Class I — Teleflex Medical
| Recalling firm | Teleflex |
|---|---|
| Registered facility | View this company's 9 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | The connector may disconnect from the tracheostomy tube during use. |
| 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. |
| Quantity | 1095 units |
| Distribution | Worldwide Distribution: US (nationwide) to CA and countries of: Austria, Belgium, France, Germany, Italy, Japan, Poland, and Turkey. |
| Initiated | 2016-08-26 |
| Classified | 2016-10-18 |
| Terminated | 2017-03-21 |
| Recall number | Z-0044-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Teleflex Medical (Z-0044-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75053/
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