FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on April 28, 2022 - 21:03 GMT

Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, ...

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: Celltrion DiaTrust COVID-19 Ag Rapid Test Product Codes: 83QKP Lot Numbers: See …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 28, 2022 - 20:21 GMT

Potential for Internal Pump Malfunction in the Medtronic HVAD System – Letter to Health Care Providers

The U.S. Food and Drug Administration (FDA) is alerting health care providers to the possibility that patients who have the Medtronic Heartware Ventricular Assist Device (HVAD) System and appear to present with pump thrombosis may have a welding defect in …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 27, 2022 - 15:06 GMT

Potential Risk of Airway Obstruction When Using Certain Electromyogram Endotracheal Tubes – Letter to Health Care Providers

April 27, 2022 The U.S. Food and Drug Administration (FDA) is evaluating the potential risk of airway obstruction when using silicone-based electromyogram (EMG) endotracheal tubes (Medtronic NIM Standard Reinforced EMG Endotracheal Tube and Medtronic NIM …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 26, 2022 - 15:18 GMT

Medtronic Recalls Harmony Delivery Catheter, Part of Transcatheter Pulmonary Valve (TPV) System, for Risk of Capsule Break During ...

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: Harmony Delivery Catheter System Product Codes and Batch Numbers: See database entry …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 23, 2022 - 03:21 GMT

Pfizer Voluntary Nationwide Recall of Lots of ACCUPRIL® (Quinapril HCl) Due to N-Nitroso-Quinapril Content

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 April 19, 2022 - 18:12 GMT

Genetic Non-Invasive Prenatal Screening Tests May Have False Results: FDA Safety Communication

Discuss the results of genetic prenatal screening tests with a genetic counselor or other health care provider.Date Issued: April 19, 2022 The U.S. Food and Drug Administration (FDA) is warning patients and health care providers about the risks of false …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 12, 2022 - 22:56 GMT

Mylan Pharmaceuticals Inc., a Viatris Company, Conducting Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin ...

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 April 11, 2022 - 17:32 GMT

Intended Use of Imaging Software for Intracranial Large Vessel Occlusion - Letter to Health Care Providers

April 11, 2022 The U.S. Food and Drug Administration (FDA) is reminding health care providers about the intended use of radiological computer-aided triage and notification (CADt) devices for intracranial large vessel occlusion (LVO). LVO is an obstruction …

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Published on April 11, 2022 - 12:25 GMT

Teleflex Announces Worldwide Recall of Gibeck® Iso-Gard® Filter

Summary Company Announcement Date: November 03, 2022 FDA Publish Date: November 04, 2022 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Bacterial and viral filters Company Name: Teleflex Incorporated Brand Name: Brand Name …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 8, 2022 - 20:25 GMT

VI-Jon, LLC Expands Voluntary Worldwide Recall of All Flavors and Lots within Expiry of Magnesium Citrate Saline Laxative 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 April 8, 2022 - 12:31 GMT

Plastikon Healthcare Expands Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum ...

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 April 5, 2022 - 14:11 GMT

Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

Date Issued: April 5, 2022 The U.S. Food and Drug Administration (FDA) is updating the April 2020 Safety Communication to provide new information supporting the transition to fully disposable duodenoscopes and those with disposable components as well as …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 4, 2022 - 17:22 GMT

UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes – Letter to Health Care Providers

April 4, 2022 As the U.S. Food and Drug Administration (FDA) continues to evaluate the risk of patient infections and contamination issues associated with reprocessed urological endoscopes, the FDA is aware that the current reprocessing instructions for …

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Published on March 30, 2022 - 21:59 GMT

Iodine-Containing Contrast Media: Drug Safety Communication - FDA Recommends Thyroid Monitoring in Babies and Young Children Who ...

[Posted 03/30/2022] AUDIENCE: Pediatrics, Radiology, Health Professional, Patient, Caregiver, Pharmacy ISSUE: The FDA approved a new warning to the prescribing information for the entire class of iodinated contrast media (ICM) injections and monitoring …

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Published on March 30, 2022 - 21:23 GMT

Unilever Issues Voluntary Nationwide Recall of Suave 24-Hour Protection Aerosol Antiperspirant Powder and Suave 24-Hour Protection ...

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 March 29, 2022 - 20:33 GMT

Teva Issues Voluntary Nationwide Recall of One Lot of IDArubicin Hydrochloride Injection USP 5 mg/5 mL Due to the Presence of ...

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 March 25, 2022 - 00:01 GMT

Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide ...

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 March 23, 2022 - 20:16 GMT

Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Labeled for Research Use Only

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: Celltrion DiaTrust COVID-19 Ag Rapid Test (labeled for Research Use Only) Product …

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Published on March 23, 2022 - 00:26 GMT

Pfizer Voluntary Nationwide Recall of Lots of ACCURETICTM (Quinapril HCl/Hydrochlorothiazide), Quinapril and Hydrochlorothiazide ...

Summary Company Announcement Date: March 22, 2022 FDA Publish Date: March 22, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of a nitrosamine, N-nitroso-quinapril Company Name: Pfizer Brand Name: Brand Name(s) …

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Published on March 22, 2022 - 20:40 GMT

Celltrion USA Recalls Certain Point of Care Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results 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. Recalled Product Product Name: Celltrion DiaTrust COVID-19 Ag Rapid Test Product Code: 83QKP Lot Numbers: See …

Distribution channels: Healthcare & Pharmaceuticals Industry