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…
FDA authorizes bivalent COVID-19 vaccines as boosters for younger groups
Editor's Note On October 12, the Food and Drug Administration (FDA) amended the emergency use authorization (EUA) of the Moderna and Pfizer-BioNTech COVID-19 vaccines, Bivalent, to authorize their use as a single booster dose in younger groups, Health Purchasing News October 12 reports. The Moderna vaccine is now authorized for…
HHS expands provider list authorized to administer monkeypox treatment
Editor's Note The US Department of Health and Human Services (HHS) on October 3 amended the Public Readiness and Emergency Preparedness Act declaration for smallpox medical countermeasures to expand the categories of providers authorized to administer vaccines and therapeutics against smallpox, monkeypox, and other orthopoxviruses during the declared emergency, Healthcare…
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…
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…
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…
FDA: Class I recall of Medtronic Xomed NIM Contact, NIM Standard Reinforced EMG Endotracheal Tubes
Editor's Note The Food and Drug Administration on September 12 identified the recall by Medtronic Xomed of its NIM Contact Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube as Class I, the most serious. The recall was initiated after Medtronic Xomed received customer complaints about obstruction of…
FDA: Reports of squamous cell carcinomas, lymphomas in breast implant scar tissue
Editor's Note The Food and Drug Administration (FDA) on September 8 issued a Safety Communication informing the public about reports of cancers, including squamous cell carcinomas and various lymphomas in the scar tissue that forms around breast implants. The various lymphomas are not the same as the lymphomas reported in…
FDA alerts patients, providers of Philips Respironics masks recall
Editor's Note The Food and Drug Administration (FDA) issued a safety communication alert on September 6 informing patients, caregivers, and healthcare providers that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due…
FDA: Class I recall of Integra’s CereLink ICP Monitor
Editor's Note The Food and Drug Administration (FDA) on August 31 identified the recall by Integra of its CereLink ICP Monitor as Class I, the most serious. The recall was initiated because the device may display incorrect values for a patient’s intracranial pressure (ICP) and display out-of-range pressure readings. If…
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