Device product
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Z-2167-2021
Product summary
- Firm
- ROi CPS LLC
- Event
- Event 88210
- Status
- Terminated
- Classification
- Class II
- Quantity
- 608 units
- Official record key
device-enforcement:Z-2167-2021
Official wording
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."
Code information: Lot Numbers: 71562J, 73679J, 74808J, 75222J
Distribution pattern: Missouri
Derived failure modes
-
Unknown
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."