OFFICIAL-SOURCE RECALL · CANADA
Maquet Percutaneous Insertion Kit and Dilator Sets Recall: The manufacturer became aware of this issue
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- Brand
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- Product
- Maquet Percutaneous Insertion Kit and Dilator Sets
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- number
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Why this product was recalled
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.
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.
Official recall notice
Maquet Percutaneous Insertion Kit and Dilator Sets
Agency: Health Canada
Official publication date: August 26, 2026
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