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Showing 66361–66380 of 68218 results

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Stryker Howmedica Osteonics Corp.: Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The...

Stryker Orthopaedics became aware that the packaging labeled as catalog number 3362-0-040; lot code E00985, 140 x 4 slot may contain a 5 hole slot.

FDAJan 25, 2005Nationwide• Stryker Howmedica Osteonics Corp.

Bio Rad Laboratories, Inc.: Bio-Rad Pathfinder RSV Test Kit. Top of kit labeled PATH...

New instructions to recommend against using samples with visibly high level of blood.

FDAJan 25, 2005Nationwide• Bio Rad Laboratories, Inc.

ela Medical Llc: Sentinel Implantable Carioverter-DefibrilIator (ICD) mode...

A change in the automatic capacitor reform schedule during the later portion of the device's useful life can result in excessive 750V charge times and disable the device's ability to report an End of Life (EOL) indicator due to excessive charge times unless the patient is receiving periodic 750V therapy shocks.

FDAJan 25, 2005AZ, CA, GA +11 more• ela Medical Llc

Kinetic Concepts, Inc: RotoProne powered patient rotation bed, part #209500, dis...

To correct software issues in software versions 1.3 and 1.5 and to upgrade hatch latch handles to a more ergonomic design.

FDAJan 24, 2005Nationwide• Kinetic Concepts, Inc

Diagnostic Products Corp: IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, ...

A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin B12 L2KVB 2, 6 kit lot 186 only.

FDAJan 24, 2005AL, CA, CO +19 more• Diagnostic Products Corp

Integra Neuro Sciences: LICOX Complete Brain IMC Probe Kit, Model IM3.ST C

LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.

FDAJan 21, 2005CA, CO, DE +21 more• Integra Neuro Sciences

Integra Neuro Sciences: LICOX temperature probe, Model C8.B

LICOX Model C8.B temperature probes manufactured by GMS mbH, an Integra company, may exhibit progen (endotoxin) levels above the FDA limit of 2.15 endotoxin units per device. Elevated endotoxin levels may result in an increased patient risk of fever.

FDAJan 21, 2005CA, CO, DE +21 more• Integra Neuro Sciences

Baxter Healthcare Corp. Rt.: Baxter Posiflow Access Device for IV Access; product code...

Product older than three years may not operate as intended.

FDAJan 20, 2005Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Extension Sets with Posiflow Access Device for IV ...

Product older than three years may not operate as intended.

FDAJan 20, 2005Nationwide• Baxter Healthcare Corp. Rt.

North Coast Medi-Tek Inc: SourceOne Healthcare Technologies brand, Ultrasound Tray,...

Outside box labeling, containing 10 trays, incorrectly identified the product as ultrasound trays. Product is Breast Biopsy trays, Cat. 255826R2. Individual tray package labeling correctly identifies the product as Breast Biopsy tray.

FDAJan 18, 2005OH• North Coast Medi-Tek Inc

Cincinnati Sub-Zero Products Inc: Electri-Cool II

There is the potential that the power switch assembly can dislodge from the cabinet during use.

FDAJan 18, 2005Nationwide• Cincinnati Sub-Zero Products Inc

Ekos Corp: Lysus Infusion System - PT-3 Control . The Lysus Infusio...

Potential for a faulty thermal channel offset to be reported to the software causing faulty lower temperature values to be reported which allow a power increase.

FDAJan 18, 2005AZ, CA, FL +4 more• Ekos Corp

Diasorin Inc.: DiaSorin Analyte Specific Reagent

Expiration date of 2005/1/6 stamped on vial label of Anti-Human igG, Fluorescein Conjugate is incorrect. Correct expiration date is 2006/1/6.

FDAJan 18, 2005MA, WA• Diasorin Inc.

Cincinnati Sub-Zero Products Inc: Micro-temp II heat therapy unit, model #747.

There is the potential that the power switch assembly can dislodge from the cabinet during use.

FDAJan 18, 2005Nationwide• Cincinnati Sub-Zero Products Inc

Biolase Technology Inc: Waterlase MD, dental laser unit, Model #6200218, serial n...

Reports that the Waterlase MD, a dental laser unit, water bottle broke under pressure during installation.

FDAJan 17, 2005Nationwide• Biolase Technology Inc

Medtronic Emergency Response Systems, Inc.: LIFEPAK 12 defibrillator/ monitors biphasic

The LIFEPAK 12 biphasic defibrillator/ monitors may deliver inappropriate energy levels and fail to escalate energy levels when configured to do so.

FDAJan 15, 2005Nationwide• Medtronic Emergency Response Systems, Inc.

Teleflex Medical: Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; a...

Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube.

FDAJan 14, 2005Nationwide• Teleflex Medical

Interpore Cross International Inc: Spinal Implant, Catalog number: 1000-3000 through 1000-...

Mislabeled.

FDAJan 14, 2005CA, CO, IN +8 more• Interpore Cross International Inc

Millar Instruments, Inc: Mikro-Tip Disposable Angiographic Catheter manufactured b...

Wire braiding protruding from the catheter.

FDAJan 14, 2005CA, IN, MN +1 more• Millar Instruments, Inc

Fischer Imaging Corporation: Bloom DTU-215-B Programmable Stimulator

Possibility that after a loss of power or brown-out, the device may transmit unintended stimulation to patients.

FDAJan 13, 2005Nationwide• Fischer Imaging Corporation

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