CLASS II ONGOING Device recall · Reported 6 Jul 2022 · FDA Enforcement Report

Sensica Urine Output System recalled by C.R. Bard

C.R. Bard is recalling Sensica Urine Output System, distributed nationwide in the US. The recall was initiated on 19 May 2022 and the FDA has classified it as Class II.

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Lot, batch or date codesUDI: (01) 0 0801741215773; Catalog Number: SCCS1002 (Lot Numbers: BMFURMSF03, BMFURMSF07, BMFURMSF08, BMFURMSF10, BMFURMSF12, BMFURMSF13, BMFURMSF15, BMFURMSF16, BMFURMSF18, BMFURMSF19, BMFURMSF20, BMFURMSF22, BMFURMSF23, BMFURMSF24, BMFURMSF25, BMFURMSF26, BMFURMSF27, BMFURMSF28, BMFURMSF29, BMFURMSF30, BMFURMSF31, BMFURMSF32, BMFURMSF33, BMFURMSF34, BMFURMSF35, BMFURMSF36, BMFURMSF37, BMFURMSF38, BMFURMSF39, BMFURMSF40, BMFURMSF41, BMFURMSF42, BMFURMSF43, BMFURMSF44, BMFURMSF45, BMFURMSF46, BMFURMSF47, BMFURMSF48, BMFURMSF49, BMFURMSF50, BMFURMSF51, BMFURMSF52, BMFURMSF53, BMFURMSF54, BMFURMSF55, BMFURMSF56, BMFURMSF57, BMFURMSF58, BMFURMSF59, BMFURMSF60, BMFVRMSQ82, BMFVRMSQ84, BMFVRMSQ85, BMFVRMSQ86, BMFVRMSQ87, BMFVRMSQ88, BMFVRMSQ92, BMFVRMSQ94, BMFVRMSQ95, BMFVRMSQ96, BMFVRMSQ97, BMFVRMSQ98, BMFVRMSQ99, BMFVRMSR00, BMFVRMSR01, BMFVRMSR02, BMFVRMSR05, BMFVRMSR06, BMFVRMSR07, BMFVRMSR08, BMFVRMSR09, BMFVRMSR10, BMFVRMSR11, BMFVRMSR12, BMFVRMSR13, BMFVRMSR14, BMFVRMSR15, BMFVRMSR19, BMFVRMSR20, BMFVRMSR22, BMFVRMSR23, BMFVRMSR24, BMFVRMSR25, BMFVRMSR26, BMFVRMSR27, BMFVRMSR28, BMFVRMSR29, BMFVRMSR31, BMFVRMSR34, BMFVRMSR36, BMFVRMSR37, BMFVRMSR38, BMFVRMSR39, BMFVRMSR40, BMFWRMSBR6, BMFWRMSBR7, BMFWRMSBR8, BMFWRMSBR9, BMFWRMSBS0, BMFWRMSBS1, BMFWRMSBS2, BMFWRMSBS3, BMFWRMSBS4, BMFWRMSBS5, BMFWRMSBS6, BMFWRMSBS7, BMFWRMSBS8, BMFWRMSBS9, BMFWRMSBT0, BMFWRMSBT1, BMFWRMSBT2, BMFWRMSBT3, BMFWRMSBT4, BMFWRMSBT5, BMFWRMSBT6, BMFWRMSBT7, BMFWRMSBT8, BMFWRMSBT9, BMFWRMSBU0, BMFWRMSBU1, BMFWRMSBU2, BMFWRMSBU3, BMFWRMSBU4, BMFWRMSBU5, BMFWRMSBU6, BMFWRMSBU7, BMFWRMSBU8, BMFWRMSBU9, BMFWRMSBV0, BMFWRMSBV1, BMFWRMSBV2, BMFWRMSBV3, BMFWRMSBV4, BMFWRMSBV5, BMFWRMSBV6, BMFWRMSBV7, BMFWRMSBV8, BMFWRMSBV9, BMFWRMSBW0, BMFWRMSBW1, BMFWRMSJ24, BMFWRMSJ25, BMFWRMSJ26, BMFWRMSJ28, BMFWRMSJ29, BMFWRMSJ30, BMFWRMSJ31, BMFWRMSJ32, BMFWRMSJ33, BMFWRMSJ34, BMFWRMSJ37, BMFWRMSJ38, BMFWRMSJ40, BMFWRMSJ42, BMFWRMSJ43, BMFWRMSJ45, BMFWRMSJ47, BMFWRMSJ48, BMFWRMSJ49, BMFWRMSJ50, BMFWRMSJ52, BMFWRMSJ53, BMFWRMSJ54, BMFWRMSJ55, BMFWRMSJ56, BMFWRMSJ57, BMFWRMSJ58, BMFWRMSJ59, BMFWRMSJ60, BMFWRMSJ61, BMFWRMSJ62, BMFWRMSJ63, BMFWRMSJ64, BMFWRMSJ65, BMFWRMSJ66, BMFWRMSJ67, BMFWRMSJ68, BMFWRMSJ69, BMFWRMSJ70, BMFWRMSJ71, BMFWRMSJ72, BMFWRMSJ73, BMFWRMSJ74, BMFWRMSJ75, BMFWRMSJ76, BMFWRMSJ77, BMFWRMSJ78, BMFWRMSJ79, BMFWRMSJ80, BMFWRMSJ81, BMFWRMSJ82, BMFWRMSJ83, BMFXRMSBA1, BMFXRMSBA2, BMFXRMSBA3, BMFXRMSBA4, BMFXRMSBA5, BMFXRMSBA6, BMFXRMSBA8, BMFXRMSBA9, BMFXRMSBB0, BMFXRMSBB1, BMFXRMSBB2, BMFXRMSBB3, BMFXRMSBB4, BMFXRMSBB5, BMFXRMSBB6, BMFXRMSBB7, BMFXRMSBB8, BMFXRMSBB9, BMFXRMSBC0, BMFXRMSBC1, BMFXRMSBC2, BMFXRMSBC3, BMFXRMSBC4, BMFXRMSBC5, BMFXRMSBC6, BMFXRMSBC7, BMFXRMSBC8, BMFXRMSBD0, BMFXRMSJ01, BMFXRMSJ02, BMFXRMSJ03, BMFXRMSJ04, BMFXRMSJ05, BMFXRMSJ06, BMFXRMSJ07, BMFXRMSJ08, BMFXRMSJ09, BMFXRMSJ10, BMFXRMSJ11, BMFXRMSJ12, BMFXRMSJ13, BMFXRMSJ14, BMFXRMSJ15, BMFXRMSJ16, BMFXRMSJ17, BMFXRMSJ18, BMFXRMSJ19, BMFXRMSJ20, BMFXRMSJ21, BMFXRMSJ22, BMFXRMSJ23, BMFXRMSJ24, BMFXRMSJ25, BMFXRMSJ26, BMFXRMSJ27, BMFXRMSJ28, BMFXRMSJ29, BMFXRMSJ30, BMFXRMSJ31, BMFXRMSJ32, BMFXRMSJ33, BMFXRMSJ34, BMFXRMSJ35, BMFXRMSJ36, BMFXRMSJ37, BMFXRMSJ38, BMFXRMSJ39, BMFXRMSJ40, BMFXRMSJ41, BMFXRMSJ42, BMFXRMSJ43, BMFXRMSJ44, BMFXRMSJ45, BMFXRMSJ46, BMFXRMSJ47, BMFXRMSJ48, BMFXRMSJ49, BMFXRMSJ50, BMFXRMSJ51, BMFXRMSJ52, BMFXRMSJ53, BMFXRMSJ54, BMFXRMSJ55, BMFXRMSJ56, BMFXRMSJ57, BMFXRMSJ58, BMFXRMSJ59, BMFXRMSJ60, BMFYRMSBA1, BMFYRMSBA2, BMFYRMSBA3, BMFYRMSBA4, BMFYRMSBA5, BMFYRMSBA6, BMFYRMSBA7, BMFYRMSBA8, BMFYRMSBA9, BMFYRMSBB0, BMFYRMSBB1, BMFYRMSBB2, BMFYRMSBB3, BMFYRMSBB4, BMFYRMSBB5, BMFYRMSBB6, BMFYRMSBB7, BMFYRMSBB8, BMFYRMSBB9, BMFYRMSBC0, BMFYRMSBC1, BMFYRMSBC2, BMFYRMSBC3, BMFYRMSBC4, BMFYRMSBC5, BMFYRMSBC6, BMFYRMSBC7, BMFYRMSBD0, BMFYRMSBD1, BMFYRMSBD2, BMFYRMSBD3, BMFYRMSBD4, BMFYRMSBD5, BMFYRMSBD6, BMFYRMSBD7, BMFYRMSBD8, BMFYRMSBD9, BMFYRMSBE0, BMFYRMSBE1, BMFYRMSBE2, BMFYRMSBE3, BMFYRMSBE4, BMFYRMSBE5, BMFYRMSBE6, BMFYRMSBE7, BMFYRMSBE8, BMFYRMSBE9, BMFYRMSBF0, BMFYRMSBF1, BMFYRMSBF2, BMFYRMSBF3, BMFYRMSBF4, BMFYRMSBF5, BMFYRMSBF6, BMFYRMSBF7, BMFYRMSBF8, BMFYRMSBF9, BMFYRMSBG0, BMFYRMSJ01, BMFYRMSJ02, BMFYRMSJ03, BMFYRMSJ04, BMFYRMSJ05, BMFYRMSJ06, BMFYRMSJ07, BMFYRMSJ08, BMFYRMSJ09, BMFYRMSJ10, BMFYRMSJ11, BMFYRMSJ12, BMFYRMSJ13, BMFYRMSJ14, BMFYRMSJ15, BMFYRMSJ16, BMFYRMSJ17, BMFYRMSJ18, BMFYRMSJ19, BMFYRMSJ20, BMFYRMSJ21, BMFYRMSJ22, BMFYRMSJ23, BMFYRMSJ24, BMFYRMSJ25, BMFYRMSJ26, BMFYRMSJ27, BMFYRMSJ28, BMFYRMSJ29, BMFYRMSJ30, BMFYRMSJ31, BMFYRMSJ32, BMFYRMSJ33, BMFYRMSJ34, BMFYRMSJ35, BMFYRMSJ36, BMFYRMSJ37, BMFYRMSJ38, BMFYRMSJ39, BMFYRMSJ40, BMFYRMSJ41, BMFYRMSJ42, BMFYRMSJ43, BMFYRMSJ44, BMFYRMSJ45, BMFYRMSJ46, BMFYRMSJ47, BMFYRMSJ48, BMFYRMSJ49, BMFYRMSJ50, BMFYRMSJ51, BMFYRMSJ52, BMFYRMSJ53, BMFYRMSJ54, BMFYRMSJ55, BMFYRMSJ56, BMFYRMSJ57, BMFYRMSJ58, BMFYRMSJ59, BMFYRMSJ60, BMFZRMS065, BMFZRMS066, BMFZRMS067, BMFZRMS068, BMFZRMS069, BMFZRMS070, BMFZRMS071, BMFZRMS072, BMFZRMS073, BMFZRMS074, BMFZRMS075, BMFZRMS076, BMFZRMS077, BMFZRMS078, BMFZRMS079, BMFZRMS080, BMFZRMS081, BMFZRMS082, BMFZRMS083, BMFZRMS084, BMFZRMS085, BMFZRMS086, BMFZRMS087, BMFZRMS088, BMFZRMS089, BMFZRMS090, BMFZRMS091, BMFZRMS092, BMFZRMS093, BMFZRMS094, BMFZRMS095, BMFZRMS096, BMFZRMS097, BMFZRMS098, BMFZRMS099, BMFZRMS100, BMFZRMS101, BMFZRMS102, BMFZRMS104, BMFZRMS105, BMFZRMS106, BMFZRMS107, BMFZRMS108, BMFZRMS109, BMFZRMS110, BMFZRMS111, BMFZRMS112, BMFZRMS113, BMFZRMS114, BMFZRMS115, BMFZRMS116, BMFZRMS117, BMFZRMS118, BMFZRMSH47, BMFZRMSH48, BMFZRMSH49, BMFZRMSH50, BMFZRMSH51, BMFZRMSH52, BMFZRMSH53, BMFZRMSH54, BMFZRMSH55, BMFZRMSH56, BMFZRMSH57, BMFZRMSH58, BMFZRMSH59, BMFZRMSH60, BMFZRMSH61, BMFZRMSH62, BMFZRMSH63, BMFZRMSH64, BMFZRMSH65, BMFZRMSH66, BMFZRMSH67, BMFZRMSH68, BMFZRMSH69, BMFZRMSH70, BMFZRMSH71, BMFZRMSH72, BMFZRMSH73, BMFZRMSH74, BMFZRMSH75, BMFZRMSH76, BMGNRMS001, BMGNRMS002, BMGNRMS003, BMGNRMS004, BMGNRMS005, BMGNRMS006, BMGNRMS007, BMGNRMS008, BMGNRMS009, BMGNRMS010, BMGNRMS011, BMGNRMS012, BMGNRMS013, BMGNRMS014, BMGNRMS015, BMGNRMS016, BMGNRMS018, BMGNRMS019, BMGNRMS020, BMGNRMS021, BMGNRMS022, BMGNRMS023, BMGNRMS024, BMGNRMS025, BMGNRMS026, BMGNRMS027, BMGNRMS028, BMGNRMS029, BMGNRMS030, BMGNRMS058, BMGNRMS059, BMGNRMS060, BMGNRMS061, BMGNRMS062, BMGNRMS063, BMGNRMS064, BMGNRMS065, BMGNRMS066, BMGNRMS067, BMGNRMS068, BMGNRMS069, BMGNRMS070, BMGNRMS071, BMGNRMS072, BMGNRMS073, BMGNRMS074, BMGNRMS075, BMGNRMS076, BMGNRMS077, BMGNRMS078, BMGNRMS079, BMGNRMS080, BMGNRMS081, BMGNRMS082, BMGNRMS083, BMGNRMS084, BMGNRMS085, BMGNRMS086, BMGNRMS087, BMGNRMSG52, BMGNRMSG53, BMGNRMSG54, BMGNRMSG55, BMGNRMSG56, BMGNRMSG57, BMGNRMSG58, BMGNRMSG59, BMGNRMSG60, BMGNRMSG61, BMGNRMSG62, BMGNRMSG63, BMGNRMSG64, BMGNRMSG65, BMGNRMSG66, BMGNRMSG67, BMGNRMSG68, BMGNRMSG69, BMGNRMSG70, BMGNRMSG71, BMGNRMSG72, BMGNRMSG73, BMGNRMSG74, BMGNRMSG75, BMGNRMSG76, BMGNRMSG77, BMGNRMSG78, BMGNRMSG79, BMGNRMSG80, BMGNRMSG81, BMFQRMYS038, BMFQRMYS040, BMFQRMYS023, BMFQRMYS028, BMFQRMYS030, BMFQRMYS033, BMFQRMYS034, BMFQRMYS037, BMFQRMYS021, BMFQRMYS022, BMFQRMYS031, BMFQRMYS032, BMFQRMYS035, BMFQRMYS036, BMFQRMYS039, BMFPRMYS005, BMFPRMYS015, BMFPRMYS020, BMFQRMYS025, BMFQRMYS026, BMFQRMYS029, BMFPRMYS003, BMFPRMYS001, BMFPRMYS002, BMFPRMYS013, BMFPRMYS014, BMFPRMYS017, BMFQRMYS024, BMFQRMYS027, BMFQRMS246, BMFPRMYS004, BMFPRMYS007, BMFPRMYS008, BMFPRMYS009, BMFPRMYS010, BMFPRMYS011, BMFPRMYS018, BMFQRMS238, BMFQRMS240, BMFQRMS244, BMFQRMS247, BMFQRMS248, BMFQRMS250, BMFQRMS253, BMFQRMS257, BMFQRMS267, BMFQRMS268, BMFQRMS272, BMFQRMS275, BMFQRMS276, BMFQRMS279, BMFQRMS280, BMFQRMS282, BMFQRMS284, BMFQRMS285, BMFQRMS286, BMFQRMS288, BMFQRMS289, BMFQRMS293, BMFQRMS294, BMFQRMS301, BMFQRMS306, BMFQRMS317, BMFQRMS324, BMFQRMS327, BMFQRMS328, BMFQRMS330, BMFQRMS334, BMFRRMS601, BMFRRMS602, BMFRRMS633, BMFRRMS645, BMFRRMS647, BMFRRMS656, BMFRRMS659, BMFRRMST97, BMFRRMSU02, BMFRRMSU05, BMFRRMSU06, BMFRRMSU09, BMFRRMSU11, BMFRRMSU12, BMFRRMSU19, BMFRRMSU24, BMFRRMSU28, BMFRRMSU34, BMFRRMSU37, BMFSRMSH84, BMFSRMSH88, BMFSRMSJ05, BMFRRMSU23, BMFPRMYS006, BMFPRMYS012, BMFQRMS241, BMFQRMS245, BMFQRMS255, BMFQRMS259, BMFQRMS270, BMFQRMS281, BMFQRMS283, BMFQRMS287, BMFQRMS290, BMFQRMS291, BMFQRMS292, BMFQRMS295, BMFQRMS296, BMFQRMS299, BMFQRMS300, BMFQRMS307, BMFQRMS308, BMFQRMS315, BMFQRMS320, BMFQRMS322, BMFQRMS325, BMFQRMS326, BMFQRMS329, BMFQRMS331, BMFQRMS332, BMFQRMS335, BMFRRMS603, BMFRRMS610, BMFRRMS621, BMFRRMS631, BMFRRMS646, BMFRRMS649, BMFRRMS657, BMFRRMS658, BMFRRMST91, BMFRRMST92, BMFRRMST96, BMFRRMST99, BMFRRMSU03, BMFRRMSU04, BMFRRMSU08, BMFRRMSU10, BMFRRMSU13, BMFRRMSU14, BMFRRMSU16, BMFRRMSU17, BMFRRMSU20, BMFSRMSH89, BMFSRMSJ35, BMFSRMSJ39, BMFRRMSU21, BMFRRMSU31, BMFRRMSU32, BMFRRMSU35, BMFRRMSU36, BMFRRMSU38, BMFRRMSU39, BMFRRMSU42, BMFRRMSU45, BMFSRMSH86, BMFQRMS231, BMFQRMS232, BMFQRMS235, BMFQRMS236, BMFQRMS239, BMFQRMS249, BMFQRMS251, BMFQRMS263, BMFQRMS264, BMFQRMS265, BMFQRMS273, BMFQRMS304, BMFQRMS310, BMFQRMS313, BMFQRMS314, BMFQRMS318, BMFQRMS321, BMFRRMS613, BMFRRMS617, BMFRRMS619, BMFRRMS622, BMFRRMS625, BMFRRMS632, BMFRRMS650, BMFRRMS651, BMFRRMS653, BMFRRMS655, BMFRRMST94, BMFRRMST98, BMFRRMSU01, BMFRRMSU15, BMFRRMSU25, BMFSRMSH91, BMFSRMSH92, BMFSRMSJ04, BMFSRMSJ08, BMFSRMSJ12, BMFSRMSJ16, BMFSRMSJ24, BMFSRMSJ40, BMFRRMSU27, BMFRRMSU29, BMFRRMSU33, BMFRRMSU40, BMFRRMSU44, BMFRRMSU47, BMFRRMSU48, BMFRRMSU50, BMFSRMSH72, BMFSRMSH76, BMFQRMS233, BMFQRMS234, BMFQRMS237, BMFQRMS242, BMFQRMS243, BMFQRMS252, BMFQRMS254, BMFQRMS256, BMFQRMS258, BMFQRMS260, BMFQRMS261, BMFQRMS266, BMFQRMS269, BMFQRMS271, BMFQRMS274, BMFQRMS297, BMFQRMS298, BMFQRMS302, BMFQRMS309, BMFQRMS319, BMFQRMS323, BMFQRMS333, BMFRRMS606, BMFRRMS607, BMFRRMS608, BMFRRMS614, BMFRRMS615, BMFRRMS618, BMFRRMS620, BMFRRMS623, BMFRRMS624, BMFRRMS652, BMFRRMS654, BMFRRMST93, BMFRRMST95, BMFRRMSU00, BMFRRMSU07, BMFRRMSU18, BMFRRMSU22, BMFRRMSU26, BMFRRMSU30, BMFRRMSU41, BMFRRMSU43, BMFRRMSU46, BMFRRMSU49, BMFRRMSU51, BMFRRMSU52, BMFSRMSH73, BMFSRMSH74, BMFSRMSH77, BMFSRMSH85, BMFSRMSH87, BMFSRMSH90, BMFSRMSH96, BMFSRMSJ41, BMFSRMSJ45, BMFSRMSJ46, BMFQRMS277, BMFQRMS278, BMFQRMS303, BMFRRMS604, BMFRRMS626, BMFRRMS629, BMFRRMS635, BMFRRMS636, BMFRRMS639, BMFRRMS641, BMFRRMS642, BMFSRMSJ11, BMFQRMS262, BMFQRMS305, BMFQRMS311, BMFQRMS312, BMFQRMS316, BMFRRMS605, BMFRRMS609, BMFRRMS611, BMFRRMS612, BMFRRMS616, BMFRRMS627, BMFRRMS628, BMFRRMS630, BMFRRMS634, BMFRRMS637, BMFRRMS638, BMFRRMS640, BMFRRMS643, BMFRRMS644, BMFRRMS648, BMFSRMSJ03, BMFSRMSJ10, BMFSRMSJ29, BMFSRMSH78, BMFSRMSH81, BMFSRMSH82, BMFSRMSJ00, BMFSRMSJ14, BMFSRMSH79, BMFSRMSH80, BMFSRMSH83, BMFSRMSH93, BMFSRMSJ15, BMFSRMSJ13, BMFSRMSJ27, BMFSRMSJ33, BMFSRMSJ34, BMFSRMSH75, BMFSRMSJ02, BMFSRMSJ06, BMFSRMSJ09, BMFSRMSJ19, BMFSRMSJ23, BMFSRMSJ28, BMFSRMSJ30, BMFSRMSJ07, BMFSRMSJ17, BMFSRMSJ21, BMFSRMSJ22, BMFSRMSJ25, BMFSRMSJ26, BMFSRMSJ32, BMFSRMSJ31, BMFSRMSJ18, BMFSRMSJ20, BMFSRMSJ43, BMFTRMS121, BMFSRMSJ38, BMFSRMSJ44, BMFSRMSJ37, BMFTRMS108, BMFTRMS114, BMFTRMS142, BMFSRMSJ36, BMFSRMSJ42, BMFTRMS106, BMFTRMS109, BMFTRMS138, BMFSRMSH94, BMFSRMSH99, BMFSRMSH97, BMFTRMS122, BMFTRMS135, BMFTRMS136, BMFVRMSQ68, BMFSRMSH95, BMFSRMSH98, BMFSRMSJ01, BMFTRMS120, BMFTRMS123, BMFTRMS137, BMFVRMSQ62, BMFVRMSQ66, BMFTRMS140, BMFVRMSQ63, BMFVRMSQ64, BMFVRMSQ77, BMFVRMSQ78, BMFVRMSQ65, BMFVRMSQ72, BMFVRMSQ75, BMFVRMSQ76, BMFVRMSQ80, BMFTRMS102, BMFTRMS105, BMFTRMS111, BMFTRMS112, BMFTRMS115, BMFTRMS116, BMFTRMS119, BMFTRMS124, BMFTRMS127, BMFTRMS128, BMFTRMS090, BMFTRMS093, BMFTRMS094, BMFTRMS098, BMFTRMS101, BMFVRMSQ60, BMFVRMSQ67, BMFTRMS130, BMFTRMS133, BMFTRMS134, BMFTRMS143, BMFTRMS144, BMFTRMS147, BMFTRMS148, BMFVRMSQ55, BMFVRMSQ56, BMFVRMSQ59, BMFTRMS089, BMFTRMS091, BMFTRMS092, BMFTRMS095, BMFTRMS096, BMFTRMS099, BMFTRMS100, BMFTRMS103, BMFTRMS104, BMFTRMS107, BMFTRMS110, BMFTRMS113, BMFTRMS117, BMFTRMS118, BMFTRMS125, BMFTRMS126, BMFTRMS129, BMFTRMS131, BMFTRMS132, BMFTRMS139, BMFTRMS141, BMFTRMS145, BMFTRMS146, BMFVRMSQ53, BMFVRMSQ57, BMFVRMSQ61, BMFVRMSQ69, BMFVRMSQ71, BMFVRMSQ91, BMFWRMSJ35, BMFVRMSQ51, BMFVRMSQ52, BMFVRMSQ81, BMFVRMSQ89, BMFVRMSQ54, BMFVRMSQ79, BMFVRMSQ83, BMFVRMSQ90, BMFWRMSJ39, BMFWRMSJ41, BMFWRMSJ44, BMFVRMSQ58, BMFWRMSJ27, BMFVRMSQ70, BMFVRMSQ73, BMFVRMSQ74, BMFVRMSR17, BMFVRMSR18, BMFVRMSR30, BMFVRMSR33, BMFVRMSR21, BMFVRMSR32, BMFVRMSR16, BMFURMSF17, BMFVRMSR35, BMFURMSF04, BMFURMSF14, BMFURMSF21, BMFURMSF02, BMFURMSF11, BMFURMSF01, BMFURMSF05, BMFWRMSJ36, BMFWRMSJ51, BMFURMSF06, BMFURMSF09, BMFVRMSR03, BMFVRMSR04 ) ; SCCS1002E (Lot Numbers: BMFQRMYS001, BMFQRMYS002, BMFQRMYS003, BMFQRMYS004, BMFQRMYS005, BMFQRMYS006, BMFQRMYS007, BMFQRMYS008, BMFQRMYS009, BMFQRMYS010, BMFQRMYS011, BMFQRMYS012, BMFQRMYS013, BMFQRMYS014, BMFQRMYS015, BMFQRMYS016, BMFQRMYS017, BMFQRMYS019, BMFQRMYS041, BMFQRMYS042, BMFQRMYS043, BMFQRMYS044, BMFQRMYS045, BMFQRMYS046, BMFQRMYS047, BMFQRMYS048, BMFQRMYS049, BMFQRMYS050, BMFQRMYS051, BMFQRMYS052, BMFQRMYS053, BMFQRMYS054, BMFQRMYS055, BMFQRMYS056, BMFQRMYS057, BMFQRMYS058, BMFQRMYS059, BMFQRMYS060, BMFQRMYS061, BMFQRMYS062, BMFQRMYS063, BMFQRMYS064, BMFQRMYS065, BMFQRMYS066, BMFQRMYS067, BMFQRMYS068, BMFQRMYS069, BMFQRMYS070, BMFQRMYS071, BMFQRMYS072, BMFQRMYS073, BMFQRMYS074, BMFQRMYS075, BMFQRMYS076, BMFQRMYS077, BMFQRMYS078, BMFQRMYS079, BMFQRMYS080, BMFQRMYS081, BMFQRMYS082, BMFQRMYS083, BMFQRMYS084, BMFQRMYS085, BMFQRMYS086, BMFQRMYS087, BMFQRMYS088, BMFQRMYS089, BMFQRMYS090, BMFQRMYS091, BMFQRMYS092, BMFQRMYS093, BMFQRMYS094, BMFQRMYS095, BMFQRMYS096, BMFQRMYS097, BMFQRMYS098, BMFQRMYS099, BMFQRMYS100, BMFQRMYS101, BMFQRMYS102, BMFQRMYS103, BMFQRMYS104, BMFQRMYS105, BMFQRMYS106, BMFQRMYS107, BMFQRMYS108, BMFQRMYS109, BMFQRMYS110, BMFQRMYS111, BMFQRMYS112, BMFQRMYS113, BMFQRMYS114, BMFQRMYS115, BMFQRMYS116, BMFQRMYS117, BMFQRMYS118, BMFQRMYS119, BMFQRMYS120, BMFQRMYS121, BMFQRMYS122, BMFQRMYS123, BMFQRMYS124, BMFQRMYS125, BMFQRMYS126, BMFQRMYS127, BMFQRMYS128, BMFQRMYS129, BMFQRMYS130, BMFQRMYS131, BMFQRMYS132, BMFQRMYS133, BMFQRMYS134, BMFQRMYS135, BMFQRMYS136, BMFQRMYS137, BMFQRMYS138, BMFQRMYS139, BMFQRMYS140, BMFQRMYS141, BMFQRMYS142, BMFQRMYS143, BMFQRMYS144, BMFQRMYS145, BMFQRMYS146, BMFQRMYS147, BMFQRMYS148, BMFQRMYS149, BMFQRMYS150, BMFQRMYS151, BMFQRMYS152, BMFQRMYS153, BMFQRMYS154, BMFQRMYS155, BMFQRMYS156, BMFQRMYS157, BMFQRMYS158, BMFQRMYS159, BMFQRMYS161, BMFQRMYS162, BMFQRMYS163, BMFQRMYS164, BMFQRMYS165, BMFQRMYS166, BMFQRMYS167, BMFQRMYS168, BMFQRMYS169, BMFQRMYS170)

Quantity recalled457 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1293-2022
FDA event ID: 90251
Recalling firm: C.R. Bard, Covington, GA
Classification: Class II
Status: Ongoing
Recall initiated: 19 May 2022
FDA classified: 27 Jun 2022
Reported: 6 Jul 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

19 May 2022	Recall initiated by company
27 Jun 2022	Classified by FDA	+39 days
6 Jul 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Complaints relating to urine output measurement accuracy.

Product as listed by the FDA

Sensica Urine Output System

Where it was distributed

US Nationwide.

Nationwide

Questions about this recall

Why was it recalled?

Complaints relating to urine output measurement accuracy.

Which lots are affected?

UDI: (01) 0 0801741215773; Catalog Number: SCCS1002 (Lot Numbers: BMFURMSF03, BMFURMSF07, BMFURMSF08, BMFURMSF10, BMFURMSF12, BMFURMSF13, BMFURMSF15, BMFURMSF16, BMFURMSF18, BMFURMSF19, BMFURMSF20, BMFURMSF22, BMFURMSF23, BMFURMSF24, BMFURMSF25, BMFURMSF26, BMFURMSF27, BMFURMSF28, BMFURMSF29, BMFURMSF30, BMFURMSF31, BMFURMSF32, BMFURMSF33, BMFURMSF34, BMFURMSF35, BMFURMSF36, BMFURMSF37, BMFURMSF38, BMFURMSF39, BMFURMSF40, BMFURMSF41, BMFURMSF42, BMFURMSF43, BMFURMSF44, BMFURMSF45, BMFURMSF46, BMFURMSF47, BMFURMSF48, BMFURMSF49, BMFURMSF50, BMFURMSF51, BMFURMSF52, BMFURMSF53, BMFURMSF54, BMFURMSF55, BMFURMSF56, BMFURMSF57, BMFURMSF58, BMFURMSF59, BMFURMSF60, BMFVRMSQ82, BMFVRMSQ84, BMFVRMSQ85, BMFVRMSQ86, BMFVRMSQ87, BMFVRMSQ88, BMFVRMSQ92, BMFVRMSQ94, BMFVRMSQ95, BMFVRMSQ96, BMFVRMSQ97, BMFVRMSQ98, BMFVRMSQ99, BMFVRMSR00, BMFVRMSR01, BMFVRMSR02, BMFVRMSR05, BMFVRMSR06, BMFVRMSR07, BMFVRMSR08, BMFVRMSR09, BMFVRMSR10, BMFVRMSR11, BMFVRMSR12, BMFVRMSR13, BMFVRMSR14, BMFVRMSR15, BMFVRMSR19, BMFVRMSR20, BMFVRMSR22, BMFVRMSR23, BMFVRMSR24, BMFVRMSR25, BMFVRMSR26, BMFVRMSR27, BMFVRMSR28, BMFVRMSR29, BMFVRMSR31, BMFVRMSR34, BMFVRMSR36, BMFVRMSR37, BMFVRMSR38, BMFVRMSR39, BMFVRMSR40, BMFWRMSBR6, BMFWRMSBR7, BMFWRMSBR8, BMFWRMSBR9, BMFWRMSBS0, BMFWRMSBS1, BMFWRMSBS2, BMFWRMSBS3, BMFWRMSBS4, BMFWRMSBS5, BMFWRMSBS6, BMFWRMSBS7, BMFWRMSBS8, BMFWRMSBS9, BMFWRMSBT0, BMFWRMSBT1, BMFWRMSBT2, BMFWRMSBT3, BMFWRMSBT4, BMFWRMSBT5, BMFWRMSBT6, BMFWRMSBT7, BMFWRMSBT8, BMFWRMSBT9, BMFWRMSBU0, BMFWRMSBU1, BMFWRMSBU2, BMFWRMSBU3, BMFWRMSBU4, BMFWRMSBU5, BMFWRMSBU6, BMFWRMSBU7, BMFWRMSBU8, BMFWRMSBU9, BMFWRMSBV0, BMFWRMSBV1, BMFWRMSBV2, BMFWRMSBV3, BMFWRMSBV4, BMFWRMSBV5, BMFWRMSBV6, BMFWRMSBV7, BMFWRMSBV8, BMFWRMSBV9, BMFWRMSBW0, BMFWRMSBW1, BMFWRMSJ24, BMFWRMSJ25, BMFWRMSJ26, BMFWRMSJ28, BMFWRMSJ29, BMFWRMSJ30, BMFWRMSJ31, BMFWRMSJ32, BMFWRMSJ33, BMFWRMSJ34, BMFWRMSJ37, BMFWRMSJ38, BMFWRMSJ40, BMFWRMSJ42, BMFWRMSJ43, BMFWRMSJ45, BMFWRMSJ47, BMFWRMSJ48, BMFWRMSJ49, BMFWRMSJ50, BMFWRMSJ52, BMFWRMSJ53, BMFWRMSJ54, BMFWRMSJ55, BMFWRMSJ56, BMFWRMSJ57, BMFWRMSJ58, BMFWRMSJ59, BMFWRMSJ60, BMFWRMSJ61, BMFWRMSJ62, BMFWRMSJ63, BMFWRMSJ64, BMFWRMSJ65, BMFWRMSJ66, BMFWRMSJ67, BMFWRMSJ68, BMFWRMSJ69, BMFWRMSJ70, BMFWRMSJ71, BMFWRMSJ72, BMFWRMSJ73, BMFWRMSJ74, BMFWRMSJ75, BMFWRMSJ76, BMFWRMSJ77, BMFWRMSJ78, BMFWRMSJ79, BMFWRMSJ80, BMFWRMSJ81, BMFWRMSJ82, BMFWRMSJ83, BMFXRMSBA1, BMFXRMSBA2, BMFXRMSBA3, BMFXRMSBA4, BMFXRMSBA5, BMFXRMSBA6, BMFXRMSBA8, BMFXRMSBA9, BMFXRMSBB0, BMFXRMSBB1, BMFXRMSBB2, BMFXRMSBB3, BMFXRMSBB4, BMFXRMSBB5, BMFXRMSBB6, BMFXRMSBB7, BMFXRMSBB8, BMFXRMSBB9, BMFXRMSBC0, BMFXRMSBC1, BMFXRMSBC2, BMFXRMSBC3, BMFXRMSBC4, BMFXRMSBC5, BMFXRMSBC6, BMFXRMSBC7, BMFXRMSBC8, BMFXRMSBD0, BMFXRMSJ01, BMFXRMSJ02, BMFXRMSJ03, BMFXRMSJ04, BMFXRMSJ05, BMFXRMSJ06, BMFXRMSJ07, BMFXRMSJ08, BMFXRMSJ09, BMFXRMSJ10, BMFXRMSJ11, BMFXRMSJ12, BMFXRMSJ13, BMFXRMSJ14, BMFXRMSJ15, BMFXRMSJ16, BMFXRMSJ17, BMFXRMSJ18, BMFXRMSJ19, BMFXRMSJ20, BMFXRMSJ21, BMFXRMSJ22, BMFXRMSJ23, BMFXRMSJ24, BMFXRMSJ25, BMFXRMSJ26, BMFXRMSJ27, BMFXRMSJ28, BMFXRMSJ29, BMFXRMSJ30, BMFXRMSJ31, BMFXRMSJ32, BMFXRMSJ33, BMFXRMSJ34, BMFXRMSJ35, BMFXRMSJ36, BMFXRMSJ37, BMFXRMSJ38, BMFXRMSJ39, BMFXRMSJ40, BMFXRMSJ41, BMFXRMSJ42, BMFXRMSJ43, BMFXRMSJ44, BMFXRMSJ45, BMFXRMSJ46, BMFXRMSJ47, BMFXRMSJ48, BMFXRMSJ49, BMFXRMSJ50, BMFXRMSJ51, BMFXRMSJ52, BMFXRMSJ53, BMFXRMSJ54, BMFXRMSJ55, BMFXRMSJ56, BMFXRMSJ57, BMFXRMSJ58, BMFXRMSJ59, BMFXRMSJ60, BMFYRMSBA1, BMFYRMSBA2, BMFYRMSBA3, BMFYRMSBA4, BMFYRMSBA5, BMFYRMSBA6, BMFYRMSBA7, BMFYRMSBA8, BMFYRMSBA9, BMFYRMSBB0, BMFYRMSBB1, BMFYRMSBB2, BMFYRMSBB3, BMFYRMSBB4, BMFYRMSBB5, BMFYRMSBB6, BMFYRMSBB7, BMFYRMSBB8, BMFYRMSBB9, BMFYRMSBC0, BMFYRMSBC1, BMFYRMSBC2, BMFYRMSBC3, BMFYRMSBC4, BMFYRMSBC5, BMFYRMSBC6, BMFYRMSBC7, BMFYRMSBD0, BMFYRMSBD1, BMFYRMSBD2, BMFYRMSBD3, BMFYRMSBD4, BMFYRMSBD5, BMFYRMSBD6, BMFYRMSBD7, BMFYRMSBD8, BMFYRMSBD9, BMFYRMSBE0, BMFYRMSBE1, BMFYRMSBE2, BMFYRMSBE3, BMFYRMSBE4, BMFYRMSBE5, BMFYRMSBE6, BMFYRMSBE7, BMFYRMSBE8, BMFYRMSBE9, BMFYRMSBF0, BMFYRMSBF1, BMFYRMSBF2, BMFYRMSBF3, BMFYRMSBF4, BMFYRMSBF5, BMFYRMSBF6, BMFYRMSBF7, BMFYRMSBF8, BMFYRMSBF9, BMFYRMSBG0, BMFYRMSJ01, BMFYRMSJ02, BMFYRMSJ03, BMFYRMSJ04, BMFYRMSJ05, BMFYRMSJ06, BMFYRMSJ07, BMFYRMSJ08, BMFYRMSJ09, BMFYRMSJ10, BMFYRMSJ11, BMFYRMSJ12, BMFYRMSJ13, BMFYRMSJ14, BMFYRMSJ15, BMFYRMSJ16, BMFYRMSJ17, BMFYRMSJ18, BMFYRMSJ19, BMFYRMSJ20, BMFYRMSJ21, BMFYRMSJ22, BMFYRMSJ23, BMFYRMSJ24, BMFYRMSJ25, BMFYRMSJ26, BMFYRMSJ27, BMFYRMSJ28, BMFYRMSJ29, BMFYRMSJ30, BMFYRMSJ31, BMFYRMSJ32, BMFYRMSJ33, BMFYRMSJ34, BMFYRMSJ35, BMFYRMSJ36, BMFYRMSJ37, BMFYRMSJ38, BMFYRMSJ39, BMFYRMSJ40, BMFYRMSJ41, BMFYRMSJ42, BMFYRMSJ43, BMFYRMSJ44, BMFYRMSJ45, BMFYRMSJ46, BMFYRMSJ47, BMFYRMSJ48, BMFYRMSJ49, BMFYRMSJ50, BMFYRMSJ51, BMFYRMSJ52, BMFYRMSJ53, BMFYRMSJ54, BMFYRMSJ55, BMFYRMSJ56, BMFYRMSJ57, BMFYRMSJ58, BMFYRMSJ59, BMFYRMSJ60, BMFZRMS065, BMFZRMS066, BMFZRMS067, BMFZRMS068, BMFZRMS069, BMFZRMS070, BMFZRMS071, BMFZRMS072, BMFZRMS073, BMFZRMS074, BMFZRMS075, BMFZRMS076, BMFZRMS077, BMFZRMS078, BMFZRMS079, BMFZRMS080, BMFZRMS081, BMFZRMS082, BMFZRMS083, BMFZRMS084, BMFZRMS085, BMFZRMS086, BMFZRMS087, BMFZRMS088, BMFZRMS089, BMFZRMS090, BMFZRMS091, BMFZRMS092, BMFZRMS093, BMFZRMS094, BMFZRMS095, BMFZRMS096, BMFZRMS097, BMFZRMS098, BMFZRMS099, BMFZRMS100, BMFZRMS101, BMFZRMS102, BMFZRMS104, BMFZRMS105, BMFZRMS106, BMFZRMS107, BMFZRMS108, BMFZRMS109, BMFZRMS110, BMFZRMS111, BMFZRMS112, BMFZRMS113, BMFZRMS114, BMFZRMS115, BMFZRMS116, BMFZRMS117, BMFZRMS118, BMFZRMSH47, BMFZRMSH48, BMFZRMSH49, BMFZRMSH50, BMFZRMSH51, BMFZRMSH52, BMFZRMSH53, BMFZRMSH54, BMFZRMSH55, BMFZRMSH56, BMFZRMSH57, BMFZRMSH58, BMFZRMSH59, BMFZRMSH60, BMFZRMSH61, BMFZRMSH62, BMFZRMSH63, BMFZRMSH64, BMFZRMSH65, BMFZRMSH66, BMFZRMSH67, BMFZRMSH68, BMFZRMSH69, BMFZRMSH70, BMFZRMSH71, BMFZRMSH72, BMFZRMSH73, BMFZRMSH74, BMFZRMSH75, BMFZRMSH76, BMGNRMS001, BMGNRMS002, BMGNRMS003, BMGNRMS004, BMGNRMS005, BMGNRMS006, BMGNRMS007, BMGNRMS008, BMGNRMS009, BMGNRMS010, BMGNRMS011, BMGNRMS012, BMGNRMS013, BMGNRMS014, BMGNRMS015, BMGNRMS016, BMGNRMS018, BMGNRMS019, BMGNRMS020, BMGNRMS021, BMGNRMS022, BMGNRMS023, BMGNRMS024, BMGNRMS025, BMGNRMS026, BMGNRMS027, BMGNRMS028, BMGNRMS029, BMGNRMS030, BMGNRMS058, BMGNRMS059, BMGNRMS060, BMGNRMS061, BMGNRMS062, BMGNRMS063, BMGNRMS064, BMGNRMS065, BMGNRMS066, BMGNRMS067, BMGNRMS068, BMGNRMS069, BMGNRMS070, BMGNRMS071, BMGNRMS072, BMGNRMS073, BMGNRMS074, BMGNRMS075, BMGNRMS076, BMGNRMS077, BMGNRMS078, BMGNRMS079, BMGNRMS080, BMGNRMS081, BMGNRMS082, BMGNRMS083, BMGNRMS084, BMGNRMS085, BMGNRMS086, BMGNRMS087, BMGNRMSG52, BMGNRMSG53, BMGNRMSG54, BMGNRMSG55, BMGNRMSG56, BMGNRMSG57, BMGNRMSG58, BMGNRMSG59, BMGNRMSG60, BMGNRMSG61, BMGNRMSG62, BMGNRMSG63, BMGNRMSG64, BMGNRMSG65, BMGNRMSG66, BMGNRMSG67, BMGNRMSG68, BMGNRMSG69, BMGNRMSG70, BMGNRMSG71, BMGNRMSG72, BMGNRMSG73, BMGNRMSG74, BMGNRMSG75, BMGNRMSG76, BMGNRMSG77, BMGNRMSG78, BMGNRMSG79, BMGNRMSG80, BMGNRMSG81, BMFQRMYS038, BMFQRMYS040, BMFQRMYS023, BMFQRMYS028, BMFQRMYS030, BMFQRMYS033, BMFQRMYS034, BMFQRMYS037, BMFQRMYS021, BMFQRMYS022, BMFQRMYS031, BMFQRMYS032, BMFQRMYS035, BMFQRMYS036, BMFQRMYS039, BMFPRMYS005, BMFPRMYS015, BMFPRMYS020, BMFQRMYS025, BMFQRMYS026, BMFQRMYS029, BMFPRMYS003, BMFPRMYS001, BMFPRMYS002, BMFPRMYS013, BMFPRMYS014, BMFPRMYS017, BMFQRMYS024, BMFQRMYS027, BMFQRMS246, BMFPRMYS004, BMFPRMYS007, BMFPRMYS008, BMFPRMYS009, BMFPRMYS010, BMFPRMYS011, BMFPRMYS018, BMFQRMS238, BMFQRMS240, BMFQRMS244, BMFQRMS247, BMFQRMS248, BMFQRMS250, BMFQRMS253, BMFQRMS257, BMFQRMS267, BMFQRMS268, BMFQRMS272, BMFQRMS275, BMFQRMS276, BMFQRMS279, BMFQRMS280, BMFQRMS282, BMFQRMS284, BMFQRMS285, BMFQRMS286, BMFQRMS288, BMFQRMS289, BMFQRMS293, BMFQRMS294, BMFQRMS301, BMFQRMS306, BMFQRMS317, BMFQRMS324, BMFQRMS327, BMFQRMS328, BMFQRMS330, BMFQRMS334, BMFRRMS601, BMFRRMS602, BMFRRMS633, BMFRRMS645, BMFRRMS647, BMFRRMS656, BMFRRMS659, BMFRRMST97, BMFRRMSU02, BMFRRMSU05, BMFRRMSU06, BMFRRMSU09, BMFRRMSU11, BMFRRMSU12, BMFRRMSU19, BMFRRMSU24, BMFRRMSU28, BMFRRMSU34, BMFRRMSU37, BMFSRMSH84, BMFSRMSH88, BMFSRMSJ05, BMFRRMSU23, BMFPRMYS006, BMFPRMYS012, BMFQRMS241, BMFQRMS245, BMFQRMS255, BMFQRMS259, BMFQRMS270, BMFQRMS281, BMFQRMS283, BMFQRMS287, BMFQRMS290, BMFQRMS291, BMFQRMS292, BMFQRMS295, BMFQRMS296, BMFQRMS299, BMFQRMS300, BMFQRMS307, BMFQRMS308, BMFQRMS315, BMFQRMS320, BMFQRMS322, BMFQRMS325, BMFQRMS326, BMFQRMS329, BMFQRMS331, BMFQRMS332, BMFQRMS335, BMFRRMS603, BMFRRMS610, BMFRRMS621, BMFRRMS631, BMFRRMS646, BMFRRMS649, BMFRRMS657, BMFRRMS658, BMFRRMST91, BMFRRMST92, BMFRRMST96, BMFRRMST99, BMFRRMSU03, BMFRRMSU04, BMFRRMSU08, BMFRRMSU10, BMFRRMSU13, BMFRRMSU14, BMFRRMSU16, BMFRRMSU17, BMFRRMSU20, BMFSRMSH89, BMFSRMSJ35, BMFSRMSJ39, BMFRRMSU21, BMFRRMSU31, BMFRRMSU32, BMFRRMSU35, BMFRRMSU36, BMFRRMSU38, BMFRRMSU39, BMFRRMSU42, BMFRRMSU45, BMFSRMSH86, BMFQRMS231, BMFQRMS232, BMFQRMS235, BMFQRMS236, BMFQRMS239, BMFQRMS249, BMFQRMS251, BMFQRMS263, BMFQRMS264, BMFQRMS265, BMFQRMS273, BMFQRMS304, BMFQRMS310, BMFQRMS313, BMFQRMS314, BMFQRMS318, BMFQRMS321, BMFRRMS613, BMFRRMS617, BMFRRMS619, BMFRRMS622, BMFRRMS625, BMFRRMS632, BMFRRMS650, BMFRRMS651, BMFRRMS653, BMFRRMS655, BMFRRMST94, BMFRRMST98, BMFRRMSU01, BMFRRMSU15, BMFRRMSU25, BMFSRMSH91, BMFSRMSH92, BMFSRMSJ04, BMFSRMSJ08, BMFSRMSJ12, BMFSRMSJ16, BMFSRMSJ24, BMFSRMSJ40, BMFRRMSU27, BMFRRMSU29, BMFRRMSU33, BMFRRMSU40, BMFRRMSU44, BMFRRMSU47, BMFRRMSU48, BMFRRMSU50, BMFSRMSH72, BMFSRMSH76, BMFQRMS233, BMFQRMS234, BMFQRMS237, BMFQRMS242, BMFQRMS243, BMFQRMS252, BMFQRMS254, BMFQRMS256, BMFQRMS258, BMFQRMS260, BMFQRMS261, BMFQRMS266, BMFQRMS269, BMFQRMS271, BMFQRMS274, BMFQRMS297, BMFQRMS298, BMFQRMS302, BMFQRMS309, BMFQRMS319, BMFQRMS323, BMFQRMS333, BMFRRMS606, BMFRRMS607, BMFRRMS608, BMFRRMS614, BMFRRMS615, BMFRRMS618, BMFRRMS620, BMFRRMS623, BMFRRMS624, BMFRRMS652, BMFRRMS654, BMFRRMST93, BMFRRMST95, BMFRRMSU00, BMFRRMSU07, BMFRRMSU18, BMFRRMSU22, BMFRRMSU26, BMFRRMSU30, BMFRRMSU41, BMFRRMSU43, BMFRRMSU46, BMFRRMSU49, BMFRRMSU51, BMFRRMSU52, BMFSRMSH73, BMFSRMSH74, BMFSRMSH77, BMFSRMSH85, BMFSRMSH87, BMFSRMSH90, BMFSRMSH96, BMFSRMSJ41, BMFSRMSJ45, BMFSRMSJ46, BMFQRMS277, BMFQRMS278, BMFQRMS303, BMFRRMS604, BMFRRMS626, BMFRRMS629, BMFRRMS635, BMFRRMS636, BMFRRMS639, BMFRRMS641, BMFRRMS642, BMFSRMSJ11, BMFQRMS262, BMFQRMS305, BMFQRMS311, BMFQRMS312, BMFQRMS316, BMFRRMS605, BMFRRMS609, BMFRRMS611, BMFRRMS612, BMFRRMS616, BMFRRMS627, BMFRRMS628, BMFRRMS630, BMFRRMS634, BMFRRMS637, BMFRRMS638, BMFRRMS640, BMFRRMS643, BMFRRMS644, BMFRRMS648, BMFSRMSJ03, BMFSRMSJ10, BMFSRMSJ29, BMFSRMSH78, BMFSRMSH81, BMFSRMSH82, BMFSRMSJ00, BMFSRMSJ14, BMFSRMSH79, BMFSRMSH80, BMFSRMSH83, BMFSRMSH93, BMFSRMSJ15, BMFSRMSJ13, BMFSRMSJ27, BMFSRMSJ33, BMFSRMSJ34, BMFSRMSH75, BMFSRMSJ02, BMFSRMSJ06, BMFSRMSJ09, BMFSRMSJ19, BMFSRMSJ23, BMFSRMSJ28, BMFSRMSJ30, BMFSRMSJ07, BMFSRMSJ17, BMFSRMSJ21, BMFSRMSJ22, BMFSRMSJ25, BMFSRMSJ26, BMFSRMSJ32, BMFSRMSJ31, BMFSRMSJ18, BMFSRMSJ20, BMFSRMSJ43, BMFTRMS121, BMFSRMSJ38, BMFSRMSJ44, BMFSRMSJ37, BMFTRMS108, BMFTRMS114, BMFTRMS142, BMFSRMSJ36, BMFSRMSJ42, BMFTRMS106, BMFTRMS109, BMFTRMS138, BMFSRMSH94, BMFSRMSH99, BMFSRMSH97, BMFTRMS122, BMFTRMS135, BMFTRMS136, BMFVRMSQ68, BMFSRMSH95, BMFSRMSH98, BMFSRMSJ01, BMFTRMS120, BMFTRMS123, BMFTRMS137, BMFVRMSQ62, BMFVRMSQ66, BMFTRMS140, BMFVRMSQ63, BMFVRMSQ64, BMFVRMSQ77, BMFVRMSQ78, BMFVRMSQ65, BMFVRMSQ72, BMFVRMSQ75, BMFVRMSQ76, BMFVRMSQ80, BMFTRMS102, BMFTRMS105, BMFTRMS111, BMFTRMS112, BMFTRMS115, BMFTRMS116, BMFTRMS119, BMFTRMS124, BMFTRMS127, BMFTRMS128, BMFTRMS090, BMFTRMS093, BMFTRMS094, BMFTRMS098, BMFTRMS101, BMFVRMSQ60, BMFVRMSQ67, BMFTRMS130, BMFTRMS133, BMFTRMS134, BMFTRMS143, BMFTRMS144, BMFTRMS147, BMFTRMS148, BMFVRMSQ55, BMFVRMSQ56, BMFVRMSQ59, BMFTRMS089, BMFTRMS091, BMFTRMS092, BMFTRMS095, BMFTRMS096, BMFTRMS099, BMFTRMS100, BMFTRMS103, BMFTRMS104, BMFTRMS107, BMFTRMS110, BMFTRMS113, BMFTRMS117, BMFTRMS118, BMFTRMS125, BMFTRMS126, BMFTRMS129, BMFTRMS131, BMFTRMS132, BMFTRMS139, BMFTRMS141, BMFTRMS145, BMFTRMS146, BMFVRMSQ53, BMFVRMSQ57, BMFVRMSQ61, BMFVRMSQ69, BMFVRMSQ71, BMFVRMSQ91, BMFWRMSJ35, BMFVRMSQ51, BMFVRMSQ52, BMFVRMSQ81, BMFVRMSQ89, BMFVRMSQ54, BMFVRMSQ79, BMFVRMSQ83, BMFVRMSQ90, BMFWRMSJ39, BMFWRMSJ41, BMFWRMSJ44, BMFVRMSQ58, BMFWRMSJ27, BMFVRMSQ70, BMFVRMSQ73, BMFVRMSQ74, BMFVRMSR17, BMFVRMSR18, BMFVRMSR30, BMFVRMSR33, BMFVRMSR21, BMFVRMSR32, BMFVRMSR16, BMFURMSF17, BMFVRMSR35, BMFURMSF04, BMFURMSF14, BMFURMSF21, BMFURMSF02, BMFURMSF11, BMFURMSF01, BMFURMSF05, BMFWRMSJ36, BMFWRMSJ51, BMFURMSF06, BMFURMSF09, BMFVRMSR03, BMFVRMSR04 ) ; SCCS1002E (Lot Numbers: BMFQRMYS001, BMFQRMYS002, BMFQRMYS003, BMFQRMYS004, BMFQRMYS005, BMFQRMYS006, BMFQRMYS007, BMFQRMYS008, BMFQRMYS009, BMFQRMYS010, BMFQRMYS011, BMFQRMYS012, BMFQRMYS013, BMFQRMYS014, BMFQRMYS015, BMFQRMYS016, BMFQRMYS017, BMFQRMYS019, BMFQRMYS041, BMFQRMYS042, BMFQRMYS043, BMFQRMYS044, BMFQRMYS045, BMFQRMYS046, BMFQRMYS047, BMFQRMYS048, BMFQRMYS049, BMFQRMYS050, BMFQRMYS051, BMFQRMYS052, BMFQRMYS053, BMFQRMYS054, BMFQRMYS055, BMFQRMYS056, BMFQRMYS057, BMFQRMYS058, BMFQRMYS059, BMFQRMYS060, BMFQRMYS061, BMFQRMYS062, BMFQRMYS063, BMFQRMYS064, BMFQRMYS065, BMFQRMYS066, BMFQRMYS067, BMFQRMYS068, BMFQRMYS069, BMFQRMYS070, BMFQRMYS071, BMFQRMYS072, BMFQRMYS073, BMFQRMYS074, BMFQRMYS075, BMFQRMYS076, BMFQRMYS077, BMFQRMYS078, BMFQRMYS079, BMFQRMYS080, BMFQRMYS081, BMFQRMYS082, BMFQRMYS083, BMFQRMYS084, BMFQRMYS085, BMFQRMYS086, BMFQRMYS087, BMFQRMYS088, BMFQRMYS089, BMFQRMYS090, BMFQRMYS091, BMFQRMYS092, BMFQRMYS093, BMFQRMYS094, BMFQRMYS095, BMFQRMYS096, BMFQRMYS097, BMFQRMYS098, BMFQRMYS099, BMFQRMYS100, BMFQRMYS101, BMFQRMYS102, BMFQRMYS103, BMFQRMYS104, BMFQRMYS105, BMFQRMYS106, BMFQRMYS107, BMFQRMYS108, BMFQRMYS109, BMFQRMYS110, BMFQRMYS111, BMFQRMYS112, BMFQRMYS113, BMFQRMYS114, BMFQRMYS115, BMFQRMYS116, BMFQRMYS117, BMFQRMYS118, BMFQRMYS119, BMFQRMYS120, BMFQRMYS121, BMFQRMYS122, BMFQRMYS123, BMFQRMYS124, BMFQRMYS125, BMFQRMYS126, BMFQRMYS127, BMFQRMYS128, BMFQRMYS129, BMFQRMYS130, BMFQRMYS131, BMFQRMYS132, BMFQRMYS133, BMFQRMYS134, BMFQRMYS135, BMFQRMYS136, BMFQRMYS137, BMFQRMYS138, BMFQRMYS139, BMFQRMYS140, BMFQRMYS141, BMFQRMYS142, BMFQRMYS143, BMFQRMYS144, BMFQRMYS145, BMFQRMYS146, BMFQRMYS147, BMFQRMYS148, BMFQRMYS149, BMFQRMYS150, BMFQRMYS151, BMFQRMYS152, BMFQRMYS153, BMFQRMYS154, BMFQRMYS155, BMFQRMYS156, BMFQRMYS157, BMFQRMYS158, BMFQRMYS159, BMFQRMYS161, BMFQRMYS162, BMFQRMYS163, BMFQRMYS164, BMFQRMYS165, BMFQRMYS166, BMFQRMYS167, BMFQRMYS168, BMFQRMYS169, BMFQRMYS170)

Where was it sold?

US Nationwide.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from C.R. Bard

All 123

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Temperature Abuse	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Temperature Abuse	Nationwide

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide