Health product recall

Bivona Pediatric Tracheostomy Tube

Last updated

Summary

Product
Bivona Pediatric Tracheostomy Tube
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Bivona Pediatric Tracheostomy Tube 4125816 60P045

Issue

Smiths Medical has identified that the manufacturing date was incorrectly included as the expiration date on the
unit box. The actual individual packaging has the correct expiration date which is march 17, 2026.
The identified incorrect expiration date on the unit box presents the potential for a customer to assess the product as expired, resulting in the potential for a delay in the availability to use the tracheostomy device.

Recall start date: August 16, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies
Smiths Medical Asd Inc.
5700 W. 23rd Avenue, Gary, Indiana, United States, 46406
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74219