Medical device recalls Moderate risk

Baxter Healthcare Corp. recalls HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R,…

Recall date
October 21, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1031-2015
FDA classification
Class II
Brand / firm
Baxter Healthcare Corp.
Sold / distributed
AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI and District of Columbia

Why it was recalled

The keypad buttons on HomeChoice devices may be activated without the operator pressing them.

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

What was recalled

HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.

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