Z-2129-2011

APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal...

Name: Z-2129-2011 APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal...
Creator: Baxter Healthcare Renal Div
Published: 2011-03-16
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2011-03-16 / Terminated

FDA source

Baxter Healthcare Renal Div began a recall of APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare... on 2011-03-16. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2129-2011
Status: Terminated
Initiated: 2011-03-16
Posted: 2011-05-03
Terminated: 2012-03-08
Recalling firm: Baxter Healthcare Renal Div
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.
Product code: FKX System, Peritoneal, Automatic Delivery
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 root 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.
Product codes and lots: all serial numbers

Product code FKX

K053512Class IIHomechoice/homechoice Pro Personal Cycler Peritoneal Dialysis System, Models 5C4471 and 5C8310Baxter Healthcare Corp / cleared 2006-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)