BEUDAMED
    FDA Recall Terminated

    Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872 Revision H, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,

    Recall: Z-0552-2011 · Initiated October 25, 2010

    Recall

    Recall Number
    Z-0552-2011
    Event Number
    57176
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 25, 2010
    Posted
    December 8, 2010
    Terminated
    March 23, 2012
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095

    Description

    Custom Kit, Sterile EO, Rx Only, Catalog No. K09-05872 Revision H, Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,

    Reason

    Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.

    Action

    Merit issued an Urgent Product Recall Notice letter dated October 25, 2010 to consignees. Copnsignees were instructed to quarantine the product immediately for return and to notify customers of recall activity and instruct them to return product.. All distributors and customers are to complete and return a Recall Notification Form. For further information about this recall, contact Merit at 800 356-3748.

    Distribution

    Nationwide Distribution in the states of CA, IL, IN, and UT.

    Quantity

    124 units