BEUDAMED
    FDA Recall Terminated

    ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured by Excelsior Medical Corporation, Neptune, NJ.

    Recall: Z-0870-06 · Initiated March 21, 2006

    Recall

    Recall Number
    Z-0870-06
    Event Number
    34961
    Firm
    Excelsior Medical Corp
    FEI Number
    1000122362
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 21, 2006
    Posted
    May 17, 2006
    Terminated
    December 7, 2006
    Address
    1923 Heck Ave, Neptune, NJ, 07753-4428

    Description

    ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured by Excelsior Medical Corporation, Neptune, NJ.

    Reason

    Potential for alarm failure when the 140 pump completes infusion and/or the pump encounters a mid-infusion occlusion, when used in the 140 mode with a 140cc syringe. The ESP Pump works correctly when used in 60 mode with a 60cc syringe or smaller.

    Action

    An 'Urgent Recall' letter was mailed certified return receipt mail on 3/22/06 to all customers per distribution list.

    Distribution

    Nationwide and Quebec, Canada

    Quantity

    3911 units