BEUDAMED
    FDA Enforcement Class II 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 · Reported November 18, 2015

    Enforcement

    Recall Number
    Z-0233-2016
    Event ID
    72462
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Utah Medical Products, Inc
    Voluntary / Mandated
    N/A
    Initial Notification
    Letter
    Report Date
    November 18, 2015
    Initiation Date
    October 16, 2015
    Classification Date
    November 6, 2015
    Termination Date
    May 2, 2016
    Address
    7043 South 300 West, N/A, Midvale, UT, 84047, United States

    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.

    Code Info

    Part numbers: 4011015 (22 ga X 1.0 long needle) 4011525 (22 ga X 1.5 long needle) 4011515 (25 ga X 1.0 long needle) Expiration dates from 10/31/15 to 12/31/17.

    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