FDAClass IIJanuary 14, 2015

Baxter Amia Automated PD systems are used in the recall

Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.

Why was Baxter Amia Automated PD systems are used in the recalled?

System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.

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
Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
Recalling firm
Baxter Healthcare Corp.
Quantity
55 units
Distribution
Nationwide Distribution including GA, MA, NC, NY, PA, and WA.
Recall date
January 14, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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