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Open, Classified

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 Recall Z-0159-2020 · Posted None

Recall StatusOpen, Classified
Product CodeHHI
Date Initiated2019-09-12
Product Quantity1106 boxes (10 filters/box)

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

Firm Action

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 [email protected] for any additional information concerning this matter.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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