BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2487-2019 · Initiated July 23, 2019

    Recall

    Recall Number
    Z-2487-2019
    Event Number
    83523
    Firm
    Instrumentation Laboratory Co.
    FEI Number
    1217183
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 23, 2019
    Terminated
    April 27, 2020
    Address
    180 Hartwell Rd, Bedford, MA, 01730-2443

    Description

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

    Reason

    Prolonged clotting times

    Action

    -Check your inventory for Lot No. 42255901 / 42255801 and destroy all remaining material. - Document the destruction on the Mandatory Tracking Response Record and return the completed and signed form to the fax number or e-mail address listed on the next page. -Contact your local representative for an alternative product lot of ROTEM ex-tem, Part No. 503-05-US / 503-05-CA. -Share this information with your laboratory staff and follow your internal procedures. -Forward this notification to all affected locations within your facility. -Retain a copy of this notification for your records. -Return the completed and signed form confirming lot destruction and quantities to: FAX No. 781-861-4207 or Email: [email protected] For Technical Questions: Call ROTEM PBM Technical Support Center at 1-800-678-0710, Option # 4 For Replacement Lot: Call IL Customer Service Center at 1-800-955-9525, Option # 0

    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