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Terminated

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

FDA Recall Z-0552-2016 · Posted 2015-12-24

Recalling FirmAirways Development LLC
Recall StatusTerminated
Product CodeBYE
Date Initiated2015-09-24
Date Terminated2016-05-09
Product Quantity1,464 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110713WATERPAP VALVEAirways Development, LLC · 2011-09-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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