Tag: FDA alert

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.…

FDA Issues Early Alert for Heart Pump Controller Software Error That May Cause Dangerous Restarts

FDA issues early alert for critical software error in Automated Impella Controller that may cause dangerous restarts during life-sustaining cardiac…

FDA Issues Early Alert on Draeger Anesthesia Machine Ventilator Failures

The FDA has issued an early alert on Draeger anesthesia workstations with a manufacturing defect that may cause ventilator failure…

FDA Issues Correction Notice for TRUE METRIX Blood Glucose Monitors Over Error Code Risk

Trividia Health has issued a correction notice for TRUE METRIX blood glucose monitors after reports of an E-5 error code…