Baxter AMIA v1.0 APD System Recall for Labeling Warning
Baxter Healthcare is recalling 55 AMIA v1.0 APD Systems to add a warning about the risk of unintended increased intraperitoneal volume for vulnerable patients.
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 describes a labeling deficiency (missing warning) rather than a reported injury or hospitalization, fitting the 'Minor labeling errors' criterion for a Moderate score.
Plain-English summary
Baxter Healthcare Corp. is recalling 55 units of the AMIA v1.0 APD System, a device used for Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. The recall is initiated to address a labeling deficiency regarding the risk of unintended Increased Intraperitoneal Volume (IIPV), also known as overfill.
The hazard specifically affects patients who are vulnerable to IIPV, including neonates, infants, small children, and any patient with significant heart and/or lung disease. The recall is limited to adding a warning to the product labeling to alert users to this specific risk.
The affected systems were distributed nationwide in the states of Georgia, Massachusetts, North Carolina, New York, Pennsylvania, and Washington. The product code for the recalled units is 5C9310. Consumers and healthcare providers should contact Baxter Healthcare Corp. for instructions on how to obtain the updated labeling or replace the device if necessary.
The recalled product
- Product
- AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
- Manufacturer
- Baxter Healthcare Corp.
- Hazard
- 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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