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Showing 62461–62480 of 68218 results

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Imaging Sciences Intl Inc: i-CAT Classic 3D Dental Imaging System

incorrect scatter labeling

FDAMar 19, 2008Nationwide• Imaging Sciences Intl Inc

Imaging Sciences Intl Inc: i-CAT 17-19 Cone Beam 3D Dental Imaging System. This prod...

Incorrect scatter information in the manual.

FDAMar 19, 2008Nationwide• Imaging Sciences Intl Inc

Unknown Manufacturer: 3M Comply EO Chemical Indicators Strips, Catalog #1251 Th...

A production specification discrepancy may cause the indicators to show an inaccurate result, which could incorrectly lead customers to conclude the sterilization cycle was adequate.

FDAMar 19, 2008Nationwide

Biomet Microfixation, Inc.: Lactosorb Trauma Plating System, part numbers: 915-2100, ...

The outer foil pouch on the Lactosorb Plate system was not properly sealed. The product is labeled as sterile, but the lot was not sterilized. These devices are intended to be implanted into bone and are required to be sterile. A heavy bioburden would increase the potential for bone infection (osteomyelitis).

FDAMar 19, 2008CA, GA, HI +5 more• Biomet Microfixation, Inc.

Integra Pain Management: Integra LifeSciences Corporation Disposable Convenience K...

Hep-Lock Flush vials included in Integra's PICC Insertion Trays contain a heparin component that has been recalled by Baxter for contaminated heparin.

FDAMar 18, 2008CO• Integra Pain Management

Elekta, Inc.: Elekta Synergy Intended to be used for radiation therapy...

Installation of a touchguard to prevent injury to patients or staff by stopping machine movements in the case of accidental collision.

FDAMar 18, 2008Nationwide• Elekta, Inc.

Stryker Howmedica Osteonics Corp.: X-Celerate Universal Block Pegless Size #3, Non Sterile;

Discovery of the potential for Pin and Punch interference of the Size 3 Scorpio Notch Preparation Guide that may result in damage to bone if a user aggressively attempts to seat an obstructed punch.

FDAMar 18, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Universal Notch Preparation Guide, Size #3; Non Sterile; ...

Discovery of the potential for Pin and Punch interference of the Size 3 Scorpio Notch Preparation Guide that may result in damage to bone if a user aggressively attempts to seat an obstructed punch.

FDAMar 18, 2008Nationwide• Stryker Howmedica Osteonics Corp.

Bio-Rad Laboratories Inc: VARIANT -thalassemia Short Program Hemoglobin Testing Sys...

Some product ROM cards have an incorrect program loaded and are unable to be updated.

FDAMar 18, 2008AR, CA, CO +13 more• Bio-Rad Laboratories Inc

Levitronix, Llc: Levitronix CentriMag Primary System, Article Number: 201-...

Stops pumping: Interruption of CentriMag System support may occur when using a Valleylab Force FX-C Electrocautery Unit

FDAMar 17, 2008Nationwide• Levitronix, Llc

Levitronix, Llc: Levitronix CentriMag Back-Up Console Article Number: 201...

Stops pumping: Interruption of CentriMag System support may occur when using a Valleylab Force FX-C Electrocautery Unit

FDAMar 17, 2008Nationwide• Levitronix, Llc

Abbott Vascular-Cardiac Therapies dba Guidant Corporation: 6F Viking Guiding Catheter, Percutaneous catheter, Shape ...

Mislabeling: The part number on the product label packaging may not match the product.

FDAMar 17, 2008Nationwide• Abbott Vascular-Cardiac Therapies dba Guidant Corporation

Diagnostic Chemicals, Ltd.: Diagnostics Chemical Limited Iron Assay Catalog Number: ...

Precipitate in product may cause elevated background absorbance interference.

FDAMar 14, 2008Nationwide• Diagnostic Chemicals, Ltd.

Edwards Lifesciences AG Parque Industrial Itabo Km. 18.5 Carr. Sanchez Haina, San Cristobal Dominican Republic: Edwards Lifesciences "VAMP Jr" (Venous Arterial blood Man...

Edwards Lifescience initiated a recall of on Edwards "VAMP Jr" Pressure Monitoring Products manufactured between 8/01/06 and 2/29/08 due to the potential for the cap on the reservoir of the "VAMP Jr" to become disconnected.

FDAMar 14, 2008PR• Edwards Lifesciences AG Parque Industrial Itabo Km. 18.5 Carr. Sanchez Haina, San Cristobal Dominican Republic

Merit Medical Systems, Inc.: CABG PACK, Surgical Convenience Kit, Sterile, Reorder #:K...

Component of convenience kit may not be sterile.

FDAMar 14, 2008OR, PA• Merit Medical Systems, Inc.

Philips Medical Systems North America Co. Phillips: AD 7 Patient table supplied with Allura Xper FD10 and All...

Potential for radiologic patient table to become immobile and unable to move again due to force sensor sensitivity to electromagnetic radiation.

FDAMar 14, 2008Nationwide• Philips Medical Systems North America Co. Phillips

Biomet, Inc.: Biomet Hybrid Glenoid Boss Cutter; item 406150. - Surgica...

Laceration Risk

The glenoid implant may not seat fully on the face of the natural glenoid due to inadequate measurement tolerances (tolerance stack-up) in the design of the cutter. Use of the instrument may lead to incomplete seating of the glenoid implant, elevating the theoretical risk of glenoid loosening, which may lead to early revision surgery. The problem may contribute to early device failure and patien

FDAMar 13, 2008Nationwide• Biomet, Inc.

Varian Medical Systems, Inc.: VariSource CT/MR Ring & Tandem Applicator Set, catalog # ...

Medical device may exhibit inaccurate positioning and lead to unintended dose delivery during brachytherapy treatment.

FDAMar 12, 2008Nationwide• Varian Medical Systems, Inc.

Ascent Healthcare Solutions, Inc.: Turbovac Suction Wand - Reprocessed Sterile device -- Ort...

Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

FDAMar 11, 2008Nationwide• Ascent Healthcare Solutions, Inc.

Ascent Healthcare Solutions, Inc.: Kendall Thigh Garment - Reprocessed Sterile device -- Com...

Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.

FDAMar 11, 2008Nationwide• Ascent Healthcare Solutions, Inc.

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