Baxter Healthcare Corporation Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Brand
Baxter Healthcare Corporation
Lot Codes / Batch 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.
Products Sold
Product Code: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.
Baxter Healthcare Corporation is recalling Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges. due to The electrical safety testing was not properly performed on the impacted devices and additional testing is required. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, FL, IL, NY, ND, OH, TX, WA
Page updated: Jan 10, 2026