Recall Z-3031-2017 ยท FRN Pump, Infusion
ICU Medical Inc
Plum 360 Infusion System
| Date | Jun 15, 2017 |
| Status | Terminated |
| Reason | Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion. |
| Root cause | Under Investigation by firm |
| Action | ICU Medical sent an Urgent - Medical Device Correction letter dated June 15, 2017, to all affected customers. The firm contracted with Stericycle for recall notification, response tracking, and effectiveness checks. The customer notification was also posted on icumed.com. The notification requested that consignees verify their unit is working and testing the CE Module. If the unit's CE Module is loose or a blank display occurs, customers are asked to record the S/N and contact ICU Medical Technical Service Support Center at 800-241-4002, option 4. If the unit is functional, return to servi |
| Quantity | 68,559 units |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution to the states of including Puerto Rico : AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VA, WA, WI, WY and District of Columbia., and to the countries of : Australia, Cana |
| FDA record | Open on fda.gov |