Device product
EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
Z-1833-2024
Product summary
- Event
- Event 94395
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8 units OUS
- Official record key
device-enforcement:Z-1833-2024
Official wording
Reason: Devices may contain elevated levels of bacterial endotoxin.
Code information: Catalogue Number: ECHO-19; GPN: G31520; UDI/DI: 00827002315204; Lot Numbers: C2145003 and C2144407.
Distribution pattern: International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
Derived failure modes
-
Unknown
Devices may contain elevated levels of bacterial endotoxin.