Recall Z-1588-2015— ICU Medical, Inc.

Name: FDA recall Z-1588-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-20

Class II · Terminated

Class II FDA medical device recall by ICU Medical, Inc., initiated 2015-04-20, terminated 2015-11-24. It names one FDA 510(k) clearance: K964435. Product: 119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.. Reason: ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-04-20
Terminated: 2015-11-24
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K964435 — PRIMARY IV SETIcu Medical, Inc.·cleared 1997-04-02

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

119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.

Reason for recall

ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.

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