FDA issues draft guideline on UDI requirements
Editor's Note The Food and Drug Administration (FDA) on June 30 issued a draft guideline: “Product Identifier Requirements Under the Drug Supply Chain Security Act−Compliance Policy.” The draft guidance describes the FDA’s enforcement of requirements related to unique device identification (UDI), specifically those that manufacturers affix or imprint on a…
FDA: Recall of potassium phosphate and succinylcholine chloride by PharMEDium Services
Editor's Note The Food and Drug Administration on June 27 announced the recall by PharMEDium Services of specific lots of potassium phosphate and succinylcholine chloride because of a lack of sterility assurance. The products being recalled were compounded using certain Hospira products, which were recalled on June 15 because microbial…
FDA announces new digital health resources
Editor's Note The Food and Drug Administration (FDA) has announced the creation of a new centralized Digital Health Unit in its Center for Devices and Radiological Health, which together with draft guidance on software as a medical device, is designed to support technological innovation and advance digital health, the June…
FDA: Fagron Sterile Services recalls three lots of succinylcholine
Editor's Note The Food and Drug Administration (FDA) on June 23 posted the recall by Fagron Sterile Services (Wichita, Kansas) of three lots of succinylcholine chloride 20 mg/mL 5 mL syringes because of microbial growth detected during a simulation of the manufacturing process. This is a secondary recall of products…
FDA: Vascular Solutions recalls Venture Catheters
Editor's Note The Food and Drug Administration (FDA) on June 21 announced the recall by Vascular Solutions (Maple Grove, Minnesota) of its Venture Catheters. The recall was initiated because there is a risk of the catheter tip splitting or separating during use and entering the patient’s bloodstream. This can result…
FDA: Alvogen recalls seven lots of clindamycin
Editor's Note The Food and Drug Administration (FDA) on June 16 announced the recall by Alvogen/Hospira Inc, a Pfizer company, of seven lots of Clindamycin Injection USP ADD-Vantage Vials. The recall was initiated because microbial growth was detected during a routine simulation of the manufacturing process, which represents the potential…
FDA: Maquet/Datascope recalls certain Intra-Aortic Balloon Pumps
Editor's Note The Food and Drug Administration (FDA) on June 19 announced the recall by Maquet/Datascope (Fairfield, New Jersey) of its System CS100, CS100i, and CS300 Intra-Aortic Balloon Pumps. The recall also applies to System 98 or System 98XT IABP that was converted to a CS100i or CS 300 IABP.…
FDA: Hospira recalls Sodium Bicarbonate, Quelicin, and Potassium Phosphates injections
Editor's Note The Food and Drug Administration (FDA) on June 16 announced the recall by Hospira, Inc, a Pfizer company, of the following: 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials 5 lots of Neut (Sodium Bicarbonate 4% additive solution) 5 mL vials 5 lots of Quelicin…
FDA issues Safety Alert for frameless stereotaxic navigation systems
Editor's Note The Food and Drug Administration (FDA) on June 15 issued a Safety Alert for frameless stereotaxic navigation systems because of navigational accuracy errors during surgical procedures. Some of these errors have led to patient deaths, serious or life-threatening injuries, and inaccurate, aborted, or prolonged surgical procedures. The FDA…
FDA releases list of reusable devices requiring new validated IFU, validation data
Editor's Note The Food and Drug Administration (FDA) on June 9 released a list of reusable devices that will require new validated instructions for use (IFU) and validation data in premarket notifications regarding cleaning, disinfection, and sterilization. These actions are effective August 8, 2017. The list includes: Bronchoscopes (flexible or…
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