Recall Z-0799-2010
Baxter Healthcare Renal Div · initiated January 8, 2010
Product
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.
Codes / lots: All serial numbers.
Reason for recall
Potential overfill of the peritoneal cavity, also referred to as Increased Intraperitoneal Volume (IIPV). IIPV can result in serious injury or death.
FDA-determined cause: Labeling design
Action taken
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 received and understood the notification, and if they still had a HomeChoice System or not. Any questions from the Home Care Coordinators are to be directed to the Baxter Global Technical Services at 1-800-553-6898.
Details
- Recall number
- Z-0799-2010
- Initiated
- January 8, 2010
- Posted by FDA
- March 1, 2010
- Terminated
- June 21, 2017
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- 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, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russia, South Africa, Saudi Arabia, Singapore…
- Recalling firm
- Baxter Healthcare Renal Div, Park, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0800-2010 | HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R…Potential overfill of the peritoneal cavity, also referred to as Increased Intraperitoneal Volume (IIPV).… | 01/08/2010Terminated |