Medical device recalls Moderate risk

CellEra LLC recalls VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144

Recall date
September 1, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2085-2019
FDA classification
Class II
Brand / firm
CellEra LLC
Sold / distributed
OH, PA, VA

Why it was recalled

Adhesive border was not sticky enough.

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

What was recalled

VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144

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