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:
Alert / recall type
Health product recall
Category
Health products - Medical devices - 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

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe