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Recall Observatory FDA recall evidence

Device product

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

Z-1031-2015

October 21, 2014

Class II

Product summary

Firm
Baxter Healthcare Corp.
Event
Event 70232
Status
Terminated
Classification
Class II
Quantity
200
Official record key
device-enforcement:Z-1031-2015

Official wording

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

Code information: all codes distributed between 4/15/2014 and 6/11/2014

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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