FDA Alerts on Omnicell Syringe Label Issues
The FDA is aware that Omnicell has issued a letter to affected customers recommending certain syringe labels used with the i.v.STATION automated compounding system be removed from where they are used or sold. Affected devices: IVSTATION SYRINGE sterile label (40MMX40MM) - part number 258920028; IVSTATION SYRINGE sterile label (20MMX40MM) - part number 258920029. On April 10, Omnicell sent all affected customers a letter recommending the following actions: Do not use labels affected by this recall. If you or your staff locate any affected labels, immediately segregate and contact Omnicell Technical Support. Omnicell received a report of mislabeling that could affect sterile syringe labels produced using i.v.STATION. Omnicell identified inconsistent label detection behavior across i.v.STATION printers when using the sterile labels affected by this recall. Inconsistent label detection could result in unlabeled or mislabeled syringe preparations after compounding completion where the above identified sterile labels are utilized. As of April 10, Omnicell has reported no serious injuries or deaths associated with this issue.
