Device product
Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.
Z-1314-2026
Product summary
- Firm
- Hologic, Inc
- Event
- Event 98172
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 681,870 units
- Official record key
device-enforcement:Z-1314-2026
Official wording
Reason: Presence of particulates in affected devices that can be deposited into breast tissue during use.
Code information: Model No - BREVDISP09; UDI - 1540045512863; All Lots within expiry.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Foreign material or chemical contamination
particulates