BEUDAMED
    FDA Enforcement Class II Terminated

    Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient.

    Recall: Z-1955-2013 · Reported August 21, 2013

    Enforcement

    Recall Number
    Z-1955-2013
    Event ID
    65822
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Fisher Scientific Co
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 21, 2013
    Initiation Date
    June 5, 2013
    Classification Date
    August 12, 2013
    Termination Date
    October 20, 2014
    Address
    300 Industry Dr, Pittsburgh, PA, 15275-1001, United States

    Description

    Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. Used in applying medications to or take specimens from a patient.

    Reason

    The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. The finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure.

    Code Info

    Product code # 14-959-81, lot #61513, expiration date: 2014-08, and lot 8710, expiration date 2014-08.

    Distribution

    Nationwide and the country of Canada.

    Quantity

    1230