Recall Z-0763-2023— Baxter Healthcare Corporation

Name: FDA recall Z-0763-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-23

Class II · Ongoing

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2022-11-23. It names one FDA 510(k) clearance: K130039. Product: Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.. Reason: Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak.

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-11-23
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K130039 — REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZERGambro Renal Products, Inc.·cleared 2013-05-02

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

Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Reason for recall

Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

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