CanadaWhat's being recalled
Companies: Medtronic Xomed Inc., 6743 Southpoint Drive North, Jacksonville, Florida, United States, 32216.
How to identify it
Affected products: Fluoroplastic Vent Tube; Lot or serial number: 0231048280; Model or catalogue number: 1013301
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)