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U.S. Department of Health and Human Services

Class 2 Device Recall SmartSite

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 Class 2 Device Recall SmartSitesee related information
Date Initiated by FirmJanuary 13, 2015
Date PostedFebruary 04, 2015
Recall Status1 Terminated 3 on March 15, 2016
Recall NumberZ-1053-2015
Recall Event ID 70260
510(K)NumberK960280 
Product Classification Set, administration, intravascular - Product Code FPA
ProductSmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing.
Code Information Lot No. 12056016, 12057027, and 12107105.
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information Contact
858-617-2000
Manufacturer Reason
for Recall		CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.
FDA Determined
Cause 2		Under Investigation by firm
ActionCareFusion sent an Urgent Medical Device Recall Notification letter dated January 13, 2015, to all affected customers. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return to CareFusion the recall response card. Customers with questions were instructed to CareFusion: Recall related questions, (888) 562-6018; Adverse Event Reports, (888) 812-3266; Technical Questions regarding the Alaris System, (888) 812-3229.
Quantity in Commerce7,440 units
DistributionNationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FPA
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