EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle recall: Endotoxin
EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Why was EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle recalled?
Devices may contain elevated levels of bacterial endotoxin.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalogue Number: ECHO-HD-19-A; GPN: G52012; UDI/DI: 00827002520127; Lot Numbers: C2145003 and C2144407.
- Product
- EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
- Recalling firm
- Cook Medical Incorporated
- Quantity
- 1 Unit OUS
- Distribution
- International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
- Recall date
- May 22, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)