Device product
Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
Z-0552-2016
Product summary
- Event
- Event 72848
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,464 units
- Official record key
device-enforcement:Z-0552-2016
Official wording
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 information: Reference #WP-7700; Lot 8605A
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.