Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
DeRoyal ST Neonatal Dressing Change Kit Recalled by DeRoyal Industries Inc Due to A kit component, the PDI Prevantics Swab was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact DeRoyal Industries Inc directly.
Affected Products
DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Quantity: 400 kits
Why Was This Recalled?
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Where Was This Sold?
US distribution to Florida, New Jersey, and Tennessee
About DeRoyal Industries Inc
DeRoyal Industries Inc has 225 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report