medical Class II Updated 2021-01-06

Smiths Medical ASD Inc. recalls PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheost

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number 3991195
View official government recall

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