Tag: Product Recalls

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: 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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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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FDA: Class I recall of Brainlab’s Cranial Image-Guided Surgery System

Editor's Note The Food and Drug Administration (FDA) on January 15 classified the recall of Brainlab’s Cranial Image-Guided Surgery (IGS) System as Class I, the most serious. The system is being recalled because of potential inaccuracies in the display by the navigation system compared to the patient’s anatomy. This could…

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By: Judy Mathias
January 19, 2016
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FDA: Class I recall of Stryker Pleural and Pneumopericardial Drainage Sets

Editor's Note The Food and Drug Administration (FDA) on January 11 classified the recall of Stryker Fuhrman’s Pleural and Pneumopericardial Drainage Sets as Class I, the most serious. Stryker (Tempe, Arizona) received two reports that the catheter included in the Drainage Set broke off in the patient’s pleural cavity during…

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By: Judy Mathias
January 12, 2016
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FDA: Hospira recalls one lot of Magnesium Sulfate Injection

Editor's Note The Food and Drug Administration (FDA) announced January 6 that Hospira, Inc (Lake Forest, Illinois) recalled one lot of Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL 2g total, 50 mL (NDC: 0409-6729-24, Lot 53-113-JT, Expiry November 1, 2016). The recall was initiated because of…

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By: Judy Mathias
January 11, 2016
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FDA: Baxter recalls two lots of IV solutions

Editor's Note The Food and Drug Administration on January 5 announced that Baxter International, Inc (Deerfield, Illinois) is recalling two lots of IV solutions because of the presence of particulate matter. The particulate matter was determined to be an insect and was identified as a result of a customer complaint.…

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By: Judy Mathias
January 7, 2016
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FDA: Class I recall of Perseus A500 Anesthesia Workstation

Editor's Note The Food and Drug Administration, on December 23, 2015, classified the recall of the Perseus A500 Anesthesia Workstation by Draeger as Class I, the most serious. Draeger Medical (Telford, Pennsylvania) recalled the workstation because a faulty power switch may fail, causing the workstation to alarm and shut down…

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By: Judy Mathias
January 4, 2016
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FDA: Boston Scientific recalls Chariot Guiding Sheath

Editor's Note The Food and Drug Administration on December 11 announced that Boston Scientific (Marlborough, Massachusetts) recalled its Chariot Guiding Sheath because of the risk of shaft separation. The company received 14 complaints of shaft separation, four of which involved separation of the distal shaft. The Sheath is used to…

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By: Judy Mathias
December 15, 2015
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