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U.S. Department of Health and Human Services

Class 2 Device Recall Ambu AuraGain Single Use Laryngeal Mask Sterile

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  Class 2 Device Recall Ambu AuraGain Single Use Laryngeal Mask Sterile see related information
Date Initiated by Firm February 10, 2016
Date Posted March 24, 2016
Recall Status1 Terminated 3 on June 22, 2016
Recall Number Z-1236-2016
Recall Event ID 73366
Product Classification Tube, tracheostomy (w/wo connector) - Product Code BTO
Product Ambu, Aura Gain - Single Use Laryngeal Mask- Sterile
for use as an alternative to a face mask for achieving and maintaining control of the airway during routine emergency anesthetic procedures.
Code Information Catalog Number:408300000  Size #3:All lots from 1632796 through lot number 1808911except lot number 1779966,1782239, 1795914   Catalog Number: 408400000 Size #4 All lots from 1632799 through lot number 1790075.   Catalog Number:408500000 Size #5 All lots from 1632802 through lot number 1810863.
Recalling Firm/
Manufacturer		 Ambu Inc.
6230 Old Dobbin Ln Ste 250
Columbia MD 21045-5955
For Additional Information Contact Sanjay Parikh
410-768-6464
Manufacturer Reason
for Recall		 Ambu, Aura Gain laryngeal Mask, was found to have lack of Sterility Assurance. The firm discovered the problem during final quality control at manufacturing site. Damage to the sterile barrier (the pouch) may compromise a medical device's sterility,leading to contamination of the product and,ultimately,patient complications.
FDA Determined
Cause 2		 Process control
Action Filed Safety Notice was sent via USPS Certified Mail to all customers on Dec 10,2015.
Quantity in Commerce Total Numbers of unit distributed: 45990 pes (USA)
Distribution Please see attached consignee list
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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