# FDA recall Z-0900-2018

> **Medtronic Perfusion Systems** · Class II · device recall initiated 2018-02-08.

## Product

BIO CAL(R) Temperature Controller, Models: (a) 370, (b) 370I    Product Usage:  The BIO CAL(R) (unit) is a thermal transfer module designed to control patient blood temperature during cardiopulmonary bypass procedures when heating or cooling of the blood is desired.

## Reason for recall

Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. As a result, an updated cleaning protocol will not be developed by Medtronic and it has been determined that the best course of action is to request BIO CAL users to discontinue use and dispose of BIO CAL devices.

## Distribution

Worldwide Distribution

## Key facts

- **Recall number:** Z-0900-2018
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-02-08
- **Report date:** 2018-03-14
- **Termination date:** 2020-08-06

- **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-0900-2018

## Citation

> AI Analytics. FDA recall Z-0900-2018. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0900-2018. Source: US FDA. Licensed CC0.

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