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AURIS HEALTH INC recalls Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Recalled November 27, 2019 · FDA recall Z-0025-2020 · AURIS HEALTH
Hazard
Reports of aspirating biopsy needle breakage · FDA Class II
Units
158
Sold at
US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.
Description
Reports of aspirating biopsy needle breakage
Product
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Manufacturer(s)
AURIS HEALTH INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →