ClearanceBrief
Recall Z-1188-06 ยท FRN Pump, Infusion

Sorenson Medical, Inc.

ambIT Ambulatory Infusion Therapy Intermittent Pump

DateJul 1, 2006 (initiated May 3, 2006)
StatusTerminated
ReasonIntermittent Infusion pump may continually dispense medication under certain conditions.
Root causeOther
ActionAll direct accounts were contacted by email and phone on 05/03/2006. Distributors were instructed to identify end users for Recalling Firm notification
Quantity72 pumps
DistributionWorldwide distribution (including-states of IL, KS, NJ, PA, WA. , countries of Germany, Malaysia, New Zealand, Slovenia.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K033425AMBIT INTERMITTENT AMBULATORY INFUSION PUMP
Sorenson Medical, Inc., Nov 6, 2003