Tag: FDA

FDA: Class I recall of Insulet Omnipod DASH PDM

Editor's Note The Food and Drug Administration (FDA) on November 16 identified the recall by Insulet of its Omnipod DASH Insulin Management System Personal Diabetes Manager (PDM) as Class I, the most serious. The recall was initiated because of PDM battery issues, including: Battery swelling Fluid leakage from the battery…

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By: Judy Mathias
November 17, 2022
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Supply chain expert warns that drug shortages will persist

Editor's Note Vials of the chemotherapy drug fludarabine could be purchased at a whole sale price of $110 last year—today, it is being sold for a much higher price, Fierce Pharma November 1 reports. One company, Areva Pharmeceuticals, increased the price to $2,736, Stat News reported on October 27. This…

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By: Bridget Brown
November 9, 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 issues Safety Communication on tracheostomy tube shortages

Editor's Note The Food and Drug Administration (FDA) on October 31 issued a Medical Device Safety Communication on tracheostomy tube shortages. Included in the shortages are Bivona tracheostomy tubes manufactured by ICU Medical, which are more likely to affect pediatric patients. Also on the shortage list are JOH Tube Tracheostomy…

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By: Judy Mathias
November 2, 2022
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FDA: Five companies are having amoxicillin shortages

Editor's Note As of November 1, the Food and Drug Administration (FDA) listed 26 amoxicillin products on its current drug shortages site. The FDA says increased demand is the largest cause of the shortage. The FDA does not list resupply dates, but the American Society of Health-System Pharmacists (ASHP) estimates…

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By: Judy Mathias
November 1, 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 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…

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By: Bridget Brown
October 12, 2022
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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…

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By: Tarsilla Moura
October 6, 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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