Infant Heel Warmer Instructions Updated for Activation Safety Warning
ROi CPS LLC is updating instructions for the Regard NEWBORN KIT infant heel warmer (688 units in Missouri) to include a warning: activate away from the face, infant, and others.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving updated safety instructions with no reported injuries or illnesses. The precautionary instruction update falls under the Moderate category per the rubric.
Plain-English summary
The Regard NEWBORN KIT (Model LD00201K, Item Number 830016011), manufactured by ROi CPS LLC, is a medical convenience device that includes an infant heel warmer. The manufacturer has updated the instructions for use to include a cautionary statement: 'Activate away from the user's face and away from the infant and others.'
Approximately 688 units have been distributed in Missouri. The affected lot numbers are 77906K, 78673K, 79327K, and 80825K.
Consumers who have this product should review the updated instructions and follow the safety guidance when using the heel warmer.
The recalled product
- Product
- Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
- Manufacturer
- ROi CPS LLC
- Hazard
- Affected units
- 688
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: 77906K
- 78673K
- 79327K
- 80825K
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by ROi CPS LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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