Smiths Medical ASD Inc. Recall 89144
Description: Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728.
Smiths Medical ASD Inc. Recall 89144 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0653-2022 |
| Event ID | 89144 |
| Event Description | Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728. |
| Product Type | Devices |
| Distribution | Distribution was nationwide, including PR, VI, GU, and MP. There was government/military/foreign distribution. |
| Quantity | 38,797 (31,065 pumps and 7,732 boards) |
| Recall Reason | There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. |
| Device Classification | 20220223 |
| Device Code Info | Medfusion 3500 and 4000 Syringe Infusion Pumps manufactured between April 2012 and June 2015; and Medfusion 3010 and 3010A (and pump models 3500 and 40000 serviced during April 20121 and June 2015 in which a main board was replaced. |
| Center Classification Date | 20220217 |
| Recall Initiation Date | 20151203 |
| Recalling Firm | Smiths Medical ASD Inc. |
| Initial Notification | Letter |
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