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U.S. Department of Health and Human Services

Class 2 Device Recall Regard NEWBORN KIT

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  Class 2 Device Recall Regard NEWBORN KIT see related information
Date Initiated by Firm June 14, 2021
Create Date July 30, 2021
Recall Status1 Terminated 3 on March 08, 2023
Recall Number Z-2169-2021
Recall Event ID 88210
Product Classification Labor and Delivery Kit - Product Code MLS
Product Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.
Code Information Lot Numbers: 82510M, 83949M, 86858M, 87282M, 87624M, 88030M, 88687M
Recalling Firm/
Manufacturer		 ROi CPS LLC
3000 E Sawyer Rd
Republic MO 65738-2758
For Additional Information Contact Lacy Stewart
417-647-3205
Manufacturer 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."
FDA Determined
Cause 2		 Process design
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.
Quantity in Commerce 976 units
Distribution Missouri
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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