Recall Z-1689-2021 ยท OXQ Dressing Change Tray
Vygon U.S.A.
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
| Date | Apr 15, 2021 |
| Status | Open, Classified |
| Reason | Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection |
| Root 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 |
| Quantity | 8,320 units |
| Distribution | US Nationwide distribution in the state of PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.