BEUDAMED
    FDA Recall Terminated

    Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7

    Recall: Z-0844-2011 · Initiated November 19, 2010

    Recall

    Recall Number
    Z-0844-2011
    Event Number
    57293
    Firm
    Fresenius Medical Care Holdings, Inc.
    FEI Number
    3001451489
    Product Code
    FJK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 19, 2010
    Posted
    January 10, 2011
    Terminated
    November 3, 2012
    Address
    920 Winter St, Waltham, MA, 02451-1521

    Description

    Fresenius Medical CombiSet BVM Hemodialysis Blood Tubing Set P/N: 03-2795-7

    Reason

    Hemodialysis Blood tubing Sets may develop kinking of the arterial line.

    Action

    Fresenius Medical issued recall notification dated 11/19/10, "URGENT RECALL FMCNA Combiset BVM Hemodialysis Blood Tubing Sets (Part Numbers 03-2695-9 and 03-27957)", by certified mail with return receipt. Customers have been instructed to check their stock immediately to determine if they have any affected lots on hand. If customers have the affected lots, they have been instructed to discontinue use immediately and place the product in a secure segregated area for return to Fresenius Medical Care North America. Customers have been instructed to contact Fresenius Medical Care Customer Service Team Representative for instructions on how to return the recalled product.

    Distribution

    Distribution Nationwide and Canada

    Quantity

    10, 032 units (418 cases x 24 units)