Company: Medex, Inc
Date of Enforcement Report: 8/6/03
Class: II
PRODUCT
Medex 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“ZE” are returned because of outdated software.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 up graded and re-distributed,
2010i has an anesthesia mode and library mode for programming.
Recall # Z-1060-03.
REASON
Inadequate warning label as pertains to use of the pump in conjunction with Extracorporeal Membrane Oxygenation (ECMO) procedures.
CODE
Series # 2001, 2201E, 2001G, 2001H, 2001VX, 2001HZE, 2001NFHU, 2001T,
2010, 2010E, 2010H, 2010HVX, 2010HZE, 2010i, 2010ik, 2010iVX, 2010iZE.
RECALLING FIRM/MANUFACTURER
Medex, Inc., Duluth, GA, by letter dated June, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
59,938 units.
DISTRIBUTION
Nationwide, and Internationally.
