 K2210, Serial # 14001
through 14321. IMPACT - Upgrade Syngo MR (MU3S), model 5751438 K2220, Serial #
15001 through 15030. IMPACT - Upgrade Syngo MR (MU3L), model 7106466 K2220, Serial
# 15501 through 15519. VISION - Upgrade Quantum, model 4772971 K2230 Serial # 16001
through 16017. VISION - Upgrade Sonata, model 7388148 K2230
Serial
# 16501 through 16513. Concerto Upgrade, model 7106995 K2221 Serial # 17201 through
17211. Concerto, model 4772906 K2221 Serial # 17301 through 17473. Syngo
Allegra, model 7106433 K2183 Serial #20101 through 20110. Upgrade Allegra syngo
MR, model 7387736 K2183 Serial # 20401 through 20421. Trio (Bruker), model
7106441 K2180 Serial #20500 through 20507. Trio, model 7387074 K2180 Serial
#20510 through
20524 and 20550 through 20552. Sonata Syngo MR, model 7104719 K2240 Serial
#21101through 21248. Syngo MR SYM-Sonata-Upgrade, model 7104735 K2240 Serial #21604
through 21612. Syngo MR Upgrade Sonata, model 7106425 K2240 Serial #21901
through 21942. Symphony syngo MR, model 7104594 K2210 Serial 22001 through
22996. Rhapsody, model 7384568 K2190 Serial # 24001 through 24004.
b) Model 7129534, Serial # 01001 through 01380, 05001 through 05600, and 10001
through 10320;
c) Model 7129534, Serial #01001 through 01380, 05001 through 05600, and 10001
through 103320.
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc.,
Malvern, PA.
REASON Software problem. This error may cause the loss of peripheral
image information when there is a difference between the dimensions of the
image matrix and the display segment.
VOLUME OF PRODUCT IN COMMERCE 1,374 units.
DISTRIBUTION Nationwide.
PRODUCT Frequency 55 Toric (methafilcon B), flexible wear contact lenses
(tinted).
CODE 1468-212, Exp. 10/2008.
RECALLING FIRM/MANUFACTURER Coopervision, Inc., Scottsville, NY.
REASON Mislabeled with incorrect sphere power.
VOLUME OF PRODUCT IN COMMERCE 152
lenses.
DISTRIBUTION Nationwide, United Kingdom, and Canada.
PRODUCT Misys Laboratory System versions 5.3 up to 5.3.2 with Lab Access
Results Workstation.
CODE Versions 5.3 up to 5.3.2.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ.
REASON Software defect. When Quality Assurance failure warnings are
missing from a patient's report abnormal results could be used for diagnosis or
treatment.
VOLUME OF PRODUCT IN COMMERCE 157.
DISTRIBUTION Nationwide, United Kingdom, Ireland, Canada, Denmark, Saudi
Arabia.
PRODUCT Olympus Image Manager Software.
CODE Versions 6.0 through 6.4.
RECALLING FIRM/MANUFACTURER Olympus America, Inc., Melville, NY.
REASON Software defect; potential under certain circumstances to
incorrectly identify endoscopy images that have been uploaded & saved to
the network system.
VOLUME OF PRODUCT IN COMMERCE 856.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Imx Rubella IgM Reagent Kit, 100 tests.
CODE List 7A24-20, lot 01687M300.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott Park,
IL.
REASON The package insert contains incomplete information for the
English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated.
VOLUME OF PRODUCT IN COMMERCE 423 kits.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
a) Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of
controls, L-0.7,M - 1.2 and H - 3.0.
b) Imx Free T4 Reagent Kit, list 2222-20, 100 test kit.
c) Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2
bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0.
CODE
a) List 9C03-10, lot numbers 95881Q100 and 95881Q101;
b) List2222-20, lot number 01550Q100;
c) List7G96-01, lot number 94493M300.
RECALLING FIRM/MANUFACTURER Abbott Park Laboratories, Abbott Park, IL.
REASON The Free T4 Controls, may yield control values that are high and
outside of the package insert ranges.
VOLUME OF PRODUCT IN COMMERCE 5,103 kits.
DISTRIBUTION Nationwide and Internationally.