FDA Device recall Z-0315-2023
regard CATARACT, EY00450K, Item Number 880295011
- FDA Device
- Class II
- terminated
- Published 2022-11-30
On 2022-11-30 the FDA classified a Class II recall of regard CATARACT, EY00450K, Item Number 880295011 by Roi Cps, citing surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0315-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-10-20 |
| Published | 2022-11-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roi Cps |
| Distribution | FL, LA, MO, NC |
Product
regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit
Reason
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Identifiers
| code_info | UDI/DI 10194717104643, Lot Numbers: 91479, exp 2/10/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0315-2023%22
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