FDA Device recall Z-0596-2024
Regard Dressing change kit, Item Number 800026006
- FDA Device
- Class I
- terminated
- Published 2024-01-10
On 2024-01-10 the FDA classified a Class I recall of Regard Dressing change kit, Item Number 800026006 by Roi Cps, citing ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0596-2024 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2023-11-20 |
| Published | 2024-01-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Roi Cps |
| Distribution | US |
Product
Regard Dressing change kit, Item Number 800026006
Reason
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Identifiers
| code_info | UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 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 CV PK, Item Numbers a) 880289014, b) 880289015
FDA Device · Class II · 2023-11-22 · Roi Cps
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0596-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.