BEUDAMED
    FDA Recall Terminated

    Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.

    Recall: Z-1183-2013 · Initiated March 1, 2013

    Recall

    Recall Number
    Z-1183-2013
    Event Number
    64504
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    FKQ
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 1, 2013
    Posted
    April 26, 2013
    Terminated
    September 3, 2014
    Address
    901 Marcon Boulevard, Allentown, PA, 18109-9512

    Description

    Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.

    Reason

    There is the potential of the residual moisture of the Diacap Ultra membrane being reduced over time, which results in the reduction of the membrane permeability (ultrafiltration coefficient).

    Action

    B. Braun Medical Inc. sent and "URGENT RECALL NOTICE" dated February 28, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Customer Support Department at (800) 848-2066 for questions regarding this issue. This recall was expanded on/about June 18, 2013 to include additional lot #s 305010113 and 305000113. Customers were notified via certified mail on/about June 14, 2013.

    Distribution

    Distribution and manufacturing dates for the expansion lots was reported as 5/23-6/14/2013 and 1/22-24/2013 respectively. Nationwide Distribution including the states of AZ, CA, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MN, MO, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, WA and WV.

    Quantity

    1580