Recall Z-2169-2021— ROi CPS LLC

Name: FDA recall Z-2169-2021
Creator: U.S. Food and Drug Administration
Published: 2021-06-14

Class II · Terminated

Class II FDA medical device recall by ROi CPS LLC, initiated 2021-06-14, terminated 2023-03-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.. Reason: 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.".

Recalling firm: ROi CPS LLC
Classification: Class II
Status: Terminated
Initiated: 2021-06-14
Terminated: 2023-03-08
Firm location: Republic, MO, United States

Product description

Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.

Reason for recall

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."

Data sourced from openFDA. This site is unofficial and independent of the FDA.