Class 2 Device Recall Vygon

• Date Initiated by Firm: April 15, 2021
• Create Date: May 28, 2021
• Recall Status: Open, Classified
• Recall Number: Z-1689-2021
• Recall Event ID: 87802
• Product Classification: Dressing change tray - Product Code OXQ
• Product: Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
• Code Information: Lot Number: 203373129 Exp. Date: June 30, 2022
• FEI Number: 2245270
• Recalling Firm/ Manufacturer: Vygon U.S.A.; 2750 Morris Rd Ste A200; Lansdale PA 19446-6681
• For Additional Information Contact: SAME; 610-539-9300
• Manufacturer Reason for Recall: Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
• FDA Determined Cause: Under Investigation by firm
• Action: Vygon USA issued Urgent Medical Device Recall letter via email on 4/15/21. Letter states reason for recall, health risk and action to take: The recall will be conducted at no cost to you; all inventory will be credited or replaced at no cost to you. To complete the return of the recalled product and replacement with new inventory, we request your cooperation in the following steps: 1. Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product. 2. Count and document your affected inventory on the Recall Acknowledgement and Inventory Return Form in Attachment 1. Please complete and return the document even if you currently have no product on hand. 3. Fax or email the form to Vygon including customer contact information. 4. Vygon customer service will contact you to issue a Return Merchandise Authorization number. 5. Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up. If you have any questions, please contact your sales representative or Vygons Customer Service Department at 1-800-473-5414 (M-F, 8am-6pm), or by e-mail at customerservice@vygonus.com.
• Quantity in Commerce: 8,320 units
• Distribution: US Nationwide distribution in the state of PA.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.