FDA recall Z-0159-2020

Olympus Corporation of the Americas · Class II · 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

Reason for recall

Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate

Distribution

US Nationwide distribution.

Key facts

Status: Ongoing
Initiation date: 2019-09-12
Report date: 2019-10-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0159-2020