ROi CPS LLC: Medical Device Recall in 2021 - (Recall #: Z-2168-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.

Product Classification:

Class II

Date Initiated: June 14, 2021

Date Posted: August 11, 2021

Recall Number: Z-2168-2021

Event ID: 88210

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."

Status: Terminated

Product Quantity: 688 units

Code Information:

Lot Numbers: 77906K, 78673K, 79327K, 80825K

Distribution Pattern:

Missouri

Voluntary or Mandated:

Voluntary: Firm initiated