# FDA recall Z-1095-2019

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

## Product

icumedical Oncology Kit w/12" (30cm) Ext Set w/Spiros w/Red Cap, Clamp, Graduated Adapter; ChemoClave Vented Vial Spike, 20mm; ChemoClave Vented Vial Spike, 13mm; Spiros wRed Cap, REF 3944. Used in IV administration sets.     The ChemoCLAVE Cytotoxic Medication Preparation and Delivery System consists of 6 previously cleared components (CLAVE, Spikes, SPIROS, GENIE, Vial Access, and Admin Sets) that can be combined into various configurations intended for use in the preparation and patient administration of cytotoxic medications.

## 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-1095-2019
- **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-1095-2019

## Citation

> AI Analytics. FDA recall Z-1095-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1095-2019. Source: US FDA. Licensed CC0.

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