Recall Z-0411-2022 ยท MLS Labor And Delivery Kit
ROi CPS LLC
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
| Date | Dec 22, 2021 (initiated Nov 4, 2021) |
| Status | Terminated |
| Reason | The kit contains a non-sterile needle. |
| Root cause | Process control |
| Action | The firm issued a letter dated 11/4/2021 via email on 11/4/2021 explaining the reason for recall, the health risk involved, and the actions to be taken by the customer. The customer was requested to check their inventory for the affected kits and immediately quarantine them without further distribution. The attached reply form was to be completed so that return of the affected kits could be arranged. If the kits were further distributed, the customer was requested to notify their customers. |
| Quantity | 40 kits |
| Distribution | Distribution was made to Missouri. There was no foreign/military/government distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.