DeRoyal Ultra/Mammo Tray, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
Check against the official notice below — it lists the full affected range.
DeRoyal Industries Inc is recalling 780 DeRoyal Ultra/Mammo Trays distributed to Florida, New Jersey, and Tennessee. The trays contain PDI Prevantics antiseptic swabs (chlorhexidine gluconate and isopropyl alcohol) used to prepare patient skin before surgery or injection. The recall was issued because the test methods used to manufacture the Prevantics Swab component could not be validated.
The affected products are identified by SKU/Part Number 89-4990.06 and UDI 00749756623599, with the following lot numbers and expiration dates: Lot 53334442 (05/01/2021), Lot 53815781 (06/01/2022), Lot 54685720 (06/01/2022), Lot 55247529 (03/01/2023), and Lot 55967067 (04/01/2023). The recall source does not specify what actions affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products.
Reason for recall: A kit component, the PDI Prevantics Swab was recalled due to uncertain validation of test methods used to manufacture the products. Distribution: US distribution to Florida, New Jersey, and Tennessee Quantity: 780 kits 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.