Tag: Product Recalls

FDA: Class I recall of Arrow AutoCAT2, AC3 IABPs

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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By: Judy Mathias
January 3, 2023
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FDA: Exela Pharma Sciences, LLC, expands recall of Sodium Bicarb

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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By: Judy Mathias
December 12, 2022
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FDA: Class I recall of Thermo Scientific Gram Negative IVD AST Sensititre Plate

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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By: Judy Mathias
December 12, 2022
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FDA: Class I recall of Baxter Hillrom WatchCare IMS for RF interference risk

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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By: Judy Mathias
November 29, 2022
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FDA: Class I recall of Teleflex Iso-Gard Filter S

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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By: Judy Mathias
November 3, 2022
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FDA: Class I recall of Jiangsu Well Biotech COVID-19 Ag Rapid Test

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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By: Judy Mathias
October 26, 2022
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FDA: Philips Respironics recalls certain BiPAP, CPAP masks

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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By: Judy Mathias
October 24, 2022
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FDA: Class I recall of LivaNova’s LifeSPARC System

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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By: Judy Mathias
October 3, 2022
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FDA: Class I recall of certain Philips Respironics BiPAP machines

Editor's Note The Food and Drug Administration (FDA) on September 23 identified the recall by Philips Respironics of certain models of its BiPAP machines as Class I, the most serious. The recall was initiated because certain machines may contain a plastic contaminated with a noncompatible material. If the plastic is…

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By: Judy Mathias
September 26, 2022
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FDA: Class I recall of Baxter Clearlink Basic Solution Set with Duovent

Editor's Note The Food and Drug Administration (FDA) on September 15 identified Baxter Healthcare Corporation’s recall of its ClearLink Basic Solution Set with Duovent as Class I, the most serious. The recall was initiated because of the risk for leaks that may expose providers and patients to hazardous toxic substances…

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By: Judy Mathias
September 19, 2022
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