BEUDAMED
    FDA Enforcement Class II Ongoing

    Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072

    Recall: Z-0657-2024 · Reported January 17, 2024

    Enforcement

    Recall Number
    Z-0657-2024
    Event ID
    93503
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Baxter Healthcare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 17, 2024
    Initiation Date
    December 6, 2023
    Classification Date
    January 5, 2024
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625, United States

    Description

    Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072

    Reason

    Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).

    Code Info

    All serial numbers a) Product code 934070, UDI/DI 5413765404610; b) Product code 934071, UDI/DI 5413765404627; c) Product code 934072, have no UDI/DI.

    Distribution

    US Nationwide distribution.