Other Medical Devices

The potential exists for the wheel to rotate freely despite engagement of hub brake.

Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only a

Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.

Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter.

Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.

Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event.

Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunctioned while recharging and produced smoke with a chemical smell.

A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.

A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.

Potential for self activation while the device is in use, which may result in unintended thermal damage.

It was discovered the CS3000/CS3070 was manufactured using the laser power settings for a Class 2 laser device instead of the Class 1 power levels as specified on the product label.

The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness.

BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.

It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.

Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected).

Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.

Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.

GranuFlo Dry Acid Concentrate may show discoloration

GranuFlo Dry Acid Concentrate may show discoloration

Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.