FDAFDA · Food and drugs·Recall number Z-1832-2024
EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Published May 22, 2024 · Recall initiated: April 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Devices may contain elevated levels of bacterial endotoxin.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Medical Incorporated
- Distributor
- International distribution in the countries of Germany, Netherlands, Switzerland, United Kingdom.
- Lot
- Catalogue Number: ECHO-HD-19-A; GPN: G52012; UDI/DI: 00827002520127; Lot Numbers: C2145003 and C2144407.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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