Z-0433-05

Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001

Name: Z-0433-05 Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001
Creator: Harvard Clinical Technology
Published: 2004-11-03
License: https://open.fda.gov/license/

Harvard Clinical Technology / initiated 2004-11-03 / Terminated

FDA source

Harvard Clinical Technology began a recall of Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001 on 2004-11-03. The reason FDA records is "Potential pump motor/encoder assembly failure may cause over infusing medication in patients". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0433-05
Status: Terminated
Initiated: 2004-11-03
Posted: 2005-01-26
Terminated: 2012-05-07
Recalling firm: Harvard Clinical Technology
Product: Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001
Product code: MEA Pump, Infusion, Pca
Reason for recall: Potential pump motor/encoder assembly failure may cause over infusing medication in patients
FDA root cause: Other
Action: Harvard Clinical Technology notified consignees by letter on 11/3/04. Harvard will contact consignees by telephone to schedule a return. The motors inside the recalled products will be replaced at Harvard Clinical. Harvard will provide Loaner pumps upon request during the repair process.
Quantity in commerce: 204 units
Distribution: AK, KY, TX, MA, NY, CA, GA, OK, IL, CT, LA, FL, MD,NC, NJ, VA, MI, WI, IA, WV,OH,
Product codes and lots: Serial number range 218002222 - 218002382 02R00222 - 02R002382 318002383 - 318002426

Product code MEA

K033054Class IIHarvard 1 Syringe Pump/harvard 1 with Pca Syringe PumpHarvard Clinical Technology / cleared 2003-12-16

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)