7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Needleless Connector is...
FDA Recall #Z-0683-2014 — Class II — December 24, 2013
Product Description
7" (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe 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.anoClave", Clamp, Luer Lock, Part No. A1000, Item No. K7089-001
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.
Recalling Firm
ICU Medical, Inc. — San Clemente, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
500 units
Distribution
Worldwide Distribution - USA including UT, TX, GA, WI, VT, NH, AL, OH, TN, IL, CA, KY,HI, NC, and Internationally to CA, BE, IN, KW, and AU.
Code Information
Lot No. 2784699
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated