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Open, Classified

EchoTip Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520

FDA Recall Z-1833-2024 · Posted 2024-05-16

Recalling FirmCook Medical Incorporated
Recall StatusOpen, Classified
Product CodeFCG
Date Initiated2024-04-01
Product Quantity8 units OUS

Reason for Recall

Devices may contain elevated levels of bacterial endotoxin.

Firm 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. Effectiveness checks for this recall will not be necessary as US Consignees were not impacted by the distribution.

Root Cause

Nonconforming Material/Component

Distribution Pattern

International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy NeedleCook Ireland, Ltd. · 2021-05-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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