FDAFDA · Food and drugs·Recall number Z-0024-2025
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Published October 16, 2024 · Recall initiated: September 9, 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
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Atrium Medical Corporation
- Distributor
- US Nationwide distribution in the states of FL, MA, MI, OH, WA.
- Lot
- UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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