Z-0488-2018 Class II Terminated
FDA device recall Z-0488-2018 was initiated by C.R. Bard, Inc. on September 29, 2017 and is designated Class II. 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 … The recall status is terminated (terminated July 7, 2021). Affected quantity: 2 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2018
- Initiation Date
- September 29, 2017
- Termination Date
- July 7, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 units
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.
Distribution Pattern
US Distribution to the state of: FL
Code Information
Catalog/PC #BK10001M