HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL
FDA device recall Z-0188-05 · posted 2004-11-11 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Renal Div
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FKX
- Quantity affected
- 12,200 units
- Distribution
- Nationwide, including Puerto Rico, and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, Guatemala, Honduras, Hong Kong, India, Japan, Korea, Malaysia, Nicaragu
- Date initiated
- 2004-11-01
- Date posted
- 2004-11-11
- Date terminated
- 2007-12-11
- Location
- Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 (K012988) | Baxter Healthcare Corp | 2001-12-05 |