OFFICIAL-SOURCE RECALL · CANADA
Maquet Percutaneous Insertion Kit and Dilator Sets Recall: The manufacturer became aware of this issue
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
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Is your product affected?
- Brand
- See official notice
- Product
- Maquet Percutaneous Insertion Kit and Dilator Sets
- Manufacturer
- See official notice
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
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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