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The FDA informs surgical, biomedical engineering, nursing personnel and risk managers that Covidien Endo GIA Articulating 60-3.5 Surgical Stapler Reloads were stolen from the manufacturer before sterilization and use of non-sterile products may increase the risk of infection. Background of Covidien Surgical Stapler Reloads Surgical Stapler Reloads, by Covidien, are used in thoracic, pediatric, gynecologic, [...]

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 [...]

Risk Managers, Pharmacy and Oncology healthcare personnel are informed by the FDA that confusion of Kadcyla (ado-trastuzumab emtansine) with Herceptin (trastuzumab) can cause dosing errors and potential harm to patients. Background of Kadcyla (ado-trastuzumab emtansine) Kadcyla (ado-trastuzumab emtansine) is used for the treatment of HER2-positive breast cancer that has spread to other parts of the [...]

The US FDA informs risk managers, biomedical engineering and nursing personnel that GemStar Infusion System, by Hospira Inc., is recalled due to lithium battery low voltage that could result in serious adverse events or death. Background of GemStar Infusion System The GemStar Infusion System, by Hospira Inc., is a small device used in intravenous, subcutaneous, [...]