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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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Product Detail

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

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 E-Mail
Distribution Pattern Distributed in the state of NH.