# FDA recall Z-2000-2020

> **ICU Medical, Inc.** · Class II · device recall initiated 2020-01-02.

## Product

Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41411-25

## Reason for recall

Inability for the guidewire to pass through the needles included with the catheter kits.

## Distribution

US Consignees including in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA and WA  OUS - Canada.

## Key facts

- **Recall number:** Z-2000-2020
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-02
- **Report date:** 2020-05-20
- **Termination date:** 2022-09-14

- **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-2000-2020

## Citation

> AI Analytics. FDA recall Z-2000-2020. Retrieved 2026-05-23 from https://api.ai-analytics.org/recall/Z-2000-2020. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*