BEUDAMED
    FDA Recall Terminated

    Custom Angiographic Kit.

    Recall: Z-0620-03 · Initiated February 13, 2003

    Recall

    Recall Number
    Z-0620-03
    Event Number
    25605
    Firm
    Merit Medical Systems, Inc
    FEI Number
    1721504
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 13, 2003
    Posted
    March 6, 2003
    Terminated
    March 7, 2003
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095

    Description

    Custom Angiographic Kit.

    Reason

    A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.

    Action

    Consignees were notified by phone and FAX on 2/12/2003.

    Distribution

    FL and Japan.

    Quantity

    250 kits