Reported Apr 13, 2022 · Terminated
DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl…
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
- 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.
- Lot codes and dates
SKU/Part Number 47-670.06UDI 00749756562942
- Lot Numbers (Expiration Date)
Lot 52585717 (exp 07/01/2021)Lot 52818525 (exp 07/01/2021)Lot 54354867 (exp 04/01/2022)Lot 55502331 (exp 04/01/2022)
- Amount recalled
- 400 kits
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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