Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2168-2021 — Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.

U.S. FDA — Device Enforcement · United States · 2021-06-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2168-2021
Date of alert
2021-06-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ROi CPS LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
830016011
Reported risk: 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."
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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