Cl II ICU Mednet(TM) Medication Management Suites

Company:ICU Medical Inc
Date of Enforcement Report 12/13/2017
Class lI:

PRODUCT

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

REASON
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.

RECALLING FIRM/MANUFACTURER
ICU Medical Inc, Lake Forest, IL on 10/30/2017. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
108 installations

DISTRIBUTION
Nationwide and Internationally

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