PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: February 7, 2018 Initiated: September 29, 2017 #Z-0488-2018

Product Description

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.

Reason for Recall

The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions.

Details

Recalling Firm
C.R. Bard, Inc.
Units Affected
2 units
Distribution
US Distribution to the state of: FL
Location
Covington, GA

Frequently Asked Questions

What product was recalled?
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.. Recalled by C.R. Bard, Inc.. Units affected: 2 units.
Why was this product recalled?
The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the loss of urine output measurement data and/or urine output measurement inaccuracies resulting in an impact on clinical treatment decisions.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 7, 2018. Severity: Moderate. Recall number: Z-0488-2018.