Kaguya Automated Peritoneal Dialysis System recall
Kaguya Automated Peritoneal Dialysis System
Why was Kaguya Automated Peritoneal Dialysis System recalled?
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code T5C8500 (distribution in Japan only)
- Product
- Kaguya Automated Peritoneal Dialysis System
- Recalling firm
- BAXTER HEALTHCARE CORPORATION
- Quantity
- 5101 units
- Distribution
- Worldwide distribution - US Nationwide distribution and the country of Japan.
- Recall date
- August 11, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)