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U.S. Department of Health and Human Services

Class 2 Device Recall Ambu

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  Class 2 Device Recall Ambu see related information
Date Initiated by Firm August 09, 2018
Create Date October 15, 2018
Recall Status1 Terminated 3 on May 10, 2019
Recall Number Z-0109-2019
Recall Event ID 81009
Product Classification Airway, oropharyngeal, anesthesiology - Product Code CAE
Product Ambu Aura40 Standard, Reusable Laryngeal Mask
Catalog Number: 340300000
Code Information Lot Numbers: MO0612G40021 and MO0605G40014
Recalling Firm/
Manufacturer		 Besmed Health Business Corporation
No.5, Lane 116, Wu-Kong 2nd Road
Wu-Ku District
New Taipei City Taiwan
Manufacturer Reason
for Recall		 Ambu Aura40 Standard, Reusable Laryngeal Mask packaged in a pouch marked AuraStraight Silicone, Single Use Laryngeal Mask Sterile
FDA Determined
Cause 2		 Error in labeling
Action Ambu issued via USPS Certified Mail/Email to customers on Aug 09, 2018 advising users of the problem. If you have affected lot in stock and you are using it as Reusable Laryngeal Mask (following accompanying instruction for use), you can continue to use it and no need to return it. Accounts requested to see if you have affected lots in stock. If you do have it, check Aura40 Standard devices for incorrect labelled pouch, and place wrongly labelled products in quarantine. For collection and replacement by Ambu..Furthermore, please instruct all customers of the received LOT(s), to check their devices for the wrong labelling as well Contact 800 262 8462 x 1121 or email mlo@ambu.com to arrange Return Authorization and replacement.
Quantity in Commerce 267 units
Distribution US Nationwide, and country of Canada.
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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