ICU Medical Recalls MedNet Medication Management Suite Software
ICU Medical Inc is recalling MedNet 6.1 and 6.21 software because it may alter piggyback medication settings without user notice.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where the software may alter medication settings without notice, but no injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical Inc is recalling the ICU Mednet(TM) Medication Management Suite 6.1 and 6.21 software. The recall involves 108 installations distributed in the United States, Canada, Australia, and the Philippines. The software is intended to facilitate networked communication between computer systems and infusion pumps, allowing healthcare professionals to configure and edit infusion programming parameters.
The recall is issued because the software may change piggyback medication entry set settings for existing defined medication entries under specific conditions. These changes include altering whether a medication may be piggybacked or whether an infusion may be interrupted by a piggyback. The software does not provide notice to the user or clinician when these settings are altered. The issues occur when specific conditions regarding medication entry names, diluent amounts, rule sets, and drug library exports and imports are met.
Healthcare facilities using the affected software should contact ICU Medical Inc for instructions on how to address the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- 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 faci
- Manufacturer
- ICU Medical Inc
- Category
- Medical Device — Software
- Affected units
- 108
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All MedNet 6.1 and 6.21 installations
Distribution
Distributed nationwide across the United States.
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