BEUDAMED
    FDA Enforcement Class II Terminated

    4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001

    Recall: Z-0585-2020 · Reported December 4, 2019

    Enforcement

    Recall Number
    Z-0585-2020
    Event ID
    84010
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    December 4, 2019
    Initiation Date
    September 24, 2019
    Classification Date
    November 27, 2019
    Termination Date
    October 21, 2020
    Address
    87 Venture Dr, Dover, NH, 03820-5914, United States

    Description

    4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001

    Reason

    Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.

    Code Info

    Product Code: VYML4S1001 Lot Number: 17B012D Exp. Date: 2021-10-31

    Distribution

    One Customer Located in TN

    Quantity

    75