Recall Z-0552-2016
Airways Development LLC · initiated September 24, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
Codes / lots: Reference #WP-7700; Lot 8605A
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.
FDA-determined cause: Nonconforming Material/Component
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.
Details
- Recall number
- Z-0552-2016
- Initiated
- September 24, 2015
- Posted by FDA
- December 24, 2015
- Terminated
- May 9, 2016
- Product code
- BYE – Attachment, Breathing, Positive End Expiratory Pressure
- Quantity
- 1,464 units
- Distribution
- Nationwide
- Recalling firm
- Airways Development LLC, Kenilworth, NJ