FDA Medical Device Recalls (openFDA)
Airways Development LLC: Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
- Recall number
- Z-0552-2016
- Recalling firm
- Airways Development LLC
- Product
- Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
- Status
- Terminated
- Initiated
- 2015-09-24
- Posted
- 2015-12-24
- Terminated
- 2016-05-09
- 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.
- 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
- 1,464 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Reference #WP-7700; Lot 8605A
- 510(k) numbers
- ["K110713"]
- PMA numbers
- not on file
- Product code
- BYE
- Firm FEI
- 3000210458
- Firm city
- Kenilworth
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28