Medex 2000 Series Syringe Infusion Pumps. The 2001 series is a general use pump, 2001E is for German use, 2001G is for u
FDA device recall Z-1060-03 · posted 2003-07-29 · Terminated
Recall details
- Recalling firm
- Medex Inc
- Reason for recall
- Inadequate warning label as pertains to use of the pump in conjunction with Extracorporeal Membrane Oxygenation (ECMO) procedures.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAJ
- Quantity affected
- 59,938 units
- Distribution
- Units were distributed to medical facilities nationwide and worldwide.
- Date initiated
- 2003-06-09
- Date posted
- 2003-07-29
- Date terminated
- 2006-03-13
- Location
- Duluth, GA
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