BEUDAMED
    FDA Enforcement Class II Terminated

    COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

    Recall: Z-1839-2016 · Reported June 8, 2016

    Enforcement

    Recall Number
    Z-1839-2016
    Event ID
    74139
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2016
    Initiation Date
    May 12, 2016
    Classification Date
    May 31, 2016
    Termination Date
    March 23, 2017
    Address
    21026 Alexander Ct, N/A, Hayward, CA, 94545-1234, United States

    Description

    COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

    Reason

    Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.

    Code Info

    HA160151, HA151205, HA151036, HA151035, HA160229

    Distribution

    Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.

    Quantity

    6,804 units