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DeRoyal Industries Inc recalls DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol
Recalled April 13, 2022 · FDA recall Z-0878-2022 · DeRoyal Industries
Hazard
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products. · FDA Class II
Units
400 kits
Sold at
US distribution to Florida, New Jersey, and Tennessee
Description
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Product
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.
Manufacturer(s)
DeRoyal Industries Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →