BEUDAMED
    FDA Recall Terminated

    MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.

    Recall: Z-2735-2015 · Initiated August 18, 2015

    Recall

    Recall Number
    Z-2735-2015
    Event Number
    72025
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    KDI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 18, 2015
    Posted
    September 4, 2015
    Terminated
    May 9, 2016
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist to manage the patient's hematocrit and fluid status.

    Reason

    Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is below product specification. These potentially affected units have been distributed as stand-alone devices and in specific lots of Medtronic Perfusion Tubing packs.

    Action

    Consignees were sent a Medtronic "Urgent Medical Device Recall" letter dated August 2015. The letter was addressed to "Risk Manager". The letter described the problem and the product involved in the recall. Informed consignees that no action is needed for product that has been used, but patients should continue to be managed in accordance with their standard patient management protocol. For unused product they recommend to immediately quarantine and return the affected product to Medtronic. Contact Customer Service at 800-854-3570 and reference RADAR #253277 to initiated a return and credit of product. Requested consignees to complete the Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. If the product has been forwarded to another facility, consignees are advised to notify that facility. For questions contact Medtronic Lifeline Technical Services at 877-526-7890 or your Medtronic representative.

    Distribution

    Worldwide Distribution-US (nationwide) including the states of AL, AR, CA, CO, FL, HI, ID, IN, KS, LA, MA, MS, MO, NY, NJ, OH, PA, TN, TX, UT, and WI, and the countries of Bolivia, Denmark, Dominican Republic, Italy, Latvia, Lebanon, Mexico, Panama, Singapore, Venezuela, and Zambia.

    Quantity

    1594 total (1306 US, 288 OUS)