Date Initiated by Firm | June 14, 2021 |
Create Date | July 30, 2021 |
Recall Status1 |
Terminated 3 on March 08, 2023 |
Recall Number | Z-2167-2021 |
Recall Event ID |
88210 |
Product Classification |
Labor and Delivery Kit - Product Code MLS
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Product | Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer. |
Code Information |
Lot Numbers: 71562J, 73679J, 74808J, 75222J
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Recalling Firm/ Manufacturer |
ROi CPS LLC 3000 E Sawyer Rd Republic MO 65738-2758
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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 | 608 units |
Distribution | Missouri |
Total Product Life Cycle | TPLC Device Report |
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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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