Recall Z-2595-2014— Catheter Connections, Inc.

Name: FDA recall Z-2595-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-05

Class II · Terminated

Class II FDA medical device recall by Catheter Connections, Inc., initiated 2014-08-05, terminated 2014-10-08. It names one FDA 510(k) clearance: K123065. Product: DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.. Reason: Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile..

Recalling firm: Catheter Connections, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-08-05
Terminated: 2014-10-08
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K123065 — CATHETER CONNECTIONS DUALCAP SOLOCatheter Connections, Inc.·cleared 2012-12-14

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

DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours under normal conditions if not removed.

Reason for recall

Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps for luer access valves due to potential improper packaging cap seal which may render the sealed cap non-sterile.

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