—#121570

Product

SmartSite Low Sorbing Infusion Set, Model#72313E The SmartSite Low Sorbing Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The SmartSite Low Sorbing set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a 1.2 micron filter, needleless SmartSite connector, low sorbing tubing segment, pinch clamps, and luer connectors.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K931550
Affected lot / code info: Lot Number 13016314

Why it was recalled

CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model 72313E, Lot Number 13016314, because of an incorrect filter was assembled on this lot. The correct filter is a 1.2 micron filter (blue color) but a 0.2 micron filter (clear color) may have been added instead.

Root cause (FDA determination)

Employee error

Action the firm took

CareFusion sent an Urgent Medical Device Recall Notification dated August 30, 2013, to all affected customers. The letter informed the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers were instructed to immediately check their inventory for the affected product, if any affected product is encountered, customers were instructed not to use. Customers were instructed to complete the customer response form and return the form to CareFusion with the affected product for replacement.. A distributor letter was also sent to distributors on August 30, 2013, to inform them of the problems identified and the actions to be taken. Distributors were instructed to contact the Customer Support Team, return customer response form, and if they have questions then they were instructed to contact the CareFusion Support Center at 1-800-562-6018. For questions regarding this recall call 858-617-4000.

Recalling firm

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

Distribution

Distribution pattern: CA, FL, AZ, and TN

Timeline

Recall initiated: 2013-08-30
Posted by FDA: 2013-09-26
Terminated: 2013-10-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #121570. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.