DeRoyal recalls neonatal dressing kits with Prevantics swabs due to uncertain test methods used in manufacturing. Affected kits contain specific lot numbers and expiration dates. Consumers should check their kit's details to determine if recalled.
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
DeRoyal is recalling neonatal dressing change kits that include a specific antiseptic swab because the manufacturing test methods are uncertain. This could lead to potential issues with the swab's effectiveness, which is important for newborn skin care.
The swab's manufacturing test methods are uncertain, which may affect its effectiveness for skin preparation. This could lead to improper skin care for newborns, but the risk is not described as causing serious injury.
New parents and caregivers who use DeRoyal neonatal dressing kits with the specific lot numbers listed. Newborns are at the highest risk due to sensitive skin.
Check the product label for the SKU/Part Number 47-670.06 or the UDI 00749756562942. Look for lot numbers: 52585717 (exp 07/01/2021), 52818525 (exp 07/01/2021), 54354867 (exp 04/01/2022), or 55502331 (exp 04/01/2022).
Look for the SKU/Part Number 47-670.06 or UDI 00749756562942 on the kit packaging.
The recall is due to uncertain validation of test methods used to manufacture the swab, which may affect its effectiveness for newborn skin care.
Lot numbers 52585717 (exp 07/01/2021), 52818525 (exp 07/01/2021), 54354867 (exp 04/01/2022), and 55502331 (exp 04/01/2022).
No immediate action is required; check the product details to see if your kit is affected.
We’ve drafted a message you can send DeRoyal to request your refund or repair — edit it as you like.
Subject: Recall Z-0878-2022 — DeRoyal DeRoyal Hello, I own a DeRoyal that is covered by recall Z-0878-2022 from DeRoyal. 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.
