Fluoroplastic Vent Tube

Vent tube devices across lot 0231048280 were identified to have been released to customers without undergoing sterilization. the issue is currently understood to originate from manufacturing (load preparation) and represents a fault condition: the product does not meet its specification for sterility (SAL 10-6) or its labeled sterile state.

Status

Active

Key date

Oct 6, 2026

Provinces

National

Added

Oct 7, 2026