EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
Recall
- Recall Number
- Z-1833-2024
- Event Number
- 94395
- Firm
- Cook Medical Incorporated
- FEI Number
- 3005580113
- Product Code
- FCG
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- April 1, 2024
- Posted
- May 16, 2024
- Address
- 400 N Daniels Way, Bloomington, IN, 47404-9155
Description
EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
Devices may contain elevated levels of bacterial endotoxin.
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.
International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
8 units OUS