BEUDAMED
    FDA Enforcement Class II Terminated

    Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated mailer box. Product Usage: Intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. Single use device.

    Recall: Z-0523-2018 · Reported February 14, 2018

    Enforcement

    Recall Number
    Z-0523-2018
    Event ID
    78419
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ecolab, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2018
    Initiation Date
    October 13, 2017
    Classification Date
    February 5, 2018
    Termination Date
    July 22, 2020
    Address
    940 Lone Oak Rd, N/A, Saint Paul, MN, 55121-2214, United States

    Description

    Disposable Light Handle Cover, Item Number B1-715-65. Packaged 1 device inside a peel pouch and sealed. Sealed pouches are packaged 10 each inside a poly liner. 5 rows of 10 pouches are placed in a labeled corrugated mailer box. Product Usage: Intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. Single use device.

    Reason

    Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.

    Code Info

    Model/Item/Part No. B1-715-65, Lot Numbers: 14224, 14225, 14226, 14237, 14238, 14239, 14240, 14255, 14253, 14254, 14252, 14261, 14266, 14260, 14265, 14262, 14279, 14276, 14269, 14275, 14273, 14258, 14274, 14281, 14286, 14287, 14283, 14282, 14288, 14272, 14280, 14289, 14308, 14307, 14309, 14310, 14311, 14337, 14342, 14335, 14338, 14345, 14346, 14336, 14343, 14339, 14344, 15015, 15013, 15019, 15020, 15021, 15022, 15030, 15029, 15028, 15033, 15036, 15037, 15035, 15034, 15041, 15043, 15042, 15044, 15055, 15048, 15056, 15054, 15083, 15078, 15072, 15082, 15070, 15068, 15079, 15142, 15146, 15154, 15149, 15148, 15153, 15147, 15084, 15047, 15049, 15085, 15026, 15086, 15012, 15051, 15009, 15027, 15091, 15090, 15092, 15096, 15050, 15098, 15089, 15097, 15100, 15216, 15218, 15103, 15224, 15212, 15211, 15215, 15222, 15231, 15239, 15240, 15232, 15229, 15230, 15243, 15226, 15237, 15252, 15261, 15266, 15247, 15251, 15264, 15265, 15272, 15275, 15274, 15268, 15267, 15279, 15271, 15280, 15286, 15282, 15296, 15295, 15300, 15301, 15306, 15294, 15302, 15308, 15313, 15315, 15317, 15322, 15321, 15316, 15323, 15328, 15336, 15334, 15327, 15324, 15337, 15342, 15357, 16006, 16008, 15351, 15352, 16007, 15341, 16071, 15343, 15344, 16076, 16078, 16089, 16081, 16082, 16083, 16091, 16092, 16109, 16103, 16106, 16110, 16099, 16098, 16116, 16134, 16139, 16144, 16137, 16140, 16141, 16145, 16172, 16174, 16176, 16173, 16175, 16168, 16190, 16169, 16193, 16194, 16195, 16196, 16217, 16221, 16222, 16223, 16229, 16224, 16225, 16228, 16245, 16232, 16230, 16235, 16236, 16237, 16242, 16251, 16252, 16208, 16210, 16209, 16214, 16211, 16257, 16253, 16256, 16258, 16270, 16271, 16272, 16273, 16277, 16349, 16350, 16354, 16351, 16355, 16356, 17002, 16357, 17011, 17004, 17009, 17012, 17040, 17013, 17041, 17039, 17045, 17046, 17044, 17052, 17053, 17058, 17054, 17060, 17061, 17065, 17066, 17081, 17086, 17089, 17093, 17094, 17090, 17095, 17088, 17097, 17177, 17100, 17186, 17180, 17188, 17192, 17191

    Distribution

    Distributed domestically to Michigan.

    Quantity

    5,958 cases (50 per case)