# FDA recall Z-2495-2020

> **Medtronic Perfusion Systems** · Class II · device recall initiated 2018-08-08.

## Product

Extra corporeal circuit with bio-active surface.

## Reason for recall

Affected products failed a sterilization test.

## Distribution

Domestic Distribution only to CA and MI.

## Key facts

- **Recall number:** Z-2495-2020
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-08-08
- **Report date:** 2020-07-15
- **Termination date:** 2020-10-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brooklyn Park, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2495-2020

## Citation

> AI Analytics. FDA recall Z-2495-2020. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-2495-2020. Source: US FDA. Licensed CC0.

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