BEUDAMED
    FDA Recall Terminated

    Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.

    Recall: Z-0663-2013 · Initiated September 14, 2012

    Recall

    Recall Number
    Z-0663-2013
    Event Number
    63231
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    3002975287
    Product Code
    NGT
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 14, 2012
    Posted
    January 10, 2013
    Terminated
    January 14, 2013
    Address
    12701 N Kingston Ave, Chester, VA, 23836-2700

    Description

    Merit Medical's Custom Procedural Tray or Kits K12T-03162B & K12T-02641F.Custom Procedural Tray or Kits is a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the product's intended uses.

    Reason

    Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection which were recalled because one confirmed customer report where four separate particulate issues were identified in four individual flexible containers. The particular matter may result acutely in local inflammation, phlebitis and/or generalized low-level allergic response to the particulate and/or embolize to other organs in the

    Action

    Merit Medical sent an "URGENT PRODUCT RECALL NOTICE" dated September 14, 2012 to all affected customers. The letter identified the affected product, description of problem and recommended user actions to be taken. Consignees were requested to ensure that all appropriate personnel are notified of the affected Merit trays so that they can take immediate action. They were instructed to quarantine all affected kits, remove the bag of 0.9% Sodium Chloride and return the affected product to Merit for credit or replacement. Consignees were requested to complete and sign the Customer Response Form and immediately fax a copy of the completed Customer Response Form to: 1-804-416-1031 and mail the completed original Customer Response Form using the provided postage-paid, self-addressed envelope to Merit. Consignees were given product return instructions.

    Distribution

    Distributed in Mississippi and New Jersey.

    Quantity

    422 total kits/trays