Baxter Healthcare Renal Div HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R
Brand
Baxter Healthcare Renal Div
Lot Codes / Batch Numbers
Units with software version 8.7 used with Physioneal Clear-Flex PD products
Products Sold
Units with software version 8.7 used with Physioneal Clear-Flex PD products
Baxter Healthcare Renal Div is recalling HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation due to A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD produ. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products.
Recommended Action
Per FDA guidance
Baxter notified the Danish Ministry of Health of the problem with the HomeChoice Pro not prompting the patient when using the Physioneal Clear-Flex PD products on 12/23/04. The patients in Denmark and Sweden will be re-evaluate and re-train each patient as needed using enhanced training materials, which will include the importance of and the rationales for breaking the peel-seal on teh Physioneal ClearFlex prior to use and what to do if mis-infusion occurs. Larger, adhesive, colored stickers will be affixed to all applicable HomeChoice Pro machines to further remind patients of the need to break all peel-seals prior to use. Patients will receive a new Pro-Card when their machine is exchanged, and the exchange will be documented. The HomeChoice Pro software will be updated to correct the software anomaly, validated and installed on the HomeChoice Pro machines.
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
IN
Page updated: Jan 10, 2026