Recall Z-0653-2022— Smiths Medical ASD Inc.
Class II · Ongoing
Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2015-12-03. It names 2 FDA 510(k) clearances: K111386, K040899. Product: 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.. 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..
- Recalling firm
- Smiths Medical ASD Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2015-12-03
- Firm location
- Minneapolis, MN, United States
510(k) clearances named in this recall
2 on FDA's record- K111386 — MEDFUSION MODEL 4000 SYRINGE INFUSION PUMP, PHARMGUARD TOOLBOX 2 MEDICATION SAFETY SOFTWARE AND SUPPORTED SYRINGES (PSS)
- K040899 — MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.