Z-0996-2013 Class II Terminated
FDA device recall Z-0996-2013 was initiated by Smiths Medical ASD, Inc. on May 14, 2010 and is designated Class II. Reason for recall: An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions. The recall status is terminated (terminated Apr 11, 2013). Affected quantity: 6.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 3, 2013
- Initiation Date
- May 14, 2010
- Termination Date
- Apr 11, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates.
Reason for Recall
An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.
Distribution Pattern
Distributed in the state of NH.
Code Information
Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0996-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026