DeRoyal Industries Inc: Medical Device Recall in 2022 - (Recall #: Z-0879-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: March 3, 2022

Date Posted: April 13, 2022

Recall Number: Z-0879-2022

Event ID: 89737

Reason for Recall:

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

Status: Terminated

Product Quantity: 780 kits

Code Information:

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)

Distribution Pattern:

US distribution to Florida, New Jersey, and Tennessee

Voluntary or Mandated:

Voluntary: Firm initiated