Baxter HomeChoice Automated Peritoneal Dialysis Systems Recalled for Updated Warnings
Baxter Healthcare is recalling HomeChoice and HomeChoice Pro Automated Peritoneal Dialysis systems because the patient guide lacks updated warnings and cautions.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states the issue is missing warnings in the guide without reporting any injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Baxter Healthcare Corp. is recalling 96,458 units of the HomeChoice Automated PD system and HomeChoice Pro Automated PD system. These devices are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. The recall covers systems distributed nationwide in the United States and in numerous countries worldwide.
The recall was initiated because there are additional and updated warnings and cautions that are not included in the Patient At-Home Guide for these systems. The source text does not specify the exact nature of the missing warnings or report any specific injuries or illnesses associated with the device.
Patients and clinicians using these systems should contact Baxter Healthcare or their dialysis center for instructions on how to obtain the updated safety information. The recall includes all serial numbers for product codes 5C4471(R) and 5C8310(R).
The recalled product
- Product
- HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000…
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 96,458
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 (3)
- Product Codes: 5C4471(R)
- 5C8310(R)
- Serial Numbers: All serial numbers
Distribution
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