BEUDAMED
    FDA Enforcement Class II Ongoing

    FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring.

    Recall: Z-0412-2024 · Reported December 6, 2023

    Enforcement

    Recall Number
    Z-0412-2024
    Event ID
    93279
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 6, 2023
    Initiation Date
    October 4, 2023
    Classification Date
    November 29, 2023
    Address
    1 Edwards Way, Irvine, CA, 92614-5688, United States

    Description

    FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring.

    Reason

    Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.

    Code Info

    MHD6AZ: UDI:00690103194722, Lot #: 64818047 64858313 64891437 64953982 MHD6AZ5: UDI: 00690103194746, Lot #: 64782419 64882668 64912054 64918246 64933574 64988043 65007223 65007224; MHD6C502: UDI: 00690103194760, Lot #: 64951410

    Distribution

    US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam

    Quantity

    11,072 units