—#192326

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.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K842648
Affected 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)

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

DeRoyal issued their recall on March 3, 2022 to the end user level by mailing recall letters to its direct accounts. The direct accounts were instructed to forward our recall notification to their customers. The direct accounts and their customers were asked to identify the affected products and return the product and the notice of return form that was provided back to DeRoyal.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

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

Timeline

Recall initiated: 2022-03-03
Terminated: 2022-09-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192326. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.