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U.S. Department of Health and Human Services

Class 1 Device Recall HomeChoice Automated Peritoneal Dialysis Systems

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 Class 1 Device Recall HomeChoice Automated Peritoneal Dialysis Systemssee related information
Date Initiated by FirmJanuary 08, 2010
Date PostedMarch 01, 2010
Recall Status1 Terminated 3 on June 21, 2017
Recall NumberZ-0799-2010
Recall Event ID 54285
510(K)NumberK053512 
Product Classification System, peritoneal, automatic delivery - Product Code FKX
ProductBaxter 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.
Code Information All serial numbers.
FEI Number 3000210122
Recalling Firm/
Manufacturer		 Baxter Healthcare Renal Div
1620 Waukegan Rd Bldg R
Mc Gaw Park IL 60085-6730
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer 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 2		Labeling design
ActionUrgent 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.
Quantity in Commerce94,076 units
DistributionWorldwide 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, Slovenia, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom and Venezuela.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FKX
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