The HomeChoice Pro APD System is a peritoneal dialysis system recalled over laceration hazard

Recall date

October 16, 2013

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Baxter Healthcare Corp. recalls The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automated Personal Cycler peritoneal…

Recall number

Z-1292-2015

FDA classification

Class II

Brand / firm

Baxter Healthcare Corp.

Sold / distributed

Worldwide Distribution-US (nationwide) including the states of AK, AR, AZ, CA, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NJ, NV, NY, OH, PA, SC, TN, TX, UT, VA, VT, WA, and WI, and the countries of Australia, Canada, and Mexico.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.