FDA Medical Device Recalls (openFDA)
ROi CPS LLC: Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
- Recall number
- Z-2167-2021
- Recalling firm
- ROi CPS LLC
- Product
- Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
- Status
- Terminated
- Initiated
- 2021-06-14
- Posted
- not on file
- Terminated
- 2023-03-08
- 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."
- Root cause
- Process design
- Action
- 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.
- Quantity
- 608 units
- Distribution
- Missouri
- Lot, serial or model codes
- Lot Numbers: 71562J, 73679J, 74808J, 75222J
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MLS
- Firm FEI
- 3014527682
- Firm city
- Republic
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28