Baxter Healthcare Renal Div HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R
Brand
Baxter Healthcare Renal Div
Lot Codes / Batch Numbers
all serial numbers
Products Sold
all serial numbers
Baxter Healthcare Renal Div is recalling HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, De due to The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posi. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The screws that secure the Power Entry Module (PEM) to the base of the HomeChoice device are not reliably grounded to the device's ground system, posing an electric shock hazard.
Recommended Action
Per FDA guidance
Baxter sent Urgent Device Correction letters worldwide to their customers on 6/21/05 and home patients on 6/22/05. The accounts were informed of teh risk of electrical shock from screws used to secure the Power Entry Module to the back of the HomeChoice system, and were instructed to always connect the power cord to the power entry module first, before plugging the power cord into a grounded electrical outlet. The users were advised to use caution to avoid contact the power entry module screws while powering on or powering off the device, and were informed that a new mounting bracket that providews more reliable grounding was installed in instruments processed through the Baxter service organization as of May 2005. All remaining instruments will receive the new mounting bracket by August 2006, and Baxter will contact the accounts to arrange for the upgrade. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 1.
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