BEUDAMED
    FDA Recall Terminated

    CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.

    Recall: Z-1767-2017 · Initiated March 17, 2017

    Recall

    Recall Number
    Z-1767-2017
    Event Number
    76749
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 17, 2017
    Posted
    March 30, 2017
    Terminated
    July 3, 2019
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    CADD Administration Set, 21-7339-24, Rx Only, Sterile EO.

    Reason

    Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD Administration Sets (part number 21-7339-24), incorrectly represent the actual filter size of the product. Although the text description on the IFU correctly identifies the product to include a 0.2 micron filter, the illustration on the IFU identifies the filter size as 2.0 microns.

    Action

    Smiths Medical sent an "Urgent Medical Device Field Safety Notice" dated March 13, 2017. The letter was addressed to "Risk Manager". It provided a list of the Affected devices, Risk to Health, Instructions to Distributors & Customers. Advised consignees to notify their customers. There is no need to return the devices to Smiths Medical. Requested consignees to complete the Urgent Medical Device Field Safety Notice (FSN) Response Form and return to [email protected]. For questions contact Stericycle at 844-265-7407. For further questions regarding this recall , please call (844) 265-7407.

    Distribution

    US:AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WV, WY. OUS: Canada

    Quantity

    38,415 (38145 US; 2268 OUS)