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1030 Elmdale Road Winners Triangle Rockingham RG41 5TS www.BD.com29th July 2021URGENT: FIELD SAFETY NOTICE MDS214144 BD Smart Site Needle Free Valve REF & Lot Numbers: See Appendix 1 Type of Action:
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Read the urgent field safety notice carefully to understand the purpose and instructions.
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Fill out all the required fields accurately, including contact information and product details.
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Who needs urgent field safety notice?
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Companies or individuals who have products that pose a safety risk and need to notify customers or stakeholders immediately.
02
Government agencies who need to inform the public about a safety concern related to a product or equipment.
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Emergency response teams who need to communicate urgent safety information to the relevant parties.
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What is urgent field safety notice?
An urgent field safety notice is a communication issued by a manufacturer or supplier to inform users and healthcare professionals about a potential risk associated with a medical device or product that requires immediate attention and action.
Who is required to file urgent field safety notice?
Manufacturers, distributors, and authorized representatives of medical devices or products are required to file an urgent field safety notice when they identify a potential safety issue.
How to fill out urgent field safety notice?
To fill out an urgent field safety notice, one must include details such as the product identification, description of the safety issue, instructions for users, and actions required to mitigate the risk.
What is the purpose of urgent field safety notice?
The purpose of an urgent field safety notice is to promptly inform stakeholders about imminent risks to health or safety associated with a product and to provide guidance on necessary actions to protect users.
What information must be reported on urgent field safety notice?
The information that must be reported includes the product name, serial or batch numbers, nature of the issue, risk assessment, corrective actions to be taken, and contact information for the manufacturer.
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