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U.S. Department of Health and Human Services

Class 2 Device Recall ICU Mednet(TM) Medication Management Suite 6.1 and 6.21

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  Class 2 Device Recall ICU Mednet(TM) Medication Management Suite 6.1 and 6.21 see related information
Date Initiated by Firm October 30, 2017
Create Date December 06, 2017
Recall Status1 Terminated 3 on September 03, 2020
Recall Number Z-0195-2018
Recall Event ID 78418
510(K)Number K141102  
Product Classification Pump, infusion - Product Code FRN
Product ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers:
(a) 16037-64-01; MedNet 6.1
b) 16037-64-02; MedNet 6.1
c) 16037-64-03; MedNet 6.1
d) 16037-64-04; MedNet 6.21


The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and MedNet compatible infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician s orders.
Code Information All MedNet 6.1 and 6.21 installations
Recalling Firm/
Manufacturer		 ICU Medical Inc
600 N Field Dr
Lake Forest IL 60045-4835
Manufacturer Reason
for Recall		 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. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when: 1. Medication entries are built with the same displayed name and diluent amount AND; 2. The piggyback or interruptible settings differ from one CCA to another AND; 3. The drug library is exported then imported into the MedNet Meds program. The changed drug library may then be finalized and downloaded to infusers for use in clinical settings. The changes are made without any notice provided to either the MedNet Meds user (pharmacist) or to the clinician operating the infuser that the piggyback or interruptible settings have been altered. Issue 2: The MedNet Meds 6.1 program, under certain conditions different from those described above in Issue 1, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when: 1. The Master Drug Formulary contains medication entries built with the same displayed name and diluent amounts but one is a Limited rule set and the other is a Full rule set AND; 2. The medication entry built as the Full rule set has a blank medication amount with the medication units in mg AND; 3. Both medication entries have different piggyback options set AND; 4. The drug library is exported then imported into the MedNet Meds program. In this case, the piggyback options will be changed during an import of such drug library.
FDA Determined
Cause 2		 Under Investigation by firm
Action ICU Medical sent an Urgent : Medical Device Correction letter dated October 30, 2017, Please Inform potential users in your organization of this notification and complete the attached response form and return it to the fax number or e-mail address on the form,even if you do not have the affected product. If you have distributed the product further, notify your accounts that received the product identified above of this notification and ask them to contact Stericycle at 1-855-215-5460 (M-F,8am-5pm ET) to receive a reply form. ICU Medical is committed to patient safety and is focused on providing exceptional product reliability and the highest level of customer satisfaction. Thank you for your prompt support on this important matter. We appreciate your cooperation.
Quantity in Commerce 108 installations
Distribution Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Canada, Australia and Philippines
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.
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