Recall Z-1292-2015— Baxter Healthcare Corp.
Class II · Terminated
Class II FDA medical device recall by Baxter Healthcare Corp., initiated 2013-10-16, terminated 2017-07-21. It names one FDA 510(k) clearance: K102936. Product: 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.. Reason: 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..
- Recalling firm
- Baxter Healthcare Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-16
- Terminated
- 2017-07-21
- Firm location
- Round Lake, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.