Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.

This recall has been terminated (originally issued December 24, 2015).

Company

Airways Development Llc

Recall Initiated

September 24, 2015

Posted

December 24, 2015

Terminated

May 9, 2016

Recall Number

Z-0552-2016

Quantity

1,464 units

Firm Location

Kenilworth, NJ

Official Source

View on FDA website ↗

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.

Distribution

Nationwide

Lot / Code Info

Reference #WP-7700; Lot 8605A

Root 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.