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
|