FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on April 15, 2021 - 22:08 GMT

Medtronic Recalls HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage 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 HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Product Numbers …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 12, 2021 - 17:28 GMT

Smisson-Cartledge Biomedical, LLC Recalls ThermaCor 1200 Disposable Sets for Risk of Patient Contact to Aluminum

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 ThermaCor 1200 Disposable Sets Disposable Set Models: PTC-1200, DNC-1200, PNC-1200 Distribution …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 12, 2021 - 17:28 GMT

Medtronic Recalls Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac ...

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 Medtronic Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 9, 2021 - 21:23 GMT

NS NY Distributor Inc Issues Voluntary Nationwide Recall of Premium OrgaZen 7000 and Ginseng Power 5000 Due to 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 April 9, 2021 - 17:53 GMT

Medtronic Recalls Valiant Navion Thoracic Stent Graft System Due to Risk of Stent Fractures and Type III Endoleaks

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 Medtronic Valiant Navion Thoracic Stent Graft System Model Number, Product Codes, Catalog or Lot …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 9, 2021 - 14:00 GMT

FDA Recommends Transition from Use of Decontaminated Disposable Respirators - Letter to Health Care Personnel and Facilities

April 9, 2021 The U.S. Food and Drug Administration (FDA) is recommending health care personnel and facilities transition away from crisis capacity conservation strategies, such as decontaminating or bioburden reducing disposable respirators for reuse. …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on April 8, 2021 - 17:04 GMT

Eco-Med Pharmaceutical Issues Voluntary Recall of Eco-Gel 200

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 7, 2021 - 15:16 GMT

Yolo Studio Issues Voluntary Nationwide Recall of PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 ...

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 6, 2021 - 22:11 GMT

Yolo Studio Issues Voluntary Nationwide Recall of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 Due ...

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 5, 2021 - 21:33 GMT

QMART Issues Voluntary Nationwide Recall of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL ...

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 5, 2021 - 19:57 GMT

Hospira Issues A Voluntary Nationwide Recall for One Lot of Sterile Water for Injection, USP, Due to the Potential 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 April 5, 2021 - 19:54 GMT

Hospira Issues A Voluntary Nationwide Recall for One Lot of 0.5% Bupivacaine Hydrochloride Injection, USP and One Lot of 1% ...

Summary Company Announcement Date: May 04, 2021 FDA Publish Date: May 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to mislabeling Company Name: Hospira, Inc. Brand Name: Brand Name(s) Product Description: Product …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 31, 2021 - 21:31 GMT

Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates: FDA Safety ...

Date Issued: March 31, 2021 The U.S. Food and Drug Administration (FDA) is informing patients, caregivers, and health care providers that certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction may have a higher chance …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 31, 2021 - 21:31 GMT

Lamictal (lamotrigine): Drug Safety Communication - Studies Show Increased Risk of Heart Rhythm Problems in Patients with Heart ...

[Posted 03/31/2021] AUDIENCE: Patient, Health Professional, Pharmacy, Neurology, Cardiology, Psychiatry ISSUE: An FDA review of study findings showed a potential increased risk of heart rhythm problems, called arrhythmias, in patients with heart disease …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 31, 2021 - 16:48 GMT

Ummzy LLC Issues Voluntary Nationwide Recall of Thumbs up 7 Red 70K, Shogun-X 15000mg, and Krazy Night 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 31, 2021 - 16:48 GMT

Nuri Trading LLC Issues Voluntary Nationwide Recall of Shogun-X 7000, Thumbs Up 7 (Black) 25K, Thumbs Up 7 (White) 11K, 69MODE ...

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 31, 2021 - 04:00 GMT

Apotex Corp. Issues Voluntary Nationwide Recall of Guanfacine Extended-Release Tablets 2mg Due to Trace Amounts of Quetiapine ...

Summary Company Announcement Date: March 31, 2021 FDA Publish Date: March 31, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Trace amounts of Quetiapine Fumarate Company Name: Apotex Corp. Brand Name: Brand Name(s) Product …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on March 30, 2021 - 17:44 GMT

Mammography Problems at Tennessee Women’s Care P.C. in Nashville, TN: FDA Safety Communication

Date Issued: March 30, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients who had mammograms at Tennessee Women’s Care P.C., located in Nashville, Tennessee, on or after November 1, 2019, about possible problems with the quality of their …

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Published on March 30, 2021 - 17:44 GMT

Bit & Bet LLC Issues Voluntary Nationwide Recall of Thumbs Up 7 Blue 69K Due to Presence of Undeclared Sildenafil and Tadalafil

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 30, 2021 - 01:14 GMT

Antoto-K Issues Voluntary Nationwide Recall of Thumbs Up 7 Red 70K Due to the Presence of Undeclared Sildenafil and Tadalafil

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