# FDA recall Z-2154-2024

> **C.R. Bard Inc** · Class II · device recall initiated 2024-05-09.

## Product

Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended for use in the drainage and/or collection and/or measurement of urine.

## Reason for recall

Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.

## Distribution

Distribution was nationwide.  There was no government/military/foreign distribution.

## Key facts

- **Recall number:** Z-2154-2024
- **Recalling firm:** C.R. Bard Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-09
- **Report date:** 2024-06-26

- **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-2154-2024

## Citation

> AI Analytics. FDA recall Z-2154-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2154-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*