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
This recall has been terminated (originally issued November 11, 2004).
- Company
- Baxter Healthcare Renal Div
- Recall Initiated
- November 1, 2004
- Posted
- November 11, 2004
- Terminated
- December 11, 2007
- Recall Number
- Z-0188-05
- Quantity
- 12,200 units
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
All units that do not bear the CE marking.
Root Cause
Other
Action Taken
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.