Recall Z-2279-2013 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
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
| Date | Sep 26, 2013 (initiated Aug 30, 2013) |
| Status | Terminated |
| Reason | 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 | Employee error |
| Action | 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 |
| Quantity | 600 units |
| Distribution | CA, FL, AZ, and TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931550 | EZ ADMINISTRATION SET Y, Jan 10, 1994 |