Reported Dec 20, 2023 · Ongoing
Sensica Urine Output System, Catalog Number SCCS1002
C.R. Bard Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: C.R. Bard Inc · 8195 Industrial Blvd Ne · Covington, GA · 30014-1497
Is this the product you have?
- Sensica Urine Output System, Catalog Number SCCS1002
- Lot codes and dates
- UDI/DI 00801741215773
- Serial numbers
148 of 148 codes
BMGPRMYS001BMGPRMYS003BMGPRMYS004BMGPRMYS005BMGPRMYS006BMGPRMYS007BMGPRMYS020BMGPRMYS026BMGPRMYS028BMGPRMYS030BMFWRMSBT4BMFWRMSJ45BMFWRMSJ49BMFZRMS104BMGNRMS085BMFSRMSH98BMFSRMSJ01BMFVRMSQ62BMFVRMSQ66BMFVRMSQ68BMFYRMSJ41BMFYRMSJ49BMFZRMS067BMFZRMS070BMFZRMS080BMFZRMS113BMFZRMS117BMGNRMS070BMFURMSF02BMFURMSF04BMFURMSF14BMFURMSF21BMFVRMSQ51BMFVRMSQ52BMFVRMSQ54BMFVRMSQ79BMFVRMSQ83BMFVRMSQ89BMFVRMSQ91BMFWRSJ46BMGPRMYS011BMGPRMYS018BMGPRMYS022BMGPRMYS023BMGPRMYS027BMFYRMSJ35BMFYRMSJ37BMFYRMSJ54BMFYRMSJ58BMGNRMS079BMGNRMSG69BMGNRMSG74BMFSRMSH94BMFSRMSH99BMFSRMSJ38BMFSRMSJ44BMFTRMS138BMFSRMSJ13BMFSRMSJ27BMFSRMSJ33
- Amount recalled
- 148 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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