BEUDAMED
    FDA Enforcement Class II Terminated

    safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1

    Recall: Z-2248-2020 · Reported June 10, 2020

    Enforcement

    Recall Number
    Z-2248-2020
    Event ID
    85478
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Radiometer Medical ApS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 10, 2020
    Initiation Date
    March 17, 2020
    Classification Date
    June 2, 2020
    Termination Date
    July 28, 2022
    Address
    Akandevej 21, N/A, Bronshoj, N/A, N/A, Denmark

    Description

    safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1

    Reason

    The SafeCLINITUBES blood sampler may have insufficient aspiration capabilities ultimately resulting in lost samples.

    Code Info

    Lot numbers: R1431 - R1495

    Distribution

    U.S.: AK, AL, AR, CA, CO, CT, FL,GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, and WI. OUS: Australia (New Zealand), Austria, Brazil Canada, China, Czech Republic (Slovakia), Denmark, Dubai (United Arab Emirates), Egypt, Finland, France, Germany, Hong Kong, Hungary, Iceland, India, Ireland, Italy, Japan, Kazakhstan, Lithuania, Malawi, Malaysia, Mauritius, Netherlands (Belgium), Nicaragua, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Sweden, Switzerland, Turkey (Cyprus), and United Kingdom.

    Quantity

    269 units