# FDA recall Z-0949-2022

> **Terumo Cardiovascular Systems Corp** · Class II · device recall initiated 2022-02-03.

## Product

Cardiovascular Procedure Kit catalog # 76645 & 73806

## Reason for recall

Potential for Cardiovascular Procedure Kit packaging damage that occurred during shipping.

## Distribution

US  Nationwide distribution in the states of CA and IN.

## Key facts

- **Recall number:** Z-0949-2022
- **Recalling firm:** Terumo Cardiovascular Systems Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-02-03
- **Report date:** 2022-04-27
- **Termination date:** 2024-02-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Ashland, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0949-2022

## Citation

> AI Analytics. FDA recall Z-0949-2022. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-0949-2022. Source: US FDA. Licensed CC0.

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