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 |
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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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510(K) Database | 510(K)s with Product Code = BZD
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