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DeRoyal Industries Inc recalls DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for pre
Recalled April 13, 2022 · FDA recall Z-0879-2022 · 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
780 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 Ultra/Mammo Tray, 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 →