Recalls / —
—#157690
Product
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 product code
- FKX — System, Peritoneal, Automatic Delivery
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K102936
- Affected lot / code info
- all codes
Why it was recalled
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.
Root cause (FDA determination)
Use error
Action the firm took
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.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Distribution pattern
- Worldwide Distribution
Timeline
- Recall initiated
- 2017-07-05
- Terminated
- 2020-10-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #157690. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.