Recall Z-0024-2025 ยท PRL Iliac Covered Stent, Arterial
Atrium Medical Corporation
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
| Date | Oct 7, 2024 (initiated Sep 9, 2024) |
| Status | Open, Classified |
| Reason | There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label. |
| Root cause | Under Investigation by firm |
| Action | An Urgent Medical Device Removal notification letter dated 9/9/24 was sent to customers. Actions to be taken by the Customer: Our records indicate that you have received one or more of the iCast Covered Stents from the affected Product REF and Serial Numbers. Please examine your inventory immediately to determine if you have any of the iCast Covered Stents with the Product REF and Serial Numbers listed in this notice, which can be found on the product label. " Should you have any affected product, do not use the product and remove it from areas of use. " Please forward this information to al |
| Quantity | 11 devices |
| Distribution | US Nationwide distribution in the states of FL, MA, MI, OH, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.