Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Reported: August 11, 2021 Initiated: June 14, 2021 #Z-2167-2021
Product Description
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
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."
Details
- Recalling Firm
- ROi CPS LLC
- Units Affected
- 608 units
- Distribution
- Missouri
- Location
- Republic, MO
Frequently Asked Questions
What product was recalled? ▼
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.. Recalled by ROi CPS LLC. Units affected: 608 units.
Why was this product recalled? ▼
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."
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 11, 2021. Severity: Moderate. Recall number: Z-2167-2021.
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