FDA recall Z-0025-2020
AURIS HEALTH INC · Class II · device
Product
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Reason for recall
Reports of aspirating biopsy needle breakage
Distribution
US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.
Key facts
- Status
- Terminated
- Initiation date
- 2019-04-19
- Report date
- 2019-11-27
- Termination date
- 2022-01-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Redwood City, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0025-2020