Product Wiki · Recalls · Health Canada — Medical Devices

Bivona Aire Cuff Wireless Endotracheal Tubes (2021-08-10) — recall 62795

Health Canada — Medical Devices · Canada · 2021-08-27 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
62795
Date of alert
2021-08-27
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Smiths Medical received complaints reporting that the bottom pouch seal of 8.0 Bivona Aire Cuff Wireless Endotracheal Tube, involving 10 different lot numbers, was partially open, allowing the tube to protrude from the packaging, compromising sterility. All complaints which were reported were at the precheck phase prior to patient use.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/bivona-aire-cuff-wireless-endo

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