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Health Canada Medical devices

Bivona Pediatric Tracheostomy Tube

Issued August 31, 2023
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
Hazard description
Labelling and packaging
Product
Product name
Bivona Pediatric Tracheostomy Tube
Reference
ID
RA-74219