BEUDAMED
    FDA Recall Terminated

    2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician.

    Recall: Z-2082-2013 · Initiated April 1, 2013

    Recall

    Recall Number
    Z-2082-2013
    Event Number
    65080
    Firm
    Fresenius Medical Care Holdings, Inc. dba Renal Solutions
    FEI Number
    3005778453
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 1, 2013
    Posted
    August 26, 2013
    Terminated
    March 2, 2015
    Address
    770 Commonwealth Dr, Ste 101, Warrendale, PA, 15086-7521

    Description

    2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician.

    Reason

    Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, and the 2008 MeDS pump tubing Set for CombiSet Bloodlines can lead to a situation where Venofer(R) delivery does not meet dosage accuracy requirements. This may lead to a slight over or under delivery of Venofer(R) that does not pose an acceptable risk to the patient. Please note that this recall

    Action

    Renal Solutions sent an Urgent Notification letter dated April 1, 2013 via certified mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to cease further use of the device. The letter informed customers that a Fresenius Medical Care Technical Service/Customer Service representative will contact customers to arrange for removal of the device. For questions contact Fresenius Medical Care Customer Service at 800-227-2572.

    Distribution

    USA Nationwide Distribution in the states of CA, MA, and NY.

    Quantity

    132