Z-0552-2016Class II

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

Name: Z-0552-2016 Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700
Creator: Airways Development LLC
Published: 2015-09-24
License: https://open.fda.gov/license/

Airways Development, LLC / initiated 2015-09-24 / Terminated / root cause: manufacturing process

FDA source

Airways Development LLC began a recall of Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700 on 2015-09-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0552-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-24
Posted: 2015-12-24
Terminated: 2016-05-09
Recalling firm: Airways Development, LLC
Product: Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
Product code: BYE Attachment, Breathing, Positive End Expiratory Pressure
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 1,464 units
Distribution: Nationwide
Product codes and lots: Reference #WP-7700; Lot 8605A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0552-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0552-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-30	2015-12-24

Product code BYE

K110713Class IIWaterpap ValveAirways Development, LLC / cleared 2011-09-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)