Class 2 Device Recall 5" Smallbore Ext Set w/MicroClave TConnector, Clamp, Rotating

• Date Initiated by Firm: December 24, 2013
• Date Posted: January 09, 2014
• Recall Status: Terminated on April 01, 2014
• Recall Number: Z-0701-2014
• Recall Event ID: 67166
• 510(K)Number: K970855
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: 5" Smallbore Ext Set w/MicroClave T-Connector, Clamp, Rotating Luer, Item # B33101-T, Lot # 2791358. 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.
• Code Information: Item # B33101-T, Lot # 2791358.
• Recalling Firm/ Manufacturer: ICU Medical, Inc.; 951 Calle Amanecer; San Clemente CA 92673-6212
• For Additional Information Contact: 949-366-2183
• Manufacturer 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.
• FDA Determined Cause: Equipment maintenance
• Action: icumedical sent an Urgent Medical Device Recall letter dated December 24, 2013, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to return completed verification forms. Customers with questions were instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30AM and 4:00PM Pacific Time: (866) 829-9025 and select option 8, or email: customerservice@icumed.com. ICU Medical reported an update on January 6, 2014, an expansion of the recall to additional lots. Updated recall letter was sent out to all customers on additional lots on January 6, 2014 via UPS with tracking. For questions regarding this recall call 949-366-2183.
• Quantity in Commerce: 800
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FPA