FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on August 25, 2021 - 17:59 GMT

Stop Using Certain N95 Respirators Manufactured by Shanghai Dasheng - Letter to Health Care Providers

August 25, 2021 The U.S. Food and Drug Administration (FDA) is alerting health care facility risk managers, procurement staff, and health care personnel to stop using certain N95 respirators manufactured by Shanghai Dasheng Health Products Manufacturing …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 24, 2021 - 16:32 GMT

Bio-Medical Equipment Service Co. Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair ...

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 Alaris Infusion Pump Module Model 8100 Bezel purchased or installed by Bio-Medical Equipment …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 24, 2021 - 15:54 GMT

Baxter Issues Urgent Medical Device Correction for All Spectrum IQ Infusion Pumps to Reinforce Important Safety Information ...

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 23, 2021 - 18:51 GMT

Cardinal Health Recalls Monoject Saline Flush Prefilled Syringes for Risk of Air Re-entering Syringe Leading to Air Embolism

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 Monoject Flush Prefilled Syringes (0.9% sodium chloride) Product Codes, All Lots: Product Code (SKU …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 20, 2021 - 15:57 GMT

Cardinal Health Issues Nationwide Recall of Select Monoject™ Flush Prefilled Saline Syringes

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 August 20, 2021 - 15:57 GMT

UPDATE: Caution with Robotically-Assisted Surgical Devices in Mastectomy: FDA Safety Communication

Date Issued: August 20, 2021 The U.S. Food and Drug Administration (FDA) is reminding patients and health care providers that the safety and effectiveness of robotically-assisted surgical (RAS) devices for use in mastectomy procedures or in the prevention …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 20, 2021 - 12:54 GMT

Cardinal Health Recalls Argyle UVC Insertion Tray Due to Missing Instructions for Use for the Safety Scalpel N11

The FDA 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: Argyle UVC Insertion Tray containing Safety Scalpel N11 Product Codes: Argyle UVC …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 18, 2021 - 14:20 GMT

Stop Using All Eco-Med Ultrasound Gels and Lotions Due to Risk of Bacterial Contamination – Letter to Health Care Providers

August 18, 2021 The U.S. Food and Drug Administration (FDA) is informing health care providers, health care facility risk managers, and procurement staff to immediately stop using and discard all ultrasound gels and lotions manufactured by Eco-Med …

Distribution channels:

Published on August 17, 2021 - 00:25 GMT

Pfizer Expands Voluntary Nationwide Recall to include Four Additional Lots of CHANTIX® (varenicline) Tablets Due to N- Nitroso ...

Summary Company Announcement Date: August 16, 2021 FDA Publish Date: August 16, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description N-Nitroso Varenicline content above acceptable daily intake level Company Name: Pfizer Brand Name: …

Distribution channels:

Published on August 12, 2021 - 18:53 GMT

Medtronic Stops Distribution and Sale of HeartWare HVAD System Due to Risk of Neurological Adverse Events, Mortality, and ...

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. The recall described in this notice is the same one that was announced in the Stop New Implants of the Medtronic …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 12, 2021 - 15:51 GMT

Baxter Healthcare Recalls Dose IQ Software Version 9.0.x, Used with Spectrum IQ Infusion Pumps, for Software Defect That May ...

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 Dose IQ Safety Software (used with Spectrum IQ Infusion System) Product Code: 35723V091 Software …

Distribution channels:

Published on August 11, 2021 - 22:33 GMT

Jongu 4308 Issues Voluntary Nationwide Recall of Hydro Pineapple Burn Due to the Presence of Undeclared Sibutramine.

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 August 10, 2021 - 22:35 GMT

SterRx, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL Due to Microbial ...

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 August 10, 2021 - 19:54 GMT

Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Transition to Safety Mode

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: INGENIO Family of Pacemakers and CRT-Ps (includes models ADVANTIO DR EL, INGENIO DR …

Distribution channels:

Published on August 10, 2021 - 13:01 GMT

Do Not Use Needle-Free Devices for Injection of Dermal Fillers – FDA Safety Communication

Date Issued: October 8, 2021 The U.S. Food and Drug Administration (FDA) is warning the public and health care professionals not to use needle-free devices such as hyaluron pens for injection of hyaluronic acid (HA) or other lip and facial fillers, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 9, 2021 - 10:36 GMT

Azurity Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of One Lot of Firvanq® (Vancomycin Hydrochloride for Oral ...

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 29, 2021 - 19:47 GMT

Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions

Philips Respironics has voluntarily recalled certain ventilators, BiPAP, and CPAP machines due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 22, 2021 - 19:30 GMT

Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure ...

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. The recall described in this notice is the same one that was announced in the FDA Safety Communication on June 30, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 22, 2021 - 18:20 GMT

Philips Respironics Recalls Certain Ventilators and BiPAP Machines Due to Potential Health Risks from PE-PUR Sound Abatement Foam

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 Mechanical ventilation devices: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent 200, BiPAP …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 21, 2021 - 17:37 GMT

Vero Biotech Recalls GENOSYL DS; Nitric Oxide Delivery System Due to Software Error

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 GENOSYL DS; Nitric Oxide Delivery System Model Number: 601588-01 Serial Numbers: All Devices …

Distribution channels: Healthcare & Pharmaceuticals Industry