FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on December 6, 2022 - 05:00 GMT

Actualización de los sistemas endovasculares de injerto de AAA Endologix AFX y el riesgo de endofuga de tipo III: Comunicado de ...

English Fecha de emisión: 6 de diciembre de 2022 La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) está actualizando nuestro comunicado de seguridad de enero de 2022 (en inglés) sobre el uso de los injertos …

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Published on November 29, 2022 - 20:48 GMT

Exela Pharma Sciences, LLC Expands Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-...

Summary Company Announcement Date: November 28, 2022 FDA Publish Date: November 29, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Vial Breakage Company Name: Exela Pharma Sciences, LLC Brand Name: Product Description: Product …

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Published on November 23, 2022 - 17:42 GMT

Baxter Hillrom Recalls WatchCare Incontinence Management System (IMS) for Risk of RF Interference with Nearby Medical Equipment

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: WatchCare Incontinence Management System (IMS) Product Models: P7900B Centrella …

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Published on November 23, 2022 - 00:00 GMT

Prolia (denosumab) by Amgen: Drug Safety Communication - FDA Investigating Risk of Severe Hypocalcemia in Patients on Dialysis

[Posted 11/22/2022] AUDIENCE: Patient, Health Professional, Pharmacy   ISSUE: The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 22, 2022 - 05:00 GMT

ACTUALIZACIÓN: Se retiran del mercado ciertos ventiladores, máquinas BiPAP y máquinas CPAP de Philips Respironics debido a ...

ACTUALIZACIÓN - 22 de noviembre de 2022: La FDA actualizó este comunicado de seguridad para proporcionar información actualizada sobre los informes de dispositivos médicos (en inglés) (MDR, por sus siglas en inglés) recibidos del 1 de agosto de 2022 al 31 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 17, 2022 - 20:24 GMT

At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative Results: FDA Safety Communication

November 17, 2022, Update: The FDA took an additional action related to the need for repeat testing following a negative COVID-19 test result on COVID-19 antigen tests -- revising the emergency use authorizations (EUAs) of all authorized COVID-19 antigen …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 16, 2022 - 21:43 GMT

Insulet Recalls Omnipod DSAH Insulin Management System's Personal Diabetes Manager (PDM) for Risk of Battery Swelling, Leakage, or ...

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: Insulet Omnipod DASH Insulin Management System Personal Diabetes Manager (PDM) …

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Published on November 15, 2022 - 17:15 GMT

Insulet Issues a Nationwide Voluntary Medical Device Correction for the Omnipod® 5 Controller

Summary Company Announcement Date: November 14, 2022 FDA Publish Date: November 15, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Issue with the Omnipod 5 Controller charging port and cable Company Name: Insulet …

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Published on November 7, 2022 - 05:00 GMT

Exactitud y limitaciones de los pulsioxímetros: Comunicado de seguridad de la FDA

English 15 de septiembre de 2022: Aviso de reunión del Comité Asesor La FDA anunció una reunión virtual del Panel de Dispositivos de Anestesiología y Terapia Respiratoria del Comité Asesor de Dispositivos Médicos del CDRH (en inglés) el 1 de noviembre de …

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Published on October 31, 2022 - 19:17 GMT

Reuse Tracheostomy Tubes or Switch to Appropriate Alternatives During Shortage: FDA Safety Communication

Date Issued: October 31, 2022 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that there is a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical. A …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 31, 2022 - 19:17 GMT

Consider Alternatives for MRI-Guided Breast Biopsy Grid Plates Due to Shortage - Letter to Health Care Providers

October 31, 2022 The U.S. Food and Drug Administration (FDA) is recommending health care providers discuss alternative options for Magnetic Resonance Imaging (MRI)-guided breast biopsy procedures with patients if a facility is unable to perform the biopsy …

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Published on October 31, 2022 - 04:00 GMT

Comunicado de seguridad de la FDA: reutilice las cánulas de traqueostomía o cambie a alternativas adecuadas durante su escasez

Fecha de emisión: 31 de octubre de 2022 La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) está alertando a los pacientes, cuidadores y proveedores de atención médica acerca de una escasez de cánulas de traqueostomía, incluidas las …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 26, 2022 - 03:23 GMT

Mylan Institutional LLC, a Viatris Company, Issues a Voluntary Recall of One Lot of Octreotide Acetate Injection, 500 mcg/mL, Due ...

Summary Company Announcement Date: October 25, 2022 FDA Publish Date: October 25, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to glass particulates Company Name: Mylan Institutional LLC, a Viatris company Brand Name: …

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Published on October 25, 2022 - 17:09 GMT

Aurobindo Pharma USA, Inc. Initiates Voluntary Nationwide Recall of Two (2) Lots of Quinapril and Hydrochlorothiazide Tablets USP ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

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Published on October 25, 2022 - 15:24 GMT

Do Not Use Certain Mighty Bliss Electric Heating Pads Due to Risk of Injury: FDA Safety Communication

Date Issued: October 25, 2022 The U.S. Food and Drug Administration (FDA) is warning consumers, caregivers and health care providers not to use the recalled Mighty Bliss electric heating pads distributed by Whele LLC (doing business as Perch) due to the …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on October 24, 2022 - 18:41 GMT

Whele LLC Announces National Voluntary Recall of Mighty Bliss Electric Heating Pad Due to Product Safety Concerns

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

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Published on October 24, 2022 - 13:08 GMT

Baxter Issues Urgent Medical Device Correction Regarding Potential Radio Frequency Interference With Other Devices Near Beds ...

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 …

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Published on October 19, 2022 - 12:51 GMT

Philips Respironics Recalls Certain Masks for BiPAP, CPAP Machines Due to Safety Issue with Magnets That May Affect Certain ...

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 …

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Published on October 13, 2022 - 15:04 GMT

Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-...

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) Product …

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Published on October 12, 2022 - 17:38 GMT

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 …

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