Z-0195-2018Class II

ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet...

Name: Z-0195-2018 ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet...
Creator: ICU Medical Inc
Published: 2017-10-30
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-10-30 / Terminated

FDA source

ICU Medical Inc began a recall of 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... on 2017-10-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0195-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-30
Posted: 2017-12-06
Terminated: 2020-09-03
Recalling firm: Abbott Medical
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.
Product code: FRN Pump, Infusion
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 root cause: 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
Product codes and lots: All MedNet 6.1 and 6.21 installations

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0195-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0195-2018	Class II	Terminated	Voluntary: Firm initiated	2017-12-13	2017-12-06

Product code FRN

K141102Class IIHospira Mednet Medication Management SuiteHospira, Inc. / cleared 2014-07-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)