FDA Device recall Z-0286-2024
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
- FDA Device
- Class I
- ongoing
- Published 2023-11-15
On 2023-11-15 the FDA classified a Class I recall of Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter by Cordis Us, citing non-sterile product labeled as sterile was distributed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0286-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-09-26 |
| Published | 2023-11-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cordis Us |
| Distribution | OK |
Product
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Reason
Non-sterile product labeled as sterile was distributed.
Identifiers
| code_info | UDI/DI 10705032025935, Lot Number 18223410 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0286-2024%22
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