FDA Device recall Z-1436-2023
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack
- 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 800706005, LD0091E - OH C-Section Pack 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-1436-2023 |
| 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 800706005, LD0091E - OH C-Section Pack.
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 #95165, exp. 10/27/2024, UDI (01)10194717116387(17)241027(10)95165; lot #95374, exp. 10/17/2024, UDI (01)1019471711…Lot #95165, exp. 10/27/2024, UDI (01)10194717116387(17)241027(10)95165; lot #95374, exp. 10/17/2024, UDI (01)10194717116387(17)241017(10)95374; and lot #95615, exp. 11/15/2024, UDI (01)10194717116387(17)241115(10)95615. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1436-2023%22
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