# FDA recall Z-1970-2020

> **C.R. Bard Inc** · Class II · device recall initiated 2020-04-15.

## Product

SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.

## Reason for recall

There is potential for a white paper-type residue attached to the catheter.

## Distribution

US Nationwide distribution including in the states of AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MO, NC, NE, NJ, NY, RI, SD, TN, TX, UT, VA, WV.

## Key facts

- **Recall number:** Z-1970-2020
- **Recalling firm:** C.R. Bard Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-15
- **Report date:** 2020-05-20
- **Termination date:** 2021-05-20

- **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-1970-2020

## Citation

> AI Analytics. FDA recall Z-1970-2020. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-1970-2020. Source: US FDA. Licensed CC0.

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