# FDA recall Z-0662-2019

> **ICU Medical, Inc.** · Class II · device recall initiated 2018-10-05.

## Product

Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate.  1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090

## Reason for recall

Potential for leakage due to defect in the thermoset check valve component.

## Distribution

United States - AL, CA, CO, DC, FL, GA, IN, KY, LA, MA, ME, MD, MI, MO,  MS, MT, NJ, NY, NC, OH, OK,  OR, PA, SC, TN, TX, VA, WA, WI, WV, WY

## Key facts

- **Recall number:** Z-0662-2019
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-10-05
- **Report date:** 2019-01-02
- **Termination date:** 2021-03-25

- **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-0662-2019

## Citation

> AI Analytics. FDA recall Z-0662-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0662-2019. Source: US FDA. Licensed CC0.

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