Permanent Life Support Set
Brand(s)
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
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