Regard NEWBORN KIT (LD00201M) with infant heel warmer recalled due to risk of burns if activated too close to infant or user. Check item numbers 82510M-88687M for affected units.
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."
Regard's Newborn Kit with infant heel warmer is recalled because using it too close to the infant or user could cause burns. This is a safety update to prevent injury during use.
The heel warmer can cause burns if activated too close to the infant's face or body, or if the user is nearby. The hazard comes from improper placement during use, which may lead to injury.
Parents or caregivers using the Regard Newborn Kit for infant care are most at risk. The kit is intended for newborns and requires careful use to avoid burns.
Check for item number 830016013 on the Regard Newborn Kit (LD00201M). Affected units have lot numbers 82510M, 83949M, 86858M, 87282M, 87624M, 88030M, or 88687M.
Ensure the heel warmer is activated away from the infant's face and body, and away from yourself to prevent burns.
No, the hazard is only if the heel warmer is activated too close to the infant or user. Using it as instructed prevents injury.
Lot numbers 82510M, 83949M, 86858M, 87282M, 87624M, 88030M, and 88687M are affected.
No, you can continue using it as long as you follow the updated instructions to keep it away from the infant and user.
We’ve drafted a message you can send Regard to request your refund or repair — edit it as you like.
Subject: Recall Z-2169-2021 — Regard Regard Hello, I own a Regard that is covered by recall Z-2169-2021 from Regard. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
