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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

C.R. Bard Inc: Sensica Urine Output System Recalled for Time Display Errors

Agency Publication Date: December 14, 2023
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Summary

C.R. Bard is recalling 148 units of the Sensica Urine Output System (Catalog Number SCCS1002) because the device displays incorrect times when connected to the internet or WiFi. This defect causes the monitoring screen to show the wrong time, incorrect hour blocks, and inaccurate catheter use times, which can lead to errors in patient monitoring and data recording. The manufacturer has received user complaints regarding these timestamp issues, though no specific injuries are mentioned in the data.

Risk

Incorrect time stamps on the monitoring device can lead to medical staff making clinical decisions based on inaccurate patient data history, potentially affecting the timing of care or the assessment of urine output over time.

What You Should Do

  1. Identify if you have a Sensica Urine Output System by checking for Catalog Number SCCS1002 and UDI/DI 00801741215773.
  2. Verify if your device's serial number is included in the recall: 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, or BMGNRMS073.
  3. If you are using an affected device, contact your healthcare provider or the manufacturer (C.R. Bard / BD) for further instructions on addressing the time display defect.
  4. For further questions or technical assistance regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction or technical support

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Sensica Urine Output System
Model / REF:
SCCS1002
UPC Codes:
00801741215773
Lot Numbers (148):
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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93375
Status: Active
Manufacturer: C.R. Bard Inc
Sold By: Authorized Medical Distributors
Manufactured In: United States
Units Affected: 148 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.