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U.S. Department of Health and Human Services

Class 2 Device Recall Medfusion Model 3500 Syringe Pump

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  Class 2 Device Recall Medfusion Model 3500 Syringe Pump see related information
Date Initiated by Firm May 14, 2010
Date Posted March 26, 2013
Recall Status1 Terminated 3 on April 11, 2013
Recall Number Z-0996-2013
Recall Event ID 63621
510(K)Number K040899  
Product Classification Pump, infusion - Product Code FRN
Product 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.
Code Information Lot/Serial Numbers: M76369, M76370, M76373, M76374, M76375, and M76377.
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul MN 55112-6929
For Additional Information Contact
651-633-2556
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action On May 14th, 2010, Smiths Medical contacted the facility that received the pumps via e-mail and requested that they immediately return the pumps. The pumps were returned per Returned Goods Authorization (RGA) and exchanged for replacement pumps manufactured with plunger rod seal G6000077.
Quantity in Commerce 6
Distribution Distributed in the state of NH.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = MEDEX, INC.
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