FDA Enforcement
Class II
Terminated
Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
Recall: Z-0552-2016
·
Reported December 30, 2015
Enforcement
- Recall Number
- Z-0552-2016
- Event ID
- 72848
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Airways Development LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 30, 2015
- Initiation Date
- September 24, 2015
- Classification Date
- December 24, 2015
- Termination Date
- May 9, 2016
- Address
- 740 Jefferson Ave, Suite B, Kenilworth, NJ, 07033-1762, United States
Description
Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
Reason
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.
Code Info
Reference #WP-7700; Lot 8605A
Distribution
Nationwide
Quantity
1,464 units