C.R. Bard, Inc. recalls BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temper…

Recall date

September 29, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0488-2018

FDA classification

Class II

Brand / firm

C.R. Bard, Inc.

Sold / distributed

US Distribution to the state of: FL

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.