Reported Jan 14, 2015 · Terminated
HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD…
Baxter Healthcare Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corp. · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
- HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000 mL. The HomeChoice and HomeChoice Pro APD
- systems are intended to be operated by1) Home patients whose physicians have prescribed this system. Patients, or their caregivers, must have received adequate training to use the system. 2) Clinicians who are using the system for patients under their care and under a prescription. Clinicians must have received adequate training to use the system. Since drain and volume requirements vary among patients, both the HomeChoice and HomeChoice Pro APD systems have a choice of modes, either Standard Fill Mode (Standard Mode) or Low Fill Mode. The dialysis center selects the Fill mode for the patient before therapy begins. The HomeChoice APD system and HomeChoice Pro APD system are the same in operation, except for the Pro Card and modem features that are only available with the HomeChoice Pro APD system. The Pro Card feature stores prescription and therapy data. The data can be transferred between your cycler and your clinician. The two systems use the same disposable sets and solutions. They perform the same therapies the same way
- Lot codes and dates
- Product Codes
5C4471(R)5C8310(R)
- Serial NumbersAll serial numbers
- Product Codes
- Amount recalled
- 96,458 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO Automated PD Systems.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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