C.R. Bard Recalls CritiCore Monitors Due to Measurement and Alarm Failures
C.R. Bard is recalling 343 CritiCore monitors because they may experience urine output and temperature measurement fluctuations and alarm errors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the device is a risk-of-harm product where measurement and alarm failures could impact patient care, but no injuries or illnesses have been reported in the source text.
Plain-English summary
C.R. Bard, Inc. is recalling 343 units of the Bard CritiCore Monitor, Model 000002N Series. The device is indicated to monitor urine output and core bladder temperature. The affected units were distributed in the United States and internationally to Japan.
The recall was initiated because the U.S. Food and Drug Administration (FDA) identified that some lots of these monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations, and alarm errors. The source text does not report any specific illnesses or injuries associated with these failures.
Healthcare facilities should check their inventory against the list of affected serial numbers provided in the recall notice. If a device is affected, it should be removed from service and returned to C.R. Bard, Inc. according to the company's instructions.
The recalled product
- Product
- BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
- Manufacturer
- C.R. Bard, Inc.
- Affected units
- 343
Distribution
Distribution scope not specified by the agency.
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