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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 Electrodessee related information
Date Initiated by FirmNovember 04, 2022
Date PostedDecember 07, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0424-2023
Recall Event ID 91100
510(K)NumberK171965 
Product Classification Resectoscope - Product Code FJL
ProductHF 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
FEI Number 2429304
Recalling Firm/
Manufacturer		 Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia 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
ActionOn 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 Commerce186 boxes (930 pieces)
DistributionUS Nationwide domestic distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FJL
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