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.
FDA Recall Z-0450-2014 · Posted 2013-12-04
Advertisement
Recalling FirmCareFusion 303, Inc.
Recall StatusTerminated
Product CodeFPA
Date Initiated2013-11-08
Date Terminated2014-05-27
Product Quantity480 units
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.
Firm 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.
Root Cause
Employee error
Distribution Pattern
US Distribution in CA, WY, OH, UT, and MA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement