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DeRoyal Industries Inc Recall 89737

Description: DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.

DeRoyal Industries Inc Recall 89737 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0879-2022
Event ID89737
Event DescriptionDeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Product TypeDevices
DistributionUS distribution to Florida, New Jersey, and Tennessee
Quantity780 kits
Recall ReasonA kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Device Classification20220413
Device Code InfoSKU/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)
Center Classification Date20220406
Recall Initiation Date20220303
Recalling FirmDeRoyal Industries Inc
Initial Notification Letter
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