Recall Z-0433-05 ยท MEA Pump, Infusion, Pca
Harvard Clinical Technology
Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001
| Date | Jan 26, 2005 (initiated Nov 3, 2004) |
| Status | Terminated |
| Reason | Potential pump motor/encoder assembly failure may cause over infusing medication in patients |
| Root cause | Other |
| Action | Harvard Clinical Technology notified consignees by letter on 11/3/04. Harvard will contact consignees by telephone to schedule a return. The motors inside the recalled products will be replaced at Harvard Clinical. Harvard will provide Loaner pumps upon request during the repair process. |
| Quantity | 204 units |
| Distribution | AK, KY, TX, MA, NY, CA, GA, OK, IL, CT, LA, FL, MD,NC, NJ, VA, MI, WI, IA, WV,OH, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033054 | HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP Harvard Clinical Technology, Dec 16, 2003 |