Recall Z-2879-2016 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe
| Date | Aug 8, 2016 |
| Status | Terminated |
| Reason | A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another. |
| Root cause | Software design |
| Action | The firm, BD, sent an "Urgent: Medical Device Recall Notification" letter dated 8/8/16 to customers to inform them that BD has identified a software anomaly associated with the Alaris Syringe module software version 9.15. The letter describes the product, problem and actions to be taken. The customers were instructed to follow the instructions and promptly complete and return the Customer Response Card to expedite the corrective action process. Customers with recall related questions are instructed to contact the BD Support Center at (888) 562-6018. Customers with adverse event reports are |
| Quantity | 12,000 units |
| Distribution | Worldwide Distribution: US(nationwide) and countries of: Canada, Australia and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023264 | MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 Alaris Medical Systems, Inc., Dec 19, 2002 |