Recall Monitor
Health Products

Maquet Percutaneous Insertion Kit and Dilator Sets

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: Maquet Percutaneous Insertion Kit and Dilator Sets
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Dilator SetsNot applicable.PIK DILATOR SET L
Percutaneous Insertion KitNot applicable.PIK 150

Issue

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.

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