FDA-Device2013-12-18Class II
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
Arrow International Inc
Hazard
There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.
Sold states
Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Brazil, Canada, China, Ireland, New Zealand, Singapore, and Thailand.
Affected count
294430
Manufactured in
2400 Bernville Road, Reading, PA, United States
Products
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0468-2014Don't want to check this manually?
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