FDA-Device2019-10-23Class II
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
Olympus Corporation of the Americas
Hazard
Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate
Sold states
US Nationwide distribution.
Affected count
1106 boxes (10 filters/box)
Manufactured in
3500 Corporate Pkwy, PO Box 610, Center Valley, PA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0159-2020Don't want to check this manually?
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