BEUDAMED
    FDA Recall Terminated

    Deltec 3000 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265 Grey Fox Road, St. Paul, MN 55112, USA, Made in UK. Reorder numbers 21-5301-01 & 21-5306-01 The product is used for general drug delivery infusion therapies. The product is only intended to be used by trained clinicians.

    Recall: Z-1604-2008 · Initiated February 27, 2008

    Recall

    Recall Number
    Z-1604-2008
    Event Number
    47482
    Firm
    Smiths Medical MD, Inc.
    FEI Number
    2183502
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 27, 2008
    Posted
    September 23, 2008
    Terminated
    December 17, 2011
    Address
    1265 Grey Fox Rd, Saint Paul, MN, 55112-6929

    Description

    Deltec 3000 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265 Grey Fox Road, St. Paul, MN 55112, USA, Made in UK. Reorder numbers 21-5301-01 & 21-5306-01 The product is used for general drug delivery infusion therapies. The product is only intended to be used by trained clinicians.

    Reason

    The Deltec, Graseby, and 3M, Large Volume Infusion Pump - Models 3000 and 3100, may deliver an unintended bolus if the pump door is opened and then immediately closed. This problem is due to a timing delay when the pumping mechanism resets itself.

    Action

    A Smiths Medical "Urgent Medical Device Correction" letter dated 2/5/08 was sent to consignees on 2/27/08. The letter was addressed to Risk/Safety Managers, Clinicians, Nursing Staff and other users of the above products. The letter also included Details on affected devices, Description of the problem , Advice on action to be taken by the user, Warning and requested the return the confirmation form. Contact Smiths Medical at 1-800-426-2448 for assistance. Please note: The 3M was the original brand for the large volume infusion pump models 3000 and 3100 marketed in the USA from 1994 through 1997. The Graseby large volume infusion pump models 3000 and 3100 were marketed from 1997 through 1999. Since 1999, the current marketed brand is the Deltec models 3000 and 3100. Smith Medical MD, Inc., included the 3M and Graseby brand large volume infusion pumps in the product field safety notice in the event these brands of infusion pumps are still in use.

    Distribution

    AL, AR, AZ, CA, CO, CT, DC, FL. GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, ,MO, MS, MT, NC, ND, NE,NH, NJ, NM, NV, NY, OH, OK OR,PA, RI,SC, TN, TX, UT,VA, VT, WA, WI, WV, and WY

    Quantity

    2303 (total)