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U.S. Department of Health and Human Services

Class 2 Device Recall EchoTip Ultra HD Ultrasound Access Needle

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  Class 2 Device Recall EchoTip Ultra HD Ultrasound Access Needle see related information
Date Initiated by Firm April 01, 2024
Date Posted May 16, 2024
Recall Status1 Open3, Classified
Recall Number Z-1833-2024
Recall Event ID 94395
510(K)Number K210476  
Product Classification Biopsy needle - Product Code FCG
Product EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
Code Information Catalogue Number: ECHO-19; GPN: G31520; UDI/DI: 00827002315204; Lot Numbers: C2145003 and C2144407.
Recalling Firm/
Manufacturer		 Cook Medical Incorporated
400 N Daniels Way
Bloomington IN 47404-9155
For Additional Information Contact Cook Medical Customer Relations Department
800-457-4500
Manufacturer Reason
for Recall		 Devices may contain elevated levels of bacterial endotoxin.
FDA Determined
Cause 2		 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. Effectiveness checks for this recall will not be necessary as US Consignees were not impacted by the distribution.
Quantity in Commerce 8 units OUS
Distribution International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FCG and Original Applicant = Cook Ireland Ltd.
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