FDA-Device2022-02-23Class II
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.
Hazard
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.
Sold states
Distribution US nationwide, including PR, VI, GU, and MP. There was government/military/foreign distribution.
Affected count
38,797 (31,065 pumps and 7,732 boards)
Manufactured in
6000 Nathan Ln N, N/A, Minneapolis, MN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0653-2022Don't want to check this manually?
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