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U.S. Department of Health and Human Services

Class 1 Device Recall MAQUET

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  Class 1 Device Recall MAQUET see related information
Date Initiated by Firm January 12, 2015
Date Posted February 06, 2015
Recall Status1 Terminated 3 on May 10, 2016
Recall Number Z-1051-2015
Recall Event ID 70257
Product Classification Condenser, heat and moisture (artificial nose) - Product Code BYD
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.
Code Information Lot numbers: 201413, 201414, 201415, 201417, 201419 and 201422.
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Tara Torres
610-378-0131
Manufacturer 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.
FDA Determined
Cause 2		 Process control
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 fieldactions@maquet.com with questions or for support this issue.
Quantity in Commerce 100 units
Distribution Distributed to FL, KS, MI and WV.
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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