PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube — Class II medical device recall Z-0726-2021
Terminated recall by Smiths Medical ASD Inc., reported 2021-01-06, distributed nationwide. A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packag
| Recall number | Z-0726-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD Inc., Minneapolis, MN, United States |
| Recall initiated | 2020-12-15 |
| Classified | 2020-12-28 |
| Reported by FDA | 2021-01-06 |
| Terminated | 2022-12-20 |
| Distributed | Nationwide (US) |
| Quantity | 238 devices |
| Lot numbers | 3991195 |
| Model numbers | 60PFSS45 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0726-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.