Smiths Medical ASD Inc. Recall 86954
Description: PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
Smiths Medical ASD Inc. Recall 86954 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0726-2021 |
| Event ID | 86954 |
| Event Description | PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45 |
| Product Type | Devices |
| Distribution | US nationwide distribution. |
| Quantity | 238 devices |
| Recall Reason | 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. |
| Device Classification | 20210106 |
| Device Code Info | Lot Number 3991195 |
| Center Classification Date | 20201228 |
| Recall Initiation Date | 20201215 |
| Recalling Firm | Smiths Medical ASD Inc. |
| Initial Notification | Letter |
| Similar To |