medical Class II Updated 2022-04-13

DeRoyal Industries Inc recalls DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (

Recalled 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.

Hazard / Issue

A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.

Issued by

FDA

Distribution: US distribution to Florida, New Jersey, and Tennessee

Lot/Code Info: SKU/Part Number 89-4990.06; UDI 00749756623599 Lot Numbers (Expiration Date): Lot 53334442 (exp 05/01/2021), Lot 53815781 (exp 06/01/2022), Lot 54685720 (exp 06/01/2022), Lot 55247529 (exp 03/01/2023), Lot 55967067 (exp 04/01/2023)

View official government recall

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