Urinometer, Electrical
FDA product code EXS · Class II (moderate risk) · 21 CFR 876.1800 · Gastroenterology, Urology
0510(k) clearances
0PMA approvals
6recalls
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0554-2024 Class II | Sensica Urine Output System, Catalog Number SCCS1002BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet… | C.R. Bard Inc | 11/15/2023Open, Classified |
| Z-1293-2022 Class II | Sensica Urine Output SystemComplaints relating to urine output measurement accuracy. | C.R. Bard Inc | 05/19/2022Open, Classified |
| Z-2243-2018 Class II | CritiCore Automated Urine Output and Temperature MonitorIssues identified with the monitor including urine output measurement errors, temperature measurement errors… | C.R. Bard, Inc. | 11/10/2017Open, Classified |
| Z-0565-2018 Class II | BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series The CritiCore(R) Automated Urine…BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output… | C.R. Bard, Inc. | 11/10/2017Terminated |
| Z-0488-2018 Class II | BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM)…The possibility exists that use of the Uros Automated Urine Output and Temperature Monitor may lead to the… | C.R. Bard, Inc. | 09/29/2017Terminated |
| Z-0719-2011 | Bard CritiCore Monitor, Software Version 2.1, Catalog number 000002N, C.R. Bard, Inc.…Error can occur in the reading of the Present Interval Output (PIO) reading when the device is subjected to… | C.R. Bard, Inc., Urological Division | 11/17/2010Terminated |