APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of pa...
FDA Recall #Z-1056-2017 — Class II — December 16, 2016
Product Description
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.
Reason for Recall
Customer complaints received for the presence of leaks
Recalling Firm
Baxter Healthcare Corporation — Deerfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
8640 eaches
Distribution
US only
Code Information
H16F16088
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated