---
title: "Automated Peritoneal Dialysis System. Used for automatic control of dialysis ... — FDA record Z-1316-2023 | Is It on Recall"
description: "The electrical safety testing was not properly performed on the impacted devices and additional testing is required"
url: https://isitonrecall.com/recall/fda-device-z-1316-2023-automated-peritoneal-dialysis-system-used-for-automatic-control-of-dialysis-solution-exchanges/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges. — FDA record Z-1316-2023

Reported ongoing

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 Feb 22, 2023. 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**: Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
- **Reason**: The electrical safety testing was not properly performed on the impacted devices and additional testing is required
- **Classification**: Class II
- **Recalling firm**: Baxter Healthcare Corporation
- **Quantity**: 16 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1316-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1316-2023%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: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603. |

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

## Distribution

US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.

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/)
- [Arkansas](https://isitonrecall.com/state/arkansas/)
- [Arizona](https://isitonrecall.com/state/arizona/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [North Dakota](https://isitonrecall.com/state/north-dakota/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Washington](https://isitonrecall.com/state/washington/)

## Dates in the source

- **Report date**: Apr 5, 2023
- **Recall initiation date**: Feb 22, 2023
- **Center classification date**: Mar 30, 2023

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-1316-2023%22)

## Related records

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