Medical equipment, implants, and diagnostic devices
Ad-Tech Medical Instrument
The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.
CooperSurgical
Discrepancy between the correct expiration dates on the individual pouches inside the boxes and incorrect expiration dates on the outer boxes, where the month and day were reversed.
Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations
Maquet Cardiovascular Us Sales
The sets are configured with quick connectors that have been assembled in reverse on the arterial and venous lines, resulting in blue (venous) to red (arterial) and red (arterial) to blue (venous) connections. Due to this incorrect assembly, the sets cannot be primed from the reservoir prior to use, and the device may not function as intended.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of the tether to release the Micra Pacemaker from the Micra Delivery System during implant.
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.
Zimmer Biomet
The locking bar not fully engaging
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
The action was initiated following notification by the U.S. FDA of their recently updated, global safety information concerning the higher incidence of anaplastic large cell lymphoma (BIA-ALCL) in patients who have textured breast implants.
Zimmer Biomet
The locking bar not fully engaging
Zimmer Biomet
The locking bar not fully engaging
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.
Zimmer Biomet
The locking bar not fully engaging
Zimmer Biomet
The locking bar not fully engaging
Instrumentation Laboratory
Prolonged clotting times
Zimmer Biomet
The locking bar not fully engaging
The affected products were inadvertently packaged with an incorrect screw component.
Zimmer Biomet
The locking bar not fully engaging
Zimmer Biomet
The locking bar not fully engaging