# FDA recall Z-1098-2019

> **ICU Medical, Inc.** · Class I · device recall initiated 2019-02-21.

## Product

SetSource ChemoClave Vented Vial Spike, 20mm, REF Z7148. Used in IV administration sets.     The ChemoClave is a needle-free Closed System Transfer Device (CSTD) that mechanically prohibits the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system during drug preparation and administration, thereby minimizing exposure of individuals, healthcare personnel and the environment to hazardous drugs.

## Reason for recall

There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.

## Distribution

Worldwide distribution: US nationwide and countries of: Canada, France, and Singapore.

## Key facts

- **Recall number:** Z-1098-2019
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-21
- **Report date:** 2019-04-24
- **Termination date:** 2024-06-04

- **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-1098-2019

## Citation

> AI Analytics. FDA recall Z-1098-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1098-2019. Source: US FDA. Licensed CC0.

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