FDA Device recall Z-2374-2016
Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to…
- FDA Device
- Class II
- terminated
- Published 2016-08-17
On 2016-08-17 the FDA classified a Class II recall of Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to… by Teleflex Medical, citing cracks may occur at the 15mm and 22mm ISO female connector.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2374-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-03 |
| Published | 2016-08-17 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Teleflex Medical |
| Distribution | US |
Product
Servo Humidifier 163, Model 01-06-8125-8, REF 6419365 Product Usage: A heat and moisture condenser (artifical nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidity gases breathed in by the patient.
Reason
Cracks may occur at the 15mm and 22mm ISO female connector.
Identifiers
| code_info | Lots 201450, 201451, 201452, 201504 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2374-2016%22
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