Automated Peritoneal Dialysis System. Used for automatic… recallZ-1316-2023 · Baxter Healthcare Corporation · initiated Feb 22, 2023
Class II Open, Classified All recalls posted in April 2023
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
FDA root cause category: Process design
What the company is doing
Baxter notified consignees via phone call on 02/22/2023. The notification outlined the issue and that Baxter was retrieving the units and then replacing them within 24 hours.
Recall details
- Recall number
- Z-1316-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Feb 22, 2023
- Posted by the FDA
- Apr 1, 2023
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 16 units
- Product code
- FKX
- FDA submissions
- K201867
- Distribution
- US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
Product description
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Code information (models, lots, serial numbers)
Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Homechoice Claria 5C6M40Baxter Healthcare Corporation · System, peritoneal, automatic delivery1 recall23 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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