Class 2 Device Recall Sensica

• Date Initiated by Firm: May 19, 2022
• Create Date: June 27, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1293-2022
• Recall Event ID: 90251
• Product Classification: Urinometer, electrical - Product Code EXS
• Product: Sensica Urine Output System
• Code Information: 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)
• Recalling Firm/ Manufacturer: C.R. Bard Inc; 8195 Industrial Blvd Ne; Covington GA 30014-1497
• For Additional Information Contact: Rima Alameddine; 770-784-5101
• Manufacturer Reason for Recall: Complaints relating to urine output measurement accuracy.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm issued a recall notification via email and Fed Ex on 05/19/2022. The letter instructs the consignee to immediately discontinue use of the system, quarantine and store to prevent usage, share the notice with users of the product, and return the response form.
• Quantity in Commerce: 457 units
• Distribution: US Nationwide.
• Total Product Life Cycle: TPLC Device Report

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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.