Baxter APD Cycler Recall for Incomplete Clinician Guide Instructions
Baxter Healthcare is recalling 10 automated peritoneal dialysis cyclers because the clinician guide lacks instructions for priming the patient line.
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 hazard is a documentation error (incomplete instructions) rather than a direct physical defect or reported injury, fitting the 'Minor labeling errors' or 'voluntary precautionary' criteria for a Moderate score.
Plain-English summary
Baxter Healthcare Corporation is recalling 10 units of the Automated Peritoneal Dialysis (APD) cycler. The recall is due to incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide. Specifically, the guide does not specify the need for an extra 200 mL of peritoneal dialysis solution to prime the patient line and for air purge operations.
The affected units were distributed to a consignee in New York, with a foreign consignee in Ecuador. The recall is limited to the specific documentation error regarding the calculation of the total recommended solution therapy volume.
Clinicians and patients using this specific system should refer to updated instructions provided by Baxter Healthcare to ensure the correct volume of solution is used for priming and air purge operations to maintain safe dialysis treatment.
The recalled product
- Product
- Automated peritoneal dialysis (APD) cycler
- Manufacturer
- Baxter Healthcare Corp.
- Affected units
- 10
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)
- N/A
Distribution
Distribution scope not specified by the agency.
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