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U.S. Department of Health and Human Services

Class 2 Device Recall Medfusion 3500 V5 Syringe Pumps

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 Class 2 Recall
Medfusion 3500 V5 Syringe Pumps
see related information
Date Posted March 14, 2012
Recall Status1 Terminated on July 25, 2013
Recall Number Z-1206-2012
Recall Event ID 61273
Premarket Notification
510(K) Number
K040899 
Product Classification Pump, Infusion - Product Code FRN
Product Smiths Medical, Medfusion® 3500 Syringe Pumps, Software version 5.0.0, Rx Only. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes.
Code Information M26722 M27294 M27864 M27960 M45874 M26723 M27295 M27865 M27961 M45875 M26724 M27296 M27866 M27962 M45876 M26725 M27297 M27867 M27963 M45877 M26727 M27298 M27868 M27964 M45878 M26728 M27299 M27871 M27966 M45879 M26729 M27300 M27872 M27967 M45880 M26730 M27301 M27873 M27968 M45881 M26731 M27302 M27874 M27969 M45882 M26732 M27303 M27875 M27970 M45883 M26733 M27304 M27876 M27971 M45884 M26734 M27305 M27877 M27973 M45885 M26735 M27306 M27878 M27972 M45886 M26736 M27307 M27879 M27974 M45887 M26737 M27308 M27880 M27975 M45888 M26738 M27309 M27882 M27976 M45889 M26739 M27310 M27883 M27977 M47924 M26740 M27311 M27884 M27978 M47925 M26741 M27312 M27885 M27979 M47926 M26742 M27313 M27886 M27980 M47927 M26743 M27314 M27887 M27981 M47928 M26744 M27315 M27888 M27982 M28016 M26745 M27316 M27889 M27983 M28017 M26746 M27317 M27891 M27984 M28018 M26747 M27318 M27892 M27985 M28019 M26749 M27319 M27893 M27986 M28020 M26750 M27320 M27894 M36853 M28021 M26751 M27321 M27895 M36854 M28022 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Recalling Firm/
Manufacturer
Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul, Minnesota 55112-6929
Manufacturer Reason
for Recall
Pumps rendered inoperable at power up (displaying a blank screen and alarm).
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Vendor Change Control
Action Smiths Medical ASD, Inc. contacted two consignees by telephone in November 2010 and January 2011. Smiths Medical worked with one of the two customers to correct 540 of the 595 devices (91%) while on-site in January 2011. The remaining devices were corrected by hospital personnel. The other customer was also made aware of the issue, root cause and corrective action. This customer reported to Smiths Medical that they understood the issue, but did not want Smiths Medical to perform the correction on their pumps at the time (January 2011). They preferred to send their pumps to Smiths Medical for repair, as and when needed. As of December 2011, The hospital has returned 67 devices to Smiths Medical. For questions regarding this recall call 651-628-7477.
Quantity in Commerce 595 (WI )+ 864 (DC) = 1459
Distribution Nationwide Distribution including WI and DC
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 = MEDEX, INC.
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