Health Canada26 Aug 2026
Maquet Percutaneous Insertion Kit and Dilator Sets
Health Canada published a recall notice for Maquet Percutaneous Insertion Kit and Dilator Sets on 26 Aug 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.
Recall
The recall notice
- Issued by
- Health Canada
- Issued
- 26 Aug 2026
- Recall type
- Health product recall
- Companies
- Maquet Cardiopulmonary GmbH · Kehler Strasse 31, Rastatt, Germany, 76437
- Official source
- Health Canada: the notice at its source
The latest from Health CanadaEvery warning and recall in Canada
Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.
The notice as issued
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. Additional information Details Original published date: 2026-08-26 Affected products: Affected products Lot or serial number Model or catalogue number Dilator Sets Not applicable. PIK DILATOR SET L Percutaneous Insertion Kit Not applicable. PIK 150 Issue
Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.