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U.S. Department of Health and Human Services

Class 2 Device Recall Airways Development LLC WaterPAP

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  Class 2 Device Recall Airways Development LLC WaterPAP see related information
Date Initiated by Firm September 24, 2015
Date Posted December 24, 2015
Recall Status1 Terminated 3 on May 09, 2016
Recall Number Z-0552-2016
Recall Event ID 72848
510(K)Number K110713  
Product Classification Attachment, breathing, positive end expiratory pressure - Product Code BYE
Product Airways Development LLC WaterPAP Positive Airway Pressure Device Reference #WP-7700.
Code Information Reference #WP-7700; Lot 8605A
Recalling Firm/
Manufacturer		 Airways Development LLC
740 Jefferson Ave
Suite B
Kenilworth NJ 07033-1762
For Additional Information Contact Ms. Karissa Gregor
908-298-9200
Manufacturer 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.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BYE and Original Applicant = AIRWAYS DEVELOPMENT, LLC
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