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Showing 20721–20740 of 22584 results

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Guidant Corporation Advanced CardiovascularSystem: Voyager RX Coronary Dilatation Catheter

Leak at guide wire exit notch could introduce air into the artery.

FDAJan 27, 2005IN• Guidant Corporation Advanced CardiovascularSystem

GE OEC Medical Systems, Inc: InstaTrak 3500 Plus system with cranial application (aid ...

Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.

FDAJan 26, 2005AL, AK, AZ +21 more• GE OEC Medical Systems, Inc

IV Flush LLC: Heparin Lock Flush Solution, manufactured by IV Flush LLC

Device marketed without 510(k) clearance and is suspected to be contaminated with P. Flourescens.

FDAJan 26, 2005Nationwide• IV Flush LLC

IV Flush LLC: Sodium Chloride Injection USP, manufactured by IV Flush LLC

Device marketed without 510(k) clearance and is suspected to be contaminated with P. Flourescens.

FDAJan 26, 2005Nationwide• IV Flush LLC

AGFA Corp.: Radiomat Lightweight Cassettes

Users of these cassettes may detect poor film to screen contact and unsatisfactory sharpness of radiographic images.

FDAJan 26, 2005Nationwide• AGFA Corp.

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

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.

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.

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 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.

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.

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

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

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

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

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