BEUDAMED
    FDA Enforcement Class II Terminated

    Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.

    Recall: Z-2249-2018 · Reported June 27, 2018

    Enforcement

    Recall Number
    Z-2249-2018
    Event ID
    80135
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vascular Solutions, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 27, 2018
    Initiation Date
    May 4, 2018
    Classification Date
    June 18, 2018
    Termination Date
    October 5, 2020
    Address
    6464 Sycamore Ct N, N/A, Maple Grove, MN, 55369-6032, United States

    Description

    Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.

    Reason

    The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.

    Code Info

    a) REF 8810, 5F x 9cm, Lot Numbers: 18037128, 18057123 (b) REF 8811, 6F x 9cm, Lot Numbers: 18026062, 18026063 (c) REF 8812, 5F x 15cm, Lot Number: 18050076

    Distribution

    US Nationwide Distribution

    Quantity

    276 units