FDAFDA · Food and drugs·Recall number Z-2168-2021
Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
Published August 11, 2021 · Recall initiated: June 14, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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."
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- ROi CPS LLC
- Distributor
- Missouri
- Lot
- Lot Numbers: 77906K, 78673K, 79327K, 80825K
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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