FDA Device recall Z-0313-2023
regard SPINE PACK , NU00193N, Item Number 880179014
- FDA Device
- Class II
- terminated
- Published 2022-11-30
On 2022-11-30 the FDA classified a Class II recall of regard SPINE PACK , NU00193N, Item Number 880179014 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-0313-2023 |
| 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 SPINE PACK , NU00193N, Item Number 880179014; neuro surgery convenience kit
Reason
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Identifiers
| code_info | UDI/DI 10194717109457, Lot Numbers: 92239, exp 11/27/2023; 91440, exp 12/7/2023 |
|---|
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-0313-2023%22
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