Recall Z-0385-2019 ยท FPA Set, Administration, Intravascular
CareFusion 303, Inc.
Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and NONPYROGENIC. 12276678 Rev 00 -VersaSafe Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 212
| Date | Apr 20, 2018 |
| Status | Terminated |
| Reason | Complaints where users were unable to prime the administration set. |
| Root cause | Process control |
| Action | A "Medical Device Safety Notification" Letter dated April 20, 2018 was to all affected customers, stating that the firm has become aware of issues with infusion pump administration sets. Customers are experiencing difficultly or failing to prime the pump administrative sets. Infusion pump administration sets, various models with check valves manufactured during January 2017 through March 2018. Issue: The Infusion pump administration sets require priming prior to patient use as described in the directions for use. It is during the priming process that this issue can be observed. During primi |
| Quantity | 118,254,342 |
| Distribution | Worldwide Distribution - US Nationwide including Guam International: Canada, Australia, New Zealand, EU, Middel East, South Africa, Okinawa, Saipan, Buenos Aires, Lima, Selangor, Hong Kong, Taiwan, and Budapest |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K894842 | IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM Imed Corp., Sep 12, 1989 |