Company:ICU Medical Inc
Date of Enforcement Report 12/13/2017
ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers:(a) 16037-64-01; MedNet 6.1b) 16037-64-02; MedNet 6.1c) 16037-64-03; MedNet 6.1d) 16037-64-04; MedNet 6.21The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and MedNet compatible infusion pumps.
Recall Number Z-0195-2018
Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries.
ICU Medical Inc, Lake Forest, IL on 10/30/2017. Voluntary firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally