Recall Z-2169-2021 ยท MLS Labor And Delivery Kit
ROi CPS LLC
Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
| Date | Jun 14, 2021 |
| Status | Terminated |
| Reason | Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others." |
| Root cause | Process design |
| Action | The firm notified their consignee on 06/24/2021 by email. The notice provided updated product labeling with a cautionary statement to remind the user to "activate away from the user's face and away from the infant and others." The distributor was directed to notify their customer. |
| Quantity | 976 units |
| Distribution | Missouri |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.