BEUDAMED
    FDA Recall Terminated

    Smiths Medical Medfusion model 3500 syringe Infusion pump, software version V3.0.6. Model 3500. Rx Only. Smiths Medical MD, Inc., St. Paul, Minnesota 55112 (USA).

    Recall: Z-0650-2010 · Initiated November 16, 2009

    Recall

    Recall Number
    Z-0650-2010
    Event Number
    53940
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    2183502
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 16, 2009
    Posted
    January 15, 2010
    Terminated
    December 18, 2011
    Address
    1265 Grey Fox Rd, Saint Paul, MN, 55112-6929

    Description

    Smiths Medical Medfusion model 3500 syringe Infusion pump, software version V3.0.6. Model 3500. Rx Only. Smiths Medical MD, Inc., St. Paul, Minnesota 55112 (USA).

    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.

    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.

    Quantity

    5393