Regard Newborn Heel Warmer Kit Recalled for Inadequate Safety Instructions
ROi CPS LLC is recalling the Regard NEWBORN KIT heel warmer (976 units in Missouri) due to incomplete safety instructions. Updated instructions now warn users to activate the device away from the infant's face and others.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recalled due to inadequate safety instructions. Although no injuries have been reported, a heat source designed for use near infants poses a potential burn or injury risk if activated near the face without proper warnings, meeting the rubric criterion of a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ROi CPS LLC is recalling the Regard NEWBORN KIT, Model LD00201M (Item Number 830016013), a medical convenience kit that includes an infant heel warmer. The recall affects approximately 976 units distributed in Missouri. The affected lot numbers are 82510M, 83949M, 86858M, 87282M, 87624M, 88030M, and 88687M.
The heel warmer's original instructions for use did not adequately address safe activation of the device. The company has updated the instructions for use to include a cautionary statement instructing users to activate the warmer away from the user's face and away from the infant and others.
If you have received a unit from one of the affected lot numbers, please review the updated instructions before using the device. The updated cautionary statement reads: "Activate away from the user's face and away from the infant and others."
The recalled product
- Product
- Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
- Manufacturer
- ROi CPS LLC
- Hazard
- burn-injury
- mis-labeling
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 (7)
- Lot Numbers: 82510M
- 83949M
- 86858M
- 87282M
- 87624M
- 88030M
- 88687M
Distribution
Distribution scope not specified by the agency.
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