Medical device recalls Moderate risk

Remel Inc. recalls SWIN 2017 database, Model YSW4000

Recall date
January 4, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1939-2020
FDA classification
Class II
Brand / firm
Remel Inc.
Sold / distributed
...

Why it was recalled

Potential for out of range microbial results

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

What was recalled

SWIN 2017 database, Model YSW4000

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