BEUDAMED
    FDA Enforcement Class II Terminated

    Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.

    Recall: Z-2049-2021 · Reported July 21, 2021

    Enforcement

    Recall Number
    Z-2049-2021
    Event ID
    87926
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RanD S.r.l.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 21, 2021
    Initiation Date
    April 30, 2021
    Classification Date
    July 9, 2021
    Termination Date
    February 5, 2024
    Address
    Strada Statale 62, Medolla, N/A, Italy

    Description

    Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.

    Reason

    The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.

    Code Info

    Lot Numbers: F180264

    Distribution

    The products were distributed to the following US states: FL, IL, TN, WI

    Quantity

    40