Z-0523-2018 Class II Terminated

Recalled by Ecolab, Inc. — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
February 14, 2018
Initiation Date
October 13, 2017
Termination Date
July 22, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,958 cases (50 per case)

Product 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 for Recall

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

Distribution Pattern

Distributed domestically to Michigan.

Code Information

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