Vygon U.S.A. Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection

Recommended Action

Per FDA guidance

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.