Recall Z-2362-2015 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
| Date | Aug 14, 2015 (initiated Jul 21, 2015) |
| Status | Terminated |
| Reason | Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached. |
| Root cause | Process control |
| Action | An Urgent Medical Device Recall Notification letter was sent on 7/20/15 to customers who purchased the Alaris Syringe Module (Model 8110) to inform them that CareFusion has identified an issue with the Alaris Syringe module manufactured between March 2014 through September 2014. The letter informs customers of the problems identified and the actions to be taken. CareFusion will replace the syringe drive train assembly on the affected units and adjust, if required. CareFusion will contact all affected customers within 60 days to initiate the scheduling process for the remediation. Customers |
| Quantity | 68,460 units |
| Distribution | Worldwide Distribution-US (nationwide) and the countries of Australia, New Zealand, South Africa, Canada, Middle East, Malaysia, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023264 | MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 Alaris Medical Systems, Inc., Dec 19, 2002 |