Home / Recalls / Medical Devices
Vygon U.S.A. recalls Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Recalled June 9, 2021 · FDA recall Z-1689-2021 · Vygon U.S.A
Hazard
Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection · FDA Class II
Units
8,320 units
Sold at
US Nationwide distribution in the state of PA.
Description
Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
Product
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Manufacturer(s)
Vygon U.S.A.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →