ROi CPS LLC Recall 88210
Description: Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
ROi CPS LLC Recall 88210 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2168-2021 |
| Event ID | 88210 |
| Event Description | Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer. |
| Product Type | Devices |
| Distribution | Missouri |
| Quantity | 688 units |
| Recall 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." |
| Device Classification | 20210811 |
| Device Code Info | Lot Numbers: 77906K, 78673K, 79327K, 80825K |
| Center Classification Date | 20210730 |
| Recall Initiation Date | 20210614 |
| Recalling Firm | ROi CPS LLC |
| Initial Notification | |
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