Recall Z-2281-2013 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller cl
| Date | Sep 26, 2013 (initiated Aug 30, 2013) |
| Status | Terminated |
| Reason | CareFusion is recalling the Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years. |
| Root cause | Employee error |
| Action | CareFusion sent an Urgent Medical Device Recall Notification letter dated August 30, 2013, to all affected customers to inform them that CareFusion is recalling the Gravity Set, Model 44000-07, Lot Numbers 12086930, 12106215, 13016408, 13016834, 13025446 and 13025672 as a result of an incorrect expiration date. 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 |
| Quantity | 2,850 units |
| Distribution | IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K820278 | INTRAVASCULAR ADMINISTRATION SET Y, Feb 18, 1982 |