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URGENT MEDICAL DEVICE RECALL NOTIFICATION PRODUCT: STRYKER CORE FORTHWITH ATTENTION: OR DIRECTOR, RISK MANAGER, MATERIALS MANAGER Cc: Chairman Medical Board and relevant Head of Departments December
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Determine the product category and if it falls under the highest-risk classification by FDA.
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FDA puts highest-risk label on products that pose the highest risk to public health.
Manufacturers and distributors of products identified as highest-risk by the FDA are required to file the label.
To fill out the FDA puts highest-risk label, manufacturers and distributors must provide detailed information about the product, its ingredients, potential risks, and any necessary warnings.
The purpose of FDA puts highest-risk label is to inform consumers and healthcare professionals about products that pose significant health risks.
Information that must be reported on FDA puts highest-risk label includes product name, manufacturer information, potential risks, warnings, and instructions for use.
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