BEUDAMED
    FDA Recall Terminated

    IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtronic Perfusion Systems, Model TS9453R29, TS9453R30, TS1470R1, TS1442R1, TS9800R32, TS8299R4.

    Recall: Z-0868-2010 · Initiated December 14, 2009

    Recall

    Recall Number
    Z-0868-2010
    Event Number
    54237
    Firm
    Medtronic Inc
    FEI Number
    3001504994
    Product Code
    KRI
    Status
    Terminated
    Root Cause
    Incorrect or no expiration date
    Initiated
    December 14, 2009
    Posted
    February 26, 2010
    Terminated
    April 20, 2011
    Address
    710 Medtronic Pkwy, Minneapolis, MN, 55432-5603

    Description

    IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtronic Perfusion Systems, Model TS9453R29, TS9453R30, TS1470R1, TS1442R1, TS9800R32, TS8299R4.

    Reason

    Medtronic has identified a small number of Autotransfusion One Source Kits and MAXPAC/Total System lots with incorrect Use Before Dates (UBD) on the outer kit package label. The UBD on the outer label of the kit/pack does not accurately reflect the UBD of the components within the kit/Pack. For affected product, the outer label lists a date which may be later than the USB of the components inclu

    Action

    Consignees were sent a Medtronic "Urgent Medical Device Recall Notice" dated December 14, 2009. The letter was addressed to "Valued Customer." The letter described the product and the problem and requested them to quarantine the product and to complete and sign the attached certificate, "Medtronic Recall Certificate (FCA 1002)." For additional information, contact the firm at 763-514-9605.

    Distribution

    CA, CO, JAPAN, CHINA.

    Quantity

    24