Z-0540-2014 Class II Terminated
FDA device recall Z-0540-2014 was initiated by Smiths Medical ASD, Inc. on Nov 22, 2013 and is designated Class II. 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… The recall status is terminated (terminated Mar 25, 2015). Affected quantity: 9560 (8601 US, 959 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Dec 25, 2013
- Initiation Date
- Nov 22, 2013
- Termination Date
- Mar 25, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9560 (8601 US, 959 OUS)
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.
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
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.
Code Information
All Medfusion¿ 4000 Syringe Pumps in the field are affected by this Field Safety Corrective Action.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0540-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026