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 issues blood donation recommendations for Zika virus
Editor's Note The Food and Drug Administration on February 16 issued a new guidance recommending the deferral of individuals from donating blood if they have: been to areas with active Zika virus transmission potentially been exposed to the virus had a confirmed Zika virus infection. The FDA is issuing these…
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FDA issues draft guidance on UDIs
Editor's Note The Food and Drug Administration (FDA) on February 3 released a draft guidance document, “Enforcement policy on national health related item code and national drug code numbers assigned to devices.”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…
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…
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: 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…
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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