EchoTip Ultra HD Endoscopic Ultrasound Access Needle recalled for elevated bacterial endotoxin
Cook Medical has recalled EchoTip Ultra HD Endoscopic Ultrasound Access Needles (lots C2145003, C2144407) due to elevated levels of bacterial endotoxin. The devices were distributed internationally in Germany, Netherlands, Switzerland, and the United Kingdom.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving elevated levels of bacterial endotoxin in a medical device designed for tissue access. No illnesses, injuries, or hospitalizations have been reported. This qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity classification.
Plain-English summary
Cook Medical Incorporated has recalled the EchoTip Ultra HD Endoscopic Ultrasound Access Needle (Model ECHO-HD-19-A, GPN G52012) because the devices may contain elevated levels of bacterial endotoxin. The affected lot numbers are C2145003 and C2144407.
The recalled devices were distributed internationally to healthcare facilities in Germany, Netherlands, Switzerland, and the United Kingdom. Healthcare providers in these countries should check whether they have products from the affected lots.
Facilities with devices from the recalled lots should contact Cook Medical for guidance on appropriate next steps.
The recalled product
- Product
- EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
- Manufacturer
- Cook Medical Incorporated
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalogue Number: ECHO-HD-19-A
- GPN: G52012
- UDI/DI: 00827002520127
- Lot Numbers: C2145003 and C2144407.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Cook Medical Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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