FDA Device recall Z-2485-2020
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
- FDA Device
- Class II
- terminated
- Published 2020-07-08
On 2020-07-08 the FDA classified a Class II recall of Pediatric Adjustable Flange Tracheostomy Tube Cuffless by Smiths Medical Asd, citing one lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2485-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-05-26 |
| Published | 2020-07-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Smiths Medical Asd |
| Distribution | MS, NE, TN, TX |
Product
Pediatric Adjustable Flange Tracheostomy Tube Cuffless
Reason
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
Identifiers
| code_info | Model Number: 60HA30, Lot: 3794165, SKU 60HA30 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2485-2020%22
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