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URGENT FIELD SAFETY NOTICE FCA # 132 Product: Retroflex Introducers Model Number: I355BF9 Lot Numbers: 61409005, 61409006, 61417169, 61446317, 61446318, 61446332, 61446333, 61468596, 61481228, 61481229,
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Companies or organizations that have identified a safety issue with their product and need to inform customers or authorities quickly.
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Urgent field safety notice is a communication issued by manufacturers or distributors to inform about a serious safety issue with a product.
Manufacturers or distributors of a product are required to file urgent field safety notice.
Urgent field safety notice should be filled out with detailed information about the safety issue, affected product, and recommended actions.
The purpose of urgent field safety notice is to protect consumers from potential harm caused by a defective product.
The information that must be reported on urgent field safety notice includes product details, safety issue description, risk assessment, and corrective actions.
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