ROi CPS LLC Recall 89078
Description: regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit - Mercy ADA, containing 2 25GA x .625IN needles.
ROi CPS LLC Recall 89078 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0411-2022 |
| Event ID | 89078 |
| Event Description | regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit - Mercy ADA, containing 2 25GA x .625IN needles. |
| Product Type | Devices |
| Distribution | Distribution was made to Missouri. There was no foreign/military/government distribution. |
| Quantity | 40 kits |
| Recall Reason | The kit contains a non-sterile needle. |
| Device Classification | 20211229 |
| Device Code Info | Lot #90074, Exp. 04/17/2023. UDI (01)10194717112938(17)230417(10)90074. |
| Center Classification Date | 20211222 |
| Recall Initiation Date | 20211104 |
| Recalling Firm | ROi CPS LLC |
| Initial Notification | Letter |
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