Medical device recalls Moderate risk

Monarch Medical Technologies recalls Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.

Recall date
May 3, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1786-2019
FDA classification
Class II
Brand / firm
Monarch Medical Technologies
Sold / distributed
Nationwide and Dubai

Why it was recalled

Insulin dosing calculations were erroneously high.

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

What was recalled

Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.

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