BEUDAMED
    FDA Recall 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 · Initiated September 12, 2019

    Recall

    Recall Number
    Z-2433-2020
    Event Number
    85367
    Firm
    Codan US Corporation
    FEI Number
    2016945
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    September 12, 2019
    Posted
    June 26, 2020
    Terminated
    April 28, 2021
    Address
    3511 W Sunflower Ave, Santa Ana, CA, 92704-6944

    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.

    Action

    The firm issued recall letters dated 9/11/2019 via certified mail and email on 9/12/2019 requesting return or destruction of the affected product.

    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