Cook Medical EchoTip Ultra needle recalled due to elevated bacterial endotoxin levels
Cook Medical is recalling EchoTip Ultra endoscopic ultrasound access needles that may contain elevated bacterial endotoxin levels. The affected units were distributed internationally.
What this means for you
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 medical device recall with potential contamination hazard (bacterial endotoxin). No reported illnesses or injuries are stated, but endotoxin is a recognized risk in medical devices that could cause significant harm during use, fitting the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cook Medical is recalling the EchoTip Ultra Endoscopic Ultrasound Access Needle (model ECHO-19, GPN G31520) following discovery that certain units may contain elevated levels of bacterial endotoxin. Eight units were affected by this recall.
The affected units were distributed internationally to Germany, Netherlands, Switzerland, and the United Kingdom. The recall involves lot numbers C2145003 and C2144407.
Users, including healthcare facilities and medical professionals, should immediately discontinue use of recalled units with matching lot numbers and catalog numbers. Contact Cook Medical directly for replacement units and additional instructions regarding the recall.
The recalled product
- Product
- EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520
- Manufacturer
- Cook Medical Incorporated
- Hazard
- bacterial-endotoxin
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-19
- GPN: G31520
- UDI/DI: 00827002315204
- Lot Numbers: C2145003 and C2144407.
Distribution
Distribution scope not specified by the agency.
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