ROi CPS LLC Recall 91984
Description: Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
ROi CPS LLC Recall 91984 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1436-2023 |
| Event ID | 91984 |
| Event Description | Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of FL and MO. There was no foreign/military/government distribution. |
| Quantity | 1,312 kits |
| Recall 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. |
| Device Classification | 20230503 |
| Device Code Info | 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. |
| Center Classification Date | 20230425 |
| Recall Initiation Date | 20230322 |
| Recalling Firm | ROi CPS LLC |
| Initial Notification | Letter |
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