Z-2734-2020Class I

Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

Name: Z-2734-2020 Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Creator: Smiths Medical ASD Inc.
Published: 2020-06-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-06-26 / Open, Classified / root cause: software

FDA source

Smiths Medical ASD Inc. began a recall of Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1 on 2020-06-26. FDA classified it as Class I and gives the reason as "Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2734-2020
Classification: Class I
Status: Open, Classified
Initiated: 2020-06-26
Posted: 2020-08-06
Recalling firm: Abbott Medical
Product: Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
Product code: FRN Pump, Infusion
Reason for recall: Inaccurate delivery can occur following an interrupted Bolus or Loading dose, if a specific sequence of events occurs.
Root cause tag: software
FDA root cause: Software design
Action: Consignees are being contacted via direct mailing and email. Consignees are asked to review and complete the Recall Response form indicating understanding of notification. Distributors are asked to forward the notification to parties to whom product has been distributed. Smiths Medical will send out 2 additional notifications by email. Phone calls will be made to non-responders.
Quantity in commerce: 35616 units
Distribution: Worldwide distribution - United Arab Emirates, United States, Afghanistan, Albania, Australia, Belgium, Bermuda, Canada, China, Germany, Denmark, Great Britain, Hong Kong, Indonesia, Ireland, India, Korea, Kuwait, Lebanon, Mexico, Malaysia, New Zealand, Oman, Panama, Philippines, Pakistan, Poland, Saudi Arabia, Trinidad and Tobago
Product codes and lots: Model Numbers: 4000-0105-249, 4000-0105-50, 4000-0105-51, 4000-0105-78, 4000-0106-00, 4000-0106-01, and 4000-0106-231. Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2734-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2734-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-08-12	2020-08-06
Z-2735-2020	Class I	Ongoing	Voluntary: Firm initiated	2020-08-12	2020-08-06

Product code FRN

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)