BEUDAMED
    FDA Recall Open, Classified

    EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

    Recall: Z-1832-2024 · Initiated April 1, 2024

    Recall

    Recall Number
    Z-1832-2024
    Event Number
    94395
    Firm
    Cook Medical Incorporated
    FEI Number
    3005580113
    Product Code
    FCG
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 1, 2024
    Posted
    May 16, 2024
    Address
    400 N Daniels Way, Bloomington, IN, 47404-9155

    Description

    EchoTip Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

    Reason

    Devices may contain elevated levels of bacterial endotoxin.

    Action

    On April 01, 2024, Cook Ireland Ltd.(CIRL) initiated a field action for the EchoTip Ultra High Definition Ultrasound Access Needle (ECHO-HD-19-A) and EchoTip Ultra Endoscopic Ultrasound Needle (ECHO-19). Cook Ireland Ltd has identified 9 devices located outside of the United States (US) that are associated with the issue and has initiated a voluntary recall due to the potential of elevated levels of bacterial endotoxins on the devices. No US customers were impacted by this Field Safety Corrective Action (FSCA). No monitoring will be required as US consignees are not impacted by this recall. Effectiveness checks for this recall will not be necessary as US Consignees were not impacted by the distribution.

    Distribution

    International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.

    Quantity

    1 Unit OUS