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
- Recall Initiated
- September 12, 2019
- Recall Number
- Z-0159-2020
- Quantity
- 1106 boxes (10 filters/box)
- Firm Location
- Center Valley, PA
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.
Lot / Code Info
Lot number: 494604
Root Cause
Process control
Action Taken
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.