EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
FDA device recall Z-1833-2024 · posted 2024-05-16 · Open, Classified
Recall details
- Recalling firm
- Cook Medical Incorporated
- Reason for recall
- Devices may contain elevated levels of bacterial endotoxin.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- FCG
- Quantity affected
- 8 units OUS
- Distribution
- International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
- Date initiated
- 2024-04-01
- Date posted
- 2024-05-16
- Location
- Bloomington, IN
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