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U.S. Department of Health and Human Services

Class 1 Device Recall MAQUET Servo Humidifier 163

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  Class 1 Device Recall MAQUET Servo Humidifier 163 see related information
Date Initiated by Firm December 04, 2014
Date Posted February 06, 2015
Recall Status1 Terminated 3 on March 21, 2017
Recall Number Z-1008-2015
Recall Event ID 70127
Product Classification Condenser, heat and moisture (artificial nose) - Product Code BYD
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.
Code Information Batch Numbers: 201321, 201323, and 201324.
Recalling Firm/
Manufacturer		 Teleflex, Inc.
550 E Swedesford Rd Ste 400
Wayne PA 19087-1601
For Additional Information Contact Customer Support
610-225-6800
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
Action An Urgent - Field Safety Notice, dated December 4, 2014, was sent to end users that identified the product, problem, and action to be taken. Customers were requested to immediately check inventory, discontinue use and distribution, quarantine. Customers were to return the Acknowledgement form and request a return authorization number from their local Maquet representative for affected devices. A credit will be issued upon receipt of the returned affected product. For questions or for support concerning this issue, a local Maquet representative should be contacted at fieldactions@maquet.com.
Quantity in Commerce 18
Distribution Distributed in the states of FL, MI, WV, and KS.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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