Medical device recalls Moderate risk

Baxter Healthcare Corp. recalls Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated periton…

Recall date
April 24, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0932-2015
FDA classification
Class II
Brand / firm
Baxter Healthcare Corp.
Sold / distributed
Nationwide Distribution including GA, MA, NC, NY, PA, and WA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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