Z-0726-2021 Class II Terminated
FDA device recall Z-0726-2021 was initiated by Smiths Medical ASD Inc. on December 15, 2020 and is designated Class II. 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. The recall status is terminated (terminated December 20, 2022). Affected quantity: 238 devices.
Recall Details
- Product Type
- Devices
- Report Date
- January 6, 2021
- Initiation Date
- December 15, 2020
- Termination Date
- December 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 238 devices
Product Description
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.
Distribution Pattern
US nationwide distribution.
Code Information
Lot Number 3991195