# FDA recall Z-2243-2018

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

## Product

CritiCore Automated Urine Output and Temperature Monitor

## Reason for recall

Issues identified with the monitor including urine output measurement errors, temperature measurement errors and undesired alarms.

## Distribution

AR, AZ, CA, FL, GA, HI, IN, JP, KS, LA, MD, MN, MO, MS, NC, NJ, OH, OK, TN, TX, VA, WA, WI, and WY

## Key facts

- **Recall number:** Z-2243-2018
- **Recalling firm:** C.R. Bard, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2017-11-10
- **Report date:** 2018-06-27

- **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-2243-2018

## Citation

> AI Analytics. FDA recall Z-2243-2018. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-2243-2018. Source: US FDA. Licensed CC0.

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