Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1008-2015 — 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

U.S. FDA — Device Enforcement · United States · 2014-12-04 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1008-2015
Date of alert: 2014-12-04
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Teleflex, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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