Automated peritoneal dialysis recall
Automated peritoneal dialysis (APD) cycler
Why was Automated peritoneal dialysis recalled?
Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot
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?
N/A
- Product
- Automated peritoneal dialysis (APD) cycler
- Recalling firm
- Baxter Healthcare Corp.
- Quantity
- 10 units
- Distribution
- US Consignee: NY ***Foreign Consignee: Ecuador
- Recall date
- May 4, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)