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U.S. Department of Health and Human Services

Class 2 Device Recall SmartSite Extension Set

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  Class 2 Device Recall SmartSite Extension Set see related information
Date Initiated by Firm October 09, 2015
Date Posted November 05, 2015
Recall Status1 Terminated 3 on March 02, 2017
Recall Number Z-0221-2016
Recall Event ID 72384
510(K)Number K960280  
Product Classification Set, administration, intravascular - Product Code FPA
Product SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Code Information Lot No. 15015769, 15035412, 15045950.
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information Contact Chuck Donlon
858-617-2000
Manufacturer Reason
for Recall		 CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.
FDA Determined
Cause 2		 Process control
Action An urgent medical device recall notification was sent to customers on 10/9/15 who purchased the SmartSite Extension Set. The letter informs the customers that CareFusion has identified potential risks with model code 20029E, lot numbers 1503541, 15015769 and 15045950 due to disconnection and leakage issues. The letter also provides the customers with the potential risk involved and the actions to be taken. Customers are instructed to complete and return to CareFusion the recall response card. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266 or email customerfeedback@carefusion.com. Customers with technical questions regarding technical questions are instructed to contact Technical Support at (888) 812-3229.
Quantity in Commerce 21,000 units
Distribution Distributed US (nationwide) and in Canada.
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 and Original Applicant = Y
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