Summary Company Announcement Date: October 21, 2022 FDA Publish Date: October 24, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for radio frequency (RF) interference with other medical devices. Company Name: Baxter International Inc. Brand Name: Brand Name(s) Product Description: Product Description Incontinence management system Company Announcement Baxter International Inc. announced…
Lo que debe saber sobre el riesgo de Cronobacter en la fórmula infantil en polvo
Image English La Administración de Alimentos y Medicamentos de EE. UU. continúa contribuyendo a garantizar la seguridad de la fórmula infantil en polvo a raíz de los informes de infecciones por Cronobacter sakazakii en cuatro bebés lo que pudo haber contribuido a la muerte de dos pacientes. Esos informes dieron lugar a una investigación de…
What to Know About the Risk of Cronobacter in Powdered Infant Formula
Image The U.S. Food and Drug Administration continues to help ensure the safety of powdered infant formula in the wake of reports of Cronobacter sakazakii infections in four infants that may have contributed to death in two patients. Those reports led to an FDA investigation of Abbott Nutrition in Sturgis, Michigan. Insanitary conditions found at…
Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain Medical Devices
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Amara View Full Face Mask DreamWisp Nasal Mask DreamWear Full Face Mask Wisp and Wisp Youth Nasal Mask Therapy Mask 3100 NC/SP Serial and Model…
FDA D.I.S.C.O. Burst Edition: FDA approval of Pedmark (sodium thiosulfate) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month and older with localized, non-metastatic solid tumors
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On September 20, 2022, the FDA approved sodium thiosulfate (brand…
FDA D.I.S.C.O. Burst Edition: FDA approval of Imfinzi (durvalumab) for adult patients with locally advanced or metastatic biliary tract cancer
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On September 2, 2022, FDA approved durvalumab (brand name Imfinzi)…
Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton Due to Vial Breakage
Summary Company Announcement Date: October 12, 2022 FDA Publish Date: October 13, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Vial Breakage Company Name: Exela Pharma Sciences, LLC Brand Name: Brand Name(s) Exela & Civica Product Description: Product Description Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial Company Announcement FOR IMMEDIATE RELEASE…
Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices That Are Not Authorized, Cleared, or Approved by the FDA
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: COVID-19 Ag Rapid Test Device Product Codes: See Recall Database Entry Distribution Dates: July 23, 2021 to January 23, 2022 Devices Recalled in the U.S.:…
El fluorouracilo y la seguridad de las mascotas
Image CaptionFoto de cortesía English Para muchos hogares, las mascotas son nuestros mejores amigos. Para algunas personas son también animales de servicio indispensables. Muchos demuestran su afecto lamiéndonos. A otros les gusta morder cosas —los muebles, los zapatos, el bolso— cualquier cosa que esté a su alcance. Esto incluye los envases de cremas medicinales que…
LivaNova (TandemLife) Recalls LifeSPARC System for Risk of Unintentional Extended Pump Stop During Controller Critical Failure
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: LifeSPARC System Product Model: LifeSPARC Controller, Model LS-1000 Distribution Dates: December 19, 2019 to present Devices Recalled in the U.S.: 484 Date Initiated by Firm:…