—#123304

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.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K944320
Affected lot / code info: Lot No: 13046215 13046641 13056285 13056577 13075931

Why it was recalled

CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer because it is not assembled with low-sorbing tubing.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: US Distribution in CA, WY, OH, UT, and MA.

Timeline

Recall initiated: 2013-11-08
Posted by FDA: 2013-12-04
Terminated: 2014-05-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #123304. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.