FDA-Device2024-05-22Class II

EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520

Cook Medical Incorporated
Hazard

Devices may contain elevated levels of bacterial endotoxin.

Sold states
International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
Affected count
8 units OUS
Manufactured in
400 N Daniels Way, N/A, Bloomington, IN, United States
Products
EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1833-2024

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