BEUDAMED
    FDA Recall Open, Classified

    Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip

    Recall: Z-1418-2023 · Initiated February 23, 2023

    Recall

    Recall Number
    Z-1418-2023
    Event Number
    91840
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    MND
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    February 23, 2023
    Posted
    April 20, 2023
    Address
    3500 Corporate Pkwy, Center Valley, PA, 18034-8229

    Description

    Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip

    Reason

    There have been complaints that the clip did not come out of the tube sheath during the procedure.

    Action

    The firm, Olympus, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 2/23/2023 to its customers. The letter described the product, the issue and actions to be taken. The customers were instructed to do the following: 1) immediately assess, cease use of and quarantine any affected (lot numbers) products you have identified. 2.) Call your Olympus customer service representative at 1-800-848-9024, option 2 to receive a RMA to return any affected product at not charge. 3.)Access the Olympus recall portal to indicate that you have received this notification at https://olympusamerica.com/recall. Enter the recall number "0421" and provide your contact information as indicated in the portal. 4.) If you have distributed these devices outside your facility, please notify your customers of this removal action immediately. Please report to Olympus any adverse events and irregularity associated with the use of the devices by contacting our Technical Assistance Center at 1 800 848 9024, option 1. Please reach out to your local sales representative for assistance regarding current product offerings. If you require additional information, please do not hesitate to contact me at (647) 999-3203 or [email protected].

    Distribution

    US Nationwide Distribution

    Quantity

    65.9 boxes (373 pieces)