BEUDAMED
    FDA Recall Terminated

    Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    Recall: Z-0337-2013 · Initiated October 24, 2012

    Recall

    Recall Number
    Z-0337-2013
    Event Number
    63581
    Firm
    Superstat Corp
    FEI Number
    3001452136
    Product Code
    LMF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 24, 2012
    Posted
    November 16, 2012
    Terminated
    February 6, 2013
    Address
    2015 E University Dr, Rancho Dominguez, CA, 90220-6411

    Description

    Superstat Modified Collagen Hemostatic Sponge, 2x2 Pledget, 3.0%, Part# 9106-00. For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques

    Reason

    The recall was initiated because Superstat Corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the Superstat Modified Collagen Hemostatic Sponge.

    Action

    Superstat initially contacted customers by telephone and sent an Urgent - Device Recall Notification Letter on October 24, 2012, to all affected customers. The recall letter provided the reason for recall was due to inadequate documentation of quarterly dose sterility audits. The recall includes all lots and part numbers of Superstat produced between 2002 and 2012. Customers are instructed to complete and return the enclosed response form as soon as possible. Customers with questions are instructed to call customer service at (800) 487-3786. For questions regarding this recall call 310-605-1655.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore.

    Quantity

    26,422 units