—#176436

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

FDA product code: HHI — System, Abortion, Vacuum
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
510(k) numbers: K030935
Affected lot / code info: Lot number: 494604

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

Root cause (FDA determination)

Process control

Action the firm took

Olympus issued notification letter on 9/12/19 via Federal Express two day delivery stating reason for recall, health risk and action to take: 1. Immediately assess any affected product you have in stock, remove it from your inventory and quarantine it until it is shipped back to us. 2.Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization in order to return any affected product at no charge to you. Olympus will issue a credit or replacement to your facility for your affected product.. 4.Fax the completed Reply form to Olympus Market Quality at 484-896-7128 regardless of whether you have any affected inventory at your facility. Contact 484-896-5688 or at laura.storms@olympus.com for any additional information concerning this matter.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy PO Box 610, Center Valley, Pennsylvania 18034-0610

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2019-09-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176436. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.