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Terminated

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.

FDA Recall Z-1051-2015 · Posted 2015-02-06

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeBYD
Date Initiated2015-01-12
Date Terminated2016-05-10
Product Quantity100 units

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.

Firm Action

Consignees were notified by an Urgent - Field Safety Notice, dated 01/12/2015. The letter identified the affected devices, a description of the problem, and actions to be taken. Customers were asked to check their inventory for any affected product, to cease use and distribution, and immediately quarantine any affected product. Customers are to complete and return the Acknowledgement form and to their local MAQUET representative, who provide a return number. A credit will be issues upon receipt of the affected product. Customer should contact their local MAQUET representative at [email protected] with questions or for support this issue.

Root Cause

Process control

Distribution Pattern

Distributed to FL, KS, MI and WV.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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