Device product
Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack
Z-0159-2020
Product summary
- Event
- Event 83826
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1106 boxes (10 filters/box)
- Official record key
device-enforcement:Z-0159-2020
Official wording
Reason: Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate
Code information: Lot number: 494604
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate