Events

Recall of Device Recall Smiths Medical Medfusion infusion pump

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
    53940
  • Event Risk Class
    Class 2
  • Event Number
    Z-0651-2010
  • Event Initiated Date
    2009-11-16
  • Event Date Posted
    2010-01-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86903
  • 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
    Infusion pump - Product Code FRN
  • Reason
    Smiths medical has become aware of an increased trend in reports of motor not running (mnr) and motor rate error (mre) alarm message events with certain medfusion¿ syringe infusion pumps, models 3010a and 3500 (pump). mnr/ mre are high priority alarm messages which can occur for a variety of reasons as part of the usual self-test functionality of the pump. the pump is designed so that when its so.
  • Action
    An Urgent Medical Device Recall letter, dated November 16, 2009, was sent to customers beginning November 16, 2009. The letter described the issue, identified affected devices, and asked that affected devices be returned to Smiths Medical to be inspected, repaired, if necessary, and returned back to medical facility. A Confirmation Form is also asked to be completed and returned to Smiths Medical. To return Pumps or for questions regarding this Urgent Recall Notice, please contact Smiths Medical Customer Service Department at 1~866-270-7060. Please report any issues with these Pumps please contact Smiths Medical Technical Customer Service Department at 1866-216-8806.

Device

Device Recall Smiths Medical Medfusion infusion pump
  • Model / Serial
    serial number: M66331, M66332, M66333, M66334, M66335, M66336, M66337, M66339, M66340, M66341, M66342, M66343, M66344, M66345, M66721, M66722, M66723, M66724, M66725, M66726, M66727, M66728, M66729, M66730, M66731, M66732, M66733, M66734.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY,OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, including Guam, Puerto Rico. OUS to include: Canada, Chile, Czech Republic,, England, France, Germany, Hong Kong, Ireland, Israel, Lebanon, Malaysia, Poland, Saudi Arabia, Scotland, Singapore, Sweden, Switzerland, United Arab Emirates.
  • Product Description
    Smiths Medical Medfusion model 3010a syringe Infusion pump. REF 3010A. Rx Only. Smiths Medical MD, Inc., St. Paul, Minnesota 55112 (USA)
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

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