Class 2 Device Recall Plum 360" Infusion System with Hospira Mednet", Smart Card Plug 'N Play, Upgrade Module

• Date Initiated by Firm: June 15, 2017
• Create Date: August 14, 2017
• Recall Status: Terminated on April 17, 2020
• Recall Number: Z-3031-2017
• Recall Event ID: 77624
• 510(K)Number: K141789 K161469
• Product Classification: Pump, infusion - Product Code FRN
• Product: Plum 360 Infusion System
• Code Information: Model No. 30010
• Recalling Firm/ Manufacturer: ICU Medical Inc; 600 N Field Dr; Lake Forest IL 60045-4835
• For Additional Information Contact: Global Complaint Management; 800-441-4100
• Manufacturer Reason for Recall: 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.
• FDA Determined 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 service. If the unit powers down without an alarm notification, use another unit and contact ICU Medical Global Complaint Management at 800-441-4100. The firm will contact reporting consignees of correction scheduling when parts become available. Adverse reactions or quality problems related to this problem should be reported to FDA's MedWatch Adverse Event Reporting Program by mail, fax, or online. Consignees are advised to inform potential users within their organization of the recall and to complete the recall response form attached to recall notification. The completed response form can be returned by email to ICUMedical7087@stericycle.com or faxed to 855-544-4814. If product was distributed, ask customers to request them to contact Stericycle for a copy of recall notification at 855-544-4813.
• Quantity in Commerce: 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, Canada, Chile, Colombia, France, Greece, Hong Kong, Ireland, Italy, Jordan, Kuwait, Mexico, New Zealand, Oman, Peru, Philippines, Poland, Saudi Arabia, Spain, Turkey, United Arab Emirates, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = Hospira, Inc; 510(K)s with Product Code = FRN and Original Applicant = HOSPIRA, INC.