Recall Z-1316-2023— Baxter Healthcare Corporation

Name: FDA recall Z-1316-2023
Creator: U.S. Food and Drug Administration
Published: 2023-02-22

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2023-02-22. It names one FDA 510(k) clearance: K201867. Product: Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.. Reason: The electrical safety testing was not properly performed on the impacted devices and additional testing is required.

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-02-22
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K201867 — Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemBaxter Healthcare Corporation·cleared 2020-11-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.

Reason for recall

The electrical safety testing was not properly performed on the impacted devices and additional testing is required

Data sourced from openFDA. This site is unofficial and independent of the FDA.