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ROi CPS LLC recalls Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
Recalled August 11, 2021 · FDA recall Z-2168-2021 · ROi CPS
Hazard
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." · FDA Class II
Units
688 units
Sold at
Missouri
Description
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."
Product
Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
Manufacturer(s)
ROi CPS LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →