# FDA recall Z-1096-2019

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

## Product

icumedical ChemoLock, 20mm,   (a) REF CL-80S  (b) REF CL-80S-10 (10 units).    Used in IV administration sets.    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. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.

## 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-1096-2019
- **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-1096-2019

## Citation

> AI Analytics. FDA recall Z-1096-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1096-2019. Source: US FDA. Licensed CC0.

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