FDA-Device2021-06-09Class II
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
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
Sold states
US Nationwide distribution in the state of PA.
Affected count
8,320 units
Manufactured in
2750 Morris Rd Ste A200, Lansdale, PA, United States
Products
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1689-2021Don't want to check this manually?
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