Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised… — Class I medical device recall Z-0044-2017
Terminated recall by Teleflex Medical, reported 2016-10-26, distributed nationwide. The connector may disconnect from the tracheostomy tube during use.
| Recall number | Z-0044-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Morrisville, NC, United States |
| Recall initiated | 2016-08-26 |
| Classified | 2016-10-18 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2017-03-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, DE, FR, IT, JP, PL, TR |
| Quantity | 1,095 units |
| Lot numbers | 15261, 15291, 15331, 15371, 15391, 15421, 15451, 15461, 15491, 15501 |
Product
Willy Rusch GmbH Tracheostomy Tube Set Cannulation of tracheotomised patients, particularly in the case of a narrow tracheostoma and narrow-lumen tracheas. When using cannulas with curr. For short term intermittent inflation.
Reason for recall
The connector may disconnect from the tracheostomy tube during use.
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-0044-2017. 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.