Recall Z-2700-2017 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris Pump Module model 8100
| Date | Jun 19, 2017 (initiated Jun 12, 2017) |
| Status | Terminated |
| Reason | There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100. |
| Root cause | Device Design |
| Action | An Urgent Medical Device Recall letter will be sent on 6/12/17 to customers to inform them that BD is issuing this letter to inform you of a potential risk associated with the Alaris Pump module. Firm identified a specific scenario that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100. This scenario is reproducible under the following situations: a) the user does not close the roller clamp on the IV administration set before the pump door is opened as recommended, and b) opening the pump door using an atypical technique with the d |
| Quantity | 35,940 units |
| Distribution | US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950419 | THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS Imed Corp., Jun 21, 1995 |