BEUDAMED
    FDA Recall Terminated

    Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems.

    Recall: Z-1455-2014 · Initiated December 9, 2013

    Recall

    Recall Number
    Z-1455-2014
    Event Number
    67797
    Firm
    Gambro Renal Products, Incorporated
    FEI Number
    1713683
    Product Code
    FJK
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 9, 2013
    Posted
    April 11, 2014
    Terminated
    December 22, 2015
    Address
    14143 Denver West Pkwy, Lakewood, CO, 80401-3266

    Description

    Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems.

    Reason

    Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.

    Action

    On 12/9/13 and 3/12/14, a field safety notice sent via UPS overnight delivery informing customers of issue and if any customer wants to return product, a hold at distribution centers and manufacturer quarantine areas. Upon reconciliation of returned product a destruction disposition with certification.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.

    Quantity

    306,525 sets (20435 boxes of 15 sets)