CanadaMaquet Percutaneous Insertion Kit (model PIK 150) and Dilator Sets (model PIK DILATOR SET L) from Maquet Cardiopulmonary GmbH are affected; look for those model/catalogue numbers on products within their shelf-life. The manufacturer identified failures in sterile barrier integrity verification testing, meaning the packaging may not consistently maintain sterility. Contact the manufacturer for additional information.
What's being recalled
Companies: Maquet Cardiopulmonary GmbH, Kehler Strasse 31, Rastatt, Germany, 76437.
How to identify it
Affected products: Dilator Sets; Lot or serial number: Not applicable.; Model or catalogue number: PIK DILATOR SET L
Affected products: Percutaneous Insertion Kit; Lot or serial number: Not applicable.; Model or catalogue number: PIK 150
The hazard
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.
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)
United States