FDA Medical Device Recalls (openFDA)
Medex Inc: 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in test labs for testing purposes, 2010 has an anesthesia mode built into the software, ''ZE are returned because of outdated software.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 upgraded and re-distributed, 2010i, has an anesthesia mode and library mode for programming.
- Recall number
- Z-1060-03
- Recalling firm
- Medex Inc
- 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in test labs for testing purposes, 2010 has an anesthesia mode built into the software, ''ZE are returned because of outdated software.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 upgraded and re-distributed, 2010i, has an anesthesia mode and library mode for programming.
- Status
- Terminated
- Initiated
- 2003-06-09
- Posted
- 2003-07-29
- Terminated
- 2006-03-13
- Reason
- Inadequate warning label as pertains to use of the pump in conjunction with Extracorporeal Membrane Oxygenation (ECMO) procedures.
- Root cause
- Other
- Action
- Consignees 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
- 59,938 units
- Distribution
- Units were distributed to medical facilities nationwide and worldwide.
- Lot, serial or model codes
- Series #2001, 2201E, 2001G, 2001H, 2001VX, 2001HZE, 2001NFHU, 2001T, 2010, 2010E, 2010H, 2010HVX, 2010HZE, 2010i, 2010iK, 2010iVX, 2010iZE
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAJ
- Firm FEI
- 1036813
- Firm city
- Duluth
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28