Z-0024-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2024
- Initiation Date
- September 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11 devices
Product Description
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Reason for Recall
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
Distribution Pattern
US Nationwide distribution in the states of FL, MA, MI, OH, WA.
Code Information
UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042