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

Starting date:

August 10, 2021

Posting date:

August 27, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-76315

Last updated: 2021-08-27

• Reason
• Affected products

Affected Products 

Bivona Aire Cuff Wireless Endotracheal Tubes

Reason

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.

Affected products