Device product
EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Z-1832-2024
Product summary
- Event
- Event 94395
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 Unit OUS
- Official record key
device-enforcement:Z-1832-2024
Official wording
Reason: Devices may contain elevated levels of bacterial endotoxin.
Code information: Catalogue Number: ECHO-HD-19-A; GPN: G52012; UDI/DI: 00827002520127; 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.