Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
FDA device recall Z-0552-2016 · posted 2015-12-24 · Terminated
Recall details
- Recalling firm
- Airways Development LLC
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- BYE
- Quantity affected
- 1,464 units
- Distribution
- Nationwide
- Date initiated
- 2015-09-24
- Date posted
- 2015-12-24
- Date terminated
- 2016-05-09
- Location
- Kenilworth, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WATERPAP VALVE (K110713) | Airways Development, LLC | 2011-09-12 |