Baxter HomeChoice APD Systems Recalled for Loud Operating Sounds
Baxter is recalling HomeChoice and HomeChoice Pro APD systems due to loud operating sounds. The devices function correctly, but the noise is unacceptable to users.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, and the hazard is limited to loud operating sounds without functional failure or reported injury, fitting the criteria for cosmetic or minor defects.
Plain-English summary
Baxter Healthcare Corp. is recalling HomeChoice and HomeChoice Pro Automated Peritoneal Dialysis (APD) systems. The recall affects 29,355 units distributed nationwide, in the District of Columbia, and in Puerto Rico from 1994 to the present. The devices are used to provide APD therapy for pediatric and adult renal patients.
The reason for the recall is that the devices produce loud operating sounds when powered on, which end users found unacceptable. The source text confirms that the HomeChoice devices continue to perform as intended, as the issue is associated only with the noise and not the function of the device.
Affected users may experience a delay in treatment if they need to change to a different system. Consumers should contact Baxter Healthcare Corp. for further instructions on how to proceed.
The recalled product
- Product
- Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
- Manufacturer
- Baxter Healthcare Corp.
- Hazard
- Affected units
- 29,355
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)
- 5C4471R
Distribution
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