FDA: Class I recall of Stryker’s Angiodynamics Soft Vu Omni Flush Angiographic Catheters
Editor's Note The Food and Drug Administration (FDA) on July 22 categorized the recall of Stryker Sustainability Solutions' (Tempe, Arizona) Angiodynamics Soft Vu Omni Flush Angiographic Catheters as Class I, the most serious. The recall was issued because of reports of separation of the catheter tip from the main body.…
CMS, FDA advocate for UDI use in insurance billing
Editor's Note The Centers for Medicare & Medicaid Services (CMS) and Food and Drug Administration (FDA) are recommending using unique device identifiers (UDIs) in universal health insurance claims forms to improve value-based reimbursement for medical devices and postmarket surveillance, the July 14 Modern Healthcare reports. Proponents say UDIs could help…
FDA: Class I recall of HeartWare Ventricular Assist Device batteries
Editor's Note The Food and Drug Administration (FDA) on June 29 categorized the recall of HeartWare Ventricular Assist Device (HVAD) batteries by HeartWare Inc (Framingham, Massachusetts) as Class I, the most serious. The batteries are being recalled because they may lose power prematurely because of faulty cells. If the HVAD…
FDA: Possible link between Mycobacterium chimaera infections and Stockert 3T Heater-Cooler System
Editor's Note The Food and Drug Administration (FDA) on June 1 issued a safety alert that the agency had received reports of US patients infected with Mycobacterium chimaera after undergoing cardiothoracic surgery that involved the use of the Stockert 3T Heater-Cooler System by Sorin Group Deustchland GmbH. Efforts are underway…
FDA: Medtronic recalls battery pack used on patient monitors because of fire risk
Editor's Note The Food and Drug Administration (FDA) on May 27 classified the recall by Medtronic of its Capnostream 20 and Capnostream 20p patient monitor battery packs as Class I, the most serious. The recall is being initiated because a manufacturing defect causes an increase in temperature in the battery…
FDA: Recall of Well Care Compounding Pharmacy sterile products in Nevada
Editor's Note The Food and Drug Administration (FDA) on May 18 announced the recall by Well Care Compounding Pharmacy of all sterile compounded products because of concern over lack of sterility assurance. The recall is for Nevada and impacts all sterile compounded products distributed between January 1 and April 29,…
FDA drops recall of Custom Ultrasonics’ System 83 Plus endoscope reprocessor
Editor's Note The Food and Drug Administration (FDA) has dropped its recall of approximately 2,800 Custom Ultrasonics’ System 83 Plus automated endoscope reprocessors. This action comes despite the FDA's finding last year that the recall was “necessary to protect public health,” the May 6 Kaiser Health News reports. The FDA…
FDA: Cook recalls all Beacon Tip catheters
Editor's Note The Food and Drug Administration (FDA) on May 4 announced the recall by Cook Medical (Bloomington, Indiana) of all lots of its catheters with Beacon Tip technology. The catheters are used in angiographic, radiographic, interventional, and urologic procedures. The catheters have been found to exhibit polymer degradation of the…
FDA: Fresenius Kabi USA recalls one lot of Sensorcaine-MPF (bupivacaine HCL)
Editor's Note The Food and Drug Administration (FDA) on April 26 announced the recall by Fresenius Kabi USA (Lake Zurich, Illinois) of one lot of Sensorcaine-MPF (bupivacaine HCL) Injection, USP, 0.75%, 7.5 mg/mL, 30 mL fill in a 30 mL vial. The recall was initiated because of the presence of…
FDA: Medtronic recalls battery pack for Capnostream 20, 20p monitors
Editor's Note The Food and Drug Administration announced on April 20 the recall by Medtronic of the battery pack used in its Covidien Oridion labeled Capnostream 20 and Capnostream 20 p patient monitors. Capnostream monitors are external devices used to assess a patient’s respiratory status. The recall was initiated because…
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