Medical device recalls Moderate risk

Monarch Medical Technologies recalls EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)

Recall date
October 1, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0354-2020
FDA classification
Class II
Brand / firm
Monarch Medical Technologies
Sold / distributed
SC, IL IN, CA

Why it was recalled

Product was distributed prior to approval or clearance from FDA.

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

What was recalled

EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)

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