# FDA recall Z-0966-2019

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2018-12-20.

## Product

Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE)  Catalog Number: 140222

## Reason for recall

Presence of natural rubber latex is not declared in the label

## Distribution

TX

## Key facts

- **Recall number:** Z-0966-2019
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-12-20
- **Report date:** 2019-03-06
- **Termination date:** 2019-08-20

- **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-0966-2019

## Citation

> AI Analytics. FDA recall Z-0966-2019. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-0966-2019. Source: US FDA. Licensed CC0.

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