Baxter HomeChoice Automated PD System Recalled for Air Delivery Risk
Baxter is recalling HomeChoice Automated PD systems because damaged cassettes may allow the device to deliver air to patients.
What this means for you
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 product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling the HomeChoice Automated PD system, model numbers 5C4471 and 5C4471R. The recall involves 15,144 units distributed worldwide.
The recall was initiated because users may be incorrectly opening disposable set packaging with sharp objects, which can damage the cassettes. If damaged cassettes are used, the cycler may fail to detect small holes in the sheeting within the patient valve region, potentially resulting in the delivery of 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 Automated PD system Model numbers: 5C4471, 5C4471R 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 dialys
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 15,144
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.
See all 2 products in this recall →Related recalls
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