WebApr 30, 2024 · BD has had shipments of Alaris pumps on hold after the FDA called for a comprehensive 510 (k) submission to cover a host of software fixes needed following a Class I-level recall in March 2024. Pumps are only going to health providers with an immediate medical need. Web1.770.784.6100 [email protected] Order Lookup Onsite Visiting 8195 Industrial BoulevardCovington, Georgia 30014United States Products Alaris™ PCA Module Provides syringe-based PCA functionality for use on adults, pediatrics and neonates. Contact Us Overview Products & Accessories EIFU & Resources Overview
BD Alaris Systems Lawsuits Reasons for Recalls, Litigation Status
WebJul 29, 2024 · Under U.S. Food and Drug Administration (FDA) guidance, BD will release Alaris™ System software version 12.1.2 and associated ancillary software to remediate the affected software. Effective today, customers can begin scheduling remediation by contacting the BD Recall Support Center at 1-888-562-6018. The new software, which … WebJul 29, 2024 · Under U.S. Food and Drug Administration (FDA) guidance, BD will release Alaris™ System software version 12.1.2 and associated ancillary software to remediate the affected software.... heated blanket throw walmart
510(k) Premarket Notification - Food and Drug Administration
WebMar 10, 2024 · BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on a previously announced voluntary recall of the BD Alaris™ System... WebBD EDTA tubes (lavender, tan & pink tops) and lithium heparin tubes (green top) instructions for use update Syringes and needles 60 mL BD® Syringe will now be 50mL FDA notice for pen needles BD Flush Product Supply Disruption Operations updates Pandemic Preparation BD Response Plan on COVID-19 (Coronavirus) Georgia … WebBetween 2024 and 2024, Becton, Dickinson and Company (BD) recalled millions of its BD Alaris System devices for defective software, hardware and other issues because of serious injuries and at least one death. The BD Alaris System is an infusion pump system that delivers fluids, medications, blood and blood products to adults, children and babies. mouth washing gum