Recall Z-1653-2022— Baxter Healthcare Corporation

Name: FDA recall Z-1653-2022
Creator: U.S. Food and Drug Administration
Published: 2022-08-09

Class I · Terminated

Class I FDA medical device recall by Baxter Healthcare Corporation, initiated 2022-08-09, terminated 2024-08-09. It names one FDA 510(k) clearance: K112893. Product: Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.. Reason: Firm noted an increase in customer reports of leaks..

Recalling firm: Baxter Healthcare Corporation
Classification: Class I
Status: Terminated
Initiated: 2022-08-09
Terminated: 2024-08-09
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K112893 — CLEARLINK LUER ACTIVATED VALVE, CLEARLINK SYSTEM NON-DEHP CATHETER EXTENSION SETSBaxter Healthcare Corporation·cleared 2011-10-18

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

Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.

Reason for recall

Firm noted an increase in customer reports of leaks.

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