Pneumosure High Flow Insufflator - High Flow II Tube Set, Heated Tube Set With Rtp (2019-03-07)

Recall Summary PneumoSure High Flow Insufflator tube sets (High Flow II and Heated Tube Set with RTP models) are being recalled in Canada because they may not deliver the correct oxygen flow rate during use, which could affect patient breathing support during medical procedures. This recall applies to all units distributed across Canada. The recall is classified as Class I, indicating a serious potential health risk.

Classification
Class I
Category
drug recall
Country
Canada
Agency
HC-DEVICES
Recall date
2019-03-28
Status
Ongoing
Distribution
Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/a81f6355-b599-4905-8ea1-96aa05fad44e