Medical device recalls Moderate risk

Vygon U.S.A. recalls Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.

Recall date
April 15, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1689-2021
FDA classification
Class II
Brand / firm
Vygon U.S.A.
Sold / distributed
US Nationwide distribution in the state of PA.

Why it was recalled

Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.

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