AMIA v1.0 APD System. For Automated Peritoneal Dialysis recall: Labeling Error
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
Why was AMIA v1.0 APD System. For Automated Peritoneal Dialysis recalled?
Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small children, and any patient with significant heart and/or lung disease.
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: 5C9310
- Product
- AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 55 systems
- Distribution
- US: Nationwide in the states of (GA, MA, NC, NY, PA, WA)
- Recall date
- March 11, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)