Recall Z-0159-2020 ยท HHI System, Abortion, Vacuum
Olympus Corporation of the Americas
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
| Date | Sep 12, 2019 |
| Status | Open, Classified |
| 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 |
| Root cause | Process control |
| 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 |
| Quantity | 1106 boxes (10 filters/box) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030935 | BERKELEY V-10 VACUUM CURETTAGE SYSTEM Acmi Corporation, Jun 23, 2003 |