HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R 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.
FDA Recall Z-3040-2017 · Posted None
Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeFKX
Date Initiated2017-07-05
Date Terminated2020-10-05
Product Quantity15144 units
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.
Firm Action
The firm notified their consignees by letter on 07/05/2017 of the potential for damaging the disposable set if tools are used to open the packaging and directing them to only open the packaging by hand by letter.
Root Cause
Use error
Distribution Pattern
Worldwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.