Baxter Recalls Kaguya Automated Peritoneal Dialysis Systems Due to Software Defect
Baxter Healthcare is recalling 1,085 Kaguya Automated Peritoneal Dialysis Systems because a software defect may cause shortened dwell times during therapy.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls with potential for significant injury or adverse health consequences (shortened dwell times in dialysis) map to a severity score of 4 (Severe).
Plain-English summary
Baxter Healthcare Corporation is recalling 1,085 units of the Kaguya Automated Peritoneal Dialysis System. The recall is due to a potential software defect in the automated PD system cyclers that can cause shortened dwell times during a Cycle-Based therapy. The system is intended for the automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis.
The affected devices are identified by product code T5C8500, and all serial numbers are affected. The devices were distributed nationwide in the United States and internationally to Canada and Japan. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Patients using these devices should contact their healthcare provider or Baxter Healthcare for further instructions on how to proceed with their dialysis treatment.
The recalled product
- Product
- Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 1,085
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 T5C8500. All serial numbers are affected.
Distribution
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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