FDA-Device2022-12-21Class II
Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
Cordis US Corp
Hazard
There is a potential for separation at the male connector.
Sold states
Nationwide distribution to AZ, CA, DC, FL, GA, KY, LA, MD, MS, NY, OH, TX, WV, WY and PR. International distribution to Japan, Korea, Republic of, United Arab Emirates, Austria, Belgium, Czech Republic, Germany, Spain, France, United Kingdom, Iceland, Ireland, Israel, Netherlands, Portugal, Russia.
Affected count
16,950 units (2,915 US and 14,000 OUS)
Manufactured in
14201 Nw 60th Ave, N/A, Miami Lakes, FL, United States
Products
Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0720-2023Don't want to check this manually?
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