CLASS II ONGOING Device recall · Reported 5 Apr 2023 · FDA Enforcement Report

Automated Peritoneal Dialysis System recalled by Baxter Healthcare

Baxter Healthcare is recalling Automated Peritoneal Dialysis System, distributed in 10 states. The recall was initiated on 22 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.

Quantity recalled16 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1316-2023
FDA event ID: 91776
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 22 Feb 2023
FDA classified: 30 Mar 2023
Reported: 5 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Feb 2023	Recall initiated by company
30 Mar 2023	Classified by FDA	+36 days
5 Apr 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

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

Alabama Arkansas Arizona Florida Illinois North Dakota New York Ohio Texas Washington

Questions about this recall

Is Automated Peritoneal Dialysis System recalled?

Yes. Baxter Healthcare recalled Automated Peritoneal Dialysis System on 22 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1316-2023.

Why was it recalled?

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

Which lots are affected?

Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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