BEUDAMED
    FDA Recall Terminated

    Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant.

    Recall: Z-1614-2012 · Initiated July 28, 2011

    Recall

    Recall Number
    Z-1614-2012
    Event Number
    59861
    FEI Number
    3000121413
    Product Code
    NBE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 28, 2011
    Posted
    May 16, 2012
    Terminated
    May 31, 2012
    Address
    Building 3 Baxter Healthcare Services L.P. 1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Coseal Surgical Sealant. Coseal is an adjunctive surgical sealant.

    Reason

    The recall is being conducted as a precautionary measure due to out of specification results observed at the 24 months time point (out of 24-month licensed shelf life to expiration) during a Coseal stability study. The parameter that is out specification is an indicator of possible failure for the product to gel appropriately . Coseal's failure to gel does not represent risk for the patient's life

    Action

    Baxter Healthcare sent an"URGENT PRODUCT RECALL" letter dated July 27, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately stop the usage/distribution of the affected product and to quarantine any units that are in inventory. Instructions for obtaining replacement product were attached to the letter. Contact the firm at 1-800-423-2090 for questions concerning this recall.

    Distribution

    Nationwide Distribution.

    Quantity

    11160