FDA Device recall Z-0293-2023
regard MAJOR EAR, ET00326J, Item Number 800070010
- FDA Device
- Class II
- terminated
- Published 2022-11-30
On 2022-11-30 the FDA classified a Class II recall of regard MAJOR EAR, ET00326J, Item Number 800070010 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-0293-2023 |
| 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 MAJOR EAR, ET00326J, Item Number 800070010; ear surgery convenience kit
Reason
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Identifiers
| code_info | UDI/DI 10194717079958, Lot Numbers: 92037, exp 1/31/2023; 91205, exp 6/30/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Other recalls by Roi Cps
- regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator
FDA Device · Class I · 2025-02-12 · Roi Cps - regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
FDA Device · Class II · 2024-09-25 · Roi Cps - Regard Kit containing the Microtek decanter
FDA Device · Class II · 2024-08-28 · Roi Cps - regard Operative LAP, Item Number 800943001
FDA Device · Class I · 2024-01-24 · Roi Cps - Regard Dressing change kit, Item Number 800026006
FDA Device · Class I · 2024-01-10 · Roi Cps
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0293-2023%22
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