Recall Z-1208-03 ยท FRN Pump, Infusion
Harvard Clinical Technology
Software Versions V1.2R,or earlier for the Harvard 2, Dual Infusion Pump (P/N 2002-001)
| Date | Sep 11, 2003 (initiated Aug 11, 2003) |
| Status | Terminated |
| Reason | Under specific sequence conditions, the unit may apper to be infusing, but is not |
| Root cause | Other |
| Action | Harvard Medical Technology inc. notified customers by letter on 8/11/03, advising users of the software upgrade to version V1.3T. Facilities will be visited by technicians who will upgrade the software. |
| Quantity | 384 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952794 | HARVARD 2 SYRINGE PUMP Harvard Apparatus, Inc., Sep 15, 1995 |