BEUDAMED
    FDA Recall Terminated

    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    Recall: Z-2246-2017 · Initiated April 28, 2014

    Recall

    Recall Number
    Z-2246-2017
    Event Number
    76394
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    KDJ
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    April 28, 2014
    Posted
    June 2, 2017
    Terminated
    July 21, 2017
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    Reason

    Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis.

    Action

    On April 28, 2014, firm sent an Urgent Product Recall to US customers via USPS 1st class mail. Baxter requested customers to locate and remove all affected product from their facility, and contact Baxter Healthcare Center for Service to arrange for return and credit. 100%, all non-respondents would be contacted by phone. All affected product would be destroyed. For general questions regarding this communication , contact The Center for One Baxter at 1-800-422-9837 , Monday through Friday, between the hours of 8:00AM and 5:00 PM Central Time.

    Distribution

    Nationwide Distribution and Internationally to Canada and Malaysia

    Quantity

    6,048