Class 2 Device Recall HomeChoice and HomeChoice Pro Cyclers

• Date Initiated by Firm: March 16, 2011
• Date Posted: May 03, 2011
• Recall Status: Terminated on March 08, 2012
• Recall Number: Z-2129-2011
• Recall Event ID: 58383
• 510(K)Number: K053512
• Product Classification: System, peritoneal, automatic delivery - Product Code FKX
• Product: APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.; 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
• Recalling Firm/ Manufacturer: Baxter Healthcare Renal Div; 1620 Waukegan Rd; Mc Gaw Park IL 60085-6730
• For Additional Information Contact: Center for One Baxter ; 800-422-9837
• Manufacturer Reason for Recall: Clinicians are being reminded of the current warning in The HomeChoice APD Systems Patient At-Home Guide, 07-19-61-244 (October 2,2009), which states on page 3-13 "To reduce the risk of bums, electrocution, fire, or injury to persons: Close supervision is necessary when this product is used by, on, or near children or those unable to care for themselves." Tubing entanglement around the neck may r
• FDA Determined Cause: Other
• Action: Baxter sent Safety Alert letters dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to consider the following safeguards for at-risk patients on HomeChoice Therapy: Have a caregiver present while the patient is performing therapy. Move the HomeChoice cycler to the foot of the bed, if possible, to minimize the likelihood of entanglement that may lead to asphyxiation. Install bed railings for patients at risk for seizures or falls from bed. Complete the attached customer reply form and fax it to Baxter at t847-270-5457. For questions regarding this recall call 888-736-2543, option 2.
• Quantity in Commerce: N/A
• Distribution: Worldwide Distribution - USA including AZ, CA, CT, DC, FL, KY, MO, NC, NM, Ny, OH, PA, TN, TX, and VA and the countries of 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, Slovania, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingom, and Venezuela.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = FKX and Original Applicant = BAXTER HEALTHCARE CORP.