# FDA recall Z-0554-2024

> **C.R. Bard Inc** · Class II · device recall initiated 2023-11-15.

## Product

Sensica Urine Output System, Catalog Number SCCS1002

## Reason for recall

BD (C.R. Bard) has received user complaints reporting that when the device was connected to WiFi/Internet, the time displayed on the Sensica device changed during a patient monitoring session which resulted in 1) incorrect time displayed on the monitoring screen, 2) incorrect hour block timestamps on the monitoring screen, 3) incorrect hour timestamps on data screens, and 4) incorrect catheter use time.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0554-2024
- **Recalling firm:** C.R. Bard Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-15
- **Report date:** 2023-12-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Covington, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0554-2024

## Citation

> AI Analytics. FDA recall Z-0554-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0554-2024. Source: US FDA. Licensed CC0.

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