Medical device recalls Moderate risk

Stradis Healthcare recalls VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS

Recall date
May 10, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1688-2022
FDA classification
Class II
Brand / firm
Stradis Healthcare
Sold / distributed
Pennsylvania

Why it was recalled

Potential for incomplete seals.

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 kit, REF AMS-8465CS

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