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Showing 18361–18380 of 22584 results

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American Medical Systems: AMS DURA-II Universal Tips, 2cm, Product Number 72009361,...

Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels.

FDAFeb 19, 2007Nationwide• American Medical Systems

Scanlan International Inc: SCANLAN International Mobin-Uddin Vein Holder, Sterile, D...

Incorrectly assembled by manufacturer

FDAFeb 19, 2007IN, MO• Scanlan International Inc

Defibtech, LLC: Defibtech Sentry Semi-Automatic External Defibrilator (AE...

Device Malfunction-The self-test software may allow a self-test to clear a previously detected low battery condition. If this occurs, the operator may be unaware of the low battery and the device may be "unable" to deliver a defibrillation shock, which could result in failure to resuscitate a patient.

FDAFeb 17, 2007Nationwide• Defibtech, LLC

General Electric Medical Systems Information Technology: GE Medical Systems CardioLab System, electrophysiological...

GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues are associated with an audio driver, and the use of the application's log and imaging windows.

FDAFeb 16, 2007PR• General Electric Medical Systems Information Technology

Baxter Healthcare Corp. Rt.: Baxter Clearlink System Vented Paclitaxel Set; a sterile ...

Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.

FDAFeb 16, 2007Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Baxter Vented Paclitaxel Set; a sterile fluid pathway wit...

Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.

FDAFeb 16, 2007Nationwide• Baxter Healthcare Corp. Rt.

bioMerieux, Inc.: BacT/ALERT FN Culture Bottles, Product Number 259793

Microbial Contamination: Bacillus sp. contamination was detected in inoculated bottles.

FDAFeb 16, 2007Nationwide• bioMerieux, Inc.

Baxter Healthcare Corp. Rt.: Baxter Interlink System Vented Paclitaxel Set; a sterile ...

Baxter has received reports of disconnections/leaks during use of vented Paclitaxel administration sets.

FDAFeb 16, 2007Nationwide• Baxter Healthcare Corp. Rt.

General Electric Medical Systems Information Technology: GE Healthcare Systems ComboLab System. Made up of both M...

GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues are associated with an audio driver, and the use of the application's log and imaging windows.

FDAFeb 16, 2007PR• General Electric Medical Systems Information Technology

General Electric Medical Systems Information Technology: GE Medical Systems Mac-Lab System, cardiac catheterizatio...

GE Healthcare has identified conditions that could cause a potential loss of real-time monitoring with the CardioLab/Mac-Lab/ComboLab Electrophysiology and Hemodynamic Monitoring Systems. These issues are associated with an audio driver, and the use of the application's log and imaging windows.

FDAFeb 16, 2007PR• General Electric Medical Systems Information Technology

Merit Medical Systems, Inc: StayFix Fixation Device for Percutaneous catheters, REF 6...

Sterility of some units may be compromised due to damaged packaging.

FDAFeb 15, 2007Nationwide• Merit Medical Systems, Inc

AGFA Corp.: Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture A...

Misidentification: The orthopedic planning X-ray images for one patient are misidentified as the images for another patient.

FDAFeb 15, 2007AZ, AR, CA +25 more• AGFA Corp.

Inverness Medical Professional Diagnostics: Clearview Simplify D-dimer, in vitro diagnostic for quali...

Laceration Risk

Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off.

FDAFeb 15, 2007PR• Inverness Medical Professional Diagnostics

Merit Medical Systems, Inc: EpiFix Fixation Device for Epidural Catheters, REF 670M, ...

Sterility of some units may be compromised due to damaged packaging.

FDAFeb 15, 2007Nationwide• Merit Medical Systems, Inc

Diasorin Inc.: DiaSorin TRYPSIK Kits, Catalog Number P2573-(assay used a...

Assay Failure: Assay failures may occur due to the kit control running outside of the established range (invalidating the assay)

FDAFeb 15, 2007CA, CO, FL +3 more• Diasorin Inc.

Becton Dickinson & Company: BD 30ml Syringe Luer-Lok tip Sterile BD, Franklin Lakes, ...

The unit label on a limited number of syringes is incorrect, citing a 20 ml size. All other levels of labeling are correct, identifying the product as 30 ml size.

FDAFeb 15, 2007Nationwide• Becton Dickinson & Company

Orthopedic Systems Inc: Doro Products Adapter, Product number 5979-300. The adap...

Material used to manufacture accessory bracket does not meet product specification. The screw is normally composed of ''Torlon'', which is yellow. The part was made of "Tercite", which is blue.

FDAFeb 14, 2007Nationwide• Orthopedic Systems Inc

Coloplast Corp Skin Care Div: Sea-Clens Wound Cleanser, 6 fl. oz., Manufactured by Col...

Coloplast Corp. is recalling Sea-Clens brands Sea-Clens wound cleaner which were found to have some particulates (foreign materials).

FDAFeb 14, 2007Nationwide• Coloplast Corp Skin Care Div

Stentor Inc A Phillips Medical Systems Co.: The iSight PACS (picture archiving and communications sys...

A defect may cause patient image orientation markers to be incorrectly labeled on Multi-Planar Reformation (MPR) images. Left and Right Anatomical orientation markers may be reversed.

FDAFeb 14, 2007Nationwide• Stentor Inc A Phillips Medical Systems Co.

Sunnex Inc.: Sunnex Celestial Star MR-16 (lamp holder) Medical Examina...

Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.

FDAFeb 13, 2007Nationwide• Sunnex Inc.

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