Custom Made Tracheostomy Device The CADD Administration Sets with… — Class II medical device recall Z-0577-2018
Terminated recall by Smiths Medical ASD, Inc., reported 2018-02-21. Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without re
| Recall number | Z-0577-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Smiths Medical ASD, Inc., Gary, IN, United States |
| Recall initiated | 2016-07-15 |
| Classified | 2018-02-09 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2020-04-24 |
| Countries outside the US | DE |
| Quantity | 1 |
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 for recall
Smiths Medical determined that a single custom Tracheostomy device had been shipped to the customer without required sterilization.
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-0577-2018. 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.