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U.S. Department of Health and Human Services

Class 2 Device Recall Medex 2000

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 Class 2 Device Recall Medex 2000see related information
Date Initiated by FirmJune 09, 2003
Date PostedJuly 29, 2003
Recall Status1 Terminated 3 on March 13, 2006
Recall NumberZ-1060-03
Recall Event ID 26633
Product Classification unknown device name - Product Code CAJ
ProductMedex 2000 Series Syringe Infusion Pumps. The 2001 series is a general use pump, 2001E is for German use, 2001G is for use in the UK, 2001T is for use in Taiwan, 2010iK is for use in Korea (the pumps with different languages have different syringes than those used in the U.S.), 001H has a different power cord connector, ''VX in the suffix means it is an evaluation pump, ''NFHU is not for human use; used in test labs for testing purposes, 2010 has an anesthesia mode built into the software, ''ZE are returned because of outdated software. They are refurbished or upgraded and re-distributed, 2010i, has an anesthesia mode and library mode for programming.
Code Information Series #2001, 2201E, 2001G, 2001H, 2001VX, 2001HZE, 2001NFHU, 2001T, 2010, 2010E, 2010H, 2010HVX, 2010HZE, 2010i, 2010iK, 2010iVX, 2010iZE
Recalling Firm/
Manufacturer		 Medex Inc
4350 River Green Parkway
Suite 200
Duluth GA 30096
For Additional Information ContactTerri Davis
614-791-5542
Manufacturer Reason
for Recall		Inadequate warning label as pertains to use of the pump in conjunction with Extracorporeal Membrane Oxygenation (ECMO) procedures.
FDA Determined
Cause 2		Other
ActionConsignees were notified via letter dated June, 2003. The firm provided each consignee with a warning label to be affixed to all pump and to the front cover of the Instruction Manual.
Quantity in Commerce59,938 units
DistributionUnits were distributed to medical facilities nationwide and worldwide.
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.
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