BEUDAMED
    FDA Recall 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 · Initiated May 12, 2016

    Recall

    Recall Number
    Z-1839-2016
    Event Number
    74139
    Firm
    Baxter Healthcare Corp
    FEI Number
    2937398
    Product Code
    NBE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 12, 2016
    Posted
    May 31, 2016
    Terminated
    March 23, 2017
    Address
    21026 Alexander Ct, Hayward, CA, 94545-1234

    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.

    Action

    An Urgent Product Recall letter dated 5/13/16 was sent to customers to inform them that Baxter Healthcare Corporation is issuing a voluntary product recall for the product codes and lots listed below due to the 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. The letter provides the customers with the list of affected products, hazards involved, and actions to be taken. Customers with questions regarding the recall communication, are instructed to contact Baxter Product Surveillance at (800) 437-5176, 8-5pm, Monday-Friday.

    Distribution

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

    Quantity

    6,804 units