Recall Z-0813-04 ยท CAJ
Medex Inc
Medex 3000 Series Syringe Infusion Pumps
| Date | Jul 20, 2004 (initiated Feb 16, 2004) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | Consignees were notified by letter starting 2/2004 and continues to the present |
| Quantity | 7896 units |
| Distribution | Nationwide, China, Hong Kong & UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.