BEUDAMED
    FDA Recall Terminated

    eSuction Small Cavity, Model ET2005

    Recall: Z-0270-2023 · Initiated October 24, 2022

    Recall

    Recall Number
    Z-0270-2023
    Event Number
    91074
    Firm
    Endo-Therapeutics, Inc.
    FEI Number
    1000132436
    Product Code
    FGX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 24, 2022
    Posted
    November 18, 2022
    Terminated
    January 24, 2024
    Address
    15201 Roosevelt Blvd, Ste 104, Clearwater, FL, 33760-3559

    Description

    eSuction Small Cavity, Model ET2005

    Reason

    Improper device regulatory classification

    Action

    Endo-Therapeutics, Inc. notified consignees via FedEx Overnight letter sent on 10/24/2022. The letter instructed consignees to cease further distribution of the affected devices immediately, notification to accounts if further distribution, return affected devices and complete and return the response form.

    Distribution

    US distribution to Florida and Pennsylvania

    Quantity

    28 devices