FDA Device recall Z-0961-2014
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is…
- FDA Device
- Class I
- terminated
- Published 2014-03-05
On 2014-03-05 the FDA classified a Class I recall of ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, Rx only, Product Usage: A tracheal tube is… by Teleflex Medical, citing the tracheal tube can kink during patient use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0961-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-01-06 |
| Published | 2014-03-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Teleflex Medical |
| Distribution | US |
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.0, 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
The tracheal tube can kink during patient use.
Identifiers
| code_info | Product Code: 5-14016, Lot numbers: 01B1200214, 01E1200462, 01B1200335, 01C1200468, 01J1300036 and 01J1300339. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0961-2014%22
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