ICU Medical recalls Medication Management Suite 6.1 and 6.21 software due to potential changes to piggyback medication settings without user notice, which could affect infusion safety.
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.
ICU Medical is recalling its Medication Management Suite software versions 6.1 and 6.21 because it can alter medication settings without warning. This could lead to incorrect infusion programming, potentially causing medication errors in clinical settings.
The software can change critical settings for piggyback medication entries when certain conditions are met, such as exporting and reimporting drug libraries. These changes happen without notification to users, which could lead to incorrect medication administration during infusions.
Healthcare professionals using the software for medication management, particularly pharmacists and clinicians operating infusion pumps. Those with the specific software versions listed are most at risk.
Check if you have ICU Mednet Medication Management Suite 6.1 or 6.21 software with product codes 16037-64-01 through 16037-64-04. The software is used in clinical settings for managing infusion pumps.
Verify your software version by checking the product code on the device or documentation.
The software can change medication settings without user notice under specific conditions, which could lead to incorrect infusion programming.
The recall does not specify a remedy, so contact ICU Medical directly for guidance.
The recall describes potential changes to medication settings, but does not explicitly state a risk of serious injury.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0195-2018 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0195-2018 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
