Medical device recalls Moderate risk

AURIS HEALTH INC recalls Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

Recall date
April 19, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0025-2020
FDA classification
Class II
Brand / firm
AURIS HEALTH INC
Sold / distributed
US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.

Why it was recalled

Reports of aspirating biopsy needle breakage

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, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

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