FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on September 30, 2024 - 19:02 GMT

Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume ...

Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement This recall involves correcting devices, and does not involve removing them from where they are used or sold …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 24, 2024 - 14:00 GMT

Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding ...

Automated Compounding Device Inlets used with Exactamix Compounding Devices may contain particulate matter that poses a risk to patients.

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 23, 2024 - 16:32 GMT

Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a ...

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 20, 2024 - 14:10 GMT

Ventilator Recall: Smiths Medical Removes ParaPAC Plus Ventilators due to Loosened or Detached Patient Outlet Connector

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: PneuPAC …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 18, 2024 - 18:52 GMT

Tracheostomy Tube Recall: Smiths Medical Removes Certain Bivona Neonatal/Pediatric and Adult Tracheostomy Tubes due to ...

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Image of torn flange due …

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Published on September 18, 2024 - 18:33 GMT

Bionpharma Inc. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Bacterial Contamination

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2024 - 13:36 GMT

Infusion Pump Correction: B. Braun Medical Inc. Issues Correction for lnfusomat Space Infusion System/Large Volume Pump, in ...

This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 17, 2024 - 13:23 GMT

Zimmer Biomet CPT Hip System Femoral Stem and Increased Risk of Thigh Bone Fracture - FDA Safety Communication

Date Issued: September 17, 2024 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, health care providers, and health care facilities about the increased risk of thigh bone fracture after surgery (postoperative periprosthetic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 16, 2024 - 16:47 GMT

Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: Ivenix LVP …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 12, 2024 - 17:44 GMT

FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause. ...

[Posted 9/12/2024] AUDIENCE: Patient, Health Professional, OBGYN, Endocrinology ISSUE: The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 23, 2024 - 18:29 GMT

Clot Removal Device Correction: Inari Medical Updates Use Instructions for ClotTriever XL Catheter due to Reports of Patient ...

This recall involves updating instructions for using the ClotTriever XL, 30mm device, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. Affected Product Product Names: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 23, 2024 - 15:21 GMT

Convenience Kit Component Recall: Medline Industries, LP, Removes Convenience Kit Syringes Manufactured in China that May Be ...

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product What to Do Do not use …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 22, 2024 - 17:08 GMT

Chest Compression Device Recall: Defibtech, LLC, Removes RMU-2000 ARM XR Chest Compression Device due to Risk of Device Stopping ...

This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 20, 2024 - 18:15 GMT

Infusion Pump Battery Correction: ICU Medical Updates Instructions for Use Regarding Batteries in Plum 360, A+ and A+3 Infusion ...

This recall involves updating instructions for using certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 13, 2024 - 02:37 GMT

Tandem Diabetes Care Provides Update on March 2024 Nationwide Recall of t:connect Mobile App for iOS Devices

Summary Company Announcement Date: August 12, 2024 FDA Publish Date: August 12, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Rapid Depletion of a User’s t:slim X2 Insulin Pump Battery Company Name: Tandem Diabetes …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 12, 2024 - 18:51 GMT

Heart Pump Recall: Abiomed Removes Certain Impella CP with SmartAssist Systems due to Failed Quality Inspections

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Name: Abiomed …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 9, 2024 - 21:23 GMT

Breas Medical Issues Voluntary U.S. Nationwide Urgent Medical Device Correction of Vivo 45 LS Ventilator

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 Summary Company …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 8, 2024 - 22:54 GMT

B. Braun Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 1000 mL in E3 Containers Due to the ...

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 …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 31, 2024 - 18:56 GMT

Abbott Issues Voluntary Medical Device Correction for a Small Number of FreeStyle Libre® 3 Sensors in the U.S.

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 Summary Company …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 31, 2024 - 18:14 GMT

Safe Use of Megadyne Mega 2000 and Mega Soft Patient Return Electrodes - Letter to Health Care Providers

July 31, 2024 The U.S. Food and Drug Administration (FDA), together with Health Canada, is raising awareness among health care providers and facilities about the safe use of Mega 2000 and Mega Soft Patient Return Electrodes by Megadyne Medical Products, …

Distribution channels: Healthcare & Pharmaceuticals Industry