Medical device recalls Moderate risk

Acera Surgical Inc recalls Restrata, Part Number RWM1-2X2

Recall date
March 21, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1030-2022
FDA classification
Class II
Brand / firm
Acera Surgical Inc
Sold / distributed
Nationwide

Why it was recalled

Misprinted expiration date on the shelf-box

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

What was recalled

Restrata, Part Number RWM1-2X2

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