Device Recall HomeChoice

all codes

Gastroenterology-Urology Devices

2

No

Worldwide Distribution

HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R || Product Usage: || The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

All HomeChoice PRO Systems with software versions 8.51 and 8.52.

Gastroenterology-Urology Devices

2

No

Nationwide, Guatemala, Chile, Brazil, Turkey, Singapore, Taiwan, Canada, Belgium, Czech Republic, Israel, Italy, Jordan, Lebanon, Malta, Spain, Sweden, Turkey and the United Kingdom.

HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R

All HomeChoice Systems with software versions 8.5 and higher.

Gastroenterology-Urology Devices

2

No

Nationwide, Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Guatemala, Hong Kong, India, Ireland, Italy, Korea, Malaysia, Mexico, Nicaragua, the Netherlands, Peru, the Philippines, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela and the United Kingdom.

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, 5C4474, 5C4474R, T5C4441, T5C4441R

All HomeChoice Systems with software versions 8.5 and higher.

Gastroenterology-Urology Devices

2

No

Nationwide, Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Guatemala, Hong Kong, India, Ireland, Italy, Korea, Malaysia, Mexico, Nicaragua, the Netherlands, Peru, the Philippines, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela and the United Kingdom.

HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R

All units that do not bear the CE marking.

Gastroenterology-Urology Devices

2

No

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.

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