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URGENT FIELD SAFETY NOTICE PhysioControl QUIKCOMBO pacing/defibrillation/ECG electrodes with EDGE System technology and OEDIPAL reconnect system February XX, 2016 Attention: Risk Management Director
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Urgent field safety notice is a notification sent out to inform relevant parties about a safety concern or issue with a product that requires immediate attention.
Manufacturers, distributors, importers, and authorized representatives are required to file urgent field safety notices.
Urgent field safety notices are typically filled out with details about the safety concern, affected product, actions to be taken, and contact information for further inquiries.
The purpose of urgent field safety notice is to protect consumers from potential harm or hazards associated with a product and to ensure prompt action is taken to address the safety issue.
Information that must be reported on urgent field safety notice includes details about the safety concern, affected product(s), proposed corrective actions, and contact information for reporting issues.
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