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.
According to the FDA, Omnicell has instructed 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. Healthcare facilities using the affected products should follow the manufacturer’s recall instructions and implement the recommended corrective actions described in the FDA recall notice.
Read the full article on GMJ Newsroom.
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