FDA: Fresenius Kabi recalls Sodium Acetate Injection, USP, 400 mEq/100 mL
Editor's Note The Food and Drug Administration on March 7 posted the recall by Fresenius Kabi USA (Lake Zurich, Illinois) of seven lots of its Sodium Acetate Injection, USP, 400 mEq/100 mL The recall was initiated because of the presence of particulate matter found in reserve and/or stability sample vials.…
FDA: Class I recall of Medtronic TurboHawk Plus Directional Atherectomy System
Editor's Note The Food and Drug Administration, on March 9, identified the recall by Medtronic of its TurboHawk Plus Directional Aherectomy System as Class I, the most serious. The recall was initiated because of the risk of the guidewire in the catheter moving downward or prolapsing when force is applied…
FDA: B. Braun Medical recalls 0.9% Sodium Chloride for Injection USP 250 ml in Excel
Editor's Note The Food and Drug Administration (FDA) on March 3 posted the recall by B. Braun Medical Inc of its nationwide recall of five lots of 0.9% Sodium Chloride for Injection USP 250 ml in Excel. The recall was initiated because of fluid leakage or low fill volume of…
FDA: Class I recall of Arrow International’s Arrow-Trerotola PTD
Editor's Note The Food and Drug Administration (FDA) on February 23 identified the recall by Arrow International (Reading, Pennsylvania), a subsidiary of Teleflex Inc, of its Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) as Class I, the most serious. The recall was initiated because of the risk of tip damage during use…
FDA: Class I recall of Vyaire Medical’s Bellavista Ventilators
Editor's Note The Food and Drug Administration (FDA) on February 17 identified the recall by Vyaire Medical (Mettawa, Illinois) of its Bellavista 1000 and 1000e Series Ventilators as Class I, the most serious. The recall was initiated because of issues with the software version 6.0.1600.0 or higher, after reports of…
FDA: Class I recall of BASE10 Genetics RNAstill MTM specimen collection kits
Editor's Note The Food and Drug Administration (FDA) on February 18 identified the recall by BASE10 Genetics of its RNAstill MTM specimen collection kits as Class I, the most serious. The specimen collection kits are intended for collection, transport, inactivation, stabilization, and long-term storage of nasopharyngeal or oropharyngeal swab samples…
FDA: Class I recall of E25Bio COVID-19 Direct Antigen Rapid Tests
Editor's Note The Food and Drug Administration (FDA) on February 18 identified the recall by E25Bio (Cambridge, Massachusetts) of its COVID-19 Direct Antigen Rapid Tests as Class I, the most serious. The tests are being recalled for several reasons, particularly because they were marketed and distributed in the US without…
FDA: Class I recall of Empowered Diagnostics COVID-19 tests
Editor's Note The Food and Drug Administration (FDA) on January 28 identified the recall by Empowered Diagnostics (Pompano Beach, Florida) of its CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test as Class I, the most serious. Empowered Diagnostics distributed these tests with labeling indicating they were…
Medtronic recalls TurboHawk Plus Directional Athrectomy System
Editor's Note On February 7, Medtronic announced that it had issued a voluntary recall of its 6Fr TurboHawk Plus Directional Atherectomy System because of the risk of tip damage caused by guidewire prolapse. To date, there have been no reports of tip damage and no reports of injuries or deaths…
FDA: Update on Class I recall of certain Philips Respironics ventilators, repair kits
Editor's Note The Food and Drug Administration (FDA) on January 26 updated the Class I recall of certain Trilogy Evo ventilators and repair kits for Trilogy Evo muffler assembly, which are manufactured by Philips Respironics. According to the update, the FDA has asked the company to have an independent laboratory…
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