BEUDAMED
    FDA Enforcement Class II 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 · Reported April 23, 2014

    Enforcement

    Recall Number
    Z-1455-2014
    Event ID
    67797
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Gambro Renal Products, Incorporated
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 23, 2014
    Initiation Date
    December 9, 2013
    Classification Date
    April 11, 2014
    Termination Date
    December 22, 2015
    Address
    14143 Denver West Pkwy, N/A, Lakewood, CO, 80401-3266, United States

    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.

    Code Info

    Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553

    Distribution

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

    Quantity

    306,525 sets (20435 boxes of 15 sets)