Recall of HOTLINE Blood and Fluid Warmer, Mole l HL90

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Smiths Medical ASD, 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
  • Event ID
  • Event Risk Class
    Class 3
  • Event Number
  • Event Initiated Date
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Warmer, thermal, infusion fluid - Product Code LGZ
  • Reason
    Hotline blood and fluid warmers included greek and danish language labeling instead of the required finnish labeling.
  • Action
    Smiths Medical sent an Urgent-Medical Device Field Safety Notice dated October 28, 2016, to all affected customers. The letter described the Reason for Field Corrective Action, Risk to Health, and Instructions to Customers. Advised consignees to notify customers and to review and complete the Recall Confirmation Form and return it to Smith Medical via e-mail to For further questions, please call (651) 633-2556.


  • Model / Serial
    S101B06231-235; S101B06318-325/327; S101B06354-362; S101B06464-473.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Internationally to Finland
  • Product Description
    HOTLINE Blood and Fluid Warmer, Mole l HL-90. Designed for use with the Hotline Fluid Warming Set (L-80, L-70 and L-70N) to warm blood and intravenous (I.V.) fluids and deliver them to the patient's intravenous access site at normothermic temperatures under gravity flow conditions.
  • Manufacturer


  • Manufacturer Address
    Smiths Medical ASD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Manufacturer Parent Company (2017)
  • Source