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U.S. Department of Health and Human Services

Class 2 Device Recall 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave TConnector

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 Class 2 Recall
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave TConnector
see related information
Date Posted January 09, 2014
Recall Status1 Open
Recall Number Z-0666-2014
Recall Event ID 67166
Product Classification Set, Administration, Intravascular - Product Code FPA
Product 6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave® TConnector, Rotating Luer, Part No. A1000, Item No. A1001 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 Lot No. 2773810 2777115 2781555
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.
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 700 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.
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
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