Recall Z-0026-2018 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alari
| Date | Aug 9, 2017 |
| Status | Open, Classified |
| Reason | The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps. |
| Root cause | Unknown/Undetermined by firm |
| Action | BD sent an Urgent: Medical Device Recall Notification dated September 1, 2017. The customer letter will instruct the customers to remove the pump from service if it shows signs of infusion at an unexpected rate and not to use the affected devices in high risk areas if possible. The customer notification letter will be addressed to the Directors of Nursing, Risk Management, and Biomedical Engineering. Customers will be required to confirm receipt of the notification by returning the Recall Response Card to BD by postage-paid, self-addressed mail, fax, or email. For further questions, plea |
| Quantity | 31,622 units (28,224 in US) |
| Distribution | Worldwide Distribution - USA (nationwide) and to the countries of : Canada, Australia, UAE, Kuwait, Saudi Arabia, 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 |