Baxter Healthcare Renal Div HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, T5C4441, T5C4441R Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, T5C4441, T5C4441R
Brand
Baxter Healthcare Renal Div
Lot Codes / Batch Numbers
All units that do not bear the CE marking.
Products Sold
All units that do not bear the CE marking.
Baxter Healthcare Renal Div is recalling HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corpor due to The on/off power switch is not grounded as a separate component in the device, and can loosen from its housing, which may result in an electrical shoc. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The on/off power switch is not grounded as a separate component in the device, and can loosen from its housing, which may result in an electrical shock to the user.
Recommended Action
Per FDA guidance
Baxter sent Urgent Device Correction letters to the Peritoneal Dialysis Home Care Coordinators on 11/1/04 and to the Home Dialysis Patients on 11/2/04. The consignees were informed of the potential for a shock if the power switch loosens in the housing, and that the switch would be replaced with a grounded power switch on a next service call basis. If the patient experiences any difficulty turing the device on or off, or if they notice that the power switch is loose, they were instructed to immediately unplug the device and contact Baxter Global Technical Service (BGTS) at 1-800-553-6898, option 1, for immediate assistance.
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 noticePage updated: Jan 10, 2026