Z-1832-2024 Class II Ongoing

Recalled by Cook Medical Incorporated — Bloomington, IN

Recall Details

Product Type
Devices
Report Date
May 22, 2024
Initiation Date
April 1, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 Unit OUS

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.

Distribution Pattern

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.