Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0939-2015 — 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 a

U.S. FDA — Device Enforcement · United States · 2014-10-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0939-2015
Date of alert: 2014-10-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Baxter Healthcare Corp.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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