Device product

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

Z-0025-2020

April 19, 2019

Class II

Product summary

Firm: AURIS HEALTH INC
Event: Event 82763
Status: Terminated
Classification: Class II
Quantity: 158
Official record key: device-enforcement:Z-0025-2020

Official wording

Reason: Reports of aspirating biopsy needle breakage

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

Distribution pattern: US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Reports of aspirating biopsy needle breakage