# FDA recall Z-2103-2019

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2019-06-14.

## Product

Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280  Exported only to Japan for inclusion into convenience kits that are sold only  within the Japanese market

## Reason for recall

Capiox NX19 Oxygenator may contain a non-functioning arterial thermistor component

## Distribution

MI  Foreign: Japan, Belgium

## Key facts

- **Recall number:** Z-2103-2019
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-06-14
- **Report date:** 2019-08-07
- **Termination date:** 2020-06-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Elkton, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2103-2019

## Citation

> AI Analytics. FDA recall Z-2103-2019. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2103-2019. Source: US FDA. Licensed CC0.

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