Recall Z-1908-2019— Baxter Healthcare Corporation

Name: FDA recall Z-1908-2019
Creator: U.S. Food and Drug Administration
Published: 2019-05-31

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2019-05-31, terminated 2020-10-05. It names one FDA 510(k) clearance: K130039. Product: REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.. Reason: There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-05-31
Terminated: 2020-10-05
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 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.

Reason for recall

There is a potential presence of ruptured dialyzer fibers which may lead to a blood leak during treatment.

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