FDA Enforcement
Class II
Ongoing
EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
Recall: Z-1833-2024
·
Reported May 22, 2024
Enforcement
- Recall Number
- Z-1833-2024
- Event ID
- 94395
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Cook Medical Incorporated
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 22, 2024
- Initiation Date
- April 1, 2024
- Classification Date
- May 16, 2024
- Address
- 400 N Daniels Way, N/A, Bloomington, IN, 47404-9155, United States
Description
EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
Reason
Devices may contain elevated levels of bacterial endotoxin.
Code Info
Catalogue Number: ECHO-19; GPN: G31520; UDI/DI: 00827002315204; Lot Numbers: C2145003 and C2144407.
Distribution
International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
Quantity
8 units OUS