PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
FDA Recall #Z-0726-2021 — Class II — December 15, 2020
Product Description
PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
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.
Recalling Firm
Smiths Medical ASD Inc. — Minneapolis, MN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
238 devices
Distribution
US nationwide distribution.
Code Information
Lot Number 3991195
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated