BEUDAMED
    FDA Enforcement Class II Terminated

    Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Wood Applicator Swab, all lots, 100 and 200 per pack culture collection and industrial surfaces

    Recall: Z-1521-2014 · Reported May 7, 2014

    Enforcement

    Recall Number
    Z-1521-2014
    Event ID
    67786
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fisher Scientific Co
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 7, 2014
    Initiation Date
    February 5, 2014
    Classification Date
    April 28, 2014
    Termination Date
    August 10, 2015
    Address
    300 Industry Dr, Pittsburgh, PA, 15275-1001, United States

    Description

    Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Aluminum Applicator Swab, .025 and .035 in Diameter, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Plastic Applicator Swab, all lots, 100 per pack Fisherbrand Sterile Swabs, Calcium Alginate Fiber Tipped Wood Applicator Swab, all lots, 100 and 200 per pack culture collection and industrial surfaces

    Reason

    A customer reported the presence of an organism in a lot of Calcium Alginate Fiber Tipped Wood Applicator Swab.

    Code Info

    all lots of article nos. 14-959-77, 14-959-78, 14-959-79, 14-959-81, 14-959-82, lots 60151, 61513, 61933, 62768, 63055, 60752, 61324, 62195, 63224, 60752, 62195, 61866, 62546, 8710, with expiration dates August 2014 through October 2015

    Distribution

    Nationwide Distribution

    Quantity

    7430