FDA recall Z-1832-2024

Cook Medical Incorporated · Class II · device

Product

EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

Reason for recall

Devices may contain elevated levels of bacterial endotoxin.

Distribution

International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.

Key facts

Status
Ongoing
Initiation date
2024-04-01
Report date
2024-05-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1832-2024