RegWardenFDA facility compliance records
Recall

Class II — Baxter Healthcare Corp.

Recalling firmBAXTER HEALTHCARE CORPORATION
Registered facilityView this company's 32 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonThe keypad buttons on HomeChoice devices may be activated without the operator pressing them.
ProductHomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
Quantity200
DistributionAL, 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
Initiated2014-10-21
Classified2015-01-29
Terminated2015-09-01
Recall numberZ-1031-2015
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Baxter Healthcare Corp. (Z-1031-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70232/

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