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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 Recall
SmartSite Extension Set
see related information
Date Posted April 16, 2014
Recall Status1 Open
Recall Number Z-1459-2014
Recall Event ID 67774
Premarket Notification
510(K) Number
K960280 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product SmartSite Extension Set, Model No. 20029E, intravascular administration set.
Code Information Lot No. 13085791
Recalling Firm/
Manufacturer
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego, California 92121-4386
Manufacturer Reason
for Recall
Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action CareFusion sent an Urgent Medical Device Recall Notification letter dated March 2014 to all customers. The letter informs the customers of the problems identified, potential risk and the actions to be taken. Customers are instructed to complete and return to CareFusion the enclosed 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 the Alaris System are instructed to contact Technical Support at (888) 812-3299.
Quantity in Commerce 7,700 units
Distribution USA Nationwide Distribution in the states of: AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, WI
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 = Y
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