The Recall Desk

FDA (Devices) recall action 89737

DeRoyal Industries Inc recalled 3 products on 2022-04-13

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2022-04-13
Critical
0
Units
2,540

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2022-04-13

    DeRoyal Ultra/Mammo Tray Medical Kits Recalled for Unvalidated Manufacturing Test Methods

    DeRoyal Industries is recalling 780 Ultra/Mammo Tray kits with antiseptic swabs due to uncertain validation of manufacturing test methods. Kits are used for patient skin preparation before surgery or injection.

    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.
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2022-04-13

    DeRoyal DEXMED Access Center Tray Recalled for Manufacturing Test Validation Uncertainty

    DeRoyal Industries is recalling 1,360 DEXMED ACCESS CENTER TRAY kits with Prevantics antiseptic swabs due to uncertain validation of manufacturing test methods. The affected kits were distributed in Florida, New Jersey, and Tennessee.

    Product
    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.
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2022-04-13

    DeRoyal ST Neonatal Dressing Change Kit recalled for unvalidated manufacturing test methods

    DeRoyal Industries is recalling 400 DeRoyal ST Neonatal Dressing Change Kits due to uncertain validation of manufacturing test methods. The recall affects kits distributed to healthcare facilities in Florida, New Jersey, and Tennessee.

    Product
    DeRoyal ST Neonatal Dressing Change Kit, containing Prevantics antiseptic (chlorhexidine gluconate and isopropyl alcohol) swab, for preparation of the patient skin prior to surgery or injection.
    Category
    Distribution
    3 states