Reported Mar 25, 2015 · Terminated
The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritoneal…
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. · 25212 W. Illinois Route 120 · Round Lake, IL · 60073-9799
Is this the product you have?
- The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
- Lot codes and dates
- Product Code5C8310
- Serial Numbers
149 of 149 codes
80415680416680418680420680421680422680424680426680427680428680429680430680438680439680440680441680444680445680448680449680452680453680454680455680456680457680459680460680461680462680463680465680467680467680469680470680472680473680475680476680477680478680480680481680482680463680484680485680486680489680490680491680494680495680496680498680499680500680501680502
- Amount recalled
- 75 units (US)
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
The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an unrecoverable system error, and/or 2) blade may separate from the back plate and cause Slow / No Flow alarm requiring therapy termination.
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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