Severity
Moderate
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 infor
Reported: December 13, 2017 Initiated: October 30, 2017 #Z-0195-2018 108 installations units
ICU Medical Inc issued this FDA Devices recall on December 13, 2017. Classified as Moderate severity (Class II). Approximately 108 installations units are affected. The recall was issued because: Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-0195-2018) was formally reported on December 13, 2017, with the manufacturer initiating the action on October 30, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. ICU Medical Inc is listed as the recalling firm, operating out of Lake Forest, IL. Federal records indicate 108 installations units are affected.
The documented reason for this recall is: 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 pig… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Canada, Australia and Philippines. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 9 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
108 installations
Related Recalls
6
6 from same agency
Product Description
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.
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.
Details
- Recalling Firm
- ICU Medical Inc
- Units Affected
- 108 installations
- Distribution
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Canada, Australia and Philippines
- Location
- Lake Forest, IL
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0195-2018 |
| Date reported | December 13, 2017 |
| Date initiated | October 30, 2017 |
| Recalling firm | ICU Medical Inc |
| Units affected | 108 installations |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Canada, Australia and Philippines |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by ICU Medical Inc. Units affected: 108 installations.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2017. Severity: Moderate. Recall number: Z-0195-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Canada, Australia and Philippines.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0195-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).