C.R. Bard recalls CritiCore Automated Urine Output and Temperature Monitors with potential urine output and temperature measurement errors and false alarms. Affected models include DYZIAA003, DYAPAA017, and other serial numbers listed in the recall.
Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.
C.R. Bard is recalling CritiCore Automated Urine Output and Temperature Monitors due to potential measurement errors in urine output and temperature readings, as well as false alarms. This could lead to incorrect medical decisions if the device is used for patient monitoring.
The monitor may provide inaccurate urine output measurements and temperature readings, which could lead to incorrect medical decisions if the device is used for patient monitoring. False alarms may also cause unnecessary disruptions in patient care.
Patients using the CritiCore monitors for urine output and temperature monitoring in hospitals or home care settings. Healthcare providers who rely on these devices for patient assessment are most at risk.
Check the product's serial number on the device or packaging. Affected models include DYZIAA003, DYAPAA017, DYARAA002, and other serial numbers listed in the recall notice.
Look for the serial number on the device or its packaging to determine if it is affected.
The monitor may have issues with urine output measurement errors, temperature measurement errors, and undesired alarms.
Affected models include DYZIAA003, DYAPAA017, DYARAA002, and other serial numbers listed in the recall notice.
The recall does not specify a stop-use action; the remedy is null, so users can continue using the monitor but should check the serial number to confirm if it is affected.
We’ve drafted a message you can send C.R. Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-2243-2018 — C.R. Bard C.R. Bard Hello, I own a C.R. Bard that is covered by recall Z-2243-2018 from C.R. Bard. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.