Recall Z-2167-2021
ROi CPS LLC · initiated June 14, 2021
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Codes / lots: Lot Numbers: 71562J, 73679J, 74808J, 75222J
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."
FDA-determined cause: Process design
Action taken
The firm notified their consignee on 06/24/2021 by email. The notice provided updated product labeling with a cautionary statement to remind the user to "activate away from the user's face and away from the infant and others." The distributor was directed to notify their customer.
Details
- Recall number
- Z-2167-2021
- Initiated
- June 14, 2021
- Terminated
- March 8, 2023
- Product code
- MLS – Labor And Delivery Kit
- Quantity
- 608 units
- Distribution
- Missouri
- Recalling firm
- ROi CPS LLC, Republic, MO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2168-2021 Class II | Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which…Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate… | 06/14/2021Terminated |
| Z-2169-2021 Class II | Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which…Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate… | 06/14/2021Terminated |