FDA-Device2023-11-08Class II
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Hazard
The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).
Sold states
Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH, PA, SC, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada.
Affected count
N/A
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0205-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief