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…
FDA: Pharmakon Pharmaceuticals recalls all sterile compounded products
Editor's Note The Food and Drug Administration (FDA) on April 20 announced that Pharmakon Pharmaceuticals (Noblesville, Indiana) issued a nationwide recall of all sterile compounded products because of a lack of sterility assurance and other quality issues. The sterile products were distributed between March 4 and April 15, 2016. …
Infections from contaminated duodenoscopes higher than previously estimated
Editor's Note A new congressional investigation shows that the number of infections from contaminated duodenoscopes is much higher than previously estimated, the April 15 Los Angeles Times reports. The Food and Drug Administration (FDA) told investigators that from 300 to 350 patients at 41 facilities in the US and abroad…
FDA issues draft guidance on hospital and health system drug compounding
Editor's Note The Food and Drug Administration (FDA) on April 15 issued draft guidance on “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act.” Hospital pharmacies or standalone pharmacies that are part of a health system provide compounded drugs for administration in the hospital or health…
FDA: Vascular Solutions recalls Guardian II hemostasis valves
Editor's Note The Food and Drug Administration (FDA) on April 11 announced the recall by Vascular Solutions, Inc (Minneapolis, Minnesota), of specific lots of Guardian II hemostasis valves used in catheterization procedures. The recall was initiated because of an increased risk of air leakage that may lead to an air…
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