Recall Z-0673-2014— ICU Medical, Inc.

Name: FDA recall Z-0673-2014
Creator: U.S. Food and Drug Administration
Published: 2013-12-24

Class II · Terminated

Class II FDA medical device recall by ICU Medical, Inc., initiated 2013-12-24, terminated 2014-04-01. It names one FDA 510(k) clearance: K970855. Product: 8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.. Reason: ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-12-24
Terminated: 2014-04-01
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K970855 — CLAVE CONNECTORIcu Medical, Inc.·cleared 1997-06-24

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

8" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Part No. A1000, Item No. A1070 The ICU Needleless Connector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.

Reason for recall

ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak.

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