Reported Apr 5, 2023 · Ongoing

Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.

Baxter Healthcare Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

  • Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Lot codes and dates

3 of 3 products

Products covered by this recall
Model / numberBarcodesProduct as published
5C6M40
0085412676463UDI/DI: 0085412676463
Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.
Amount recalled
16 units

Where it was sold

Why it was recalled

The electrical safety testing was not properly performed on the impacted devices and additional testing is required

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.