Automated Peritoneal Dialysis System. Used for recall
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Why was Automated Peritoneal Dialysis System. Used for recalled?
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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: 5C6M40; UDI/DI: 0085412676463; Serial Numbers: 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2204078503, 2203109603.
- Product
- Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 16 units
- Distribution
- US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA.
- Recall date
- April 5, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)