Date Initiated by Firm | September 12, 2019 |
Create Date | October 17, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0159-2020 |
Recall Event ID |
83826 |
510(K)Number | K030935 |
Product Classification |
System, abortion, vacuum - Product Code HHI
|
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 |
Code Information |
Lot number: 494604 |
Recalling Firm/ Manufacturer |
Olympus Corporation of the Americas 3500 Corporate Pkwy PO Box 610 Center Valley PA 18034-0610
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For Additional Information Contact | SAME 484-896-5000 |
Manufacturer 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 |
FDA Determined Cause 2 | 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 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. |
Quantity in Commerce | 1106 boxes (10 filters/box) |
Distribution | US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = HHI
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