Smiths Medical ASD Inc. recalls Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced durin…

Recall date

December 3, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0653-2022

FDA classification

Class II

Brand / firm

Smiths Medical ASD Inc.

Sold / distributed

Distribution US nationwide, including PR, VI, GU, and MP. There was government/military/foreign distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.