Z-0024-2025 Class II Ongoing
FDA device recall Z-0024-2025 was initiated by Atrium Medical Corporation on September 9, 2024 and is designated Class II. Reason for recall: There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label. The recall status is ongoing. Affected quantity: 11 devices.
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