FDA: Baxter recalls one lot of 0.9% Sodium Chloride Solution for Irrigation
Editor's Note The Food and Drug Administration on February 18 announced the recall by Baxter (Deerfield, Illinois) of one lot of 0.9% Sodium Chloride Irrigation, USP, 500 mL, plastic pour bottle solution—Lot G120162, expiration 11/30/2018. The solution is being recalled because of a customer complaint of the presence of particulate…
FDA: Class I recall of Drager Oxylog Emergency Transport Ventilators
Editor's Note The Food and Drug Administration (FDA) on February 10 classified the recall of the Oxylog 2000 Plus, 3000, and 3000 plus Emergency Transport Ventilators by Drager Medical (Telford, Pennsylvania) as Class I, the most serious. The recall was initiated because of an electrical issue that may cause the…
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…
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…
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…
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…
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…
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…
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…
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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