BEUDAMED
    FDA Recall Terminated

    Calcium Sulfate Hemihydrate 1.0 gram kits.

    Recall: Z-1806-2010 · Initiated May 14, 2010

    Recall

    Recall Number
    Z-1806-2010
    Event Number
    55698
    Firm
    Ace Surgical Supply Co., Inc.
    FEI Number
    1287163
    Product Code
    LYC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 14, 2010
    Posted
    June 16, 2010
    Terminated
    February 2, 2012
    Address
    1034 Pearl St, Brockton, MA, 02301

    Description

    Calcium Sulfate Hemihydrate 1.0 gram kits.

    Reason

    Fast set 4% potassium sulfate solution may not be sterile. For customers who have used the Calcium Sulfate Hemihydrate kit without the Fast Set solution, then these potential risks identified do not apply. Risks of adverse health consequences with the Fast Set 4% potassium sulfate solution include tissue inflammation and infection.

    Action

    Ace Surgical has become aware through internal review of possibility sterility issues with one of the components included in the Calcium Hemihydrate 0.5 and 1.0 gram kits. Customers with questions should contact ACE Surgical using the recall hot line at (800) 441-3100 Ext. 204.

    Distribution

    Class 2 recall - Worldwide distribution . Item Number 505-2001: South Africa, Australia, Vietnam, Ontario, Canada, Italy, Lebanon, Petaling Jaya, Malaysia, Portugal, and West Indies. Item Number 505-2002: Australia, Bermuda, Canada, Lebanon, Petaling Jaya, Malaysia, and Portugal.

    Quantity

    7930