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U.S. Department of Health and Human Services

Class 1 Device Recall Medfusion 4000 V1.0 &V1.1 Syringe Infusion Pump

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 Class 1 Device Recall Medfusion 4000 V1.0 &V1.1 Syringe Infusion Pump see related information
Date Posted August 01, 2012
Recall Status1 Terminated on November 14, 2012
Recall Number Z-2107-2012
Recall Event ID 61247
510(K)Number K111386 
Product Classification Pump, infusion - Product Code FRN
Product Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78.

Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
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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
Smiths Medical has identified a software anomaly in the Medfusion 4000 Syringe Infusion Pump that causes a device history log corruption and triggers a Watchdog Fail-Safe alarm. When the device exhibits this failure mode, visual and audible alarms will sound and the device ceases operation.
FDA Determined
Cause 2
Software design
Action Consignees of Medfusion¿ 4000 pumps with software version 1.0 & 1.1 were visited by a Smiths Medical representative on 2/14/12 informing them that their pumps require a software upgrade. A record of this software upgrade was documented as part of the records for this action.
Quantity in Commerce 607 pumps (257 USA, 350 Canada)
Distribution Worldwide Distribution -- USA, including the state of CA, and country of Canada.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = SMITHS MEDICAL MD, INC.
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