EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
This recall is currently active, issued May 16, 2024. It was issued by Cook Medical Incorporated.
- Company
- Cook Medical Incorporated
- Recall Initiated
- April 1, 2024
- Posted
- May 16, 2024
- Recall Number
- Z-1833-2024
- Quantity
- 8 units OUS
- Firm Location
- Bloomington, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Devices may contain elevated levels of bacterial endotoxin.
Distribution
International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
Lot / Code Info
Catalogue Number: ECHO-19; GPN: G31520; UDI/DI: 00827002315204; Lot Numbers: C2145003 and C2144407.
Root Cause
Nonconforming Material/Component
Action Taken
On April 01, 2024, Cook Ireland Ltd.(CIRL) initiated a field action for the EchoTip Ultra High Definition Ultrasound Access Needle (ECHO-HD-19-A) and EchoTip Ultra Endoscopic Ultrasound Needle (ECHO-19). Cook Ireland Ltd has identified 9 devices located outside of the United States (US) that are associated with the issue and has initiated a voluntary recall due to the potential of elevated levels of bacterial endotoxins on the devices. No US customers were impacted by this Field Safety Corrective Action (FSCA). No monitoring will be required as US consignees are not impacted by this recall. Effectiveness checks for this recall will not be necessary as US Consignees were not impacted by the distribution.