Events

Recall of Device Recall Smiths Medical

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
    Recall
  • Event ID
    67714
  • Event Risk Class
    Class 2
  • Event Number
    Z-1444-2014
  • Event Initiated Date
    2014-03-17
  • Event Date Posted
    2014-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126134
  • 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
    Injection port of the set may leak blood/ iv fluids from the septum of the injection port or the septum may become dislodged.
  • Action
    Smiths Medical issued Urgent Field Safety Notice Recall on 3/17/14 via mail service. Distributors will be instructed to notify their customers. The Field Safety Notice will also include an Urgent Recall Notice Confirmation Form (Confirmation Form) that consignees will be instructed to send back to Smiths Medical for carrying out the action and tracking effectiveness.Accounts are to inspect inventory and return recalled product. If you should have any questions regarding this information, please contact Shirley Duggan, Quality System Engineer at 1-781-763-9335 or by E-Mail Shirley.duggan@smiths-medical.com.

Device

Device Recall Smiths Medical
  • Model / Serial
    2513261 2531612 2540540 2545044 2588656
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of: AU, CA, CL, CN, CZ, GT, ID, IN, IT, JP, LY, NZ, QA, SG, SK, TR, TW.
  • Product Description
    Smiths Medical HOTLINE¿ Fluid Warming Set L-80. || Product Usage: intended for the delivery of warmed blood and intravenous fluids at normothermic temperatures under gravity || conditions
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Manufacturer Address
    Smiths Medical ASD, Inc., 160 Weymouth St, Rockland MA 02370-1136
  • Source
    USFDA