Tag: FDA alert
FDA Issues Safety Alert for Boston Scientific Accolade Pacemakers Over Premature Battery Depletion
FDA warns of premature battery depletion in Boston Scientific Accolade pacemakers, requiring enhanced patient monitoring and potential early device replacement.…
FDA Recalls Omnicell Syringe Labels After Automated Compounding System Failures
FDA recalls Omnicell syringe labels for automated compounding systems after label detection failures that could result in mislabeled sterile medications.…
FDA Issues Early Alert for Baxter Volara Breathing Device Air Leaks
FDA issues early safety alert for Baxter Volara breathing device circuits that may leak air and medication during therapy. Healthcare…
FDA Issues Early Alert for Hamilton Medical Ventilator Circuit Obstruction Risk
FDA issues early safety alert for Hamilton Medical ventilator breathing circuits due to potential obstruction risks that could compromise patient…
FDA Issues Early Alert for Insulin Pump Leak Risk in Omnipod Devices
FDA issues early alert for Omnipod insulin pump pods due to tubing tears causing insulin leakage. Healthcare providers advised to…
FDA Issues Early Alert for GE HealthCare Infant Resuscitation System Safety Issue
FDA issues early alert for GE HealthCare infant resuscitation systems due to air-oxygen blender knob shaft loosening that may affect…
FDA Issues Early Alert for Abiomed Catheter Kit Linked to Blood Clot Formation
FDA warns that prolonged use of Abiomed 14Fr Low Profile Introducer catheter may cause blood clot formation. Healthcare providers advised…
FDA Recalls Omnicell Syringe Labels After Automated Compounding System Failures
FDA recalls Omnicell syringe labels for automated compounding systems after label detection failures that could result in mislabeled sterile medications.…