# FDA recall Z-0064-2022

> **ZOLL Circulation, Inc.** · Class II · device recall initiated 2021-08-06.

## Product

Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer

## Reason for recall

Labeling update concerning potential leaks from  the catheter or the start-up kit (SUK) tubing

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the countries Australia, CANADA, CHINA, GERMANY, HUNGARY, PORTUGAL, SINGAPORE, TAIWAN, THAILAND.

## Key facts

- **Recall number:** Z-0064-2022
- **Recalling firm:** ZOLL Circulation, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-08-06
- **Report date:** 2021-10-13
- **Termination date:** 2024-10-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0064-2022

## Citation

> AI Analytics. FDA recall Z-0064-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0064-2022. Source: US FDA. Licensed CC0.

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