Supply Chain/Technology

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July 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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Three cybersecurity companies offering free service to US hospitals

Editor's Note OR Manager recently reported on the increased cybersecurity risk the Russia/Ukraine conflict poses to US healthcare systems. With two new malware threats identified last week, the Cybersecurity and Infrastructure Security Agency and the FBI are urging US organizations and the private sector, including healthcare, to stay vigilant and…

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By: Tarsilla Moura
March 8, 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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Cybersecurity alert: Two new malware threats identified, increased risk

Editor's Note On February 23, the American Hospital Association (AHA) released a Cybersecurity Advisory report because of the heightened risk of cyberattacks due to the current Russia-Ukraine conflict. According to AHA, just this past weekend, the Cybersecurity and Infrastructure Security Agency and the FBI urged the US private sector, including…

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By: Tarsilla Moura
March 1, 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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The Joint Commission issues Quick Safety on instrument reprocessing

Editor's Note The Joint Commission on February 14 issued a new Quick Safety on “Ensuring critical instruments and devises are appropriate for reuse.” The Quick Safety highlights reprocessing guidance from the Food and Drug Administration (FDA) as well as special considerations for single use devices reprocessed by third parties that…

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By: Judy Mathias
February 16, 2022
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