Recall Z-0760-2023— Baxter Healthcare Corporation

Name: FDA recall Z-0760-2023
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 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.. Reason: Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer.

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 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.

Reason for recall

Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer

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