The U.S. Food and Drug Administration (FDA) has announced a Class I recall involving specific sterile syringe labels used with the Omnicell i.v.STATION Automated Compounding System. According to the FDA, inconsistent detection of certain syringe labels may result in unlabeled or mislabeled sterile filled syringes, creating the potential for medication errors that could cause serious adverse health consequences or death.
The FDA advises customers to discontinue use of the affected sterile syringe labels, quarantine affected inventory, use the manufacturer’s recommended alternative labels, and contact Omnicell Technical Support for replacement products and additional guidance. According to the FDA, as of April 10, 2024, Omnicell had not reported any serious injuries or deaths associated with this issue.
Read the full article on GMJ Newsroom.
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