Z-2550-2016 Class II Terminated
FDA device recall Z-2550-2016 was initiated by Resmed Corporation on July 12, 2016 and is designated Class II. 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. The recall status is terminated (terminated September 26, 2016). Affected quantity: 42 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 24, 2016
- Initiation Date
- July 12, 2016
- Termination Date
- September 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42 units
Product Description
Quattro Air FFM MED AMER, Product Code: 62702, full face mask for use with active-exhaust-valve ventilators
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.
Distribution Pattern
US nationwide distribution
Code Information
Lot 1142623