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Cardinal Health

Various Presource Kits Containing a Pre-Assembled Anesthesia Circuit, by Cardinal Health, Recalled (Class I)

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 [...]

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Kadcyla

Kadcyla (ado-trastuzumab emtansine): Potential Medication Errors due to Name Confusion

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 [...]

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GemStar

GemStar Infusion System, by Hospira Inc., Recalled (Class I) due to Lithium Battery Low Voltage

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, [...]

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Anticoagulant

Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit by Fenwal Recalled due to Labeling Issue

The FDA informs risk managers, pharmacy and health professionals that one lot of Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit by Fenwal is recalled because of incorrect labeling. FDA Alert on Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit FDA’s reason for the recall is that one lot of Anticoagulant Citrate Phosphate [...]

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