BEUDAMED
    FDA Enforcement Class II Terminated

    ROTEM ex-tem Rest of the world part No: 503-05 (ROW)

    Recall: Z-2487-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2487-2019
    Event ID
    83523
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Instrumentation Laboratory Co.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2019
    Initiation Date
    July 23, 2019
    Classification Date
    September 6, 2019
    Termination Date
    April 27, 2020
    Address
    180 Hartwell Rd, Bedford, MA, 01730-2443, United States

    Description

    ROTEM ex-tem Rest of the world part No: 503-05 (ROW)

    Reason

    Prolonged clotting times

    Code Info

    Lot # : 42255701

    Distribution

    States: IL WI MI Canada, Spain, Portugal, Poland, Italy, Israel, Switzerland, Denmark, Kazakhstan, United Kingdom, Germany, Netherlands, Belgium, France, Jordan, India, Hong Kong, Austria, Czechia, Australia, Sri Lanka, Argentina, Vietnam, Singapore, Japan, South Korea, Cyprus, Ireland, Hungary, Sweden, Serbia.

    Quantity

    722 kits