FDA Press Releases - EIN Presswire - Press Release Distribution Service

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

Published on July 20, 2021 - 14:38 GMT

Statins: Drug Safety Communication - FDA Requests Removal of Strongest Warning Against Using Cholesterol-lowering Statins During ...

[Posted 07/20/2021] AUDIENCE: Patient, Health Professional, OBGYN, Cardiology, Endocrinology, Pharmacy   ISSUE: The FDA is requesting revisions to the information about use in pregnancy in the prescribing information of the entire class of statin …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 19, 2021 - 19:00 GMT

Pfizer Issues a Voluntary Nationwide Recall for Twelve Lots of CHANTIX® (Varenicline) Tablets Due to N-Nitroso Varenicline Content

Summary Company Announcement Date: July 16, 2021 FDA Publish Date: July 19, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description N-Nitroso Varenicline content above ADI level Company Name: Pfizer Brand Name: Product Description: …

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Published on July 15, 2021 - 18:38 GMT

Potential Concerns with NuVasive MAGEC System Implants - FDA Safety Communication

Date Issued: July 15, 2021 The U.S. Food and Drug Administration (FDA) is informing patients, their caregivers, and health care providers of potential mechanical failures and concerns about tissue incompatibility (biocompatibility) associated with …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 15, 2021 - 00:27 GMT

Johnson & Johnson Consumer Inc. Issues Voluntary Recall of Specific NEUTROGENA® and AVEENO® Aerosol Sunscreen Products 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 Summary Company …

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Published on July 12, 2021 - 14:54 GMT

Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance

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 12, 2021 - 14:45 GMT

Teligent Pharma, Inc.’s Issues Worldwide Voluntary Recall of Lidocaine HCl Topical Solution USP 4% Due to Super Potency

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 10, 2021 - 10:11 GMT

UPDATE: Safe Use of Surgical Staplers and Staples - Letter to Health Care Providers

October 7, 2021 The U.S. Food and Drug Administration (FDA) is providing additional recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with surgical staplers and staples for internal …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 9, 2021 - 18:47 GMT

ICU Medical Issues a Voluntary Nationwide Recall of Aminosyn II 15%, An Amino Acid Injection, Sulfite Free IV Solution Due to the ...

Summary Company Announcement Date: September 03, 2021 FDA Publish Date: September 07, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of visible particulate matter Company Name: ICU Medical, Inc. Brand Name: Product …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 8, 2021 - 17:29 GMT

Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers

July 8, 2021 The U.S. Food and Drug Administration (FDA) is informing health care providers about potential biocompatibility concerns associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium. The FDA is also …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 7, 2021 - 19:40 GMT

Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative Results

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 Lyra SARS-CoV-2 Assay (M120) Lot codes: 031620A, 031620B, 031620C, 032320, 032420, 032720, 032820A, …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 30, 2021 - 19:25 GMT

Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

Date Issued: June 30, 2021 The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 30, 2021 - 19:25 GMT

Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators - Letter to Health Care ...

June 30, 2021 The U.S. Food and Drug Administration (FDA) is revoking the Emergency Use Authorizations (EUAs) for non-NIOSH-approved disposable respirators (revocation effective July 6, 2021) and the EUAs for decontamination and bioburden reduction systems …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 25, 2021 - 20:39 GMT

Smiths Medical Recalls Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes for Skewed Graduated Marks on Syringe Barrel That ...

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 Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes Models and Lot Model Number Name Lot …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 25, 2021 - 16:51 GMT

Avid Medical Recalls Medical Convenience Kits for Risk of Fungal Contamination

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 Adult Chest Tube Tray Fistula On-Off Kit Fistula (On/Off All in One bag) Dialysis Access Part and …

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Published on June 25, 2021 - 16:51 GMT

DeRoyal Industries Recalls Surgical Procedure Packs for Mislabeled Lidocaine

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 DeRoyal Pacemaker Tray Pgybk Lot Number 54239375, exp. 02/01/2022 DeRoyal Heart Cath Procedure …

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Published on June 25, 2021 - 14:13 GMT

Flexible Bronchoscopes and Updated Recommendations for Reprocessing: FDA Safety Communication

Date Issued: June 25, 2021 The U.S. Food and Drug Administration (FDA) is providing updated information about medical device adverse event reports and recommendations for health care providers on bronchoscopes. This is a supplement to the 2015 safety …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on June 22, 2021 - 19:34 GMT

Sanit Technologies Adds Label Clarification to Existing Voluntary Hand Sanitizer Recall

COMPANY ANNOUNCEMENT Some product packaging form labels are being added to ensure last stage of recall is complete When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA …

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