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Anesthesiology, biomedical engineering, surgery personnel and risk managers are informed by the FDA that various presource kits containing pre-assembled anesthesia circuit, by Cardinal Health, are recalled because they main contain outer plastic packaging. Remnants of the plastic may cause serious adverse events including death. Background of Presource Kits Pre-Assembled Filter and Anesthesia Circuits, by Cardinal [...]

Surgery healthcare personnel and risk managers are informed by the FDA that ShapeMatch Cutting Guide is recalled due to software defect that can result to wider cutting ranges and may lead to serious adverse events. Background of ShapeMatch Cutting Guide ShapeMatch Cutting Guide, by Stryker Orthopaedics, is used as surgical instrumentation to assist in the [...]

Surgery and Operating Room Nursery personnel have been informed by the FDA that air or gas embolisms have occurred during or immediately after application of hemostatic drug or biological products using air- or gas-pressurized sprayers. These embolisms are life threatening. Background of Air- or Gas-Pressurized Spray Devices Air- or gas-pressurized sprayers are dual syringe products [...]

The FDA has notified risk managers, eye care and surgery personnel that the Alcon Constellation Vision System is recalled due to software and hardware problems that may cause eye injuries, including blindness. Background of Constellation Vision System The Constellation Vision System, by Alcon, is an ophthalmic microsurgical system used by eye surgeons to perform various [...]