Medex 3000 Series Syringe Infusion Pumps
FDA device recall Z-0813-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Medex Inc
- Reason for recall
- 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 taken
- Consignees were notified by letter starting 2/2004 and continues to the present
- Root cause
- Other
- Status
- Terminated
- Product code
- CAJ
- Quantity affected
- 7896 units
- Distribution
- Nationwide, China, Hong Kong & UK
- Date initiated
- 2004-02-16
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-07
- Location
- Duluth, GA
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