Z-0314-2018 Class II Terminated
FDA device recall Z-0314-2018 was initiated by Smiths Medical ASD Inc. on Aug 22, 2017 and is designated Class II. Reason for recall: Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid… The recall status is terminated (terminated Apr 14, 2025). Affected quantity: 9,787 units in total.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 10, 2018
- Initiation Date
- Aug 22, 2017
- Termination Date
- Apr 14, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,787 units in total
Product Description
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
Reason for Recall
Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "Invalid Syringe Size" alarm.
Distribution Pattern
Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.
Code Information
Model No. 3500; Reference No. 3500-0600-51
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0314-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026