FDAClass IISeptember 16, 2020

Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This recall

Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29…

Why was Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This recalled?

Label has the incorrect size for the tracheotomy tube.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# 3952216

Product
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29…
Recalling firm
Smiths Medical ASD Inc.
Quantity
3 units
Distribution
US Distribution to state of: CT
Recall date
September 16, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls