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U.S. Department of Health and Human Services

Class 2 Device Recall Quattro Air full face mask (FFM)

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  Class 2 Device Recall Quattro Air full face mask (FFM) see related information
Date Initiated by Firm July 12, 2016
Create Date August 16, 2016
Recall Status1 Terminated 3 on September 26, 2016
Recall Number Z-2550-2016
Recall Event ID 74736
510(K)Number K123979  
Product Classification Ventilator, non-continuous (respirator) - Product Code BZD
Product Quattro Air FFM MED  AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
Code Information Lot 1142623
Recalling Firm/
Manufacturer		 Resmed Corporation
9001 Spectrum Center Blvd
San Diego CA 92123-1438
For Additional Information Contact
858-836-5000
Manufacturer Reason
for Recall		 Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask.
FDA Determined
Cause 2		 Packaging process control
Action An urgent product recall notification letter was sent to all customers on 7/12/16 to inform them that ResMed is recalling NV Quattro Air & Quattro Air Mask due to a mislabeling Issue. The letter informs the customers that during the investigation of a product complaint, ResMed identified that a small number of masks labelled and sold as 62702 Quattro Air FFM MED  AMER, Lot 1142623 actually contain an NV Quattro Air FFM Large mask. The letter informs the customers to notify anyone they may have sold the products to. Customers with any questions are instructed to call the ResMed Customer Service team: 858-836-5968.
Quantity in Commerce 42 units
Distribution US nationwide distribution
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.
510(K) Database 510(K)s with Product Code = BZD and Original Applicant = RESMED LTD.
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