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Health Canada Medical devices

Sapphire Infusion Pump

Issued September 27, 2023
Issue
Due to a software issue, Sapphire Infusion Pump with SW Version 16.10.1 and 16.10.2 may sometimes fail to identify air in line (AIL). AIL may lead to air embolism. No complaints or patient harm has been reported due to this issue. Recall start Date: September 22, 2023
Hazard description
Performance
Product
Product name
Sapphire Infusion Pump
Reference
ID
RA-74340