# FDA recall Z-0565-2018

> **C.R. Bard, Inc.** · Class II · device recall initiated 2017-11-10.

## Product

BARD(R) CRITICORE(R) MONITOR, Model: 000002N Series    The CritiCore(R) Automated Urine Output and Temperature Monitor is indicated to monitor urine output and core bladder temperature.

## Reason for recall

BMD has identified that some lots of CritiCore(R) monitors may experience failures involving urine output volume measurement fluctuations, core bladder temperature measurement fluctuations and alarm errors.

## Distribution

US Distribution and Internationally to Japan

## Key facts

- **Recall number:** Z-0565-2018
- **Recalling firm:** C.R. Bard, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-10
- **Report date:** 2018-02-21
- **Termination date:** 2021-09-22

- **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-0565-2018

## Citation

> AI Analytics. FDA recall Z-0565-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0565-2018. Source: US FDA. Licensed CC0.

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