FDA Device recall Z-1008-2015
MAQUET Servo Humidifier 163
- FDA Device
- Class I
- terminated
- Published 2015-02-18
On 2015-02-18 the FDA classified a Class I recall of MAQUET Servo Humidifier 163 by Teleflex, citing connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1008-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-12-04 |
| Published | 2015-02-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Teleflex |
| Distribution | FL, KS, MI, WV |
Product
MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial 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 humidify gases breathed in by a patient.
Reason
Connector mount cracks which may lead to a leak failure during use and necessitate immediate replacement in the breathing circuit. If leak exists and is left untreated, patient may be deprived of adequate anesthetic gases over a period of time and serious adverse health consequences may occur.
Identifiers
| code_info | Batch Numbers: 201321, 201323, and 201324. |
|---|
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-1008-2015%22
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