Recall Z-0552-2016— Airways Development LLC

Name: FDA recall Z-0552-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-24

Class II · Terminated

Class II FDA medical device recall by Airways Development LLC, initiated 2015-09-24, terminated 2016-05-09. It names one FDA 510(k) clearance: K110713. Product: Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.. 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..

Recalling firm: Airways Development LLC
Classification: Class II
Status: Terminated
Initiated: 2015-09-24
Terminated: 2016-05-09
Firm location: Kenilworth, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K110713 — WATERPAP VALVEAirways Development, LLC·cleared 2011-09-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.