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URGENT FIELD SAFETY NOTICE FCA #131 Miller Balloon (model 830515F) and Fog arty Dilation (model 830705F) Atrioseptostomy Catheters Lot Numbers: All lots within 15 months expiryMEDICAL DEVICE RECALL
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How to fill out field safety notice for
How to fill out field safety notice for
01
Gather all necessary information about the incident or safety concern.
02
Complete the required fields on the field safety notice form, including details about the product, the issue, and any corrective actions taken.
03
Provide any supporting documentation, such as photos or test results, if applicable.
04
Submit the completed field safety notice to the appropriate regulatory agency or governing body.
05
Follow up as needed to ensure that the issue is addressed and resolved.
Who needs field safety notice for?
01
Manufacturers
02
Distributors
03
Healthcare facilities
04
Medical device users
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What is field safety notice for?
Field safety notice is used to inform authorities about a safety issue with a product and to initiate a recall if necessary.
Who is required to file field safety notice for?
Manufacturers, distributors, and importers of medical devices are required to file a field safety notice when a safety issue is identified.
How to fill out field safety notice for?
Field safety notices are typically filled out online through the appropriate regulatory authority's portal, providing details about the safety issue and proposed actions.
What is the purpose of field safety notice for?
The purpose of a field safety notice is to protect public health by promptly addressing safety issues with medical devices.
What information must be reported on field safety notice for?
Information such as the product name, description of the safety issue, affected lot numbers, and proposed actions must be reported on a field safety notice.
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