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U.S. Department of Health and Human Services

Enforcement Report - Week of April 3, 2013

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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.

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
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