Recall Z-2205-2012 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral
| Date | Aug 17, 2012 (initiated Jun 15, 2012) |
| Status | Terminated |
| Reason | The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly |
| Root cause | Device Design |
| Action | CareFusion sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated July 20, 2012. The letter identified the product, problem, and actions to be taken by the customers. The potential risk identified in the letter was that when the pump module door keypad overlay has delaminated (loose, peeled away or separated from the door assembly) this could cause a potential for fluid ingress which could lead to a keypad malfunction causing termination of infusion with alarm. Termination of infusion could result in serious injury or death. Customers were informed that CareFusion will contact t |
| Quantity | 43,862 units total (40,780 units in the US) |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa. |
| 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 |