Recall Z-0159-2020— Olympus Corporation of the Americas

Name: FDA recall Z-0159-2020
Creator: U.S. Food and Drug Administration
Published: 2019-09-12

Class II · Ongoing

Class II FDA medical device recall by Olympus Corporation of the Americas, initiated 2019-09-12. It names one FDA 510(k) clearance: K030935. 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: Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate.

Recalling firm: Olympus Corporation of the Americas
Classification: Class II
Status: Ongoing
Initiated: 2019-09-12
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K030935 — BERKELEY V-10 VACUUM CURETTAGE SYSTEMAcmi Corporation·cleared 2003-06-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.