Recall Z-1409-2020— Baxter Healthcare Corporation

Name: FDA recall Z-1409-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-15

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2019-11-15, terminated 2020-11-20. It names one FDA 510(k) clearance: K130039. Product: Revaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L. Reason: There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2019-11-15
Terminated: 2020-11-20
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 Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745L

Reason for recall

There is the potential presence of particular matter in the header caps of ten lots the Revaclear 300 Dialyzer.

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