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U.S. Department of Health and Human Services

Class 2 Device Recall HF Resection Electrodes

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  Class 2 Device Recall HF Resection Electrodes see related information
Date Initiated by Firm November 04, 2022
Date Posted December 07, 2022
Recall Status1 Open3, Classified
Recall Number Z-0424-2023
Recall Event ID 91100
510(K)Number K171965  
Product Classification Resectoscope - Product Code FJL
Product HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
Code Information Model Number/ UDI-DI/ Lot Number WA22602S 14042761085127 1000090824 WA22603S 14042761085134 1000092201 WA22621S 14042761085172 1000080316 WA22657S 14042761085301 1000092202
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information Contact Cynthia Ow
647-999-3203
Manufacturer Reason
for Recall		 An incompatible HF cable may be packaged with the HF Resection Electrodes. This cable cannot be connected to the electrosurgical generator and may lead to delay or cancellation of the surgical procedure.
FDA Determined
Cause 2		 Packaging process control
Action On November 4, 2022, the firm notified affected customers. Customers were instructed to identify any affected product in their inventory. Affected product should be returned to Olympus, who will issue a credit to the customer upon return of affected product. Those who have distributed the devices outside their facility should notify their customers of this removal action immediately. To return product, contact your Olympus customer service representative at 1-800-848-9024.
Quantity in Commerce 186 boxes (930 pieces)
Distribution US Nationwide domestic 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 = FJL and Original Applicant = Olympus Winter & Ibe GmbH
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