Recall Z-2185-2012 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid space
| Date | Aug 15, 2012 (initiated Jun 29, 2012) |
| Status | Terminated |
| Reason | The recall was initiated because Carefusion identified a potential risk associated with the Alaris Pump module model 8100. Carefusion has received reports of customers experiencing motor stalls during infusion with Alaris Pump Module (model 8100) manufactured between August 2010 and July 2011. |
| Root cause | Under Investigation by firm |
| Action | CareFusion sent an Urgent Medical Device Recall Notification letter dated July 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Required action for users instructed high risk patients undergoing infusions at high rates, consider having additional devices as back up. Clinicians should weigh the risk/benefit to the patients before continuing to use the device. Customers with recall related questions were instructed to contact Carefusion support center at (888) 562-6018. Customers with adverse event report questi |
| Quantity | 102,248 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of: South Africa and Canada. Additional Countries: Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950419 | THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS Imed Corp., Jun 21, 1995 |