Health product recall

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

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

Bivona Aire Cuff Wireless Endotracheal Tubes

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number
  • 25W080
  • 25W085
  • 25W090
  • 35W080
  • 35W085
  • 35W090
  • 35W095
Companies
Manufacturer

Smiths Medical ASD, Inc.

6000 Nathan Lane North

Minneapolis

55442

Minnesota

UNITED STATES