Z-0205-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 8, 2023
- Initiation Date
- August 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
Reason for Recall
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).
Distribution Pattern
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.
Code Information
Lot #4125816, exp. 3/17/2026, UDI-DI 15021312005769.