BEUDAMED
    FDA Enforcement Class II Terminated

    CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on the label is CODAN US CORPORATION, Santa Ana, CA.

    Recall: Z-2433-2020 · Reported July 8, 2020

    Enforcement

    Recall Number
    Z-2433-2020
    Event ID
    85367
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Codan US Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 8, 2020
    Initiation Date
    September 12, 2019
    Classification Date
    June 26, 2020
    Termination Date
    April 28, 2021
    Address
    3511 W Sunflower Ave, N/A, Santa Ana, CA, 92704-6944, United States

    Description

    CODAN SWAN-LOCK Swabable Needlefree Connector, Catalog #BC1000N, REF 16.7220, individually packaged, 504/case, Sterile. The firm name on the label is CODAN US CORPORATION, Santa Ana, CA.

    Reason

    Individual packages of connectors may have incomplete or bad seals which would compromise sterility.

    Code Info

    Lot number 78503

    Distribution

    Distribution was made to CA, MI, NY, PA, and VA. There was no military/government distribution. Foreign distribution was made to Canada, Australia, New Zealand, and Chile.

    Quantity

    34,776 units