FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on September 20, 2023 - 15:35 GMT

Medline Industries Recalls Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Due to Being Non-Sterile

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: Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution Product Codes: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 13, 2023 - 18:57 GMT

Abbott Medical Recalls Proclaim and Infinity IPGs for Inability to Exit Magnetic Resonance Imaging (MRI) 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 Device Use The Abbott Proclaim neurostimulation systems delivers low-intensity electrical impulses …

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Published on September 12, 2023 - 18:11 GMT

Bone Matrix Product: FDA Safety Communication - Important Information for Human Cell, Tissue and Cellular and Tissue-based Product ...

[Posted 09/06/2023] AUDIENCE: Patient, Health Professional, Infectious Disease, Surgery, Transplantation ISSUE: FDA is working closely with the Centers for Disease Control and Prevention (CDC) to investigate recent reports of a tuberculosis (TB) outbreak …

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Published on September 12, 2023 - 13:49 GMT

Mallinckrodt Manufacturing, LLC Recalls One-Way Valve, 22F x 22M for Not Opening Properly

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: One-Way Valve, 22F x 22M Product Codes: See Recall Database Entry Model Numbers: …

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Published on September 11, 2023 - 18:16 GMT

Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL ...

Summary Company Announcement Date: September 11, 2023 FDA Publish Date: September 11, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Crystal formation which could potentially result in incorrect dosing Company Name: Novartis …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 11, 2023 - 13:02 GMT

Labeling Updates for BD Mesh Products - Letter to Health Care Providers

November 9, 2023 The U.S. Food and Drug Administration (FDA) is informing health care providers about labeling updates for Becton, Dickinson and Company (BD) mesh products: Phasix Mesh Phasix ST Mesh Phasix Plug and Patch Phasix ST Mesh with Open …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 8, 2023 - 04:00 GMT

Church & Dwight Issues Voluntary Nationwide Recall of One Specific Lot of TheraBreath Strawberry Splash for Kids 16oz Sold ...

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 31, 2023 - 17:11 GMT

Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Gas Loss and Gas Gain ...

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: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 31, 2023 - 17:11 GMT

Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Power Failures When Device is ...

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 Recalled Product: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 31, 2023 - 17:11 GMT

Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for Autofill Failure Alarms ...

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 Recalled Product: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 31, 2023 - 17:10 GMT

Getinge/Maquet/Datascope Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for System Over Temperature ...

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 Recalled Product: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra- …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 31, 2023 - 17:10 GMT

UPDATE: Risk of Device Failures for Getinge’s Maquet/Datascope Cardiosave Intra-Aortic Balloon Pump (IABP) – Letter to Health Care ...

August 31, 2023 The U.S. Food and Drug Administration (FDA) is providing an update about device failures for Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices. The FDA is issuing this letter to help ensure …

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Published on August 31, 2023 - 17:10 GMT

Marlex Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg ...

Summary Company Announcement Date: August 30, 2023 FDA Publish Date: August 31, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Label Mix-Up Company Name: Marlex Pharmaceuticals, Inc. Brand Name: Brand Name(s) Marlex …

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Published on August 31, 2023 - 16:42 GMT

Universal Meditech Inc. Issues Nationwide Recall of All Products Manufactured Between March 2021 and November 2022

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 August 30, 2023 - 16:02 GMT

Hamilton Medical Inc. Recalls HAMILTON-C1, C2, C3, T1 Ventilators for Software Issues that May Cause Ventilators to Stop Without ...

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 Device Use Hamilton ventilators are used for people who require full or partial breathing …

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Published on August 26, 2023 - 15:31 GMT

Dr. Berne’s Whole Health Products Issues Voluntary Nationwide Recall of Dr. Berne’s MSM Drops 5% and 15% Solution Eye Drops Due to ...

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 August 23, 2023 - 22:17 GMT

Inmar Supply Chain Solutions, LLC, Issues a Voluntary Recall of Product Stored at its Arlington, Texas Facility Due to Conditions ...

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 August 23, 2023 - 18:26 GMT

Draeger Recalls Carina Sub-Acute Care Ventilators for Contaminants in Airpath

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. Please be aware, this recall is a voluntary correction, not a product removal. Draeger will be updating affected …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 17, 2023 - 20:51 GMT

Abiomed Recalls the Labeling for Impella RP Flex with SmartAssist for Risk of Blood Clots

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. Please be aware, this recall is a voluntary correction, not a product removal. Recalled Product Product Names: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 17, 2023 - 16:37 GMT

Datascope/Maquet/Getinge Recalls Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) for PCBA Failures Affecting the ...

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: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue Intra- …

Distribution channels: Healthcare & Pharmaceuticals Industry