medical Class II Updated 2022-04-13

DeRoyal Industries Inc recalls DeRoyal ST Neonatal Dressing Change Kit, containing Prevanti

Recalled 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.

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 47-670.06; UDI 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)
View official government recall

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