BEUDAMED
    FDA Enforcement Class II Terminated

    Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501 *NOT DISTRIBUTED WITHIN THE US

    Recall: Z-2283-2021 · Reported August 18, 2021

    Enforcement

    Recall Number
    Z-2283-2021
    Event ID
    88270
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 18, 2021
    Initiation Date
    July 9, 2021
    Classification Date
    August 12, 2021
    Termination Date
    January 29, 2024
    Address
    1 Edwards Way, N/A, Irvine, CA, 92614-5688, United States

    Description

    Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501 *NOT DISTRIBUTED WITHIN THE US

    Reason

    There is a potential for internal leaks within catheters.

    Code Info

    Lot Numbers: 62489900, 62505764, 62544663, 62706301, 62714762, 62889054, 62889102, 63091148

    Distribution

    US: CA, TX, FL, AZ, PA, IN, NY, NJ, MI, WA, MD, OH, FL, OUS: Japan, Mexico, Brazil, Colombia, Taiwan, India, Poland, Germany, United Arab Emirates, Israel, Switzerland, Bahrain, Iman, Tunisia, Austria, Belgium, France, Netherlands, Italy, Spain, Canary Islands, Portugal, Greece, Costa Rica, Canada

    Quantity

    152 units