Z-0653-2022Class II

Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps...

Name: Z-0653-2022 Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps...
Creator: Smiths Medical ASD Inc.
Published: 2015-12-03
License: https://open.fda.gov/license/

Abbott Medical / initiated 2015-12-03 / Open, Classified

FDA source

Smiths Medical ASD Inc. began a recall of 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... on 2015-12-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0653-2022
Classification: Class II
Status: Open, Classified
Initiated: 2015-12-03
Posted: 2022-02-17
Recalling firm: Abbott Medical
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.
Product code: FRN Pump, Infusion
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.
FDA 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 prior to replacement, the consignee is to immediately remove the pump from service for repair by a trained biomedical technical at the recalling firm or at their facility. If the device with the affected serial number is sent to the recalling firm for any other unrelated repair, the supercapacitor will be replaced at that time. No response form was enclosed with the bulletin.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0653-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0653-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-23	2022-02-17

Product code FRN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)