Smiths Medical ASD, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0540-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: November 22, 2013

Date Posted: December 25, 2013

Recall Number: Z-0540-2014

Event ID: 66987

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

Status: Terminated

Product Quantity: 9560 (8601 US, 959 OUS)

Code Information:

All Medfusion¿ 4000 Syringe Pumps in the field are affected by this Field Safety Corrective Action.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated