FDA recall Z-2168-2021

Product

Regard NEWBORN KIT, LD00201K, Item Number: 830016011. 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."

Distribution

Missouri

Key facts

Status

Terminated

Initiation date

2021-06-14

Report date

2021-08-11

Termination date

2023-03-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Republic, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2168-2021