Olympus Corporation of the Americas recalls Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervi…

Recall date

September 12, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0159-2020

FDA classification

Class II

Brand / firm

Olympus Corporation of the Americas

Sold / distributed

US Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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