FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on December 23, 2020 - 20:37 GMT

Cook Medical Recalls Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers Due to Separation in Device

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 Products Flexor Check-Flo Introducers Catalog and Lot numbers: See Full List Manufacturing Dates: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on December 15, 2020 - 21:34 GMT

Penumbra’s Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious ...

The U.S. Food and Drug Administration (FDA) is alerting you that Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on November 23, 2020 - 18:11 GMT

Fusion Health and Vitality Issues Voluntary Nationwide Recall of Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 ...

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 November 19, 2020 - 23:18 GMT

Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-...

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 November 12, 2020 - 17:06 GMT

Cook Medical Recalls Fixed Core Wire Guides, Due to Device Damage from a Manufacturing 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 Cook Medical Fixed Core Wire Guide Affected Models: o Model TSCF-35-260-3 Lots: Manufacturing Dates …

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Published on October 29, 2020 - 15:36 GMT

Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma ...

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 October 28, 2020 - 14:39 GMT

Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% 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 October 16, 2020 - 00:12 GMT

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Drug Safety Communication - Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later

AUDIENCE: Consumer, Patient, Health Professional, Pharmacy ISSUE: FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 30, 2020 - 17:33 GMT

Potential Risk of Infection during Cardiac Surgery When Using the CardioQuip Modular Cooler-Heater Device – Letter to Health Care ...

The U.S. Food and Drug Administration (FDA) continues to monitor the risk of Nontuberculous mycobacteria (NTM) infections in patients who have undergone cardiothoracic surgery using heater-cooler devices, and to collaborate with stakeholders including …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 30, 2020 - 16:49 GMT

DMM VISSION, S.A. DE C.V. Issues Voluntary Nationwide Recall of Cleaner Hand Sanitizer 500 mL and 1200 mL Bottles 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 September 25, 2020 - 14:59 GMT

Mammography Problems at Allison Breast Center at Monument Radiology in Richmond, Virginia: FDA Safety Communication

Date Issued: September 25, 2020 The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Allison Breast Center at Monument Radiology, located in Richmond, Virginia, on or after June 17, 2018, about possible problems with the …

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Published on September 24, 2020 - 21:43 GMT

Benadryl (diphenhydramine): Drug Safety Communication - Serious Problems with High Doses of the Allergy Medicine

TOPIC: Benadryl (diphenhydramine): Drug Safety Communication - Serious Problems with High Doses of the Allergy Medicine AUDIENCE: Consumer, Patient, Health Professional, Pharmacy ISSUE: FDA is warning that taking higher than recommended doses of the common …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 24, 2020 - 16:03 GMT

Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication

Date Issued: September 24, 2020 The U.S. Food and Drug Administration (FDA) is providing recommendations about the use of dental amalgam in certain groups of people who may be at greater risk to the potential adverse health effects of mercury exposure, to …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 23, 2020 - 19:52 GMT

Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use

TOPIC: Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: The FDA is requiring the Boxed Warning, FDA’s most prominent warning, be updated by adding other …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 23, 2020 - 19:08 GMT

Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of RIOMET ER™ (Metformin Hydrochloride for Extended-Release ...

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 22, 2020 - 03:39 GMT

BD Announces FDA Classifications for August 4th Recalls of BD Alaris™ System Hardware for Keypads, Incorrect Module Types and/or ...

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 September 18, 2020 - 03:24 GMT

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Two Lots of NP Thyroid®, Thyroid Tablets, USP Due to Sub 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 September 16, 2020 - 17:11 GMT

Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris™ Syringe and Alaris™ PCA Modules Due to Potential Incorrect Display of ...

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 BD Alaris™ Syringe Module; and BD Alaris™ PCA Module, Syringe/PCA Sizer Sensor Replacement Kit …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 14, 2020 - 18:43 GMT

Becton Dickinson (BD) CareFusion 303 Recalls Alaris System Infusion Pumps Due to Damaged Inter-Unit Interface Connectors, Loose or ...

The FDA has identified the occurrence of Situation 1, 2 and 3 as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The FDA has identified the occurrence of Situation 4 as a Class II recall and use …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on September 14, 2020 - 18:02 GMT

Becton Dickinson (BD) CareFusion 303, Inc. Recalls Alaris™ System PC Unit and PC Unit Front Case Keypad Replacement Kits Due to ...

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 BD Alaris™ PC Unit Model 8015, PC Unit Front Case with Keypad Replacement Kits Affected Models: …

Distribution channels: Healthcare & Pharmaceuticals Industry