# FDA recall Z-0805-2019

> **ICU Medical, Inc.** · Class I · device recall initiated 2019-01-03.

## Product

icumedical ChemoLock Vial Spike, 20mm, REF CL-80S     The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system.

## Reason for recall

There is a potential for one lot of ChemoLock Vial Spike to contain burr particulate

## Distribution

US Distribution to states of: OH, FL, IA, CA, PA, IL, VA; and internationally to: AUSTRIA, CHINA (TAIWAN), IRELAND, ITALY and SINGAPORE.

## Key facts

- **Recall number:** Z-0805-2019
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-03
- **Report date:** 2019-03-06
- **Termination date:** 2024-05-29

- **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-0805-2019

## Citation

> AI Analytics. FDA recall Z-0805-2019. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0805-2019. Source: US FDA. Licensed CC0.

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