Recall Z-0552-2016 ยท BYE Attachment, Breathing, Positive End Expiratory Pressure
Airways Development LLC
Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
| Date | Dec 24, 2015 (initiated Sep 24, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | Airways Development Inc. sent Product Alert notices dated 9/24/2015 to their customers via email. The alert informed customers about the related product issue and how to identify affected product. Airways Development is replacing any affected product left in their customers stock. Customers were also instructed to notify their customers if the product was further distributed. A point of contact was provided if the customers had any related questions. |
| Quantity | 1,464 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110713 | WATERPAP VALVE Airways Development, LLC, Sep 12, 2011 |