Smiths Medical ASD Inc.: 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).

Details from the source

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: 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. Quantity: N/A Lot/code info: Lot #4125816, exp. 3/17/2026, UDI-DI 15021312005769.

UPC codes

15021312005769

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.