• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

  • Print
  • Share
  • E-mail

Event Detail

Event ID 63621
Product Type Devices
Status Completed
Recalling Firm Smiths Medical ASD, Inc.
City Saint Paul
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-05-14
Initial Firm Notification of
Consignee or Public
Distribution Pattern Distributed in the state of NH.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377. Class II 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. 6 Z-0996-2013