FDA-Device2021-08-11Class II
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
ROi CPS LLC
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."
Sold states
Missouri
Affected count
608 units
Manufactured in
3000 E Sawyer Rd, Republic, MO, United States
Products
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2167-2021Don't want to check this manually?
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