ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port… — Class I medical device recall Z-0963-2014
Terminated recall by Teleflex Medical, reported 2014-03-05, distributed nationwide. The tracheal tube can kink during patient use.
| Recall number | Z-0963-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Research Triangle Park, NC, United States |
| Recall initiated | 2014-01-06 |
| Classified | 2014-02-21 |
| Reported by FDA | 2014-03-05 |
| Terminated | 2016-06-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | BB, BE, BO, CA, CL, CR, DO, EC, KR, MX, NL, NZ, SV, TH |
| Lot numbers | 01B1200213, 01B1200336 |
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Reason for recall
The tracheal tube can kink during patient 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-0963-2014. 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.