PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 25, 2017 Initiated: December 16, 2016 #Z-1056-2017

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

Details

Units Affected
8640 eaches
Distribution
US only
Location
Deerfield, IL

Frequently Asked Questions

What product 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.. Recalled by Baxter Healthcare Corporation. Units affected: 8640 eaches.
Why was this product recalled?
Customer complaints received for the presence of leaks
Which agency issued this recall?
This recall was issued by the FDA Devices on January 25, 2017. Severity: Moderate. Recall number: Z-1056-2017.