PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend recall
PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
Why was PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend recalled?
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.
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 Number 3991195
- Product
- PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- 238 devices
- Distribution
- US nationwide distribution.
- Recall date
- January 6, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)