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Permanent life support set
Official notice
14 Nov 2022
Last checked
14 Nov 2022
An official Health Canada notice concerns Permanent life support set. 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 Published 2022-11-14.
What to do now
Contact the manufacturer if you require additional information.
Recall number
72188
Official notice
2022-11-14
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Maquet Cardiopulmonary, Permanent Life Support Set.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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