Z-1833-2024 Class II Ongoing
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
- 8 units OUS
Product Description
EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
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-19; GPN: G31520; UDI/DI: 00827002315204; Lot Numbers: C2145003 and C2144407.