HomeChoice and Yume Automated Peritoneal Dialysis Systems recallZ-0188-05 · Baxter Healthcare Renal Div · initiated Nov 1, 2004
Terminated All recalls posted in November 2004
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 Renal Div 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 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.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0188-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 1, 2004
- Posted by the FDA
- Nov 11, 2004
- Recalling firm
- Baxter Healthcare Renal Div
- Quantity
- 12,200 units
- Product code
- FKX
- FDA submissions
- K012988
- Distribution
- Nationwide, including Puerto Rico, and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, Guatemala, Honduras, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, New Zealand, Peru, Philippines, Saudi Arabia, Singapore, South Africa, Taiwan, Turkey, Uruguay and Venezuela.
Product description
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
Code information (models, lots, serial numbers)
All units that do not bear the CE marking.
Other devices under the same FDA submission
1 device cleared under K012988 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- LOW RECIRCULATION VOLUME APD SET 5C8302CBaxter International Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY9 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 30274).
- Z-0189-05 · TerminatedHomeChoice PRO and Yume Plus Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C83…
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.
How recalls are matched to devices · Editorial policy · Report an error on this page