MAQUET — Class I medical device recall Z-1051-2015
Terminated recall by Teleflex Medical, reported 2015-02-18, distributed in FL, KS, MI, WV. Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female con
| Recall number | Z-1051-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teleflex Medical, Durham, NC, United States |
| Recall initiated | 2015-01-12 |
| Classified | 2015-02-06 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2016-05-10 |
| Distributed | FL, KS, MI, WV |
| Quantity | 100 units |
| Reason classes | packaging |
| Lot numbers | 201413, 201414, 201415, 201417, 201419, 201422 |
| Model numbers | 01-06-8125-8, XKC01-06-8125-8 |
Product
MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. 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 for recall
Defects: Cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm ISO female connector.
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-1051-2015. 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.