Tag: FDA

FDA: Cook recalls Central Venous Catheters and Pressure Monitoring Sets and Trays

Editor's Note The Food and Drug Administration (FDA) on February 11 announced that Cook Medical (Bloomington, Indiana) initiated a recall of 360 specific lots of Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays because of the potential for catheter tip fracture or separation. The products were distributed…

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By: Judy Mathias
February 11, 2016
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FDA issues draft guidance on UDIs

Editor's Note The Food and Drug Administration (FDA) on February 3 released a draft guidance document, “Enforcement policy on national health related item code and national drug code numbers assigned to devices.” The draft describes the FDA’s intent not to enforce before September 24, 2021, the prohibition against National Health…

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By: Judy Mathias
February 4, 2016
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FDA posts updated information on duodenoscope reprocessors

Editor's Note The Food and Drug Administration (FDA) on February 1 posted updated information on which manufacturers of automated endoscope reprocessors (AERs) for duodenoscopes have completed validation testing with adequate results. There are five companies in the US that manufacture AERs labeled to reprocess duodenoscopes. Companies that have completed their…

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By: Judy Mathias
February 2, 2016
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FDA: Class I recall of Optisure Dual Coil Defibrillation Leads

Editor's Note The Food and Drug Administration (FDA) on January 27 classified the recall of St Jude Medical’s (St Paul, Minnesota) Optisure Dual Coil Defibrillation Leads as Class I, the most serious. The recall was initiated because of a manufacturing error that may have damaged the insulation layer of one…

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By: Judy Mathias
January 29, 2016
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FDA: Baxter recalls four lots of IV solutions

Editor's Note The Food and Drug Administration (FDA) on January 27 announced that Baxter (Deerfield, Illinois) is recalling four lots of IV solutions because of the potential for leaking containers and particulate matter. The recall affects the following: 0.9% Sodium Chloride Injection, USP, 100 mL in Mini-Bag Plus Container (lot…

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By: Judy Mathias
January 28, 2016
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FDA: Draft guidance on designing interoperable devices

Editor's Note The Food and Drug Administration (FDA) on January 26 published draft guidance for “Design considerations and premarket submission recommendations for interoperable medical devices” to assist medical device manufacturers in designing products that are interoperable and can securely share data. The draft includes factors to consider when developing the…

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By: Judy Mathias
January 27, 2016
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FDA: Abbott recalls all sterile compounded products

Editor's Note Abbott’s Compounding Pharmacy (Berkeley, California) is recalling all lots of sterile compounded products because of concerns of lack of sterility assurance. Products include injectable medications, sterile solutions, eye drops, and eye ointments. The recall was issued after a series of onsite inspections by the Food and Drug Administration…

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By: Judy Mathias
January 26, 2016
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FDA issues final guidance for devices labeled as sterile

Editor's Note The Food and Drug Administration (FDA) on January 21 issued final guidance for “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." The document updates and clarifies information regarding sterilization processes and details about pyrogenicity the FDA recommends that sponsors include…

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By: Judy Mathias
January 21, 2016
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FDA: Draft cybersecurity recommendations for device manufacturers

Editor's Note The Food and Drug Administration (FDA) on January 15 issued a draft guidance that outlines important steps manufacturers should take to address postmarket management of cybersecurity vulnerabilities in medical devices. The guidance builds on the FDA’s existing efforts to ensure the safety and effectiveness of medical devices at…

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By: Judy Mathias
January 20, 2016
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Olympus recalls, redesigns Olympus TJF-Q180V duodenoscope

Editor's Note The Food and Drug Administration (FDA)  on January 15 cleared the Olympus TJF-Q180V duodenoscope with design and label modifications intended to reduce the risk of bacterial infections. The new design of the elevator channel sealing mechanism creates a tighter seal and reduces the potential for leakage of fluids…

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By: Judy Mathias
January 19, 2016
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