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On June 13, 2016, Health Canada issued a recall of Ethicon's Physiomesh Flexible Composite Mesh Product used for ventral hernia repair. [13] The product had been on the Canadian market since September 2010 and patients claimed a range of complications following surgery. [14]
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(Reuters) - The U.S. Food and Drug Administration on Wednesday classified a recall of Boston Scientific's catheters used in a type of minimally invasive surgery as "most serious".
As a drug delivery system, a hernia mesh can be used to deliver antibiotics, [23] antiseptics, [24] antimicrobials, [21] antimicrobial peptides [25] or nanoparticles. [26] Different techniques can be used to implement the integration of such substances, including dipping/soaking, physical coating, chemical surface functionalization and ...
The U.S. Food and Drug Administration has issued a Class I recall, the agency's most serious, for a Medtronic device used to temporarily drain spinal fluid from patients after surgery for a ...
The recall is a correction, not a product removal, the FDA said. "This notification is not a device removal and Impella heart pumps remain on the market and available for patients," a J&J ...
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
The U.S. health regulator said it had received reports of pediatric and adult patients suffering burn injuries when the tools, sold under the brand names MEGA 2000 and MEGA SOFT Reusable Patient ...
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