# FDA recall Z-0652-2025

> **ICU Medical, Inc.** · Class II · device recall initiated 2024-11-06.

## Product

ChemoLock Close Vial Spike REF CL-80    The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants.  The Chemolock is needle free and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

## Reason for recall

Due to finished goods incorrectly packaged and labeled.

## Distribution

Worldwide - U.S. Nationwide distribution in the state of IL and the country of Canada.

## Key facts

- **Recall number:** Z-0652-2025
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-06
- **Report date:** 2024-12-18

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0652-2025

## Citation

> AI Analytics. FDA recall Z-0652-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0652-2025. Source: US FDA. Licensed CC0.

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