FDAFDA · Food and drugs·Recall number Z-1689-2021
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Published June 9, 2021 · Recall initiated: April 15, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Vygon U.S.A.
- Distributor
- US Nationwide distribution in the state of PA.
- Lot
- Lot Number: 203373129 Exp. Date: June 30, 2022
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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