Baxter HomeChoice Pro Automated Peritoneal Dialysis System Recall
Baxter is recalling HomeChoice Pro Automated PD systems because damaged cassettes may allow air delivery to 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm medical device where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling 23,732 units of the HomeChoice Pro Automated PD system, including models 5C8310 and 5C8310R. The recall covers units distributed worldwide.
The recall is due to a risk that users may incorrectly open disposable set packaging with sharp objects, damaging the cassettes. If damaged cassettes are used, the cycler may fail to detect small holes or cuts in the patient valve region, potentially delivering air into the patient.
This recall affects pediatric and adult renal failure patients undergoing peritoneal dialysis who use the HomeChoice or HomeChoice PRO cyclers. Consumers should stop using the affected devices and contact Baxter Healthcare Corporation for further instructions.
The recalled product
- Product
- HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal…
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 23,732
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)
- all codes
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Similar recalls
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