FDA Device recall Z-2168-2021
Regard NEWBORN KIT, LD00201K, Item Number: 830016011
- FDA Device
- Class II
- terminated
- Published 2021-08-11
On 2021-08-11 the FDA classified a Class II recall of Regard NEWBORN KIT, LD00201K, Item Number: 830016011 by Roi Cps, citing 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.".
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2168-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-14 |
| Published | 2021-08-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roi Cps |
| Distribution | MO |
Product
Regard NEWBORN KIT, LD00201K, Item Number: 830016011. 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."
Identifiers
| code_info | Lot Numbers: 77906K, 78673K, 79327K, 80825K |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2168-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.