BEUDAMED
    FDA Recall Open, Classified

    HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S

    Recall: Z-0424-2023 · Initiated November 4, 2022

    Recall

    Recall Number
    Z-0424-2023
    Event Number
    91100
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FJL
    Status
    Open, Classified
    Root Cause
    Packaging process control
    Initiated
    November 4, 2022
    Posted
    December 7, 2022
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    HF Resection Electrodes, Model Numbers WA22602S, WA22603S, WA22621S and WA22657S

    Reason

    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.

    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.

    Distribution

    US Nationwide domestic distribution.

    Quantity

    186 boxes (930 pieces)