Recall Z-1188-06 ยท FRN Pump, Infusion
Sorenson Medical, Inc.
ambIT Ambulatory Infusion Therapy Intermittent Pump
| Date | Jul 1, 2006 (initiated May 3, 2006) |
| Status | Terminated |
| Reason | Intermittent Infusion pump may continually dispense medication under certain conditions. |
| Root cause | Other |
| Action | All direct accounts were contacted by email and phone on 05/03/2006. Distributors were instructed to identify end users for Recalling Firm notification |
| Quantity | 72 pumps |
| Distribution | Worldwide distribution (including-states of IL, KS, NJ, PA, WA. , countries of Germany, Malaysia, New Zealand, Slovenia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033425 | AMBIT INTERMITTENT AMBULATORY INFUSION PUMP Sorenson Medical, Inc., Nov 6, 2003 |