Events

Recall of MyeloNate CSF Sampling Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Utah Medical Products, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72462
  • Event Risk Class
    Class 2
  • Event Number
    Z-0233-2016
  • Event Initiated Date
    2015-10-16
  • Event Date Posted
    2015-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141130
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Kit, surgical instrument, disposable - Product Code KDD
  • 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.

Device

MyeloNate CSF Sampling Kit
  • Model / Serial
    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.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Utah Medical Products, Inc

Manufacturer

Utah Medical Products, Inc
  • Manufacturer Address
    Utah Medical Products, Inc, 7043 South 300 West, Midvale UT 84047
  • Manufacturer Parent Company (2017)
    Utah Medical Products, Inc.
  • Source
    USFDA