Summary Company Announcement Date: January 11, 2021 FDA Publish Date: January 11, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Delivery System Issues Potential inability to release the delivery system Company Name: …
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 …
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 …
January 8, 2021 The SARS-CoV-2 virus can mutate over time, resulting in genetic variation in the population of circulating viral strains. The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that false …
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 …
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries. Recalled Product LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Lot codes: LeadCare II: 2013M, 2014M, 2015M, …
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 …
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 …
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. 2021 Safety Communications Content current as of: 01 …
Date Issued: January 4, 2021 The U.S. Food and Drug Administration (FDA) is alerting patients and health care providers of the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test. Risks to a patient of a false …
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 …
April 1, 2021 The U.S. Food and Drug Administration (FDA) wants to raise awareness among health care providers, including those working in reprocessing units in health care facilities, about the risk of infections associated with reprocessed urological …
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 (Include the following information) HVAD Pump Implant Kits for the HeartWare HVAD System RMS ( …
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 …
Date issued: December 29, 2020 The U.S. Food and Drug Administration (FDA) is updating our February 2020 safety communication on laparoscopic power morcellators to provide new information on the safe and effective use of laparoscopic power morcellation for …
Summary Company Announcement Date: December 28, 2020 FDA Publish Date: December 28, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential contamination with Burkholderia lata Company Name: Sunstar Americas, Inc. Brand Name: …
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 …
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: …
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 …
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 …
