Recall Z-0871-2015— Baxter Corporation Englewood

Class II · Terminated

Class II FDA medical device recall by Baxter Corporation Englewood, initiated 2014-12-04, terminated 2016-11-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile. Reason: Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation..

Recalling firm
Baxter Corporation Englewood
Classification
Class II
Status
Terminated
Initiated
2014-12-04
Terminated
2016-11-30
Firm location
Englewood, CO, United States

Product description

Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile

Reason for recall

Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation.

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