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

Recall Z-1039-2015 — Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use settings.

U.S. FDA — Device Enforcement · United States · 2014-12-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1039-2015
Date of alert: 2014-12-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Baxter Healthcare Corp.
Product category: device
Product type: Devices

Reported risk: Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialysis set with Cassette 3 prong due to complaints received for leakage.

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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