BEUDAMED
    FDA Enforcement Class II Terminated

    Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures.

    Recall: Z-1451-2013 · Reported June 12, 2013

    Enforcement

    Recall Number
    Z-1451-2013
    Event ID
    65160
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maytex Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2013
    Initiation Date
    May 15, 2013
    Classification Date
    June 4, 2013
    Termination Date
    October 29, 2013
    Address
    23521 Foley St, N/A, Hayward, CA, 94545-1676, United States

    Description

    Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 3100P, # 3100G, # 3100Y, # 3100W; Product is manufactured and distributed by Maytex Corporation, CA Ear-loop face mask for basic medical/dental procedures.

    Reason

    Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard of "Differential Pressure of only 1.6 Delta P (mm H2O/cm2)" as indicated on the box/package of the product; and also product manufactured between 2008 - 2012 cannot be guaranteed as Fluid Resistant.

    Code Info

    All cases of item #: 3100 face mask with PO #. PO #, Date of receipt: 809-01, 2/5/08; 837-02, 7/29/08; 852-03, 10/10/08; 901-01, 2/3/09; 921-02, 6/8/09; 923-03, 7/8/09; 926-04, 8/26/09; 931-05, 11/10/09; 942-06, 12/16/09; 001-01, 2/17/10; 003-03, 4/12/10; 002-02 , 3/24/10; 003-03A, 7/23/10; 042-04, 11/29/10; 105-01, 1/31/11; 117-02, 4/29/11; 127/03, 7/8/11; 147-04, 12/16/11; 202-01, 3/8/2012; 224-02, 5/24/2012; 235-03, 9/12/2012; 253-04 , 12//192012

    Distribution

    Worldwide distribution: USA (nationwide) including states of: AL, AZ, CA, CO, FL, GA, HI, ID, IL, IN, MA, MD, ME, MI, MN, MO, MT, NE, NH, NJ, NM, NY, OK, OR, PA, PR, TN, TX, UT, WA, and WI; and country of: Mexico.

    Quantity

    43,915 Cases