Z-0996-2013Class II

Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for...

Name: Z-0996-2013 Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for...
Creator: Smiths Medical ASD, Inc.
Published: 2010-05-14
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-05-14 / Terminated / root cause: design

FDA source

Smiths Medical ASD, Inc. began a recall of Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely... on 2010-05-14. FDA classified it as Class II and gives the reason as "An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0996-2013
Classification: Class II
Status: Terminated
Initiated: 2010-05-14
Posted: 2013-03-26
Terminated: 2013-04-11
Recalling firm: Abbott Medical
Product: Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
Product code: FRN Pump, Infusion
Reason for recall: An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.
Root cause tag: design
FDA root cause: Device Design
Action: On May 14th, 2010, Smiths Medical contacted the facility that received the pumps via e-mail and requested that they immediately return the pumps. The pumps were returned per Returned Goods Authorization (RGA) and exchanged for replacement pumps manufactured with plunger rod seal G6000077.
Quantity in commerce: 6
Distribution: Distributed in the state of NH.
Product codes and lots: Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0996-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0996-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-26

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)