Z-0813-04

Medex 3000 Series Syringe Infusion Pumps

Name: Z-0813-04 Medex 3000 Series Syringe Infusion Pumps
Creator: Medex Inc
Published: 2004-02-16
License: https://open.fda.gov/license/

Medex Inc / initiated 2004-02-16 / Terminated / root cause: labeling and UDI

FDA source

Medex Inc began a recall of Medex 3000 Series Syringe Infusion Pumps on 2004-02-16. The reason FDA records is "Inadequate warning label: Medex has determined that it is possible for an Extracorporeal Membrane Oxygenation (ECMO) circuit to generate high negative pressures on the inlet side". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0813-04
Status: Terminated
Initiated: 2004-02-16
Posted: 2004-07-20
Terminated: 2005-11-07
Recalling firm: Medex Inc
Product: Medex 3000 Series Syringe Infusion Pumps
Product code: CAJ
Reason for recall: Inadequate warning label: Medex has determined that it is possible for an Extracorporeal Membrane Oxygenation (ECMO) circuit to generate high negative pressures on the inlet side.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified by letter starting 2/2004 and continues to the present
Quantity in commerce: 7896 units
Distribution: Nationwide, China, Hong Kong & UK
Product codes and lots: Model numbers: 3010 (General use pump for use with 3cc to 60cc syringes, 3010a (Pump for use with 1 cc to 60cc syringes), 3010aE (Use with 1cc to 60cc syringes in UK), 3010aVX (Evaluation pump for use with 1cc to 60cc syringes), 3010aZE (Refurbished pump for use with 1cc to 60cc syringes), 3010E (Pump for use with 3-60cc used in the UK), 3010SD (Model 3010 pump used for demonstrations), 3010VX (Evaluation pump for use with 3-60cc syringes), 3010E, 3500 (Pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits), 3500BC (Not currently in distribution, 3500E (Pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits used I the UK), 3500G (Pump with face plates and software for rapid occlusion detection and upper and lower programmable infusion dose limits in the German language), 3500SD (Model 3500 pump used for demonstrations, 3500VX (Evaluation pump with software for rapid occlusion detection and upper and lower programmable infusion dose limits.

Product code CAJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)