BEUDAMED
    FDA Recall Terminated

    Medtronic HMS PLUS, Hemostasis Management System, Model 30514. It is a microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.

    Recall: Z-1070-2010 · Initiated December 14, 2009

    Recall

    Recall Number
    Z-1070-2010
    Event Number
    54251
    Firm
    Medtronic Inc
    FEI Number
    3001504994
    Product Code
    JOX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 14, 2009
    Posted
    March 11, 2010
    Terminated
    December 24, 2011
    Address
    710 Medtronic Pkwy, Minneapolis, MN, 55432-5603

    Description

    Medtronic HMS PLUS, Hemostasis Management System, Model 30514. It is a microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.

    Reason

    Recently the US Food and Drug Administration (FDA) issued an alert, communicating a change in the United States Pharmacopeia (USP) monograph for heparin, introducing a new USP reference standard that will in effect, change potency, and harmonize the USP unit dose with the WHO International Standard (IU) unit dose. Users of the Medtronic Hemostasis Management System (HMS Plus) must be aware o

    Action

    Consignees were sent a Medtronic "Urgent Medical Device Notice' dated December 14, 2009. The letter was addressed to "Valued Customer". The letter described the product and the problem. Advised customers to configure the HMS Plus appropriately. The Field Notification was sent to all current HMS Plus users. The current HMS Plus users were identified by the sales of HMS Plus disposable product -Heparin Assay Cartridges from the period of August 1, 2008 to date. This time was considered appropriate, being more than twice the longest expiration date of any of the HMS disposable.

    Distribution

    All states in USA (Including DC) except RI and VT.

    Quantity

    580