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U.S. Department of Health and Human Services

Class 2 Device Recall SmartSite

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 Class 2 Recall
SmartSite
see related information
Date Posted September 26, 2013
Recall Status1 Open
Recall Number Z-2285-2013
Recall Event ID 66151
Premarket Notification
510(K) Number
K944320 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
Code Information Lot Numbers 13015883 and 13025342.
Recalling Firm/
Manufacturer
CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego, California 92121-4386
Manufacturer Reason
for Recall
CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.
FDA Determined
Cause 2
DESIGN: Process Design
Action A customer letter dated August 30, 2013 will be sent to customers to inform them that CareFusion is recalling the SmartSite® Low Sorbing Infusion Set Models 10015048, Lot Numbers 130153883 and 13025342 as a result of a potential for separation at the tubing sleeve below the drip chamber.The letter informs the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers are instructed to complete the customer response form and return the form to CareFusion. Customers are instructed to return recalled products directly to distributors. A distributor letter will also be sent to distributors on 8/30/13 to inform them of the problems identified and the actions to be taken. Distributors are instructed to contact the Customer Support Team, return customer response form, and they are instructed to contact the CareFusion Support Center at 1-800-562-6018 with any questions. .
Quantity in Commerce 15860 units
Distribution Nationwide in US: PA, OK, TX, FL, NC, CA, IN, 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 = IMED CORP.
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