BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1379-2015 · Initiated October 23, 2014

    Recall

    Recall Number
    Z-1379-2015
    Event Number
    70690
    Firm
    TEM Systems Inc
    FEI Number
    3008366794
    Product Code
    JPA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 23, 2014
    Posted
    April 3, 2015
    Terminated
    August 13, 2015
    Address
    4309 Emperor Blvd, Ste 100, Durham, NC, 27703-8069

    Description

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

    Reason

    Some of vials were found to be partially filled.

    Action

    Tem sent an Dear Customer letter dated October 23, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You are entitled to return products delivered to you in the event that they are defective or otherwise not in conformity with your order when you received them. If you observe a low level of diluent in a box of Rotrol P lot number 41819801 at your location, please contact us for a free of charge replacement box from a new lot of Rotrol P. You can reach us at: Email: [email protected] Phone: 919-941-7777, Option 2 Toll Free: 1-866-597-1652, Option 2 We apologize for any inconvenience you may experience.

    Distribution

    Nationwide Distribution

    Quantity

    Total 1574 x 5 vials per box