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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78419

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 13, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ecolab, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0523-2018
Recall number
Z-0523-2018
Initiated
October 13, 2017
Classification
Class II
Status
Terminated
Recalling firm
Ecolab, Inc.
Quantity
5,958 cases (50 per case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

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

Distribution pattern

Distributed domestically to Michigan.