Tag: Product Recalls

FDA: Class I recall of certain Celltrion USA COVID-19 test kits labeled for research use only

Editor's Note The Food and Drug Administration (FDA), on March 23, identified the recall by Celltrion USA of certain point of care DiaTrust COVID-19 Ag Rapid Test kits (labeled for research use only) as Class I, the most serious. The recall was initiated because the kits were distributed to customers…

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By: Judy Mathias
March 29, 2022
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FDA: Class I recall of Philips Respironics V60, V60 Plus Ventilators

Editor's Note The Food and Drug Administration (FDA) on March 21 identified the recall by Philips Respironics of certain V60 and V60 Plus Ventilators as Class I, the most serious. The recall was initiated because a subset of these devices had parts that were put together using an expired adhesive.…

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By: Judy Mathias
March 28, 2022
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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.…

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By: Judy Mathias
March 10, 2022
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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…

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By: Judy Mathias
March 9, 2022
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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…

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By: Judy Mathias
March 8, 2022
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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…

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By: Judy Mathias
February 24, 2022
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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…

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By: Judy Mathias
February 24, 2022
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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…

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By: Judy Mathias
February 23, 2022
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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…

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By: Judy Mathias
February 22, 2022
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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…

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By: Judy Mathias
February 8, 2022
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