Recall Z-0424-2023
Olympus Corporation of the Americas · initiated November 4, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S
Codes / lots: Model Number/ UDI-DI/ Lot Number WA22602S 14042761085127 1000090824 WA22603S 14042761085134 1000092201 WA22621S 14042761085172 1000080316 WA22657S 14042761085301 1000092202
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: Packaging process control
Action taken
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.
Details
- Recall number
- Z-0424-2023
- Initiated
- November 4, 2022
- Posted by FDA
- December 7, 2022
- Product code
- FJL – Resectoscope
- Quantity
- 186 boxes (930 pieces)
- Distribution
- US Nationwide domestic distribution.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA