Device product
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Z-1689-2021
Product summary
- Firm
- Vygon U.S.A.
- Event
- Event 87802
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,320 units
- Official record key
device-enforcement:Z-1689-2021
Official wording
Reason: Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
Code information: Lot Number: 203373129 Exp. Date: June 30, 2022
Distribution pattern: US Nationwide distribution in the state of PA.
Derived failure modes
-
Unknown
Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection