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Class 2 Device Recall Disposable Light Handle Cover |
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Date Initiated by Firm |
October 13, 2017 |
Create Date |
February 05, 2018 |
Recall Status1 |
Terminated 3 on July 22, 2020 |
Recall Number |
Z-0523-2018 |
Recall Event ID |
78419 |
Product Classification |
Light, surgical, accessories - Product Code FTA
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Product |
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.
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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 |
Recalling Firm/ Manufacturer |
Ecolab, Inc. 940 Lone Oak Rd Saint Paul MN 55121-2214
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For Additional Information Contact |
Roman Blahoski 651-250-4385
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Manufacturer Reason for Recall |
Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Ecolab sent and Urgent Medical Device Recall letter dated October 13, 2017 to customers. The identified the affected product, problem and actions to be taken. Instructions include to immediately quarantine lots in inventory, notify customers since the product has been further distributed, return affected product, and complete and return the Recall Response Form. For questions call 903-597-2568. |
Quantity in Commerce |
5,958 cases (50 per case) |
Distribution |
Distributed domestically to Michigan. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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