Medical device recalls Moderate risk

Baxter Healthcare Corporation recalls APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure…

Recall date
December 16, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1056-2017
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
US only

Why it was recalled

Customer complaints received for the presence of leaks

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

What was recalled

APD Set with Cassette 3-Prong Peritoneal Dialysis Set 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.

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