ROi CPS LLC Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Brand
ROi CPS LLC
Lot Codes / Batch Numbers
Lot Numbers: 71562J, 73679J, 74808J, 75222J
Products Sold
Lot Numbers: 71562J, 73679J, 74808J, 75222J
ROi CPS LLC is recalling Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an in due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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."
Recommended Action
Per FDA guidance
The firm notified their consignee on 06/24/2021 by email. The notice provided updated product labeling with a cautionary statement to remind the user to "activate away from the user's face and away from the infant and others." The distributor was directed to notify their customer.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MO
Page updated: Jan 10, 2026