BEUDAMED
    FDA Recall Terminated

    Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy

    Recall: Z-2423-2021 · Initiated August 3, 2021

    Recall

    Recall Number
    Z-2423-2021
    Event Number
    88235
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FED
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    August 3, 2021
    Terminated
    January 10, 2023
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    Description

    Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501; ARV120 ENDOCUFF-V L GREEN PK8, Part Number: E0420500; ARV130 ENDOCUFF-V S PURPLE PK8, Part Number: E0420502; ARV140 ENDOCUFF-V XL ORANGE PK8 ARV110, Part Number: E0420503 Intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy

    Reason

    Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.

    Action

    Olympus Own Label Distributor US issued letter 8/3/21 via UPS Ground, letter states reason for recall, health risk and action to take: Olympus requires you to take the following immediate action: 1. Carefully read the content of this Field Safety Notice. 2. Below are examples of a gap in the seal between the lid and the plastic package 3. As per the instructions for use, do not use if packaging is damaged. If you observe this packaging anomaly or any other damage to the packaging, immediately cease any further use of any affected product you have, remove it from your inventory and quarantine it until it is shipped back to us. 4. Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit or replacement to your facility for your affected product. 5. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number Recall-0399 and provide your contact information as indicated in the portal. 6. If you have further distributed this product, identify your customers, forward them this Field Safety Notice, and appropriately document your notification process. Please do not hesitate to contact me directly at 484-896-5688 or at email [email protected] for any additional information concerning this matter

    Distribution

    Nationwide

    Quantity

    711,157 units units