iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Reported: October 16, 2024 Initiated: September 9, 2024 #Z-0024-2025
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.
Details
- Recalling Firm
- Atrium Medical Corporation
- Units Affected
- 11 devices
- Distribution
- US Nationwide distribution in the states of FL, MA, MI, OH, WA.
- Location
- Merrimack, NH
Frequently Asked Questions
What product was recalled? ▼
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616. Recalled by Atrium Medical Corporation. Units affected: 11 devices.
Why was this product recalled? ▼
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 16, 2024. Severity: Moderate. Recall number: Z-0024-2025.
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