Smiths Medical ASD Inc.: Medical Device Recall in 2021 - (Recall #: Z-0726-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45

Product Classification:

Class II

Date Initiated: December 15, 2020

Date Posted: January 6, 2021

Recall Number: Z-0726-2021

Event ID: 86954

Reason for Recall:

A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.

Status: Terminated

Product Quantity: 238 devices

Code Information:

Lot Number 3991195

Distribution Pattern:

US nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated