Maquet Percutaneous Insertion Kit and Dilator Sets

Product Maquet Percutaneous Insertion Kit and Dilator Sets Issue Medical devices - Sterility What to do Contact the manufacturer if you require additional information. Audience Healthcare

The manufacturer became aware of this issue during retrospective review of historical packaging verification documentation. It was identified that there have been failures in sterile barrier integrity verification testing. As these failures were not previously addressed in accordance with packaging verification requirements, the packaging may not consistently maintain sterile barrier integrity. Therefore, this FSCA is limited to all products of the PIK line within shelf-life.

RA-82527