Baxter Amia Automated PD Systems Recalled for Battery Charging Error
Baxter Healthcare is recalling 55 Amia Automated PD systems due to a battery charging error that prevents the device from functioning.
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, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating involving a functional defect without reported harm.
Plain-English summary
Baxter Healthcare Corp. is recalling 55 units of the Baxter Amia Automated PD system. These devices are used to perform automated peritoneal dialysis for adult patients with renal failure. The recall is due to a system error (01779) that occurs when the battery cannot be charged because of specific voltage differences between the battery and the charger.
The affected units were distributed nationwide, including in Georgia, Massachusetts, North Carolina, New York, Pennsylvania, and Washington. The product code for the recalled items is 5C9310.
Consumers and healthcare providers should stop using the affected devices and contact Baxter Healthcare for further instructions on repair or replacement.
The recalled product
- Product
- Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 55
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)
- Product Code: 5C9310
Distribution
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