BEUDAMED
    FDA Recall Open, Classified

    RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX

    Recall: Z-0998-2023 · Initiated December 20, 2022

    Recall

    Recall Number
    Z-0998-2023
    Event Number
    91292
    Firm
    Bolton Medical Inc.
    FEI Number
    1000135961
    Product Code
    MIH
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    December 20, 2022
    Posted
    January 19, 2023
    Address
    799 International Pkwy, Sunrise, FL, 33325-6220

    Description

    RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX

    Reason

    The product may be shorter than packaging indicates

    Action

    On 12/15/2022, Terumo Aortic/Bolton Medical, Inc. issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees by mail. The notice explained the problem and the risk, and requested the return of the device to a Terumo Sales Representative.

    Distribution

    Worldwide distribution - US Nationwide and the countries of UK, France, Germany, Italy, Netherlands, Chile, Japan, and China.

    Quantity

    640 units