BEUDAMED
    FDA Recall Terminated

    Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape, three gauze pads, and one spot bandage.

    Recall: Z-0233-2016 · Initiated October 16, 2015

    Recall

    Recall Number
    Z-0233-2016
    Event Number
    72462
    Firm
    Utah Medical Products, Inc
    FEI Number
    1718873
    Product Code
    KDD
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    October 16, 2015
    Posted
    November 6, 2015
    Terminated
    May 2, 2016
    Address
    7043 South 300, West Midvale, UT, 84047

    Description

    Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape, three gauze pads, and one spot bandage.

    Reason

    Utah Medical is conducting a recall of Myelo-Nate CSF Sampling Kit due to an internal post-sterilization inspection that found a sterile finished tray where the seal between the Tyvek lid and the PETG tray on one side of the tray had been compromised.

    Action

    Consignees notified on 10/15/15 via letter and email, instructed to return product to distributor.

    Distribution

    Worldwide Distribution-US (nationwide) including Puerto Rico and the states of CA, CO, MD, WI, FL, GA, IL, IA, ID, IN, KS, KY, LA, MI, MN, MO, MS, NC, NE, NJ, NV, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI, and the countries of Canada, United Kingdom, Saudi Arabia, Jordan, United Arab Emirates, Kuwait, and Costa Rica.

    Quantity

    21,403 trays