Recall Z-0653-2022 ยท FRN Pump, Infusion
Smiths Medical ASD Inc.
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.
| Date | Feb 17, 2022 (initiated Dec 3, 2015) |
| Status | Open, Classified |
| 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. This recall occurred in 2015. |
| Root cause | Component change control |
| Action | The firm issued Customer Information Bulletin dated 03-Dec-2015. It explained the details of the issue and provides the consignee a list of serial numbers for pumps in their facility that may be impacted. In addition, it informs the consignee if they have purchased main boards between April 2012 and June 2015 for part numbers G6000361, G6000435, G6001260, G6001560 and G6002728, they are included in the enclosed file. The consignee is to contact the recalling firm to make arrangements to begin the replacement process. If the Supercap Post alarm or the Backup Audible Alarm error code occurs |
| Quantity | 38,797 (31,065 pumps and 7,732 boards) |
| Distribution | Distribution US nationwide, including PR, VI, GU, and MP. There was government/military/foreign distribution. |
| FDA record | Open on fda.gov |