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U.S. Department of Health and Human Services

Class 2 Device Recall Teleflex MEDICAL LMA(TM) MADgic(TM)

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  Class 2 Device Recall Teleflex MEDICAL LMA(TM) MADgic(TM) see related information
Date Initiated by Firm March 19, 2018
Create Date May 23, 2018
Recall Status1 Terminated 3 on August 27, 2019
Recall Number Z-1628-2018
Recall Event ID 79643
510(K)Number K274296  
Product Classification Applicator (laryngo-tracheal), topical anesthesia - Product Code CCT
Product Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region
Code Information Lot Number 161212
Recalling Firm/
Manufacturer		 Teleflex Medical Europe Ltd
Ida Business Park
Athlone Ireland
Manufacturer Reason
for Recall		 Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.
FDA Determined
Cause 2		 Process control
Action The recall notice was disseminated by letter on 03/19/2018. The letter stated the following: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot number listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter."
Quantity in Commerce 25 units
Distribution TX
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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