Author: Asebey Law

17 January

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Wismettac Asian Foods Issues Allergy Alert on Undeclared Milk in Curvee Puffs Corn Puff Snack Curry Flavor

Posted by Asebey Law

Wismettac Asian Foods, Inc., Santa Fe Springs, CA is recalling 2.46 oz packages of Shirakiku brand Curvee Puffs Corn Puff Snack Curry Flavor. The product contains the undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reacti Read More (external link)...

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16 January

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Update: Evaluation of Airborne Chemicals from Neonatal Incubators – Letter to Health Care Providers

Posted by Asebey Law

The FDA issued an update on the recommendations about the potential for exposure to airborne chemicals from neonatal incubators. Read More (external link)...

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16 January

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Early Alert: Infusion Pump Software Issue from Fresenius Kabi USA

Posted by Asebey Law

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program Read More (external link)...

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15 January

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Mutual Trading Co., Issues Allergy Alert Undeclared Milk in Prepared Monkfish Liver

Posted by Asebey Law

New York Mutual Trading Co., Inc of Secaucus, NJ is recalling 7.05 oz of Prepared Monkfish Liver (Ankimobo) because the package label contains undeclared milk allergen. People who have an allergy or severe sensitivity to milk allergen run the risk of serious or life-threatening allergic reaction if Read More (external link)...

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15 January

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Endoscopic Vessel Harvesting (EVH) System Correction: Getinge and Maquet Cardiovascular Update Use Instructions for VasoView HemoPro 2 (VH-4000 and VH-4001) EVH Systems due to Risk for Bent or Detached Heater Wires and Silicone Peeling or Detaching During Use

Posted by Asebey Law

HemoPro EVH Systems have updated instructions related to bent/detached heater wires and peeling/detaching silicone during minimally invasive surgery. Read More (external link)...

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14 January

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Quaker Issues Limited Recall on Undeclared Milk in Pearl Milling Company Original Pancake & Waffle Mix Distributed in 11 States

Posted by Asebey Law

January 14, 2025 – The Quaker Oats Company today issued a recall of a limited number of two pound boxes of Pearl Milling Company Original Pancake & Waffle Mix that may contain undeclared milk, after being alerted by a retail partner. Those with an allergy or severe sensitivity to milk run the risk o Read More (external link)...

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14 January

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Max Mobility / Permobil Issues Nationwide Recall of SmartDrive Speed Control Dial Due to the Motor Being Unresponsive to the User

Posted by Asebey Law

Max Mobility/Permobil has initiated a nationwide recall of the Speed Control Dial component used with the SmartDrive MX2+ Power Assist Device due to potential safety and performance concerns. Read More (external link)...

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13 January

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Former Senior Partner at McKinsey & Company Pleads Guilty

Posted by Asebey Law

FDA-OCI, McKinsey & Company, McKinsey, McKinsey & Co., Martin Elling, Abingdon, Virginia, Bangkok, Thailand Read More (external link)...

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13 January

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Outpatient Telemetry Correction: Philips Issues Correction for Monitoring Service Application used with Mobile Cardiac Outpatient Telemetry Due to Potential for Missed Information or Notifications That May Impact Patient Care Impact

Posted by Asebey Law

Philips Monitoring Service Application processes mobile cardiac telemetry data but failed to send critical data for review by healthcare professionals. Read More (external link)...

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10 January

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Lifestyle Evolution Voluntarily Recalls NuGo Dark Chocolate Chip and NuGo Dark Pretzel Due to Undeclared Milk

Posted by Asebey Law

Lifestyle Evolution Inc., is recalling select lots of NuGo Dark Chocolate Chip and Dark Chocolate Pretzel nutrition bars because they may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume Read More (external link)...

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09 January

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The Mochi Ice Cream Company LLC Issues Allergy Alert on Undeclared Egg in Peach Mango Sorbet

Posted by Asebey Law

The Mochi Ice Cream Company LLC, Vernon, California is recalling 1350 cases of Peach Mango Sorbet, because it may contain undeclared pasteurized cooked egg white. People who have an allergy or severe sensitivity to eggs, run the risk of serious or life-threatening allergic reaction if they consume t Read More (external link)...

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07 January

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FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication

Posted by Asebey Law

FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy: FDA Safety Communication Read More (external link)...

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03 January

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Dierbregs Markets Issues Allergy Alert on Undeclared Wheat in Product

Posted by Asebey Law

Dierbergs is recalling all 16oz Premium Home-Style Mashed Potatoes with a Sell By Date of January 09, 2025. The product carries an undeclared allergen of Wheat. The affected product is identifiable by a label ID number of 92 in the lower left-hand corner above the UPC code. Read More (external link)...

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29 October

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2024 Letters to Health Care Providers

Posted by Asebey Law

The FDA posts letters to health care providers about the safe use of medical devices. Read More (external link)...

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23 October

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Veteran FDA Attorney Launches Boutique Life Sciences Law Firm, Asebey Life Science Law

Posted by Asebey Law

in Life Science Law Blog

Firm integrates scientific knowledge and regulatory expertise to offer comprehensive legal solutions and scientific guidance to life science companies. FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Edgar J. Asebey, a seasoned attorney with over 20 years of FDA regulatory law experience, has launched Asebey Life Science Law, a boutique law firm specializing in FDA regulatory law, transactional law, and strategic advisory services for the life sciences industry. As a former scientist, biotech founder, venture capital fund advisor, and equity partner at an AM 100 law firm, Edgar is uniquely qualified to lead a firm that provides much needed regulatory guidance, enforcement defense and industry expertise to FDA-regulated...

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05 September

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Ventilator Correction: Breas Medical Updates Use Instructions for Vivo 45 LS due to Potential Elevated Formaldehyde Levels in Newly Manufactured Ventilators

Posted by Asebey Law

Vivo 45 LS ventilators support breathing in homes and health settings. New devices may expose users to elevated formaldehyde levels for a short time. Read More (external link)...

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19 August

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Gutierrez Distributor Recalls El Servidor Corp Ground Cinnamon Because of Possible Health Risk

Posted by Asebey Law

Gutierrez Distributor of Passaic, NJ is recalling El Servidor Corp brand ground cinnamon because it has the potential to be contaminated with elevated levels of lead. Short term exposures to very low levels of lead may not elicit any symptoms. It is possible that increased blood lead levels may be t Read More (external link)...

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16 August

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UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

Posted by Asebey Law

UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication Read More (external link)...

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16 August

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2024 Safety Communications

Posted by Asebey Law

Listing of Medical Device 2024 Safety Communications Read More (external link)...

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15 August

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Two Plead Guilty to Bank Fraud Conspiracy Targeting Payment Card Industry

Posted by Asebey Law

FDA-OCI, Boston, Massachusetts, Mohammad Diab, Moe Diab, Glendale, California, Amy Rountree, Logan, Utah, Allied Wallet, Inc. Read More (external link)...

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