Health product recall

Permanent Life Support Set

Last updated

Summary

Product
Permanent Life Support Set
Issue
Medical devices - Sterility Issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Permanent Life Support Set

3000221769

BE-PLS 2051

Issue

PLS set itself is delivered sterile and compliant, this issue relates to maintaining sterility after opening the pls set and removal of components (5) and (14) from the pls set tray for use in a later stage of extracorporeal circulation application.  The packaging material of these two components may be inadequate to maintain the sterile barrier after removal from the primary sterile packaging (open tyvek on the tray) if not consumed immediately during the priming process.

Recall start date: November 2, 2022

Additional information

Details
Original published date: 2022-11-17
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
Companies

Maquet Cardiopulmonary Gmbh

Kehler Strasse 31, Rastatt, Germany, 76437

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72188