FDA-Device2022-04-13Class II
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.
DeRoyal Industries Inc
Hazard
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Sold states
US distribution to Florida, New Jersey, and Tennessee
Affected count
400 kits
Manufactured in
200 Debusk Ln, Powell, TN, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0878-2022Don't want to check this manually?
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