Editor's Note The Food and Drug Administration (FDA) on January 27 posted an addition to the Class I recall by LivaNova (TandemLife) of its LifeSPARC System Controller. The addition to the recall provides information about a software update now available to address the previous software malfunction and recall. The System…

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Editor's Note The Food and Drug Administration (FDA) on December 16 identified the recall by Teleflex and Arrow International, LLC, of its Arrow MAC Two-Lumen Central Venous Access Kits and Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits as Class I, the most serious. The recall…

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Editor's Note The Food and Drug Administration (FDA), on December 20, identified the recall by Arrow International, LLC, subsidiary of Teleflex, Inc, of its Arrow AutoCAT 2 and AC3 intra-aortic balloon pumps (IABPs) as Class I, the most serious. IABPs are used in patients having cardiac and non-cardiac surgery, and…

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Editor's Note The Food and Drug Administration (FDA) on November 29 posted Exela Pharma Sciences’ expansion of its recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. The product poses a safety concern because of vial breakage with flying glass when pressurized while preparing the product for…

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Editor's Note The Food and Drug Administration (FDA) on December 9 identified the recall by Remel, Inc, of its Thermo Scientific Gram Negative IVD AST Sensititre Plate as Class I, the most serious. The Plates are used to test the susceptibility of Gram-negative bacterial infections to specific antibiotics. The recall…

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Editor's Note The Food and Drug Administration, on November 23, identified the recall by Baxter Hillrom of its WatchCare Incontinence Management System (IMS) as Class I, the most serious. The recall was initiated because of the risk for radiofrequency (RF) emissions from WatchCare devices that may interfere with other devices,…

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Editor's Note The Food and Drug Administration (FDA) on November 1 identified the recall of Teleflex’s Iso-Gard Filter S as Class I, the most serious. Iso-Gard filters are breathing circuit bacterial filters that are connected to respiratory equipment or breathing systems in operating rooms and ICUs. The recall was initiated…

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Editor's Note The Food and Drug Administration (FDA) on October 12 identified the recall of Jiangsu Well Biotech’s COVID-19 Ag Rapid Test Devices as Class I, the most serious. The recall was initiated because the tests were distributed to US customers without authorization, clearance, or approval from the FDA. No…

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Editor's Note The Food and Drug Administration (FDA) on October 19 identified the recall by Philips Respironics of certain masks for BiPAP and CPAP machines as Class I, the most serious. The recall was initiated because magnetic headgear clips that hold the masks in place can cause injury or death…

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Editor's Note The Food and Drug Administration (FDA) on September 30 identified the recall by LivaNova (TandemLife) of its LifeSPARC System, Model LS-1000, as Class I, the most serious. The recall was initiated because of the risk of unintentional extended pump stop during Controller Critical Failure mode, caused by a…

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