Baxter HomeChoice Peritoneal Dialysis Systems Recalled for Software Defect
Baxter is recalling HomeChoice and HomeChoice PRO automated peritoneal dialysis systems due to a software defect that may cause serious complications in patients with ascites.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the defect 'can cause serious problems' in patients with ascites, and the agency classification is Class II, which aligns with the 'Severe' rubric criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Baxter Healthcare Corp. is recalling approximately 65,590 units of HomeChoice and HomeChoice PRO automated peritoneal dialysis systems. The recall affects product codes 5C4471, 5C4471R, 5C8310, and 5C8310R, covering all serial numbers. These devices are intended for the automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
The recall is due to a software defect in systems with version 10.4 software Initial Drain logic. The device attempts to drain the patient to empty at the beginning of therapy, a process the operator can stop but cannot bypass. This design is intended to mitigate Unintended Increased Intraperitoneal Volume (IIVP) but can cause serious problems in patients who have an unrelated co-morbid condition of ascites.
The affected units were distributed worldwide, including the United States (nationwide including Puerto Rico), Australia, Canada, New Zealand, and Japan. Patients and healthcare providers should contact Baxter Healthcare Corp. for instructions on how to proceed with the recall and ensure patient safety.
The recalled product
- Product
- 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro…
- Manufacturer
- Baxter Healthcare Corp.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: All serial numbers
Distribution
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