Recall Z-1179-2016 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
| Date | Feb 15, 2016 |
| Status | Terminated |
| Reason | CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set. |
| Root cause | Other |
| Action | A customer notification letter dated 2/15/16 will be sent to customers to inform them that CareFusion is recalling the Alaris VersaSafe Infusion set number 2122-0007, Lot number 13085603. The letter informs the customers that Separation or leakage at the VersaSafe split septum port and tubing may lead to leakage of the administration set. The separation and leakage may occur during infusion. The letter informs customers of the potential risk and actions to be taken. Customers with recall related equations are instructed to contact CareFusion Support Center at (888) 562-6018, 7am-4pm PST. C |
| Quantity | 5,760 units |
| Distribution | Michigan |
| 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 |