DeRoyal Industries Inc: Medical Device Recall in 2022 - (Recall #: Z-0880-2022)

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 DEXMED ACCESS CENTER 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-0880-2022

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: 1360 kits

Code Information:

SKU/Part Number 89-5300.07; UDI 00749756632317 Lot Numbers (Expiration Date): Lot 53059743 (exp 06/01/2022), Lot 53632941 (exp 06/01/2022), Lot 53666113 (exp 06/01/2022), Lot 54205909 (exp 06/01/2022), Lot 54279422 (exp 06/01/2022), Lot 54327332 (exp 06/01/2022), Lot 54473313 (exp 06/01/2022), Lot 55573404 (exp 06/01/2022)

Distribution Pattern:

US distribution to Florida, New Jersey, and Tennessee

Voluntary or Mandated:

Voluntary: Firm initiated