EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
FDA Recall #Z-1832-2024 — Class II — April 1, 2024
Product Description
EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Reason for Recall
Devices may contain elevated levels of bacterial endotoxin.
Recalling Firm
Cook Medical Incorporated — Bloomington, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1 Unit OUS
Distribution
International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
Code Information
Catalogue Number: ECHO-HD-19-A; GPN: G52012; UDI/DI: 00827002520127; Lot Numbers: C2145003 and C2144407.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated