Drug recall
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel…
FDA recall event 88210 · Class II · ROi CPS LLC
Key facts
| Event ID | 88210 |
|---|---|
| Recall numbers | Z-2167-2021, Z-2168-2021, Z-2169-2021 |
| Recalling firm | ROi CPS LLC |
| Product type | Devices |
| Products | Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer., Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer., Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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." |
| Initiation date | Jun 14, 2021 |
| Report date | Aug 11, 2021 |
| Termination date | Mar 8, 2023 |
| City | Republic |
| State | MO |
| Country | United States |
| FEI number | 3014527682 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: