Recall Z-0799-2010 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Renal Div
Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R, 5C4474D and 5C447DR. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL.
| Date | Mar 1, 2010 (initiated Jan 8, 2010) |
| Status | Terminated |
| Reason | Potential overfill of the peritoneal cavity, also referred to as Increased Intraperitoneal Volume (IIPV). IIPV can result in serious injury or death. |
| Root cause | Labeling design |
| Action | Urgent Product Recall letters dated January 8, 2010 were mailed to all Peritoneal Dialysis Clinicians on January 8, 2010 and letters dated January 12, 2010 to all Home Care Coordinators and Home Dialysis Patients on January 12, 2010, informing them of steps to take to help reduce or eliminate overfill, also referred to as Increased Intraperitoneal Volume, associated with HomeChoice/Homechoice Pro cyclers. Baxter Healthcare Corporation explained that they had received complaints of IIPV. The accounts were requested to complete and return the enclosed response form, indicating that they receiv |
| Quantity | 94,076 units |
| Distribution | Worldwide Distribution -- United States, Austria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Ireland, Israel, Italy, South Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Pa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053512 | HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 Baxter Healthcare Corp, Feb 16, 2006 |