Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
Summary
The FDA issued a Class II for Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit by ROi CPS LLC. Reason: 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 .
Details
Source
Device Recall
External ID
Z-2168-2021
Action Date
2021-08-11
Status
Terminated
Category
device
Product Description
Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.
Lot/Code Info: Lot Numbers: 77906K, 78673K, 79327K, 80825K
Quantity Affected: 688 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."
Distribution
Missouri
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-14
Company
Republic, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 113 device recalls issued in the same week, part of 403 device-related FDA actions this month.
ROi CPS LLC has 78 FDA actions in our database, including 78 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ROi CPS LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ROi CPS LLC have FDA actions?
ROi CPS LLC has 78 FDA actions in our database, including 78 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2168-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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