C.R. Bard recalls CritiCore monitors with serial numbers listed that may have urine output and temperature measurement fluctuations, causing potential inaccuracies in patient monitoring.
BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.
C.R. Bard is recalling some CritiCore automated urine output and temperature monitors due to possible measurement fluctuations. This could lead to inaccurate readings, which might affect patient care decisions.
The monitors may experience fluctuations in urine output volume measurements and core bladder temperature readings, which could lead to inaccurate patient monitoring data. This might cause healthcare providers to make incorrect clinical decisions based on faulty information.
Healthcare providers using the CritiCore monitor for urine output and temperature monitoring in patients are likely affected. Patients using the device for critical care monitoring are at risk if the device provides inaccurate readings.
Check if your CritiCore monitor has a serial number starting with DYZ, DYA, DYB, or DYB followed by specific digits as listed in the recall notice. The product is sold for use in hospitals and critical care settings.
Verify your monitor's serial number against the list of affected numbers provided in the recall notice.
The recall is due to potential measurement fluctuations in urine output and core bladder temperature readings, which could lead to inaccurate patient monitoring data.
Check your monitor's serial number against the list of affected numbers provided in the recall notice. If it's listed, contact C.R. Bard for further instructions.
The recall does not indicate a risk of serious injury; the hazard is limited to potential measurement inaccuracies that could affect patient monitoring decisions.
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-0565-2018 — C.R. Bard C.R. Bard Hello, I own a C.R. Bard that is covered by recall Z-0565-2018 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.
