C.R. Bard Recalls Uros Automated Urine Output and Temperature Monitor
C.R. Bard is recalling two units of the Uros Automated Urine Output and Temperature Monitor in Florida due to potential measurement inaccuracies.
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 involves a medical device where measurement inaccuracies could impact clinical treatment decisions, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
C.R. Bard, Inc. is recalling two units of the Uros Automated Urine Output and Temperature Monitor, Model BK10001M. The device is indicated to monitor urine output and core bladder temperature. The recall is limited to units distributed in the state of Florida.
The recall is being issued because the possibility exists that use of the monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies. These issues could result in an impact on clinical treatment decisions.
The source text does not specify instructions for consumers or healthcare providers regarding the return or disposal of the affected units.
The recalled product
- Product
- BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.
- Manufacturer
- C.R. Bard, Inc.
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog/PC #BK10001M
Distribution
Distributed in 1 state:
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