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U.S. Department of Health and Human Services

Class 2 Device Recall MAQUET

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  Class 2 Device Recall MAQUET see related information
Date Initiated by Firm December 03, 2015
Date Posted August 29, 2016
Recall Status1 Terminated 3 on January 24, 2017
Recall Number Z-2683-2016
Recall Event ID 74793
Product Classification Condenser, heat and moisture (artificial nose) - Product Code BYD
Product MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
Code Information Model number: 01-06-8125-8, Product code: XKC01-06-8125-8, Lot numbers: 201450, 201451, 201452 and 201504.
Recalling Firm/
Manufacturer		 Teleflex Medical
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
For Additional Information Contact Alice Harper
610-378-0131 Ext. 60372
Manufacturer Reason
for Recall		 Cracking may occur at the 15mm and 22mm ISO female connector.
FDA Determined
Cause 2		 Device Design
Action INMED sent an Urgent - Field Safety Notice dated December 3, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. They were instructed to cease use and distribution of stock of the affected product batch and quarantine immediately. Customers are to return all affected product to MAQUET. An Acknowledgement form was included to be completed and returned to their MAQUET representative. If the product was distributed, they were instructed to provide the field safety notice to all of their customers who have received product in scope of the Field Action. Their customer is then required to complete the Acknowledgement form and return it to them. Should you require any further information or support concerning this issue, please contact your local MAQUET representative at fieldactions@maquet.com. INMED is committed to providing high quality, safe and effective products. W e sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service. For further questions, please call (610) 378-0131.
Quantity in Commerce 2,700 units
Distribution US Distribution to 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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