Z-2167-2021 Class II Terminated
FDA device recall Z-2167-2021 was initiated by ROi CPS LLC on June 14, 2021 and is designated Class II. 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." The recall status is terminated (terminated March 8, 2023). Affected quantity: 608 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 11, 2021
- Initiation Date
- June 14, 2021
- Termination Date
- March 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 608 units
Product Description
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
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."
Distribution Pattern
Missouri
Code Information
Lot Numbers: 71562J, 73679J, 74808J, 75222J