Vygon U.S.A. Recall 87802
Description: Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Vygon U.S.A. Recall 87802 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1689-2021 |
| Event ID | 87802 |
| Event Description | Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of PA. |
| Quantity | 8,320 units |
| Recall Reason | Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection |
| Device Classification | 20210609 |
| Device Code Info | Lot Number: 203373129 Exp. Date: June 30, 2022 |
| Center Classification Date | 20210528 |
| Recall Initiation Date | 20210415 |
| Recalling Firm | Vygon U.S.A. |
| Initial Notification | Letter |
| Similar To |