Newborn Heel Warmer Kit Instructions Updated for Activation Safety
The Regard Newborn Kit heel warmer is being recalled. Updated instructions now require that the device be activated away from the user's face and away from the infant 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 recall where instructions have been updated to address potential thermal injury from the heel warmer. No illnesses or injuries have been reported, making this a risk-of-harm scenario where injury has not yet been reported, which corresponds to Level 3 (High) per the rubric.
Plain-English summary
ROi CPS LLC is recalling the Regard Newborn Kit (LD00201j, Item Number 830016010), a medical convenience kit that includes an infant heel warmer. Approximately 608 units were distributed in Missouri, with affected lot numbers 71562J, 73679J, 74808J, and 75222J.
The instructions for use have been updated with a cautionary statement regarding the heel warmer. The updated instructions require that the heel warmer be activated away from the user's face and away from the infant and other individuals.
Consumers who have purchased this product should review and follow the updated safety instructions to ensure the heel warmer is used correctly and safely.
The recalled product
- Product
- Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
- Manufacturer
- ROi CPS LLC
- Hazard
- burn-injury
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: 71562J
- 73679J
- 74808J
- 75222J
Distribution
Distribution scope not specified by the agency.
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