FDA Device recall Z-0577-2018
Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infus…
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infus… by Smiths Medical Asd, citing smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0577-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-15 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Smiths Medical Asd |
| Distribution | n/a |
Product
Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
Reason
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
Identifiers
| code_info | GS025081 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0577-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.