Z-2169-2021Class II

Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel...

Name: Z-2169-2021 Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel...
Creator: ROi CPS LLC
Published: 2021-06-14
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2021-06-14 / Terminated / root cause: manufacturing process

FDA source

ROi CPS LLC began a recall of Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer on 2021-06-14. FDA classified it as Class II and gives the reason as "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."". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2169-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-14
Posted: 2021-07-30
Terminated: 2023-03-08
Recalling firm: ROi CPS LLC
Product: Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
Product code: MLS Labor And Delivery Kit
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."
Root cause tag: manufacturing process
FDA 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 in commerce: 976 units
Distribution: Missouri
Product codes and lots: Lot Numbers: 82510M, 83949M, 86858M, 87282M, 87624M, 88030M, 88687M

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2169-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2167-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-11	2021-07-30
Z-2168-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-11	2021-07-30
Z-2169-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-11	2021-07-30

Product code MLS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)