BEUDAMED
    FDA Recall Terminated

    MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz Aesthetics, In., Manufactured by TSK Laboratory. The intended use of the Cannula is the injection of fluids into, or withdrawal of fluids from, parts of the body below the surface of the skin.

    Recall: Z-0694-2012 · Initiated December 16, 2011

    Recall

    Recall Number
    Z-0694-2012
    Event Number
    60851
    Firm
    Merz Aesthetics, Inc.
    FEI Number
    3003407669
    Product Code
    FMI
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 16, 2011
    Terminated
    July 27, 2012
    Address
    4133 Courtney Rd, Ste 10, Franksville, WI, 53126-9127

    Description

    MERZ AESTHETICS, 27G X 1.0 " (25MM) Cannula, Sterile R, QTY 20, Model 9015M1X20, Distributed by Merz Aesthetics, In., Manufactured by TSK Laboratory. The intended use of the Cannula is the injection of fluids into, or withdrawal of fluids from, parts of the body below the surface of the skin.

    Reason

    Merz Aesthetics is initiating a medical device recall on TSK Closed Tip Cannula (27GA x 25mm) due to a labeling error on the secondary (outer) packaging. The outer package label states that the carton contains Cannulas that are 27GA x 25 mm in size instead of 27G x 38 mm. Length of the cannula is a matter of user preference and is unlikely to impact patient safety.

    Action

    Merz Aesthetics Inc, initially contacted customers by telephone on December 16, 2011. They were informed that the wrong size cannula were sent with their last order and would need to be returned and a replacement order would be sent. . Merz Aesthetics sent a "Urgent Medical Device Recall" letter dated January 6, 2012. The letter identified the product the problem and the action needed to be taken by the customer. In addition, if you have further distributed this product, please identify your customers and notify them of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. You may contact Merz Aesthetics Customer Service at (866) 862-1211 or (262) 835- 3333 ,for instructions regarding the return and immediate replacement of the product, or if you have any further questions or concerns..

    Distribution

    Nationwide Distribution including the states of CA, NY, OK, and TN.

    Quantity

    5 boxes (20 units per box)