---
title: "Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular p... — FDA record Z-1019-2022 | Is It on Recall"
description: "There is a potential for foreign matter."
url: https://isitonrecall.com/recall/fda-device-z-1019-2022-flo-thru-intraluminal-shunt-used-in-coronary-artery-or-peripheral-vascular-procedures-used-to-shunt/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the an... — FDA record Z-1019-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 1, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allowing blood to flow distal to the anastomosis.
- **Reason**: There is a potential for foreign matter.
- **Classification**: Class II
- **Recalling firm**: Baxter Healthcare Corporation
- **Quantity**: 300 devices
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-1019-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1019-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | Product Code: FT12150; Lot: SP21J21-1584173 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

Distribution in the United States including AL, CA, KY, NY, OR, PA, and TX OUS distribution to Japan, Italy, Netherlands, Switzerland, and United Kingdom

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Alabama](https://isitonrecall.com/state/alabama/)
- [California](https://isitonrecall.com/state/california/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Oregon](https://isitonrecall.com/state/oregon/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: May 11, 2022
- **Recall initiation date**: Apr 1, 2022
- **Center classification date**: Apr 29, 2022
- **Termination date**: Jul 10, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1019-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Baxter Healthcare Corporation records](https://isitonrecall.com/brand/baxter-healthcare-corporation/)