FDA-Device2017-05-10Class II
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Terumo Medical Corporation
Hazard
Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.
Sold states
Nationwide Distribution.
Affected count
5,252 eaches
Manufactured in
950 Elkton Blvd, Elkton, MD, United States
Products
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2033-2017Don't want to check this manually?
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