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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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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