Z-0025-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2019
- Initiation Date
- April 19, 2019
- Termination Date
- January 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 158
Product Description
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Reason for Recall
Reports of aspirating biopsy needle breakage
Distribution Pattern
US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.
Code Information
Lots: RS181129-1 RS181129-2 RS181210-1 RS181210-2 RS181210-3 RS181210-4 RS190117-1 RS190125-1 RS190211-1 RS190225-3 RS190308-1 RS190319-1