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U.S. Department of Health and Human Services

Class 2 Device Recall SmartSite Low Sorbing Infusion Sets

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 Class 2 Recall
SmartSite Low Sorbing Infusion Sets
see related information
Date Posted December 04, 2013
Recall Status1 Terminated on May 27, 2014
Recall Number Z-0450-2014
Recall Event ID 66759
Premarket Notification
510(K) Number
K944320 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 24301-0007T The SmartSite Low Sorbing Infusion Sets with Texium Male Luer are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Code Information Lot No: 13046215 13046641 13056285 13056577 13075931
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 with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.
FDA Determined
Cause 2
TRAINING: Employee Error
Action The firm, CareFusion, sent an "URGENT: Medical Device Recall Notification" letter dated November 8, 2013 to all customers who purchased the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to immediately complete and return to CareFusion the enclosed, pre-addressed and postage paid, Recall Response Card and return all recalled product directly to the distributor form whom it was purchased. Customers with questions are instructed to contact their distributor directly or call the CareFusion Support Center at (888) 562-6018. If you have recall related questions or need support, please call CareFusion Support Center at 1-888-562-6018; hours: 7am to 4pm PST or Technical Support at 1-888-812-3229; hours 7am to 5pm PST.
Quantity in Commerce 480 units
Distribution US Distribution in CA, WY, OH, UT, and MA.
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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