Recall Z-1833-2024 ยท FCG Biopsy Needle
Cook Medical Incorporated
EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
| Date | May 16, 2024 (initiated Apr 1, 2024) |
| Status | Open, Classified |
| Reason | Devices may contain elevated levels of bacterial endotoxin. |
| Root cause | Nonconforming Material/Component |
| Action | 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. Ef |
| Quantity | 8 units OUS |
| Distribution | International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial Hig Cook Ireland, Ltd., May 20, 2021 |