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U.S. Department of Health and Human Services

Class 2 Device Recall Servo Humidifier 163

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  Class 2 Device Recall Servo Humidifier 163 see related information
Date Initiated by Firm December 03, 2015
Date Posted August 09, 2016
Recall Status1 Terminated 3 on April 14, 2017
Recall Number Z-2374-2016
Recall Event ID 74681
Product Classification Condenser, heat and moisture (artificial nose) - Product Code BYD
Product Servo Humidifier 163, Model 01-06-8125-8, REF 6419365

Product Usage:
A heat and moisture condenser (artifical 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 humidity gases breathed in by the patient.
Code Information Lots 201450, 201451, 201452, 201504
Recalling Firm/
Manufacturer		 Teleflex Medical
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
For Additional Information Contact Alice Harper
610-378-0131
Manufacturer Reason
for Recall		 Cracks may occur at the 15mm and 22mm ISO female connector.
FDA Determined
Cause 2		 Release of Material/Component prior to receiving test results
Action Inmed, a division of Teleflex sent an Urgent Field Safety Notice letter dated December 3, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to check inventory, cease use and distribution of stock of the affected product batch and quarantine immediately.. The letter included an acknowledgment form which was to be completed and returned your MAQUET representative. For further information or support concerning this issue, contact your local MAQUET representative at fieldactions@maquet.com. For questions contact your local sales representative or Customer Service.
Quantity in Commerce 2,700 ea.
Distribution US Nationwide Distribution in the states of FL, KS 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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