Z-0078-2024Class II

Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f)...

Name: Z-0078-2024 Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f)...
Creator: Smiths Medical ASD Inc.
Published: 2023-08-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2023-08-16 / Open, Classified / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5, and v6 on 2023-08-16. FDA classified it as Class II and gives the reason as "A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0078-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-16
Posted: 2023-10-06
Recalling firm: Abbott Medical
Product: Medfusion Syringe Pump, Model 3500-0600-XX: a) 0600-00; b) 0600-01; c) 0600-50; d) 0600-51; e) 0600-82; f) 0600-249; software versions: v3, v4, v5, and v6
Product code: FRN Pump, Infusion
Reason for recall: A force sensor in the occlusion detector may drift out of calibration leading to increased occlusion detection times, false occlusion alarms, or a System Failure Alarm. If the force sensor calibration shift is large enough, the pump will display a System Failure Alarm (including Force Sensor BGND Test, Force Sensor Bridge Test, or Force Sensor Test). However, if the calibration shift is not large enough to trigger a System Failure Alarm, the threshold to detect an occlusion may increase, increasing the time to occlusion detection, or the threshold may decrease, leading to false occlusion alarms. Although shifts in the force sensor calibration may occur over time with any device, an increased potential for such shifts has been reported in devices produced before April 2022 due to mechanical interference between parts of the plunger head assembly. Out of an abundance of caution, we are notifying all customers of this potential issue.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Smiths Medical sent an URGENT MEDICAL DEVICE CORRECTION notice to its direct consignees on 08/16/2023 by traceable mailing. The notice explained the issue, potential risk to the patient, and requested the following actions be taken: Customer Required Actions 1. Locate all Medfusion Model 3500 and Medfusion Model 4000 syringe pumps in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations. 2. Ensure all Medfusion Model 3500 and Medfusion Model 4000 syringe pumps in your possession have undergone all tests in the Annual Maintenance List including the new Force Sensor Check within the past 12 months, including new pumps that have not yet undergone annual maintenance. 3. Complete and return the attached Response Form to [email protected] within ten days of receipt to acknowledge your understanding of this notification. 4. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to [email protected]
Quantity in commerce: 20383 pumps
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: a) 0600-00, UDI/DI 10610586041259; b) 0600-01, UDI/DI 10610586041242; c) 0600-50, UDI/DI 10610586043284; d) 0600-51, UDI/DI 10610586043291; e) 0600-82, UDI/DI 10610586043017; f) 0600-249, UDI/DI 10610586041297; All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0078-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0076-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06
Z-0077-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06
Z-0078-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06
Z-0079-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06
Z-0080-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06
Z-0081-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-06

Product code FRN

K040899Class IIMedex 3000 Series Mr Syringe Infusion PumpMedex, Inc. / cleared 2004-04-30

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)