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U.S. Department of Health and Human Services

Class 2 Device Recall BD Sensica

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  Class 2 Device Recall BD Sensica see related information
Date Initiated by Firm November 15, 2023
Date Posted December 14, 2023
Recall Status1 Open3, Classified
Recall Number Z-0554-2024
Recall Event ID 93375
Product Classification Urinometer, electrical - Product Code EXS
Product Sensica Urine Output System, Catalog Number SCCS1002
Code Information UDI/DI 00801741215773, Serial numbers: BMGPRMYS001 , BMGPRMYS003, BMGPRMYS004, BMGPRMYS005, BMGPRMYS006, BMGPRMYS007, BMGPRMYS020, BMGPRMYS026, BMGPRMYS028, BMGPRMYS030, BMFWRMSBT4, BMFWRMSJ45, BMFWRMSJ49, BMFZRMS104, BMGNRMS085, BMFSRMSH98, BMFSRMSJ01, BMFVRMSQ62, BMFVRMSQ66, BMFVRMSQ68, BMFYRMSJ41, BMFYRMSJ49, BMFZRMS067, BMFZRMS070, BMFZRMS080, BMFZRMS113, BMFZRMS117, BMGNRMS070, BMFURMSF02, BMFURMSF04, BMFURMSF14, BMFURMSF21, BMFVRMSQ51, BMFVRMSQ52, BMFVRMSQ54, BMFVRMSQ79, BMFVRMSQ83, BMFVRMSQ89, BMFVRMSQ91, BMFWRSJ46, BMGPRMYS011, BMGPRMYS018, BMGPRMYS022 , BMGPRMYS023, BMGPRMYS027, BMFYRMSJ35, BMFYRMSJ37, BMFYRMSJ54, BMFYRMSJ58, BMGNRMS079, BMGNRMSG69, BMGNRMSG74, BMFSRMSH94, BMFSRMSH99, BMFSRMSJ38, BMFSRMSJ44, BMFTRMS138, BMFSRMSJ13, BMFSRMSJ27, BMFSRMSJ33, BMFSRMSJ34, BMFQRMS248, BMFQRMS250, BMFRRMS646, BMFRRMS647, BMGPRMYS008, BMGPRMYS009, BMGPRMYS010, BMGPRMYS013, BMGPRMYS014, BMGPRMYS016, BMFZRMS073, BMFSRMSH78, BMFSRMSH79, BMFSRMSH80, BMFSRMSH81, BMFSRMSH82, BMFSRMSH83, BMFSRMSH93, BMFSRMSJ00, BMFSRMSJ14, BMFSRMSJ15, BMFQRMS246, BMFWRMSJ39, BMFWRMSJ41, BMFSRMSJ36, BMFSRMSJ37, BMFSRMSJ42, BMFTRMS106, BMFTRMS109, BMFTRMS114, BMFTRMS142, BMFURMSF01, BMFURMSF05, BMFSRMSH95, BMFSRMSH97, BMFTRMS120, BMFTRMS122, BMFTRMS123, BMFTRMS135, BMFTRMS136, BMFTRMS137, BMGPRMYS002, BMGPRMYS012, BMGPRMYS019 , BMGPRMYS029, BMFPRMYS009, BMFQRMS244, BMFQRMS272, BMFQRMS276, BMFQRMS286, BMFQRMS293, BMFSRMSJ43, BMFTRMS121, BMGNRMS067, BMGNRMS076, BMFVRMSQ58, BMFVRMSQ70, BMFVRMSQ73, BMFVRMSQ74, BMFVRMSQ90, BMFVRMSR17, BMFWRMSJ27, BMFWRMSJ35, BMFURMSF06, BMFURMSF09, BMFWRMSJ36, BMFWRMSJ51, BMFZRMS068, BMFQRMS294, BMFZRMS105, BMFSRMSJ20, BMFTRMS140, BMFVRMSQ63, BMFVRMSQ64, BMFVRMSQ65, BMFVRMSQ72, BMFVRMSQ75, BMFVRMSQ76, BMFVRMSQ77, BMFVRMSQ78, BMFVRMSQ80, BMFYRMSJ39, BMFZRMS081, BMFZRMS116, BMGNRMS015, BMGNRMS029, BMGNRMS073
Recalling Firm/
Manufacturer		 C.R. Bard Inc
8195 Industrial Blvd Ne
Covington GA 30014-1497
For Additional Information Contact North American Regional Complaint Center
844-823-5433
Manufacturer Reason
for Recall		 BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.
FDA Determined
Cause 2		 Under Investigation by firm
Action BD (CR Bard) issued an URGENT Medical Device Product Advisory to its consignees on 11/15/2023, via FedEx and email. The notice explained the problem with the device, potential hazard, and requested that the consignee perform Operating System and Sensica Software settings changes per the instructions provided on all devices within your facility s control using the attached directions.
Quantity in Commerce 148 units
Distribution US Nationwide distribution.
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.
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