Regard NEWBORN KIT recall
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Why was Regard NEWBORN KIT 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."
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: 71562J, 73679J, 74808J, 75222J
- Product
- Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
- Recalling firm
- ROi CPS LLC
- Quantity
- 608 units
- Distribution
- Missouri
- Recall date
- August 11, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)