“`htmlThe 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.
FDA Announces Class I Recall
According to the FDA recall notice, Omnicell is recalling specific sterile syringe labels used with the i.v.STATION Automated Compounding System because inconsistent detection of certain syringe labels may result in unlabeled or mislabeled sterile filled syringes.
The FDA states that use of an unlabeled or mislabeled sterile filled syringe may result in medication errors that could cause serious adverse health consequences or death.
Manufacturer Actions
According to the FDA, Omnicell notified 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.
Inconsistent detection of certain syringe labels may result in unlabeled or mislabeled sterile filled syringes.
— U.S. Food and Drug Administration
Key takeaways
- FDA classified the recall as Class I, the agency’s most serious recall category.
- The recall involves specific sterile syringe labels used with the Omnicell i.v.STATION Automated Compounding System.
- Inconsistent detection of certain syringe labels may result in unlabeled or mislabeled sterile filled syringes.
- Healthcare facilities should discontinue use of affected labels and follow Omnicell’s recall instructions.
- According to the FDA, no serious injuries or deaths had been reported as of April 10, 2024.
Frequently asked questions
Which Omnicell products are affected by this recall?
The recall applies to specific sterile syringe labels used with the Omnicell i.v.STATION Automated Compounding System.
Why were these products recalled?
According to the FDA, inconsistent detection of certain syringe labels may result in unlabeled or mislabeled sterile filled syringes.
What should healthcare facilities do?
Healthcare facilities should follow Omnicell’s recall instructions, 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.
How serious is this recall?
The FDA has classified this action as a Class I recall, meaning there is a reasonable probability that use of the affected product will cause serious adverse health consequences or death.
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.
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