Z-0540-2014Class II

Medfusion 4000 Syringe Infusion Pumps Medfusion 4000 Syringe Infusion Pumps are designed for use in care...

Name: Z-0540-2014 Medfusion 4000 Syringe Infusion Pumps Medfusion 4000 Syringe Infusion Pumps are designed for use in care...
Creator: Smiths Medical ASD, Inc.
Published: 2013-11-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2013-11-22 / Terminated / root cause: design

FDA source

Smiths Medical ASD, Inc. began a recall of Medfusion 4000 Syringe Infusion Pumps Medfusion 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring... on 2013-11-22. FDA classified it as Class II and gives the reason as "Smiths Medical is conducting a recall involving all Medfusion 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power receptacle. Shorting can occur when saline...". 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-0540-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-22
Posted: 2013-12-19
Terminated: 2015-03-25
Recalling firm: Abbott Medical
Product: Medfusion 4000 Syringe Infusion Pumps Medfusion 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes.
Product code: FRN Pump, Infusion
Reason for recall: Smiths Medical is conducting a recall involving all Medfusion 4000 Syringe Infusion Pumps. Smiths Medical has identified an issue with electrical shorting at the AC power receptacle. Shorting can occur when saline solution or other conductive fluids (e.g., potassium chloride) enter the AC power receptacle. When this happens, sparking and/ or flames, accompanied by smoke, may appear at the AC po
Root cause tag: design
FDA root cause: Device Design
Action: Smiths Medical sent an "Urgent Medical Device Correction" letter dated November 22, 2013, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customers. All customers will be provided with instructions on inspection, cleaning, and prevention regarding this issue, for the continued safe and effective use of these pumps. Additionally, customers will be instructed to: 1. Return damaged pumps for servicing or damaged AC power cords for replacement to Smiths Medical. 2. Return the completed Confirmation Form to acknowledge receipt and understanding of the information provided in the Urgent Medical Device Correction letter, via fax or email, to Smiths Medical for processing. "The Instructions for preventing this issue", "Mitigations", Conclusions", " Action to be taken by the User", and "Transmission of this Urgent Medical Device Correction". The consignees were also asked to complete the "Urgent Medical Device confirmation Form" and fax it to 1-800-237-8033 or by sending an electronic copy via e-mail to [email protected]. For questions regarding this information, consignees should contact their local Sales Representative, Smiths Medical's Customer Service Department at 1-800-258-5361, or via e-mail at [email protected]. UPDATE: Consignees were sent a follow-up letter dated 13 January 2014 from the one dated November 22, 2013. The letter was addressed to Risk / Safety Managers, Biomedical Professionals, Clinicians who oversee the use of Medfusion Pumps, Distributors, and other users of these devices. The "Urgent Medical Device Recall" letter included Advise on Action to be Taken by the User. This included customers to have their Pumps undergo a free correction. The correction consists of the installation of a new AC power Receptacle seal. Smith Medical provided options for completing the correction process which included: 1) Consignees were a
Quantity in commerce: 9560 (8601 US, 959 OUS)
Distribution: Worldwide Distribution - USA (nationwide ) including the states of : AZ, NY, TN, MS, AR, WV, VA, VT, PA, DE, DC, OH, CO, NH, MI, CA, FL, CT, WA, MD, NM, RI, MA, TX, NC, IL, KY, WI and MI., and the countries of CANADA, SAUDI ARABIA and AUSTRALIA.
Product codes and lots: All Medfusion¿ 4000 Syringe Pumps in the field are affected by this Field Safety Corrective Action.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0540-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0540-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-19

Product code FRN

K111386Class IIMedfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported Syringes (Pss)Smiths Medical MD, Inc. / cleared 2011-08-29

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)