FDA Device recall Z-1434-2023
Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath
- FDA Device
- Class II
- ongoing
- Published 2023-05-03
On 2023-05-03 the FDA classified a Class II recall of Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath by Roi Cps, citing the recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit compon….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1434-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-22 |
| Published | 2023-05-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roi Cps |
| Distribution | US |
Product
Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
Reason
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Identifiers
| code_info | Lot #95383, exp. 10/29/2024, UDI (01)10194717105374(17)241029(10)95383. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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-1434-2023%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.