BEUDAMED
    FDA Enforcement Class II Terminated

    ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.

    Recall: Z-1379-2015 · Reported April 15, 2015

    Enforcement

    Recall Number
    Z-1379-2015
    Event ID
    70690
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TEM Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 15, 2015
    Initiation Date
    October 23, 2014
    Classification Date
    April 3, 2015
    Termination Date
    August 13, 2015
    Address
    4309 Emperor Blvd Ste 100, N/A, Durham, NC, 27703-8069, United States

    Description

    ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.

    Reason

    Some of vials were found to be partially filled.

    Code Info

    Article number 503-25 (US ROTROL P), Lot no. 41819801, exp date 2016-11 and Lot no. 41855701, exp date 2017-06.

    Distribution

    Nationwide Distribution

    Quantity

    Total 1574 x 5 vials per box