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BD.commended URGENT MEDICAL DEVICE RECALL August 30, 2017Product Name BD Syringes with the BD Ultrafine TM needle mL 12.7 mm 30GCatalogNDC/HRI # inner/HRI # in(Ref) No. Shelf BoxPolybagLot No. 629176832846608290328466082908466016312558
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What is amended urgent medical device?
An amended urgent medical device is a revised version of a medical device that is required to be reported to regulatory authorities.
Who is required to file amended urgent medical device?
The manufacturer or distributor of the medical device is required to file the amended urgent medical device.
How to fill out amended urgent medical device?
The amended urgent medical device form must be filled out with all relevant information regarding the changes made to the device.
What is the purpose of amended urgent medical device?
The purpose of the amended urgent medical device report is to inform regulatory authorities of any changes that may impact the safety or effectiveness of the device.
What information must be reported on amended urgent medical device?
The amended urgent medical device report must include details of the changes made to the device, any new risks identified, and any actions taken to address these risks.
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