Automated Compounding System Recall: Omnicell Removes Syringe Labels Used with the i.v.STATION Automated Compounding System
Omnicell is removing specific syringe labels used with the i.v.STATION automated compounding system because certain labels may not be detected by the system. This failure can result in the production of mislabeled sterile filled syringes.
Healthcare facilities and pharmacies utilizing the Omnicell i.v.STATION automated compounding system, as well as pharmacy technicians and quality control personnel responsible for sterile labeling workflows.
A failure in label detection within an automated compounding workflow poses a significant risk of medication errors. Since the device handles sterile filled syringes, mislabeling could lead to the administration of the wrong drug or concentration to patients. Regulatory and QA teams should consider this a critical failure of the automated verification process, necessitating an immediate audit of compounding outputs produced with the affected labels.
Facilities using the i.v.STATION should immediately identify and sequester affected labels as per manufacturer instructions. QA teams must review sterile syringe inventory for mislabeling and verify that system sensors are functioning correctly with replacement labeling materials.
Certain labels used with i.v.STATION automated compounding systems may not be detected, leading to mislabeled sterile filled syringes.
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