HomeChoice Pro Automated PD system Model numbers: 5C8310 — Class II medical device recall Z-3041-2017

Terminated recall by Baxter Healthcare Corporation, reported 2017-08-23. Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Oper

Recall number	`Z-3041-2017`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Baxter Healthcare Corporation, Deerfield, IL, United States
Recall initiated	2017-07-05
Classified	2017-08-15
Reported by FDA	2017-08-23
Terminated	2020-10-05
Quantity	23,732 units
Model numbers	`5C8310`, `5C8310R`

Product

HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

Reason for recall

Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set packaging while setting up their Peritoneal Dialysis (PD) therapy, damaging the cassettes for the HomeChoice or HomeChoice PRO cyclers. If damaged cassettes are used, the cyclers may not consistently detect very small holes/cuts in the sheeting of the cassette in the patient valve region and the cycler may deliver air into the patient.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3041-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.