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U.S. Department of Health and Human Services

Class 2 Device Recall The Berkeley VC10 Vacuum Curettage System

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  Class 2 Device Recall The Berkeley VC10 Vacuum Curettage System see related information
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
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
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.
510(K) Database 510(K)s with Product Code = HHI and Original Applicant = ACMI CORPORATION
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