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Terminated

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

FDA Recall Z-2169-2021 · Posted None

Recalling FirmROi CPS LLC
Recall StatusTerminated
Product CodeMLS
Date Initiated2021-06-14
Date Terminated2023-03-08
Product Quantity976 units

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."

Firm 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.

Root Cause

Process design

Distribution Pattern

Missouri

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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