BEUDAMED
    FDA Recall Terminated

    Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062

    Recall: Z-0944-03 · Initiated June 3, 2003

    Recall

    Recall Number
    Z-0944-03
    Event Number
    26382
    Firm
    Safco Dental Supply Co. Inc.
    FEI Number
    1416277
    Product Code
    FXX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 3, 2003
    Posted
    June 21, 2003
    Terminated
    March 24, 2004
    Address
    2121 Shermer, Northbrook, IL, 60062

    Description

    Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062

    Reason

    The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.

    Action

    Recalled by letter dated 5/30/03, informing the dentists that the earloop masks were mislabled with the wrong particle filtration efficiency. Correction labels were included with the letter for the dentists to field correct the boxes of masks in their office inventory.

    Distribution

    Nationwide

    Quantity

    60,000 boxes