Z-0653-2022 Class II Ongoing
FDA device recall Z-0653-2022 was initiated by Smiths Medical ASD Inc. on Dec 3, 2015 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 38,797 (31,065 pumps and 7,732 boards).
Recall Details
- Product Type
- Devices
- Report Date
- Feb 23, 2022
- Initiation Date
- Dec 3, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 38,797 (31,065 pumps and 7,732 boards)
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.
Distribution Pattern
Distribution US nationwide, including PR, VI, GU, and MP. There was government/military/foreign distribution.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0653-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026