FDA Recall
Terminated
Medex 3000 Series Syringe Infusion Pumps
Recall: Z-0813-04
·
Initiated February 16, 2004
Recall
- Recall Number
- Z-0813-04
- Event Number
- 28699
- Firm
- Medex Inc
- FEI Number
- 1036813
- Product Code
- CAJ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 16, 2004
- Posted
- July 20, 2004
- Terminated
- November 7, 2005
- Address
- 4350 River Green Pkwy, Ste 200, Duluth, GA, 30096-8321
Description
Medex 3000 Series Syringe Infusion Pumps
Reason
Inadequate warning label: Medex has determined that it is possible for an Extracorporeal Membrane Oxygenation (ECMO) circuit to generate high negative pressures on the inlet side.
Action
Consignees were notified by letter starting 2/2004 and continues to the present
Distribution
Nationwide, China, Hong Kong & UK
Quantity
7896 units