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U.S. Department of Health and Human Services

Class 2 Device Recall 17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave ( Light Blue,

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 Class 2 Recall
17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave ( Light Blue,
see related information
Date Posted January 09, 2014
Recall Status1 Terminated on April 01, 2014
Recall Number Z-0707-2014
Recall Event ID 67166
Premarket Notification
510(K) Number
K970855 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product 17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave® ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves, Rotating Luer, Item #011-A1096, Lot # 2796668. 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 #011-A1096, Lot # 2796668.
Recalling Firm/
Manufacturer
ICU Medical, Inc.
951 Calle Amanecer
San Clemente, California 92673-6212
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 2
PRODUCTION CONTROLS: 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 100
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = ICU MEDICAL, INC.
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