FDA-Device2019-11-27Class II
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
AURIS HEALTH INC
Hazard
Reports of aspirating biopsy needle breakage
Sold states
US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.
Affected count
158
Manufactured in
150 Shoreline Dr, N/A, Redwood City, CA, United States
Products
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0025-2020Don't want to check this manually?
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