Summary Company Announcement Date: January 05, 2024 FDA Publish Date: January 08, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential for superpotent drug Company Name: Leiters Health Brand Name: Brand Name(s) Leiters, Compounding Health Product Description: Product Description Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags Company Announcement FOR IMMEDIATE…
Getinge / Atrium Medical Corporation Issues Medical Device Correction for Nurse Assist Syringes Provided with Express Drains
Summary Company Announcement Date: January 03, 2024 FDA Publish Date: January 04, 2024 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Syringes provided with Express Drains could not be verified to be sterile. Company Name: Getinge/Atrium Medical Corporation Brand Name: Brand Name(s) Product Description: Product Description Express Drains Company Announcement On December 13,…
Do Not Use Synovo Total Hip Resurfacing System: FDA Safety Communication
Date Issued: January 3, 2024 The U.S. Food and Drug Administration (FDA) is providing recommendations for health care providers considering using the Total Hip System, including resurfacing implants, manufactured by Synovo Production, Inc. (Synovo) and for patients who may have received certain implants used in the Synovo Total Hip System after 2019. Three components of…
2024 Safety Communications
The FDA posts Medical Device Safety Communications to describe the FDA’s current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. 2024 Safety Communications Content current as of: 01/03/2024 Article source: http://www.fda.gov/medical-devices/safety-communications/2024-safety-communications
HSV-2 Tests for Genital Herpes Can Produce False Reactive Results – Letter to Clinical Laboratory Staff and Health Care Providers
December 27, 2023 The U.S. Food and Drug Administration (FDA) is reminding health care providers and clinical laboratory staff about the potential for false reactive (false positive) results in herpes simplex virus type 2 (HSV-2) serological tests for genital herpes. Recommendations The FDA recommends that health care providers and clinical laboratory staff do the following:…
Olympus Corporation of the Americas Recalls Bronchofiberscopes and Bronchovideoscopes Because They Can Lead to Burns and Fire
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 correction, not a product removal. Recalled Product Product Names: Olympus bronchofiberscopes and bronchovideoscopes Product Codes: See Recall Database Entry Model Numbers: See full…
Hospira, Inc. Issues A Voluntary Nationwide Recall For 4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection, and Atropine Sulfate Injection Due to the Potential Presence of Glass Particulate Matter
Summary Company Announcement Date: December 21, 2023 FDA Publish Date: December 26, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of Glass Particulate Matter Company Name: Hospira, Inc. Brand Name: Brand Name(s) Product Description: Product Description 4.2% Sodium bicarbonate injection, 8.4% Sodium bicarbonate injection, Atropine sulfate injection Company Announcement FOR IMMEDIATE RELEASE…
Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety Communication
Español Update: December 19, 2023 Additional Related Recalls of Saline and Sterile Water Medical Products Associated with Nurse Assist In direct response to the Nurse Assist, LLC recall on November 6, 2023, distributors of Nurse Assist water-based medical products and manufacturers of kits and trays that contain Nurse Assist recalled products are initiating voluntary recalls. …
Philips North America LLC Recalls Panorama 1.0T HFO due to a Risk of Explosion During a Quench Procedure Caused by Excessive Pressure Buildup of Helium Gas
Please be aware, this recall is a correction, not a product removal. 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: Panorama 1.0T HFO Product Codes: LNH Model Numbers: 781250 and 781350 Distribution Dates:…
Insight Pharmaceuticals Issues Voluntary Nationwide Recall of Americaine® 20% Benzocaine Topical Anesthetic Spray Due to the Presence of Benzene
Summary Company Announcement Date: December 22, 2023 FDA Publish Date: December 22, 2023 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of benzene Company Name: Insight Pharmaceuticals Brand Name: Brand Name(s) Americaine Product Description: Product Description Benzocaine Topical Anesthetic Spray Company Announcement TARRYTOWN, N.Y., Dec. 22, 2023 (GLOBE NEWSWIRE) — Insight Pharmaceuticals, a…