Recall Z-2285-2013 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
| Date | Sep 26, 2013 (initiated Aug 30, 2013) |
| Status | Terminated |
| Reason | CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber. |
| Root cause | Process design |
| Action | A customer letter dated August 30, 2013 will be sent to customers to inform them that CareFusion is recalling the SmartSite Low Sorbing Infusion Set Models 10015048, Lot Numbers 130153883 and 13025342 as a result of a potential for separation at the tubing sleeve below the drip chamber.The letter informs the customers of the problem identified, issues, potential risk, and the immediate actions to be taken. Customers are instructed to complete the customer response form and return the form to CareFusion. Customers are instructed to return recalled products directly to distributors. A distributo |
| Quantity | 15860 units |
| Distribution | Nationwide in US: PA, OK, TX, FL, NC, CA, IN, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944320 | VENTED/NON-VENTED GEMINI ADMINISTRATION SET Imed Corp., Feb 14, 1995 |