Z-0552-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 30, 2015
- Initiation Date
- September 24, 2015
- Termination Date
- May 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,464 units
Product Description
Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
Reason for Recall
Airways Development LLC has received a complaint about a canister leaking from WaterPAP Lot 8605A. During a review with their supplier it could not be determined if this was an isolated incident or if the whole lot is impacted.
Distribution Pattern
Nationwide
Code Information
Reference #WP-7700; Lot 8605A