BEUDAMED
    FDA Recall Terminated

    Mistique Infusion Catheter, K12-MIC09005, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    Recall: Z-0892-2010 · Initiated January 6, 2010

    Recall

    Recall Number
    Z-0892-2010
    Event Number
    54228
    Firm
    Merit Medical Systems, Inc.
    FEI Number
    1721504
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Storage
    Initiated
    January 6, 2010
    Posted
    March 2, 2010
    Terminated
    September 13, 2010
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095

    Description

    Mistique Infusion Catheter, K12-MIC09005, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095 Intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

    Reason

    Infusion catheters may become brittle and break during use.

    Action

    All affected sales reps were notified by phone and a Mistique Infusion Catheter - Product Recall letter on 01/06/2010 and instructed to contact their accounts, inform them of the recall situation, and complete the Recall Notification form with a site representative. Accounts were to immediately cease use of any affected units and to arrange for return to Merit. Recall actions are to be completed by Jan 22, 2010. Questions should be directed to Greg Turner at 801-316-4998 or Liz Pratt at 801-208-4828.

    Distribution

    Worldwide Distribution -- USA, including states of AL, CA, IN, LA, MO, MS, NC, NY, OH, PA, SC, UT, and VA and countries of India, Japan, Poland, San Marino, and UK.

    Quantity

    240 units