Z-2121-2010

MEDFUSION SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2, 2.0.3, AND 2.0.4...

Name: Z-2121-2010 MEDFUSION SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2, 2.0.3, AND 2.0.4...
Creator: Smiths Medical ASD, Inc.
Published: 2010-06-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2010-06-22 / Terminated / root cause: software

FDA source

Smiths Medical ASD, Inc. began a recall of MEDFUSION SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are designed for use in... on 2010-06-22. The reason FDA records is "Smiths Medical is conducting a correction of Medfusion Syringe Infusion Pumps, Models 3010 and 3010a, with obsolete software versions 2.0.2, 2.0.3, and 2.0.4. Smiths Medical has found that pumps with obsolete software...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2121-2010
Status: Terminated
Initiated: 2010-06-22
Posted: 2010-08-02
Terminated: 2012-04-17
Recalling firm: Abbott Medical
Product: MEDFUSION SYRINGE INFUSION PUMP, MODELS 3010 AND 3010a WITH SOFTWARE VERSIONS 2.0.2, 2.0.3, AND 2.0.4 Medfusion Syringe Infusion Pumps are designed for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
Product code: FRN Pump, Infusion
Reason for recall: Smiths Medical is conducting a correction of Medfusion Syringe Infusion Pumps, Models 3010 and 3010a, with obsolete software versions 2.0.2, 2.0.3, and 2.0.4. Smiths Medical has found that pumps with obsolete software may continue to run past the set volume limit. This can result in an over-delivery if the syringe is over-filled. Smiths Medical has received no reports of serious patient in
Root cause tag: software
FDA root cause: Software design
Action: Consignees were sent on 6/22/10 a Smith Medical "Urgent Medical Device Correction Notice', dated June 11, 2010. The letter was addressed to Dear Risk/ Safety Managers, Distributors, Clinical/ Biomedical Engineering, Clinicians, Critical Care Physicians, Pediatricians, Pediatric Intensivists, Neonatologists; and Nursing, Pharmacy,and Anesthesia Professionals. The letter described the problem and product involved. It provided Advise on Action to be Taken by the User which included to 1) Determine the software version of their Medfusion pump 2. Complete and return the Confirmation Form 3. Return the completed Software Update Test Form 4. If unable or unwilling to perform the software upgrade they provided information for returning the pumps to Smiths Medical for the upgrade. For further information please contact Smiths Medical at 651-628-7280.
Quantity in commerce: 4816
Distribution: Worldwide Distribution: AL, AK, AZ, AR, CA,CO, CT, DC, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV,NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI. and countries of CANADA, MEXICO, NEW ZEALAND, BRASIL, HONG KONG, and GREAT BRITAIN.
Product codes and lots: All Medfusion¿ Syringe Infusion Pumps, Models 3010 and 3010a, with Software Versions 2.0.2, 2.0.3. or 2.0.4

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)