BEUDAMED
    FDA Enforcement Class II Terminated

    Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15. 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-0332-2013 · Reported November 28, 2012

    Enforcement

    Recall Number
    Z-0332-2013
    Event ID
    63581
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Superstat Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 28, 2012
    Initiation Date
    October 24, 2012
    Classification Date
    November 16, 2012
    Termination Date
    February 6, 2013
    Address
    2015 E University Dr, N/A, Rancho Dominguez, CA, 90220-6411, United States

    Description

    Superstat Modified Collagen Hemostatic Sponge, 50mm Disc, 1.5%, Part# 9200-15. 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.

    Code Info

    Lot#R0117D, SSK03D.

    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