Maquet Percutaneous Insertion Kit and Dilator Sets

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.

Status

Active

Key date

Aug 26, 2026

Provinces

National

Added

Aug 26, 2026