# FDA recall Z-0003-2022

> **Medtronic Perfusion Systems** · Class II · device recall initiated 2021-09-13.

## Product

Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.

## Reason for recall

There was a label mix-up between two model numbers resulting in the incorrect guidewire being contained in the kits for both model numbers.

## Distribution

Worldwide distribution - US Nationwide distribution in the state of Massachusetts and the countries of Belgium, France, Germany Japan, Korea, Saudi Arabia, Spain, and Turkey.

## Key facts

- **Recall number:** Z-0003-2022
- **Recalling firm:** Medtronic Perfusion Systems
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-13
- **Report date:** 2021-10-13

- **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-0003-2022

## Citation

> AI Analytics. FDA recall Z-0003-2022. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0003-2022. Source: US FDA. Licensed CC0.

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